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Sample records for arv drug patents

  1. Designing ARVs Patent Pool Up to Trade & Policy Evolutionary Dynamics

    PubMed Central

    Dionisio, Daniele; Racalbuto, Vincenzo; Messeri, Daniela

    2010-01-01

    Patent pools for second and third-line Fixed Dose Combination (FDC) antiretroviral drugs (ARVs) should not be delayed as they are instrumental to urgent public health needs in the under-served markets. Nonetheless, multinational originator companies still seem to perceive patent pooling for ARVs as a minefield that would offer the generic competitors lots of deeply exploitable opportunities, to the detriment of patent owner’s rights. This paper analyses the brand industry concerns, while looking for a strategy up to a really equitable and free world market, without any discrimination between end-users in wealthy and resource-limited countries. This strategy would urge partnerships between originator companies first to make newer FDC ARVs quickly available and allow patent pool agreements with generic counterparts to be negotiated straight afterwards. The patent pool strategy highlighted in this paper would assert the primacy of health over for-profit policies, while aligning with the 61st WHO’s Assembly recommendations and G7, G8 and World Trade Organisation’s warnings and pledges against trade protectionism. PMID:20200604

  2. Designing ARVs Patent Pool Up to Trade & Policy Evolutionary Dynamics.

    PubMed

    Dionisio, Daniele; Racalbuto, Vincenzo; Messeri, Daniela

    2010-01-19

    Patent pools for second and third-line Fixed Dose Combination (FDC) antiretroviral drugs (ARVs) should not be delayed as they are instrumental to urgent public health needs in the under-served markets.Nonetheless, multinational originator companies still seem to perceive patent pooling for ARVs as a minefield that would offer the generic competitors lots of deeply exploitable opportunities, to the detriment of patent owner's rights.This paper analyses the brand industry concerns, while looking for a strategy up to a really equitable and free world market, without any discrimination between end-users in wealthy and resource-limited countries.This strategy would urge partnerships between originator companies first to make newer FDC ARVs quickly available and allow patent pool agreements with generic counterparts to be negotiated straight afterwards.The patent pool strategy highlighted in this paper would assert the primacy of health over for-profit policies, while aligning with the 61(st) WHO's Assembly recommendations and G7, G8 and World Trade Organisation's warnings and pledges against trade protectionism.

  3. Drug resistance, patent resistance: Indian pharmaceuticals and the impact of a new patent regime.

    PubMed

    Halliburton, M

    2009-01-01

    This article highlights potential public health effects of India's Patents Act of 2005, which was implemented to conform to the requirements of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Agreement (TRIPS), a new legal regime that will likely have a significant impact on access to HIV/AIDS medications in much of the world. This new patent law may play a role in keeping new antiretroviral (ARV) medications, including improved first-line medications and second-line drugs that are being developed for first-line drug resistant HIV, financially out of reach for many people living with HIV/AIDS in poor countries. India's drug industry, which had thrived under earlier patent laws that protected processes but not products in the case of medications, had brought down the price of ARV drugs in South Asia and Africa by more than 90%. While most existing drugs are grandfathered under the new patent laws, newer ARV medications may be barred from manufacture by Indian companies. This article analyses the effects of the coming together of this new legal regime, the global political economy and emerging resistance to HIV/AIDS medications, and evaluates efforts to mitigate the negative public health effects of the new patent laws.

  4. Patents and access to essential drugs.

    PubMed

    Loff, Bebe

    2003-01-01

    This paper provides a brief overview of historical developments in patent law including its recent incorporation into world trade law. The impact of patents on access to essential drugs will be discussed. The relationship between intellectual property rights and the right to health will be considered.

  5. Drug patents and intellectual property rights.

    PubMed

    Raj, Gerard Marshall; Priyadarshini, Rekha; Mathaiyan, Jayanthi

    2015-04-01

    Inquisitive scientists are untiring and relentless in the hard work they perform day in and day out. In this pursuit, a researcher has to exercise their intellectual expertise in its entirety. Eventually, all credit of the invention is vested with the inventor who has the right of control over their intellectual creation. Likewise, pharmaceutical companies spend extravagantly in successfully introducing a novel drug from hundreds and thousands of lead compounds. Hence, it is a prerogative for every company to protect its innovative products from unauthorized duplication. Certainly, "patents" are the sole custodians of these products of medical intelligence - the drugs! This review focuses on the various intricacies of the drug patent system all over the world with special emphasis on India, Europe, and the United States. A note on other intellectual properties such as copyrights, trademarks, and designs is also added.

  6. Patents Associated with High-Cost Drugs in Australia

    PubMed Central

    Christie, Andrew F.; Dent, Chris; McIntyre, Peter; Wilson, Lachlan; Studdert, David M.

    2013-01-01

    Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by “evergreening” blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug's originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators. PMID:23577165

  7. India: Court upholds patent law denying patents for slightly modified versions of existing drugs.

    PubMed

    Swamy, Madhavi

    2007-12-01

    In August 2007, the Madras High Court struck down a petition by the Swiss pharmaceutical company Novartis to declare the anti-evergreening provision in Indian patent law invalid. Evergreening is the practice of effectively extending the patent on a drug by filing a new patent for a marginal modification to that drug, such as a change in its shape, dosing range or color. The Court's decision is critical for global access to essential medicines in the form of affordable generic drugs from India

  8. Competitive intelligence and patent analysis in drug discovery.

    PubMed

    Grandjean, Nicolas; Charpiot, Brigitte; Pena, Carlos Andres; Peitsch, Manuel C

    2005-01-01

    Patents are a major source of information in drug discovery and, when properly processed and analyzed, can yield a wealth of information on competitors activities, R&D trends, emerging fields, collaborations, among others. This review discusses the current state-of-the-art in textual data analysis and exploration methods as applied to patent analysis.:

  9. 'Government Patent Use': A Legal Approach To Reducing Drug Spending.

    PubMed

    Kapczynski, Amy; Kesselheim, Aaron S

    2016-05-01

    The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need-meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development.

  10. Bioengineered bugs, drugs and contentious issues in patenting.

    PubMed

    Chakrabarty, Ananda M

    2010-01-01

    Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable.

  11. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  12. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  13. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  14. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  15. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  16. Drug patent expirations and the speed of generic entry.

    PubMed Central

    Bae, J P

    1997-01-01

    OBJECTIVE: Using recent data, to analyze the generic drug entry phenomenon to determine the factors that influence the speed and likelihood of generic drug entries. DATA SOURCES: Data for 81 drugs that have lost patent between 1987 and 1994. Patent and exclusive marketing rights expiration dates: Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations (1986-1989). Generic entry dates: FDA Drug and Device Product Approvals (Jan. 1987-Dec. 1994). Numbers of pending generic applications: FDA Office of Generic Drugs Quantitative Report-ANDAs and AADAs (Nov. 1990-Jan. 1993). Sales revenue: Pharmaceutical Data Services, Walsh-America. STUDY DESIGN: This study appropriately recognizes generic entry as a survival problem, and uses a proportional hazard method for analysis. PRINCIPAL FINDINGS: (1) There is a negative relationship between an innovative drug's sales revenue and the time to generic entry. (2) Entries of generics tend to be slower for drugs that have either very few or a very large number of competing brands in the marketplace. (3) The time to generic entry increased overall between 1987 and 1994. (4) Drugs that primarily treat chronic symptoms tend to enter faster than the types of drugs that primarily treat acute illnesses. CONCLUSIONS: The analysis shows that the generic industry is targeting large-revenue products and chronic drug markets. Entry of a generic drug is influenced by the existing branded substitutes in the marketplace. Surprisingly, the generic drug entry process has slowed despite many changes that would facilitate entry. PMID:9108806

  17. Herbal drugs for diabetic treatment: an updated review of patents.

    PubMed

    Wais, Mohd; Nazish, Iram; Samad, Abdus; Beg, Sarwer; Abusufyan, S; Ajaj, S Ajaz; Aqil, Mohd

    2012-04-01

    Diabetes mellitus is the most common endocrine disorder, affecting 16 million individuals in the United States and 200 million worldwide. Despite the use of advanced synthetic drugs for the treatment, use of herbal remedies is gaining higher importance because of synthetic drugs have drawbacks and limitations. The herbal drugs with antidiabetic activity are extensively formulated commercially because of easy availability, affordability and less side effects as compared to the synthetic antidiabetic drugs. Antidiabetic herbal formulations (AHF) are considered to be more effective for the management of diabetes. There are around 600 herbal drug manufacturers in India of which almost all manufacturers are developing AHF in addition to others. Till date, no article is published to give detailed information of the patents on AHF. Thus, this review article undertake the attempt for providing updated information on the type of diabetes and patented AHF which will enhance the existing knowledge of the researchers.

  18. [Drug effects informational services: databases for patenting and marketing].

    PubMed

    Shkarenkova, L S; Orlovskaya, T T; Ovchinnikovaq, T V

    1997-01-01

    The review is concerned with databases (DB) for patent and commercial aspects of new drugs marketing. The DB characteristics are given and the search peculiarities in every DB and its possible access are discussed. BD accessible through the STN International are presented.

  19. Preferred supplier contracts in post-patent prescription drug markets.

    PubMed

    Blankart, Carl Rudolf; Stargardt, Tom

    2016-02-22

    In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

  20. Unsettling drug patent settlements: a framework for presumptive illegality.

    PubMed

    Carrier, Michael A

    2009-10-01

    A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining that the agreements reduce costs, increase innovation, and are reasonable based on the presumption of validity accorded to patents. Although scholars and the Federal Trade Commission have voiced strong arguments against courts' leniency, these have fallen on judicial deaf ears. In this Article, I apply the framework that the Supreme Court articulated in Verizon Communications v. Law Offices of Curtis V. Trinko, LLP, which underscored the importance in antitrust analysis of a regulatory regime addressing the challenged activity. In particular, the Hatch-Waxman Act provides Congress's views on innovation and competition in the drug industry, freeing courts from the thorny task of reconciling the patent and antitrust laws. Unfortunately, mechanisms that Congress employed to encourage patent challenges--such as an exclusivity period for the first generic to challenge validity--have been twisted into barriers preventing competition. Antitrust can play a central role in resuscitating the drafters' intentions and promoting competition. Given the Act's clear purpose to promote patent challenges, as well as the parties' aligned incentives and the severe anticompetitive potential of reverse payments, courts should treat such settlements as presumptively illegal. If the parties can demonstrate that the payments represent

  1. Bioengineered bugs, drugs and contentious issues in patenting

    PubMed Central

    2010-01-01

    Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable. PMID:21327122

  2. [Analysis on composition principles of Chinese patent drugs containing ginseng].

    PubMed

    Shen, Dan; Tang, Shi-Huan; Lu, Peng; Yang, Hong-Jun

    2013-06-01

    Use traditional Chinese medicine inheritance support system (TCMISS) to analyze the composition principles of Chinese patent drugs containing Renshen (Panax ginseng) in national standard for Chinese patent drugs (NSCPD) enacted by Ministry of Public Health of China. Via analyzing the regularity of prescriptions containing Ginseng which are recorded in NSCPD, to identify composition pattern and rule. Tweenty four drugs are used more than 50 times, in which, drugs that tonify qi and nourish flood have the highest frequency, and then medicines of liver and kidney tonifying, yin enriching and yang warming follow. Then 45 commonly used core combinations are analyzed via data mining methods such as association rules, improved mutual information method, etc. Meantime, three diseases, namely, palpitation, amnesia and chest discomfort are chosen from the 24 diseases that Ginseng most frequently used to make deeper analysis, which reflect the composition principle of Chinese patent drugs containing Ginseng. Therefore, TCMISS is an important tool in composition principle exploring of herbal formulae and meanwhile, the comparative analysis method contributes a lot to the exploration as well.

  3. Detection of AR-V7 mRNA in whole blood may not predict the effectiveness of novel endocrine drugs for castration-resistant prostate cancer.

    PubMed

    Takeuchi, Takumi; Okuno, Yumiko; Hattori-Kato, Mami; Zaitsu, Masayoshi; Mikami, Koji

    2016-01-01

    A splice variant of androgen receptor (AR), AR-V7, lacks in androgen-binding portion and leads to aggressive cancer characteristics. Reverse transcription-polymerase chain reactions (PCRs) and subsequent nested PCRs for the amplification of AR-V7 and prostate-specific antigen (PSA) transcripts were done for whole blood of patients with prostate cancer and male controls. With primary reverse transcription PCRs, AR-V7 and PSA were detected in 4.5% and 4.7% of prostate cancer, respectively. With nested PCRs, AR-V7 messenger RNA (mRNA) was positive in 43.8% of castration-sensitive prostate cancer and 48.1% of castration-resistant prostate cancer (CRPC), while PSA mRNA was positive in 6.3% of castration-sensitive prostate cancer and 18.5% of CRPC. Whole-blood samples of controls showed AR-V7 mRNA expression by nested PCR. Based on multivariate analysis, expression of AR-V7 mRNA in whole blood was not significantly correlated with clinical parameters and PSA mRNA in blood, while univariate analysis showed a correlation between AR-V7 mRNA and metastasis at initial diagnosis. Detection of AR-V7 mRNA did not predict the reduction of serum PSA in patients with CRPC following abiraterone and enzalutamide administration. In conclusion, AR-V7 mRNA expression in normal hematopoietic cells may have annihilated the manifestation of aggressiveness of prostate cancer and the prediction of the effectiveness of abiraterone and enzalutamide by the assessment of AR-V7 mRNA in blood.

  4. Discussion point: should governments buy drug patents?

    PubMed

    del Llano, Juan

    2007-06-01

    Between just 1995 and 2003, the number of new chemical entities fell from 45 to 25, while the costs increased by two and a half times in the same period. Firms in the USA accounted for more than half of biotech drugs from 1982 to 2003. European firms are losing competitiveness. In this hostile environment for investment in pharmaceutical R&D, providing quick access to market for real innovations is the main challenge for regulatory agencies. More initiatives, more entrepreneurial spirit and easier work regulation are needed to facilitate the growth of firms in this field, especially in emerging economies like the Spanish. A new open source model proposes the use of pre-competitive public platforms formed by young and qualified human capital carrying out research in areas not sufficiently attractive for private initiatives, followed by the introduction of pharmaceutical companies to carry out the clinical research. The last step would be fast and effective approval by assessment agencies. Governments should, therefore, facilitate the regulation of socially effective innovations, bringing in manufacturers to take part in the post-clinical trial period after entering the market. The gathering of incentives between regulatory agencies and pharmaceutical industry must be approached through innovation and authorization stimulating systems.

  5. Drug delivery via porous silicon: a focused patent review.

    PubMed

    Kulyavtsev, Paulina A; Spencer, Roxanne P

    2017-03-01

    Although silicon is more commonly associated with computer chips than with drug delivery, with the discovery that porous silicon is a viable biocompatible material, mesoporous silicon with pores between 2 and 50 nm has been loaded with small molecule and biomolecule therapeutics and safely implanted for controlled release. As porous silicon is readily oxidized, porous silica must also be considered for drug delivery applications. Since 2010, only a limited number of US patents have been granted, primarily for ophthalmologic and immunotherapy applications, in contrast to the growing body of technical literature in this area.

  6. Mapping lifecycle management activities for blockbuster drugs in Japan based on drug approvals and patent term extensions.

    PubMed

    Yamanaka, Takayuki; Kano, Shingo

    2016-02-01

    Drug lifecycle management (LCM), which entails acquiring drug approvals and patent protections, contributes to maximizing drug discovery investment returns. In a previous survey, a comparative analysis between Japan and the USA indicated that a unique patent term extension system has an important role in Japanese drug LCM. Therefore, in this survey, we focused on drug approvals and patent term extensions, and found that the LCM for blockbuster drugs in Japan can be categorized into three types (drug approval-oriented LCM, patent term extension-oriented LCM, and inactive-type LCM), of which the first two have been implemented recently. Here, we suggest a strategy for selecting a suitable LCM approach among these three types based on the prospects for drug improvements.

  7. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the date a major health or environmental effects test on the drug was initiated or the date an..., 1988, and (i) If no major health or environmental effects test on the drug was initiated and no request... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED...

  8. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the date a major health or environmental effects test on the drug was initiated or the date an..., 1988, and (i) If no major health or environmental effects test on the drug was initiated and no request... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED...

  9. Strategic options for brand-name prescription drugs when patents expire.

    PubMed

    Mehta, S C; Mehta, S S

    1997-01-01

    Pharmaceutical companies face a very hostile competitive environment from generic drugs once the patents on their brand name drugs expire. Depending on the country, such patents usually last 10-15 years but no sooner do the patents expire then copies of off-patent brand name drugs, called generics, are introduced, generally by smaller-size and lesser known companies, at significantly lower prices. As health care costs escalate all over the world, efforts to control medication costs have created a major market for generic prescription drugs, particularly in government funded hospitals and in dispensing general practitioner markets of the Asia Pacific and the third world. The world market for generics is estimated at US$20 billion, doubling in only five years and capturing over 30% of the market share. Because of adverse effects on sales and profitability due to the launching of generics, most research based companies that produce original brand-name patented drugs are forced to take counter measures to overcome this problem, particularly when R&D costs for new patents are skyrocketing. This paper develops a brief perspective on this problem and then examines the experiences of many multinational companies in the Singapore market in dealing with the problem. While several different approaches are identified, only one company experience appeared to work successfully and this is discussed in relative detail.

  10. The Effect of Pharmaceutical Patent Term Length on Research and Development and Drug Expenditures in Canada

    PubMed Central

    Grootendorst, Paul; Matteo, Livio Di

    2007-01-01

    While pharmaceutical patent terms have increased in Canada, increases in patented drug spending have been mitigated by price controls and retrenchment of public prescription drug subsidy programs. We estimate the net effects of these offsetting policies on domestic pharmaceutical R&D expenditures and also provide an upper-bound estimate on the effects of these policies on Canadian pharmaceutical spending over the period 1988–2002. We estimate that R&D spending increased by $4.4 billion (1997 dollars). Drug spending increased by $3.9 billion at most and, quite likely, by much less. Cutbacks to public drug subsidies and the introduction of price controls likely mitigated drug spending growth. In cost–benefit terms, we suspect that the patent extension policies have been beneficial to Canada. PMID:19305720

  11. Patent issues in drug development: perspectives of a pharmaceutical scientist-attorney.

    PubMed

    Melethil, Srikumaran

    2005-10-27

    The major purpose of this article is to emphasize the need for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Economic incentives for drug discovery and development clash with societal needs for low-cost pharmaceuticals in the United States and all over the world. The Hatch-Waxman Act of 1984 was enacted to promote public health by balancing the interests of brand name and generic companies. Patent protection, which provides a monopoly for a limited time, is aimed to provide such incentives. Creation of patents requires the interaction between scientists and lawyers, an endeavor made difficult by the differing intellectual spheres of their respective disciplines. Therefore, in the first place, a thorough understanding of patent fundamentals among pharmaceutical scientists will help them work more efficiently with patent attorneys. Second, it will enable them to appreciate the strengths and weaknesses of individual patents, which is critical in developing strategies amidst the ongoing patent tug-of-war between brand-name and generic companies.

  12. Compulsory patent licensing and local drug manufacturing capacity in Africa.

    PubMed

    Owoeye, Olasupo Ayodeji

    2014-03-01

    Africa has the highest disease burden in the world and continues to depend on pharmaceutical imports to meet public health needs. As Asian manufacturers of generic medicines begin to operate under a more protectionist intellectual property regime, their ability to manufacture medicines at prices that are affordable to poorer countries is becoming more circumscribed. The Doha Declaration on the TRIPS Agreement and Public Health gives member states of the World Trade Organization (WTO) the right to adopt legislation permitting the use of patented material without authorization by the patent holder, a provision known as "compulsory licensing". For African countries to take full advantage of compulsory licensing they must develop substantial local manufacturing capacity. Because building manufacturing capacity in each African country is daunting and almost illusory, an African free trade area should be developed to serve as a platform not only for the free movement of goods made pursuant to compulsory licences, but also for an economic or financial collaboration towards the development of strong pharmaceutical manufacturing capacity in the continent. Most countries in Africa are in the United Nations list of least developed countries, and this allows them, under WTO law, to refuse to grant patents for pharmaceuticals until 2021. Thus, there is a compelling need for African countries to collaborate to build strong pharmaceutical manufacturing capacity in the continent now, while the current flexibilities in international intellectual property law offer considerable benefits.

  13. Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings

    PubMed Central

    Stalter, Randy M; Moench, Thomas R; MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H

    2016-01-01

    Introduction Poor adherence to product use has been observed in recent trials of antiretroviral (ARV)-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage. Methods To identify technologies that have potential future application for vaginal ring adherence measurement, a comprehensive literature search was conducted that covered a number of biomedical and public health databases, including PubMed, Embase, POPLINE and the Web of Science. Published patents and patent applications were also searched. Technical experts were also consulted to gather more information and help evaluate identified technologies. Approaches were evaluated as to feasibility of development and clinical trial implementation, cost and technical strength. Results Numerous approaches were identified through our landscape analysis and classified as either point measures or cumulative measures of vaginal ring adherence. Point measurements are those that give a measure of adherence at a particular point in time. Cumulative measures attempt to measure ring adherence over a period of time. Discussion Approaches that require modifications to an existing ring product are at a significant disadvantage, as this will likely introduce additional regulatory barriers to the development process and increase manufacturing costs. From the point of view of clinical trial implementation, desirable attributes would be high acceptance by trial participants, and little or no additional time or training requirements on the part of participants or clinic staff. We have identified four promising approaches as being high priority for further development

  14. Off-patent drugs at brand-name prices: a puzzle for policymakers

    PubMed Central

    Tallapragada, Naren P.

    2016-01-01

    In August 2015, Turing Pharmaceuticals acquired the marketing rights to Daraprim (pyrimethamine), a drug used to treat parasitic infections like malaria and toxoplasmosis. Soon after, Turing caused an uproar when it announced that it would raise the price per tablet of Daraprim from \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\rm{\\$ 13.50\\ to\\ \\$ 750}$\\end{document}, a 5500% price hike for a drug that has been on the market for over 60 years and off patent since the 1970s. Old, off-patent drugs are becoming increasingly expensive; Daraprim is the archetypal example. Turing had the power to set a high price for Daraprim because the drug's limited patient population, the absence of competing manufacturers, and a lack of therapeutic alternatives all created an effective monopoly. Similar forces have driven up the prices of other off-patent drugs that treat diseases as diverse as heart failure and multi-drug-resistant tuberculosis. Thus, policymakers will have to consider how the high cost of off-patent drugs impacts public health as well as public spending. In this Note I outline the extent of the high-cost off-patent drug problem, drawing special attention to the problem's negative effects on both health outcomes and government budgets. After discussing some of the problem's underlying causes, I present several solutions to the problem that policymakers could consider, with a focus on proposals like reference pricing and expanded compounding that have received relatively little media attention. PMID:27774247

  15. Patents of bio-active compounds based on computer-aided drug discovery techniques.

    PubMed

    Prado-Prado, Francisco; Garcia-Mera, Xerardo; Rodriguez-Borges, Jose Enrique; Concu, Riccardo; Perez-Montoto, Lazaro Guillermo; Gonzalez-Diaz, Humberto; Duardo-Sanchez, Aliuska

    2013-01-01

    In recent times, there has been an increased use of Computer-Aided Drug Discovery (CADD) techniques in Medicinal Chemistry as auxiliary tools in drug discovery. Whilst the ultimate goal of Medicinal Chemistry research is for the discovery of new drug candidates, a secondary yet important outcome that results is in the creation of new computational tools. This process is often accompanied by a lack of understanding of the legal aspects related to software and model use, that is, the copyright protection of new medicinal chemistry software and software-mediated discovered products. In the center of picture, which lies in the frontiers of legal, chemistry, and biosciences, we found computational modeling-based drug discovery patents. This article aims to review prominent cases of patents of bio-active organic compounds that involved/protect also computational techniques. We put special emphasis on patents based on Quantitative Structure-Activity Relationships (QSAR) models but we include other techniques too. An overview of relevant international issues on drug patenting is also presented.

  16. [Clinical orientation of post-marketing Chinese patent drugs: an evidence-based practice].

    PubMed

    Shang, Hong-Cai; Zhang, Bo-Li; Li, You-Ping

    2008-09-01

    Unclear clinical orientation in practice has become one of the common problems with the effective application of famous and excellent Chinese herbal drugs, consequently restricting their development. The authors suggest that there are three aspects to be considered in dealing with this problem. Clinical evaluation and orientation of the famous and excellent Chinese herbal drugs is an important task, and it is also a requirement for the internationalization of traditional Chinese medicine. Literature evaluation-pharmacology research-clinical expertise analysis method will establish a theoretical basis and method for post-marketing development of famous and excellent Chinese patent drugs.

  17. Antifungal drug discovery, six new molecules patented after 10 years of feast: why do we need new patented drugs apart from new strategies?

    PubMed

    Krcmery, Vladimir; Kalavsky, Erich

    2007-11-01

    After 10 years absence (between 1990-1999) of new antifungal agents and intensive research being introduced into clinical practice, 3 new azoles (Voriconazole - Pfizer, Posaconazole - Schering-Plough, Ravuconazole - Bristol-Myers Squibb) and 3 new echinocandins (Caspofungin - MSD, Anidulafungin - Astellas-Pfizer, Micafungin - Fujisawa) were patented. The question raises if we really need 6 new antifungal agents in such a short time? Perhaps, they are not here because we need them all, but because of at least fifteen years effort of many groups of investigators who successfully discovered, proved and introduced these agents to the drug market. Voriconazole (2000), Posaconazole (2005), Ravuconazole (2007) from the group of azoles; and Caspofungin (2002), Anidulafungin (2004) and Micafungin (2006) from the group of echinocandins, with unique mode(s) of action (cell wall synthesis inhibition) different from polyens, azoles, antimetabolites and new monoclonal antifungal antibody (Mycograb), were approved and introduced to the clinical practice. This paper contains some useful information regarding the recent patents on antifungal drug discovery, their current position in the strategy of treatment of invasive fungal infections is briefly reviewed.

  18. Recent Techniques and Patents on Solid Lipid Nanoparticles as Novel Carrier for Drug Delivery.

    PubMed

    Khatak, Sunil; Dureja, Harish

    2015-01-01

    The various approaches have been utilized in the treatment of a variety of diseases by applying drug delivery system such as polymeric nanoparticles, self-emulsifying delivery systems, liposomes, microemulsions and micellar solutions. Recently, solid lipid nanoparticles (SLNs), nanostructured lipid carriers (NLCs) and lipid-drug conjugates (LDCs) have been exploited as a carrier of lipophilic and hydrophilic/amphiphilic substances for invasive and non-invasive routes of delivery. SLNs are colloidal drug carrier system and are like nanoemulsion, however, the lipid content in SLNs is solid in nature. These novel type of lipid nanoparticles with solid matrix offers to develop new prototype therapeutics in drug delivery, which could be used for controlled release, drug targeting, gene therapy, physical and chemical stability and site-specific drug delivery and thereby attracted the research groups worldwide. This manuscript overviews the recent patents, advantages, formulation techniques, stability aspects and applications of SLNs.

  19. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals

    PubMed Central

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Introduction Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Objectives Trends in FDA approved FDC in the period 1980–2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. Materials and Methods New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. Results During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. Conclusion FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination. PMID:26469277

  20. Pricing and reimbursement of in-patent drugs in seven European countries: a comparative analysis.

    PubMed

    Garattini, Livio; Cornago, Dante; De Compadri, Paola

    2007-08-01

    The main objective of this comparative analysis was to assess regulations applied by EU governments to reward potentially innovative drugs. We focused on the pharmaceutical policy for in-patent drugs in seven EU countries: Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK. A common scheme was applied to all seven countries: first, pricing and reimbursement procedures for new and innovative drugs were investigated; secondly, we focused on the use in the regulatory process of economic evaluations. The analysis involved reviewing the literature and interviewing a selected panel of local experts in each country. According to our comparative analysis, a first sensible step might be to classify active ingredients as those addressing neglected pathologies and those for diseases that are already successfully treated, thus offering more limited therapeutic gains by definition. A reasonable solution to reward real innovation could be to admit a premium price for very innovative drugs according to their estimated cost-effectiveness. New drugs with modest improvement could be grouped in therapeutic clusters and submitted to a common reference price, despite patent expiration. Such a "dual approach" could be a sensible compromise to restrict pharmaceutical expenditure while at the same time rewarding companies that invest in high-risk basic research.

  1. Self-assembling peptides: implications for patenting in drug delivery and tissue engineering.

    PubMed

    Kumar, Pradeep; Pillay, Viness; Modi, Girish; Choonara, Yahya E; du Toit, Lisa C; Naidoo, Dinesh

    2011-01-01

    In this paper, a comprehensive review of recent patents concerning the molecular self-assembly of peptides, peptide amphiphiles and peptidomimetics into molecules through nanoarchitectures to hydrogels is provided. Their potential applications in the field of drug delivery and tissue engineering have been highlighted. The design rules of this rapidly growing field are centered mainly on the construction of peptides in the form of peptide amphiphiles, aromatic short peptide derivatives, all-amino acid peptide amphiphiles, lipidated peptides with single and multiple alkyl chains and peptide-based block copolymers and polymer peptide conjugates. The interest in patenting of self-assembling peptides is also driven by their type (I, II, III and IV) and their ability to form well-regulated highly-ordered structures such as β-sheets/β-hairpins, α-helices/coiled coils and to hierarchically self-organize into supra-molecular structures. The applicability of these systems in cell culture scaffolds for tissue engineering, drug and gene delivery and as templates for nanofabrication and biomineralization has inspired various groups over the globe. This resulted in development of self-assembling peptides as synthetic replacements of biological tissues, designing materials for specific medical applications, and materials for new applications such as diagnostic technologies. Furthermore, biologically derived and commercially available systems are also discussed herein along with a brief account of various awarded and pending patents in the past 10 years. An overview of the diversity of the patent applications is also provided for self-assembling systems based on nano- and/or micro-scale such as fibers, fibrils, gels, hydrogels, vesicles, particles, micelles, bilayers and scaffolds.

  2. A review of recent patents on the protozoan parasite HSP90 as a drug target.

    PubMed

    Angel, Sergio O; Matrajt, Mariana; Echeverria, Pablo C

    2013-04-01

    Diseases caused by protozoan parasites are still an important health problem. These parasites can cause a wide spectrum of diseases, some of which are severe and have high morbidity or mortality if untreated. Since they are still uncontrolled, it is important to find novel drug targets and develop new therapies to decrease their remarkable social and economic impact on human societies. In the past years, human HSP90 has become an interesting drug target that has led to a large number of investigations both at state organizations and pharmaceutical companies, followed by clinical trials. The finding that HSP90 has important biological roles in some protozoan parasites like Plasmodium spp, Toxoplasma gondii and trypanosomatids has allowed the expansion of the results obtained in human cancer to these infections. This review summarizes the latest important findings showing protozoan HSP90 as a drug target and presents three patents targeting T. gondii, P. falciparum and trypanosomatids HSP90.

  3. Click chemistry patents and their impact on drug discovery and chemical biology.

    PubMed

    Xu, Hua; Jones, Lyn H

    2015-01-01

    First introduced by K Barry Sharpless in 2001, the term 'click chemistry' soon became a widely used description of chemical reactions that proceed rapidly, cleanly and in a manner that is often compatible with aqueous solutions. Click chemistry is frequently employed throughout the process of drug discovery, and greatly helps advance research programs in the pharmaceutical industry. It facilitates library synthesis to support medicinal chemistry optimization, helps identify the targets and off-targets of drug candidates, and can facilitate the determination of drug efficacy in clinical trials. In the last decade, a large number of patent applications covering the various types and utilities of click chemistry have been filed. In this review, we provide the first analysis of click chemistry applications.

  4. Nanosuspension Technology For Poorly Soluble Drugs: Recent Researches, Advances and Patents.

    PubMed

    Agarwal, Vijay; Bajpai, Meenakshi

    2015-01-01

    Nowadays, in pharmaceutical industries, the attention on nanosized materials is growing gradually due to their wide applications in drug delivery systems. Recently, out of different nanosize systems, nanosuspension system has undergone a lot of interest in such a way to rectify the solubility and bioavailability problem due to their technical simplicity and cost-effectiveness property compared to other colloidal systems. Nanosuspension technology has proven that it can be a superior substitute over alternative approaches, which are available for enhancing the bioavailability of different drugs having low solubility. Since today, nanosuspensions have been greatly evolved for a huge number of drugs and also investigated for their potential applications. The various unique features make the nanosuspension to enable their utilization in numerous dosage forms and given through different routes, including parenteral, oral, topical, peroral, ocular and pulmonary routes. A large number of products grounded in nanosuspension technology are present in the market, and some are on the way. In fact, the number of such types of products is much more in comparison of other nanotechnologies based products. Additionally, the different preparation methods used to prepare the nanosuspensions are also well- established and patented. This article reviews the recent research, advances in formulation and their approaches related to nanosuspensions with emphasis given on different patents related to nanosuspension methods.

  5. Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

    PubMed Central

    Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

    2013-01-01

    Background Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”). Methods and Findings We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100). Conclusions Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to

  6. Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study – PEDA Study

    PubMed Central

    Thammajaruk, Narukjaporn; Pussadee, Kanitta; Riyaten, Prakit; Kerr, Stephen; Avihingsanon, Anchalee; Phanuphak, Praphan; Ruxrungtham, Kiat

    2016-01-01

    Objectives Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. Methods We sampled Tenofovir 300mg, Efavirenz 600mg and Lopinavir/ritonavir 200/50mg from 10 primary hospitals randomly selected from those participating in the National AIDS Program, 2 non-government organization ARV clinics, and 3 private drug stores. Quality of ARV was analyzed by blinded investigators at the Faculty of Pharmaceutical Science, Chulalongkorn University. The analysis included an identification test for drug molecules, a chemical composition assay to quantitate the active ingredients, a uniformity of mass test and a dissolution test to assess in-vitro drug release. Comparisons were made against the standards described in the WHO international pharmacopeia. Results A total of 42 batches of ARV from 15 sources were sampled from January–March 2015. Among those generics, 23, 17, 1, and 1 were Thai-made, Indian-made, Vietnamese-made and Chinese-made, respectively. All sampled products, regardless of manufacturers or sources, met the International Pharmacopeia standards for composition assay, mass uniformity and dissolution. Although local regulations restrict ARV supply to hospitals and clinics, samples of ARV could be bought from private drug stores even without formal prescription. Conclusion Sampled generic ARVs distributed within Thailand and 1 Vietnamese pharmacy showed consistent quality. However some products were illegally supplied without prescription, highlighting the importance of dispensing ARV for treatment or prevention in facilities where continuity

  7. Applicability, Commercial Utility and Recent Patents on Starch and Starch Derivative as Pharmaceutical Drug Delivery Carrier.

    PubMed

    Pandey, Shreya; Malviya, Rishabha; Sharma, Pramod K

    2015-01-01

    Natural polymers are widely utilized in pharmaceutical and food industries. Starch, a major carbohydrate is a staple food in human and animal diets which is simply extractable from various sources, like potato, maize, corn, wheat, etc. It is widely used as a raw material in various food and non food industries as well as in paper, textile and other industries. This article summarizes the starch and modification of starch and to produce a novel molecule with various applications in industries including number of advances in pharmaceutical industry. The unique characteristics of starch and their modified form can be successfully used as drug delivery carriers in various pharmaceutical preparations. It is widely used as controlled and sustained release polymer, tablet disintegrant, drug delivery carrier, plasma volume expander and also finds its applicability in bone tissue engineering and in artificial red cells. It also includes the patents related to starch and modified starch based products and their commercial utility.

  8. Reflection on the Pharmaceutical Formulation Challenges Associated with a Paediatric Investigation Plan for an Off-Patent Drug.

    PubMed

    Walsh, Jennifer

    2017-02-01

    In Europe, the development of pediatric medicines for new patent protected products is mandatory and applicants are required to submit a Paediatric Investigation Plan (PIP) to the regulatory authorities. The process is voluntary for off-patent medicines and despite the availability of incentives, there is still a huge unmet need for the development of off-patent pediatric medicines. The aim of the EU grant funded "Labeling of Enalapril from Neonates to Adolescents" (LENA) project is to develop a new pediatric dosage form of the off-patent drug enalapril, for the treatment of heart failure in patients aged from birth to 18 years. This article provides an overview of some of the key formulation challenges that were faced during the product development programme and PIP process, including selection of dosage form and excipients, methodology for administration of the product and evaluation of patient acceptability.

  9. Wnt Drug Discovery: Weaving Through the Screens, Patents and Clinical Trials

    PubMed Central

    Lu, Benjamin; Green, Brooke A.; Farr, Jacqueline M.; Lopes, Flávia C.M.; Van Raay, Terence J.

    2016-01-01

    The Wnt signaling pathway is intricately involved in many aspects of development and is the root cause of an increasing number of diseases. For example, colorectal cancer is the second leading cause of death in the industrialized world and aberration of Wnt signaling within the colonic stem cell is the cause of more than 90% of these cancers. Despite our advances in successfully targeting other pathways, such as Human Epidermal Growth Factor Receptor 2 (HER2), there are no clinically relevant therapies available for Wnt-related diseases. Here, we investigated where research activities are focused with respect to Wnt signaling modulators by searching the United States Patent and Trade Office (USPTO) for patents and patent applications related to Wnt modulators and compared this to clinical trials focusing on Wnt modulation. We found that while the transition of intellectual property surrounding the Wnt ligand-receptor interface to clinical trials is robust, this is not true for specific inhibitors of β-catenin, which is constitutively active in many cancers. Considering the ubiquitous use of the synthetic T-cell Factor/Lymphoid Enhancer Factor (TCF/Lef) reporter system and its success in identifying novel modulators in vitro, we speculate that this model of drug discovery does not capture the complexity of in vivo Wnt signaling that may be required if we are to successfully target the Wnt pathway in the clinic. Notwithstanding, increasingly more complex models are being developed, which may not be high throughput, but more pragmatic in our pursuit to control Wnt signaling. PMID:27598201

  10. A guide to drug discovery. Protecting your inventions: the patent system.

    PubMed

    Webber, Philip M

    2003-10-01

    Whether you work for a multi-national pharmaceutical company, a biotech start-up or a university, a knowledge of the patent system is essential for understanding how best to protect the fruits of your research. The aim of this article is to give an overview of what a patent is, how you might get one and the rights that a patent confers.

  11. [Patented photobioreactor to commercial production of new drugs and nutraceuticals from microalgae].

    PubMed

    Talbierz, Szymon; Kujawska, Natalia; Latała, Adam

    2012-01-01

    Microalgae - microscopic photosynthetic plants are an inexhaustible source of compounds with potential pharmaceutical applications. However, the development of microalgal biotechnology in particular for the production of new drugs and nutraceuticals has been slowed by the limited growth performance of algae in industrial photobioreactors. This is due to low light intensity, necessary for photosynthesis, which causes growth of algae. Flat-Plate photobioreactor with a solar-tracker system which is reported to protect with the Patent Office of RP enables optimal positioning of culture vessel to the direction of the sun's rays and thus can increase the efficiency of biomass growth (by 30%) and lipid content, compared with photobioreactors without it. The use of the invention in industrial plants can significantly contribute to lower costs and make all the technology more profitable.

  12. Comprehensive Quantitative Analysis of 32 Chemical Ingredients of a Chinese Patented Drug Sanhuang Tablet.

    PubMed

    Fung, Hau-Yee; Lang, Yan; Ho, Hing-Man; Wong, Tin-Long; Ma, Dik-Lung; Leung, Chung-Hang; Han, Quan-Bin

    2017-01-12

    Sanhuang Tablet (SHT) is a Chinese patented drug commonly used for the treatment of inflammations of the respiratory tract, gastrointestinal tract, and skin. It contains a special medicinal composition including the single compound berberine hydrochloride, extracts of Scutellariae Radix and Rhei Radix et Rhizoma, as well as the powder of Rhei Radix et Rhizoma. Despite advances in analytical techniques, quantitative evaluation of a Chinese patented drug like SHT remains a challenge due to the complexity of its chemical profile. In this study, ultra-high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UHPLC-Q-TOF-MS) was used to simultaneously quantify 29 non-sugar small molecule components of SHT (11 flavonoids, two isoflavonoids, one flavanone, five anthraquinones, two dianthranones, five alkaloids, two organic acids and one stilbene). Three major saccharide components, namely fructose, glucose, and sucrose, were also quantitatively determined using high performance liquid chromatography-charged aerosol detector (HPLC-CAD) on an Asahipak NH₂P-50 4E amino column. The established methods were validated in terms of linearity, sensitivity, precision, accuracy, and stability, and then successfully applied to analyze 27 batches of commercial SHT products. A total of up to 57.61% (w/w) of SHT could be quantified, in which the contents of the determined non-saccharide small molecules varied from 5.91% to 16.83% (w/w) and three saccharides accounted for 4.41% to 48.05% (w/w). The results showed that the quality of the commercial products was inconsistent, and only four of those met Chinese Pharmacopoeia criteria.

  13. [Sexual complaints and dysfunction among PLHIV receiving ARV treatment for ten years in Senegal].

    PubMed

    Diaw, J; Taverne, B; Coutherut, J

    2014-10-01

    The sexual health of people who have been living with HIV (PLHIV) and who have been receiving ARV drug treatment for several years is still a virtually unexplored topic in Africa today. A study was conducted in Senegal on people who have been treated with ARVs for ten years. Half of those interviewed believe that their sexuality has deteriorated. HIV infection has become a chronic disease in which sexual dysfunction related to the disease or age is interpreted in the context of popular representations of HIV infection and those on sexuality defined by social norms.

  14. Research and Development of Hepatitis B Drugs: An Analysis Based on Technology Flows Measured by Patent Citations

    PubMed Central

    Wan, Jian-bo; He, Chengwei; Hu, Yuanjia

    2016-01-01

    Despite the existence of available therapies, the Hepatitis B virus infection continues to be one of the most serious threats to human health, especially in developing countries such as China and India. To shed light on the improvement of current therapies and development of novel anti-HBV drugs, we thoroughly investigated 212 US patents of anti-HBV drugs and analyzed the technology flow in research and development of anti-HBV drugs based on data from IMS LifeCycle databases. Moreover, utilizing the patent citation method, which is an effective indicator of technology flow, we constructed patent citation network models and performed network analysis in order to reveal the features of different technology clusters. As a result, we identified the stagnant status of anti-HBV drug development and pointed the way for development of domestic pharmaceuticals in developing countries. We also discussed about therapeutic vaccines as the potential next generation therapy for HBV infection. Lastly, we depicted the cooperation between entities and found that novel forms of cooperation added diversity to the conventional form of cooperation within the pharmaceutical industry. In summary, our study provides inspiring insights for investors, policy makers, researchers, and other readers interested in anti-HBV drug development. PMID:27727319

  15. Lipid-based nanocarriers for drug delivery and targeting: a patent survey of methods of production and characterization.

    PubMed

    Carbone, Claudia; Cupri, Sarha; Leonardi, Antonio; Puglisi, Giovanni; Pignatello, Rosario

    2013-09-01

    Among the colloidal vectors proposed for the controlled delivery and targeting of drugs and other biologically active compounds, lipid-based nanocarriers are acquiring an increasing role due to a number of peculiar technological and physical features. Solid lipid nanoparticles, lipid nanocapsules, nanostructured lipid carriers, and drug-lipid conjugates are all examples of how it can be possible to combine the properties of the more acknowledged liposomal systems, such as biocompatibility and biodegradability, with the stability and compositional flexibility, distinctive of polymeric nanosystems. This article introduces recent patents, filed in years 2007-2013, that deal with novel or amended methods of production of the various types of lipid-based nanocarriers. Although a significant gap still remains between basic research and patenting activity in this field, many of the proposed methods can attain an industrial value. Furthermore, the critical analysis of these patents further supports the position that a general revision of patenting systems at an international level would be necessary for nanosized pharmaceutical systems.

  16. Scaling-up the use of generic antiretrovirals in resource-limited countries: generic drugs for health.

    PubMed

    Beck, Eduard J; Passarelli, Carlos; Lui, Iris; Guichard, Anne-Claire; Simao, Mariangela; De Lay, Paul; Loures, Luiz

    2014-01-01

    The number of people living with HIV (PLHIV) continues to increase around the world because of the increasing number on antiretroviral therapy (ART) and their associated increase of life expectancy, in addition to the number of people newly infected with HIV each year. Unless a 'cure' can be found for HIV infection, PLHIV can anticipate the need to take antiretroviral drugs (ARVs) for the rest of their lives. Because ARVs are now being used for HIV prevention, as well as for therapeutic purposes, the need for effective, affordable ARVs with few adverse effects will continue to rise. It is important to note that the dramatic growth in treatment coverage of PLHIV seen during the past decade has been primarily due to the increased use of generic ARVs. Thus, there will be a need to scale-up the research and development, production, distribution and access to generic ARVs and ART regimens. However, these processes must occur within national and international regulated free-market economic systems and must deal with increasingly multifaceted patent issues affecting the price while ensuring the quality of the ARVs. National and international regulatory mechanisms will have to evolve, which will affect broader national and international economic and trade issues. Because of the complexity of these issues, the Editors of this Supplement conceived of asking experts in their fields to describe the various steps from relevant research and development, to production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A main objective was to highlight how these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited countries can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of drugs to people in low- and middle-income countries.

  17. Legal developments and practical implications of gene patenting on targeted drug discovery and development.

    PubMed

    Klein, R D

    2010-06-01

    The use of genetic information to design and guide therapies creates novel patent issues. Gene patents have been integral to the introduction of new biologics, but their role in diagnostic testing is controversial. Genotype-phenotype associations are at the heart of personalized medicine. The intellectual property rules by which these biological relationships are governed have profound implications for the growth of this field. Several cases currently before the courts may add reason and clarity to the law in this area.

  18. Software Patents.

    ERIC Educational Resources Information Center

    Burke, Edmund B.

    1994-01-01

    Outlines basic patent law information that pertains to computer software programs. Topics addressed include protection in other countries; how to obtain patents; kinds of patents; duration; classes of patentable subject matter, including machines and processes; patentability searches; experimental use prior to obtaining a patent; and patent…

  19. Off-Patent Generic Medicines vs. Off-Patent Brand Medicines for Six Reference Drugs: A Retrospective Claims Data Study from Five Local Healthcare Units in the Lombardy Region of Italy

    PubMed Central

    Colombo, Giorgio L.; Agabiti-Rosei, Enrico; Margonato, Alberto; Mencacci, Claudio; Montecucco, Carlo Maurizio; Trevisan, Roberto

    2013-01-01

    The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet. Methods We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04. Results The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines. Conclusions Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic

  20. Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment

    PubMed Central

    Nunn, Amy S; Fonseca, Elize M; Bastos, Francisco I; Gruskin, Sofia; Salomon, Joshua A

    2007-01-01

    Background Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005. Methods and Findings We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir–ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six

  1. Achieving a Dream: Meeting Policy Goals Related to Improving Drug Access

    PubMed Central

    Zakus, David; Kohler, Jillian Clare; Zakriova, Venera; Yarmoshuk, Aaron

    2010-01-01

    International experts recognize that significant inequities exist in the accessibility of life-saving medicines among poor and vulnerable populations, especially in developing countries. This article highlights that drug access even for relatively cheap medicines is out of reach for the vast numbers of global poor. This badly affects people living with HIV/AIDS who face serious obstacles in accessing ARVs. The same concerns are attributed to neglected diseases. Despite international meetings, promises from the pharmaceutical industry and a lot of media attention little has changed in the past 20 years. The accessibility gap to life-saving drugs could be reduced by the UNITAID initiative to pool patents for the many different ARVs, but the reality is that UNITAID is still a promise. To surmount this global problem of inequity requires a rethinking of traditional models of drug access and health objectives that should not be compromised by commercial interests. PMID:20148088

  2. ARV-based HIV prevention for women – where we are in 2014

    PubMed Central

    Mastro, Timothy D; Sista, Nirupama; Abdool-Karim, Quarraisha

    2014-01-01

    Women continue to be at special risk for HIV acquisition due to a complex mix of biological, behavioural, structural, cultural and social factors, with unacceptable rates of new infection. Scientific advances over the past decade have highlighted the use of antiretroviral (ARV) drugs as pre-exposure prophylaxis (PrEP) to prevent HIV acquisition (sexually, parenterally and vertically) and ARV treatment (ART) for HIV-positive patients to prevent onward transmission (treatment as prevention – TasP). This paper reviews the evidence base for PrEP and TasP, describes new products in development and the need to translate research findings into programmes with impact at the population level. PMID:25224614

  3. AUSTRALIAN COMPETITION AND CONSUMER COMMISSION v PFIZER: EVERGREENING AND MARKET POWER AS A BLOCKBUSTER DRUG GOES OFF PATENT.

    PubMed

    Faunce, Thomas

    2015-06-01

    In Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd [2015] FCA 113, the ACCC alleged that Pfizer's "Project LEAP" involved a scheme to lock pharmacists into substituting its generic version of the high sales volume anti-cholesterol drug, patent-expired atorvastatin (Lipitor), which took advantage of a substantial degree of market power for a purpose proscribed by s 46(1)(c) of the Competition and Consumer Act 2010 (Cth). The ACCC also claimed that Pfizer's actions constituted a course of exclusive dealing pursuant to s 47(1)(d) and (e) for the proscribed purpose of lessening competition. Flick J in the Federal Court of Australia, in a judgment heavy with quotations but sparse in reasoning, dismissed the ACCC's Amended Originating Application alleging abuse of market power and ordered the ACCC to pay Pfizer's costs. The ACCC has now appealed the decision. This column explores this case in the context of Pfizer's broader strategies to preserve its income globally from this high sales volume drug in the period following its patent expiration.

  4. Patents and nanomedicine.

    PubMed

    Bawa, Raj

    2007-06-01

    Big pharma's business model, which relies on a few blockbusters to generate profits, is clearly broken. Patent expiration on numerous blockbusters in recent years is already altering the drug landscape. Drug companies are also facing other challenges that necessitate development and implementation of novel R&D strategies, including those that focus on nanotechnology and miniaturization. Clearly, there is enormous excitement and expectation regarding nanomedicine's potential impact. However, securing valid and defensible patent protection will be critical. Although early forecasts for nanomedicine commercialization are encouraging, there are numerous bottlenecks as well. One of the major hurdles is an emerging thicket of patent claims, resulting primarily from patent proliferation as well as continued issuance of surprisingly broad patents by the US Patent and Trademark Office (PTO). Adding to this confusion is the fact that the US National Nanotechnology Initiative's widely cited definition of nanotechnology is inaccurate and irrelevant from a nanomedicine perspective. It is also the cause of the inadequate patent classification system that was recently unveiled by the PTO. All of this is creating a chaotic, tangled patent landscape in various sectors of nanomedicine where the competing players are unsure of the validity and enforceability of numerous issued patents. If this trend continues, it could stifle competition and limit access to some inventions. Therefore, reforms are urgently needed at the PTO to address problems ranging from poor patent quality and questionable examination practices to inadequate search capabilities, rising attrition, poor employee morale and a skyrocketing patent application backlog. Only a robust patent system will stimulate the development of commercially viable nanomedicine products that can drastically improve a patient's quality of life and reduce healthcare costs.

  5. Patenting genome research tools and the law.

    PubMed

    Eisenberg, Rebecca

    2003-01-01

    Patenting genes encoding therapeutic proteins was relatively uncontroversial in the early days of biotechnology. Controversy arose in the era of high-throughput DNA sequencing, when gene patents started to look less like patents on drugs and more like patents on scientific information. Evolving scientific and business strategies for exploiting genomic information raised concerns that patents might slow subsequent research. The trend towards stricter enforcement of the utility and disclosure requirements by the patent offices should help clarify the current confusion.

  6. Targeted suppression of AR-V7 using PIP5K1α inhibitor overcomes enzalutamide resistance in prostate cancer cells

    PubMed Central

    Sarwar, Martuza; Semenas, Julius; Miftakhova, Regina; Simoulis, Athanasios; Robinson, Brian; Wingren, Anette Gjörloff; Mongan, Nigel P.; Heery, David M.; Johnsson, Heather; Abrahamsson, Per-Anders; Dizeyi, Nishtman; Luo, Jun; Persson, Jenny L.

    2016-01-01

    One mechanism of resistance of prostate cancer (PCa) to enzalutamide (MDV3100) treatment is the increased expression of AR variants lacking the ligand binding-domain, the best characterized of which is AR-V7. We have previously reported that Phosphatidylinositol-4-phosphate 5-kinase alpha (PIP5Kα), is a lipid kinase that links to CDK1 and AR pathways. The discovery of PIP5Kα inhibitor highlight the potential of PIP5K1α as a drug target in PCa. In this study, we show that AR-V7 expression positively correlates with PIP5K1α in tumor specimens from PCa patients. Overexpression of AR-V7 increases PIP5K1α, promotes rapid growth of PCa in xenograft mice, whereas inhibition of PIP5K1α by its inhibitor ISA-2011B suppresses the growth and invasiveness of xenograft tumors overexpressing AR-V7. PIP5K1α is a key co-factor for both AR-V7 and AR, which are present as protein-protein complexes predominantly in the nucleus of PCa cells. In addition, PIP5K1α and CDK1 influence AR-V7 expression also through AKT-associated mechanism dependent on PTEN-status. ISA-2011B disrupts protein stabilization of AR-V7 which is dependent on PIP5K1α, leading to suppression of invasive growth of AR-V7-high tumors in xenograft mice. Our study suggests that combination of enzalutamide and PIP5K1α may have a significant impact on refining therapeutic strategies to circumvent resistance to antiandrogen therapies. PMID:27588408

  7. Targeted suppression of AR-V7 using PIP5K1α inhibitor overcomes enzalutamide resistance in prostate cancer cells.

    PubMed

    Sarwar, Martuza; Semenas, Julius; Miftakhova, Regina; Simoulis, Athanasios; Robinson, Brian; Gjörloff Wingren, Anette; Mongan, Nigel P; Heery, David M; Johnsson, Heather; Abrahamsson, Per-Anders; Dizeyi, Nishtman; Luo, Jun; Persson, Jenny L

    2016-09-27

    One mechanism of resistance of prostate cancer (PCa) to enzalutamide (MDV3100) treatment is the increased expression of AR variants lacking the ligand binding-domain, the best characterized of which is AR-V7. We have previously reported that Phosphatidylinositol-4-phosphate 5-kinase alpha (PIP5Kα), is a lipid kinase that links to CDK1 and AR pathways. The discovery of PIP5Kα inhibitor highlight the potential of PIP5K1α as a drug target in PCa. In this study, we show that AR-V7 expression positively correlates with PIP5K1α in tumor specimens from PCa patients. Overexpression of AR-V7 increases PIP5K1α, promotes rapid growth of PCa in xenograft mice, whereas inhibition of PIP5K1α by its inhibitor ISA-2011B suppresses the growth and invasiveness of xenograft tumors overexpressing AR-V7. PIP5K1α is a key co-factor for both AR-V7 and AR, which are present as protein-protein complexes predominantly in the nucleus of PCa cells. In addition, PIP5K1α and CDK1 influence AR-V7 expression also through AKT-associated mechanism dependent on PTEN-status. ISA-2011B disrupts protein stabilization of AR-V7 which is dependent on PIP5K1α, leading to suppression of invasive growth of AR-V7-high tumors in xenograft mice. Our study suggests that combination of enzalutamide and PIP5K1α may have a significant impact on refining therapeutic strategies to circumvent resistance to antiandrogen therapies.

  8. The Demand for Antiretroviral Drugs in the Illicit Marketplace: Implications for HIV disease management among vulnerable populations

    PubMed Central

    Tsuyuki, Kiyomi; Surratt, Hilary L.; Levi-Minzi, Maria A.; O’Grady, Catherine L.; Kurtz, Steven P.

    2014-01-01

    The diversion of antiretroviral medications (ARVs) has implications for the integrity and success of HIV care, however little is known about the ARV illicit market. This paper aimed to identify the motivations for buying illicit ARVs and to describe market dynamics. Semi-structured interviews (n=44) were conducted with substance-involved individuals living with HIV with a history of purchasing ARVs on the street. Grounded theory was used to code and analyze interviews. Motivations for buying ARVs on the illicit market were: to repurchase ARVs after having diverted them for money or drugs; having limited access or low quality health care; to replace lost or ruined ARVs; and to buy a back-up stock of ARVs. This study identified various structural barriers to HIV treatment and ARV adherence that incentivized ARV diversion. Findings highlight the need to improve patient-provider relationships, ensure continuity of care, and integrate services to engage and retain high-needs populations. PMID:25092512

  9. The Demand for Antiretroviral Drugs in the Illicit Marketplace: Implications for HIV Disease Management Among Vulnerable Populations.

    PubMed

    Tsuyuki, Kiyomi; Surratt, Hilary L; Levi-Minzi, Maria A; O'Grady, Catherine L; Kurtz, Steven P

    2015-05-01

    The diversion of antiretroviral medications (ARVs) has implications for the integrity and success of HIV care, however little is known about the ARV illicit market. This paper aimed to identify the motivations for buying illicit ARVs and to describe market dynamics. Semi-structured interviews (n = 44) were conducted with substance-involved individuals living with HIV who have a history of purchasing ARVs on the street. Grounded theory was used to code and analyze interviews. Motivations for buying ARVs on the illicit market were: to repurchase ARVs after having diverted them for money or drugs; having limited access or low quality health care; to replace lost or ruined ARVs; and to buy a back-up stock of ARVs. This study identified various structural barriers to HIV treatment and ARV adherence that incentivized ARV diversion. Findings highlight the need to improve patient-provider relationships, ensure continuity of care, and integrate services to engage and retain high-needs populations.

  10. Driving a decade of change: HIV/AIDS, patents and access to medicines for all

    PubMed Central

    2011-01-01

    Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of

  11. Advances in recent patent and clinical trial drug development for Alzheimer's disease.

    PubMed

    Liu, Haibin; Wang, Lirong; Su, Weiwei; Xie, Xiang-Qun

    2014-07-01

    Alzheimer's disease (AD) is a progressive neurodegenerative disease, involving a large number of genes, proteins and their complex interactions. Currently, no effective therapeutic agents are available to either stop or reverse the progression of this disease, likely due to its polygenic nature. The complicated pathophysiology of AD remains unresolved. Although it has been hypothesized that the amyloid β cascade and the hyper-phosphorylated tau protein may be primarily involved, other mechanisms, such as oxidative stress, deficiency of central cholinergic neurotransmitter, mitochondrial dysfunction and inflammation have also been implicated. The main focus of this review is to document current therapeutic agents in clinical trials and patented candidate compounds under development based on their main mechanisms of action. It also discusses the relationship between the recent understanding of key targets and the development of potential therapeutic agents for the treatment of AD.

  12. Trends in Nanopharmaceutical Patents

    PubMed Central

    Antunes, Adelaide; Fierro, Iolanda; Guerrante, Rafaela; Mendes, Flavia; Alencar, Maria Simone de M.

    2013-01-01

    Investment in nanotechnology is now a given constant by governments, research centers and companies in both more developed countries and emerging markets. Due to their characteristics, such as high stability, ability to enable antigen identification on specific cells in the human body and controlling the release of drugs and, therefore, improving therapies, nanoparticles have been the subject of research and patent applications in the pharmaceutical field. According to the Organization for Economic Co-operation and Development (OCDE), patent data can be used as a source of information in order to measure science and technology activities. Thereby, this paper presents an analysis based on patent documents related to nanotechnology in the pharmaceutical sector. As a result, the analysis of patents demonstrate primarily that nanobiotechnology attracts high levels of R&D investments, including nanoparticle-based chemotherapeutic agents/drugs, monoclonal antibody nanoparticle complexes and their role in drug delivery or contrast agents with non-toxic effects. PMID:23535336

  13. 78 FR 31885 - Patent Term Extension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... Patent and Trademark Office Patent Term Extension ACTION: Proposed collection; comment request. SUMMARY... term restoration portion of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L... (USPTO) to extend the term of protection under a patent to compensate for delay during regulatory...

  14. Patent Law's Reproducibility Paradox.

    PubMed

    Sherkow, Jacob S

    2017-01-01

    Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible--their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but also legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine hamper or even actively dissuade reproducible data in patents. This Article assesses the difficulties in reconciling these basic goals of scientific research and patent law. More concretely, it provides several examples of irreproducibility in patents on blockbuster drugs--Prempro, Xigris, Plavix, and Avastin--and discusses some of the social costs of the misalignment between good clinical practice and patent doctrine. Ultimately, this analysis illuminates several current debates concerning innovation policy. It strongly suggests that a proper conception of enablement should take into account after-arising evidence. It also sheds light on the true purpose--and limits--of patent disclosure. And lastly, it untangles the doctrines of enablement and utility.

  15. Production of antiretroviral drugs in middle- and low-income countries.

    PubMed

    Pinheiro, Eloan dos Santos; Brüning, Karin; Macedo, M Fernanda; Siani, Antonio C

    2014-01-01

    This review outlines the main issues concerning the production of antiretroviral (ARV) drugs in middle- and low-income countries and the relevant political, legal and technical requirements for supporting such production. The requirements for efficient local production, including the manufacture of generic and branded products and public demand, have been considered from economic, market and socio-political perspectives. A steady and consistent government policy is crucial to success. Additional crucial factors in establishing local production are adequate infrastructure, qualified human resources in technical and managerial areas, and production-distribution logistics systems. The creation or strengthening of a national drug regulatory agency is a basic requirement. Production of ARVs relies on the structure of the international market for active pharmaceutical ingredients (APIs), which are highly monopolized for inclusion in branded or patented drugs, or are concentrated in a few Asian generic companies. Countries seeking to begin local production must develop strategies to overcome the various barriers. For instance, sub-Saharan African countries may benefit from developing multilateral health agreements with neighbouring countries. Such agreements are recommended and should be complemented by technology transfers, especially for the manufacture of APIs. Achieving a production level that is sustainable in the long term is crucial to maintaining patients' access to ARVs.

  16. A method to manage and share anti-retroviral (ARV) therapy information of human immunodeficiency virus (HIV) patients in Vietnam.

    PubMed

    Nguyen, Phung Anh; Syed-Abdul, Shabbir; Minamareddy, Priti; Lee, Peisan; Ngo, Thuy Dieu; Iqbal, Usman; Nguyen, Phuong Hoang; Jian, Wen-Shan; Li, Yu-Chuan Jack

    2013-08-01

    Management of antiretroviral (ARV) drug and HIV patients data is an important component of Vietnam Administration of HIV/AIDS Control (VAAC) Department and hospitals/health care units when people often travel in other places of Vietnam; therefore, it would lead to a number of medical errors in treatment as well as patients do not adhere to ARV therapy. In this paper, we describe a system that manages and shares antiretroviral therapy information of 4438 HIV patients in three healthcare centers in Hanoi capital of Vietnam. The overall design considerations, architecture and the integration of centralized database and decentralized management for the system are also presented. The findings from this study can serve as a guide to consider in the implementation model of health care to manage and share information of patients not only in HIV infection, but also in the other chronic and non-communicable diseases.

  17. Miltefosine lipid nanocapsules: Intersection of drug repurposing and nanotechnology for single dose oral treatment of pre-patent schistosomiasis mansoni.

    PubMed

    El-Moslemany, Riham M; Eissa, Maha M; Ramadan, Alyaa A; El-Khordagui, Labiba K; El-Azzouni, Mervat Z

    2016-07-01

    A dual drug repurposing/nanotechnological approach was used to develop an alternative oral treatment for schistosomiasis mansoni using miltefosine (MFS), an anticancer alkylphosphocholine, and lipid nanocapsules (LNCs) as oral nanovectors. We demonstrated earlier that MFS possesses significant activity against different developmental stages of Schistosoma mansoni in the mouse model using 5 successive 20mg/kg/day oral doses. Moreover, an effective single dose (20mg/kg) oral treatment against the adult stage of S. mansoni in mice was developed using LNCs, particularly modified with CTAB, a positive charge imparting agent (MFS-LNC-CTAB(+)), or oleic acid as membrane permeabilizer (MFS-LNC-OA). Efficacy enhancement involved, at least in part, targeting of the worm tegument with MFS-LNCs as a new therapeutic entity. As the tegument surface charge and composition may differ in pre-patent stages of the parasite, it was of importance in the present study to assess the efficacy of a single oral dose of the two MFS-LNC formulations against invasive and immature stages for potential advantage relative to praziquantel. Results indicated potent schistosomicidal effects against both invasive and immature stages of S. mansoni in infected mice, efficacy being both formulation and developmental stage dependent. This was indicated by the significant reduction in the total worm burden of the invasive stage by 91.6% and 76.8% and the immature stage by 82.7% and 96.7% for MFS-LNC-CTAB+ and MFS-LNC-OA, respectively. Histopathological findings indicated amelioration of hepatic pathology with regression of the granulomatous inflammatory reaction and reduction in granulomas number and size, verifying marked improvement in architecture of hepatic lobules. From a clinical perspective, MFS-LNCs offer potential as an alternative single oral dose nanomedicine with a wide therapeutic profile for the mass chemotherapy of schistosomiasis mansoni.

  18. Patenting DNA.

    PubMed

    Bobrow, Martin; Thomas, Sandy

    2002-12-01

    The protection of inventions based on human DNA sequences has been achieved mainly through application of the patent system. Over the past decade, there has been continuing debate about whether this use of intellectual property rights is acceptable. Companies and universities have been active during this period in filing thousands of patent applications. Although many have argued that to claim a DNA sequence in a patent is to claim a discovery, patent law allows discoveries that are useful to be claimed as part of an invention. As the technology to isolate DNA sequences has advanced, the criterion for inventiveness, necessary for any invention to be eligible for filing, has become more difficult to justify in the case of claims to DNA sequences. Moreover, the discovery that a gene is associated with a particular disease is, it is argued, to discover a fact about the world and undeserving of the status of an invention. Careful examination of the grounds for allowing the patenting of DNA sequences as research tools suggests such rewards will rarely be justified. The patenting of DNA sequences as chemical intermediates necessary for the manufacture of therapeutic proteins is, however, reasonable given that the information within the sequence is applied to produce a tangible substance which has application as a medicine. Despite the legal, technical and political complexities of applying the flexibilities with the current law, it is argued that much could be achieved in the area of patenting DNA by raising the thresholds for patentability.

  19. Canada's Patented Medicines (Notice of Compliance) Proceedings and Intellectual Property.

    PubMed

    Bian, Henry; McCourt, Conor

    2015-01-08

    Canada's Patent Register is a tool created by the Patented Medicines (Notice of Compliance) Regulations to help innovators protect their inventions relating to pharmaceuticals. This tool exists at the intersection between the intellectual property and drug approval regimes. By listing a patent on the Patent Register, an innovator can prevent a generic manufacturer from entering the marketplace rather than having to wait for his or her patent to be infringed. This article provides information on the requirements for listing a patent on the Patent Register and an overview of how the Patent Medicines (Notice of Compliance) Regulations affect the drug approval process.

  20. The RNA helicase DDX39B and its paralog DDX39A regulate androgen receptor splice variant AR-V7 generation.

    PubMed

    Nakata, Daisuke; Nakao, Shoichi; Nakayama, Kazuhide; Araki, Shinsuke; Nakayama, Yusuke; Aparicio, Samuel; Hara, Takahito; Nakanishi, Atsushi

    2017-01-29

    Mounting evidence suggests that constitutively active androgen receptor (AR) splice variants, typified by AR-V7, are associated with poor prognosis and resistance to androgen deprivation therapy in prostate cancer patients. However, mechanisms governing the generation of AR splice variants are not fully understood. In this study, we aimed to investigate the dynamics of AR splice variant generation using the JDCaP prostate cancer model that expresses AR splice variants under androgen depletion. Microarray analysis of JDCaP xenografts before and after expression of AR splice variants suggested that dysregulation of RNA processing pathways is likely involved in AR splice variant generation. To explore factors contributing to generation of AR-V7 mRNA, we conducted a focused RNA interference screen in AR-V7-positive JDCaP-hr cells using an shRNA library targeting spliceosome-related genes. This screen identified DDX39B as a regulator of AR-V7 mRNA expression. Simultaneous knockdown of DDX39B and its paralog DDX39A drastically and selectively downregulated AR-V7 mRNA expression in multiple AR-V7-positive prostate cancer cell lines. DDX39B was upregulated in relapsed JDCaP xenografts expressing AR splice variants, suggesting its role in expression of AR splice variants. Taken together, our findings offer insight into the mechanisms of AR splice variant generation and identify DDX39 as a potential drug target for the treatment of AR splice variant-positive prostate cancer.

  1. A Repurposing Approach Identifies Off-Patent Drugs with Fungicidal Cryptococcal Activity, a Common Structural Chemotype, and Pharmacological Properties Relevant to the Treatment of Cryptococcosis

    PubMed Central

    Butts, Arielle; DiDone, Louis; Koselny, Kristy; Baxter, Bonnie K.; Chabrier-Rosello, Yeissa; Wellington, Melanie

    2013-01-01

    New, more accessible therapies for cryptococcosis represent an unmet clinical need of global importance. We took a repurposing approach to identify previously developed drugs with fungicidal activity toward Cryptococcus neoformans, using a high-throughput screening assay designed to detect drugs that directly kill fungi. From a set of 1,120 off-patent medications and bioactive molecules, we identified 31 drugs/molecules with fungicidal activity, including 15 drugs for which direct antifungal activity had not previously been reported. A significant portion of the drugs are orally bioavailable and cross the blood-brain barrier, features key to the development of a widely applicable anticryptococcal agent. Structural analysis of this set revealed a common chemotype consisting of a hydrophobic moiety linked to a basic amine, features that are common to drugs that cross the blood-brain barrier and access the phagolysosome, two important niches of C. neoformans. Consistent with their fungicidal activity, the set contains eight drugs that are either additive or synergistic in combination with fluconazole. Importantly, we identified two drugs, amiodarone and thioridazine, with activity against intraphagocytic C. neoformans. Finally, the set of drugs is also enriched for molecules that inhibit calmodulin, and we have confirmed that seven drugs directly bind C. neoformans calmodulin, providing a molecular target that may contribute to the mechanism of antifungal activity. Taken together, these studies provide a foundation for the optimization of the antifungal properties of a set of pharmacologically attractive scaffolds for the development of novel anticryptococcal therapies. PMID:23243064

  2. Antiretroviral drug use and HIV drug resistance among HIV-infected Black men who have sex with men: HIV Prevention Trials Network 061

    PubMed Central

    Chen, Iris; Connor, Matthew B.; Clarke, William; Marzinke, Mark A.; Cummings, Vanessa; Breaud, Autumn; Fogel, Jessica M.; Laeyendecker, Oliver; Fields, Sheldon D.; Donnell, Deborah; Griffith, Sam; Scott, Hyman M.; Shoptaw, Steven; del Rio, Carlos; Magnus, Manya; Mannheimer, Sharon; Wheeler, Darrell P.; Mayer, Kenneth H.; Koblin, Beryl A.; Eshleman, Susan H.

    2015-01-01

    BACKGROUND HPTN 061 enrolled Black men who have sex with men in the United States. Some men with low/undetectable HIV RNA had unusual patterns of antiretroviral (ARV) drug use or had drugs detected in the absence of viral suppression. This report includes a comprehensive analysis of ARV drug use and drug resistance among men in HPTN 061 who were not virally suppressed. METHODS The analysis included 169 men who had viral loads >400 copies/mL at enrollment, including three with acute infection and 13 with recent infection. By self-report, 88 were previously diagnosed, including 31 in care; 137 men reported no ARV drug use. Samples from these 169 men and 23 seroconverters were analyzed with HIV genotyping and ARV drug assays. RESULTS Forty-eight (28%) of the 169 men had ≥1 drug resistance mutation (DRM); 19 (11%) had multi-class resistance. Sixty men (36%) had ≥1 ARV drug detected, 42 (70%) of whom reported no ARV drug use. Nine (23%) of 39 newly-infected men had ≥1 DRM; 10 had ≥1 ARV drug detected. Unusual patterns of ARV drugs were detected more frequently in newly-diagnosed men than previously-diagnosed men. The rate of transmitted drug resistance (TDR) was 23% based on HIV genotyping and self-reported ARV drug use, but was 12% after adjusting for ARV drug detection. CONCLUSIONS Many men in HPTN 061 had drug-resistant HIV and many were at risk of acquiring additional DRMs. ARV drug testing revealed unusual patterns of ARV drug use and provided a more accurate estimate of TDR. PMID:25861015

  3. Deletion of murine Arv1 results in a lean phenotype with increased energy expenditure

    PubMed Central

    Lagor, W R; Tong, F; Jarrett, K E; Lin, W; Conlon, D M; Smith, M; Wang, M Y; Yenilmez, B O; McCoy, M G; Fields, D W; O'Neill, S M; Gupta, R; Kumaravel, A; Redon, V; Ahima, R S; Sturley, S L; Billheimer, J T; Rader, D J

    2015-01-01

    Background: ACAT-related enzyme 2 required for viability 1 (ARV1) is a putative lipid transporter of the endoplasmic reticulum that is conserved across eukaryotic species. The ARV1 protein contains a conserved N-terminal cytosolic zinc ribbon motif known as the ARV1 homology domain, followed by multiple transmembrane regions anchoring it in the ER. Deletion of ARV1 in yeast results in defective sterol trafficking, aberrant lipid synthesis, ER stress, membrane disorganization and hypersensitivity to fatty acids (FAs). We sought to investigate the role of Arv1 in mammalian lipid metabolism. Methods: Homologous recombination was used to disrupt the Arv1 gene in mice. Animals were examined for alterations in lipid and lipoprotein levels, body weight, body composition, glucose tolerance and energy expenditure. Results: Global loss of Arv1 significantly decreased total cholesterol and high-density lipoprotein cholesterol levels in the plasma. Arv1 knockout mice exhibited a dramatic lean phenotype, with major reductions in white adipose tissue (WAT) mass and body weight on a chow diet. This loss of WAT is accompanied by improved glucose tolerance, higher adiponectin levels, increased energy expenditure and greater rates of whole-body FA oxidation. Conclusions: This work identifies Arv1 as an important player in mammalian lipid metabolism and whole-body energy homeostasis. PMID:26479315

  4. Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

    PubMed

    Kanavos, Panos

    2014-11-01

    This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market.

  5. The Impact of HIV/AIDS and ARV Treatment on Worker Absenteeism: Implications for African Firms

    ERIC Educational Resources Information Center

    Habyarimana, James; Mbakile, Bekezela; Pop-Eleches, Cristian

    2010-01-01

    We characterize medium and long-run labor market impacts of HIV/AIDS and ARV treatment using unique panel data of worker absenteeism and information from an AIDS treatment program at a large mining firm in Botswana. We present robust evidence of an inverse-V shaped pattern in worker absenteeism around the time of ARV treatment inception.…

  6. Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries: A Forecast Analysis 2015-2025

    PubMed Central

    Gupta, Aastha; Juneja, Sandeep; Vitoria, Marco; Habiyambere, Vincent; Nguimfack, Boniface Dongmo; Doherty, Meg; Low-Beer, Daniel

    2016-01-01

    With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025. UNAIDS estimates 24.7 million person-years of ART in 2020 and 28.5 million person-years of ART in 2025 (24.3 million on first-line treatment, 3.5 million on second-line treatment, and 0.6 million on third-line treatment). Our analysis showed that TAF and DTG will be major players in the ART regimen by 2025, with 8 million and 15 million patients using these ARVs respectively. However, as safety and efficacy of dolutegravir (DTG) and tenofovir alafenamide (TAF) during pregnancy and among TB/HIV co-infected patients using rifampicin is still under debate, and ART scale-up is predicted to increase considerably, there also remains a clear need for continuous supplies of existing ARVs including TDF and EFV, which 16 million and 10 million patients—respectively—are predicted to be using in 2025. It will be important to ensure that the existing capacities of generics manufacturers, which are geared towards ARVs of higher doses (such as TDF 300mg and EFV 600mg), will not be adversely impacted due to the introduction of lower dose ARVs such as TAF 25mg and DTG 50mg. With increased access to viral load testing, more patients would be using protease inhibitors containing regimens in second-line, with 1 million patients on LPV/r and 2.3 million on ATV/r by 2025. However, it will remain important to continue monitoring the evolution of ARV market in LMICs to

  7. Patent Family Databases.

    ERIC Educational Resources Information Center

    Simmons, Edlyn S.

    1985-01-01

    Reports on retrieval of patent information online and includes definition of patent family, basic and equivalent patents, "parents and children" applications, designated states, patent family databases--International Patent Documentation Center, World Patents Index, APIPAT (American Petroleum Institute), CLAIMS (IFI/Plenum). A table…

  8. Drug discovery using very large numbers of patents. General strategy with extensive use of match and edit operations

    NASA Astrophysics Data System (ADS)

    Robson, Barry; Li, Jin; Dettinger, Richard; Peters, Amanda; Boyer, Stephen K.

    2011-05-01

    A patent data base of 6.7 million compounds generated by a very high performance computer (Blue Gene) requires new techniques for exploitation when extensive use of chemical similarity is involved. Such exploitation includes the taxonomic classification of chemical themes, and data mining to assess mutual information between themes and companies. Importantly, we also launch candidates that evolve by "natural selection" as failure of partial match against the patent data base and their ability to bind to the protein target appropriately, by simulation on Blue Gene. An unusual feature of our method is that algorithms and workflows rely on dynamic interaction between match-and-edit instructions, which in practice are regular expressions. Similarity testing by these uses SMILES strings and, less frequently, graph or connectivity representations. Examining how this performs in high throughput, we note that chemical similarity and novelty are human concepts that largely have meaning by utility in specific contexts. For some purposes, mutual information involving chemical themes might be a better concept.

  9. Drug-drug interactions: antiretroviral drugs and recreational drugs.

    PubMed

    Staltari, Orietta; Leporini, Christian; Caroleo, Benedetto; Russo, Emilio; Siniscalchi, Antonio; De Sarro, Giovambattista; Gallelli, Luca

    2014-01-01

    With the advances in antiretroviral (ARV) therapy, patients with Human Immunodeficiency Virus (HIV) infection are living longer, however, some patients encounter co- morbidities which sometimes require treatment. Therefore, during the treatment with ARV drugs these patients could take several recreational drugs (e.g. amphetamines, hallucinogenes, opiates, or alcohol) with a possible development of drug-drug interactions (DDIs). In particular, Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs) are mainly excreted through the kidney and are not substrates of the cytochrome P450 or P-glycoprotein, therefore the DDIs during this treatment are minimal. In contrast, the other ARV drugs (i.e. non-nucleoside reversetranscriptase inhibitors, Protease inhibitors, Integrase inhibitors, chemokine receptor 5 antagonists and HIV-fusion inhibitors) are an important class of antiretroviral medications that are frequent components of HAART regimens but show several DDIs related to interaction with the cytochrome P450 or P-glycoprotein. In this paper we will review data concerning the possibility of DDI in HIV patients treated with ARV and taking recreational drugs.

  10. Aurora A regulates expression of AR-V7 in models of castrate resistant prostate cancer

    PubMed Central

    Jones, Dominic; Noble, Martin; Wedge, Steve R.; Robson, Craig N.; Gaughan, Luke

    2017-01-01

    Androgen receptor variants (AR-Vs) provide a mechanism of therapy evasion in castrate-resistant prostate cancer (CRPC), yet mechanisms of regulation remain largely unknown. Here we investigate the role of Aurora A kinase on AR-Vs in models of CRPC and show depletion of Aurora A reduces AR-V target gene expression. Importantly, knockdown of Aurora A reconfigures splicing of AR pre-mRNA to discriminately down-regulate synthesis of AR-V transcripts, including AR-V7, without effecting full-length AR mRNA; and as a consequence, AR-V-driven proliferation and survival of CRPC cells is markedly reduced. Critically, these effects are reproduced by Aurora A inhibition. We show that Aurora A levels increase in advanced disease and AURKA is an AR-V target gene demonstrating a positive feedback mechanism of androgenic signalling in CRPC. In all, our data suggests that Aurora A plays a pivotal role in regulation of AR-V7 expression and represents a new therapeutic target in CRPC. PMID:28205582

  11. Aurora A regulates expression of AR-V7 in models of castrate resistant prostate cancer.

    PubMed

    Jones, Dominic; Noble, Martin; Wedge, Steve R; Robson, Craig N; Gaughan, Luke

    2017-02-16

    Androgen receptor variants (AR-Vs) provide a mechanism of therapy evasion in castrate-resistant prostate cancer (CRPC), yet mechanisms of regulation remain largely unknown. Here we investigate the role of Aurora A kinase on AR-Vs in models of CRPC and show depletion of Aurora A reduces AR-V target gene expression. Importantly, knockdown of Aurora A reconfigures splicing of AR pre-mRNA to discriminately down-regulate synthesis of AR-V transcripts, including AR-V7, without effecting full-length AR mRNA; and as a consequence, AR-V-driven proliferation and survival of CRPC cells is markedly reduced. Critically, these effects are reproduced by Aurora A inhibition. We show that Aurora A levels increase in advanced disease and AURKA is an AR-V target gene demonstrating a positive feedback mechanism of androgenic signalling in CRPC. In all, our data suggests that Aurora A plays a pivotal role in regulation of AR-V7 expression and represents a new therapeutic target in CRPC.

  12. [A survey on the use of patent expired drugs in psychiatric disorders: the psychiatrists' and neurologists' opinion and competence].

    PubMed

    Bersani, Giuseppe

    2015-01-01

    The use of generic drugs is an increasing phenomenon in Italy, as well as in most other Countries. In front of this, the level of information of medical doctors about their characteristics is still frequently uncompletely defined and insufficiently documented. The Survey "InfoMind" explored by an on line questionnaire the level of knowledge and the principal modes of use of generic drugs in a wide group of Italian Psychiatrists and Neurologists. The attention was focused on the use of generic drugs both in general and in the field of antidepressant treatments. In the group of participants (246) who fulfilled the questionnaire, a valid degree of attention to the critical issues related to the use of generic drugs and a variable level of information with respect to the explored areas were found. Main topics of discordant opinions were those of the pharmacokinetic differences among generic and original drugs, the related potential influence on clinical response, the regulatory rules on production and quality control of generic drugs respect to original. The main issues emerged as critical also respect the use of antidepressant drugs. Also the opinions regarding the legal implications of the choice of prescribed drugs appear variable and of the greatest interest.

  13. Long-term efficacy and toxicity of abacavir/lamivudine/nevirapine compared to the most prescribed ARV regimens before 2013 in a French Nationwide Cohort Study.

    PubMed

    de Boissieu, Paul; Dramé, Moustapha; Raffi, François; Cabie, André; Poizot-Martin, Isabelle; Cotte, Laurent; Garraffo, Rodolphe; Delobel, Pierre; Huleux, Thomas; Rey, David; Bani-Sadr, Firouzé

    2016-09-01

    Data on the long-term efficacy and safety of abacavir/lamivudine (ABC/3TC) and nevirapine (NVP) are scarce. This combination has the advantage of simplifying treatment and improving long-term tolerance. The aim of this study was to compare the rate of any discontinuation of antiretroviral (ARV) regimen because of virologic failure (VF), and/or adverse drug reaction (ADR) among patients receiving stable ARV regimens for at least 6 months.ABC/3TC/NVP was compared to ABC/3TC with either ritonavir-boosted darunavir (DRV/r) or ritonavir-boosted atazanavir (ATV/r), unboosted ATV, or tenofovir/emtricitabine (TDF/FTC) with either one of the following: ATV/r, unboosted ATV, DRV/r, efavirenz (EFV), or NVP, in the French prospective multicenter Dat'AIDS cohort.The study enrolled 16,511 patients treated with following ARV regimens: ABC/3TC/NVP (n = 1089), TDF/FTC/NVP (n = 1542), ABC/3TC/DRV/r (n = 1065), ABC/3TC/ATV/r (n = 1847), ABC/3TC/ATV (n = 563), TDF/FTC/ATV/r (n = 3519), TDF/FTC/DRV/r (n = 2767), TDF/FTC/ATV (n = 419), and TDF/FTC/EFV (n = 3700). Mean follow-up was 36 ± 24 months. Patients treated with ABC/3TC/NVP received this regimen as a switch regimen in 97% of cases. By multivariable analysis, the risk of treatment discontinuation due to VF was similar between ABC/3TC/NVP and other ARV regimens, except for TDF/FTC/ATV and ABC/3TC/ATV, which were associated with a higher risk of treatment interruption due to VF (hazard ratio [HR] 1.99; 95% confidence interval [CI] 1.29-3.06 and HR 2.19; 95% CI 1.51-3.18, respectively). Treatment discontinuation due to ADR was lowest with the ABC/3TC/NVP regimen. Other ARV regimens were associated with a 1.80- to 3.19-fold increase in the risk of treatment discontinuation due to ADR (P < 0.0001 for all comparisons).ABC/3TC/NVP as a simplification regimen is a long-term effective regimen with lower discontinuation due to long-term toxicity compared with other standard ARV regimens.

  14. CUDC-101, a Novel Inhibitor of Full-Length Androgen Receptor (flAR) and Androgen Receptor Variant 7 (AR-V7) Activity: Mechanism of Action and In Vivo Efficacy.

    PubMed

    Sun, Huiying; Mediwala, Sanjay N; Szafran, Adam T; Mancini, Michael A; Marcelli, Marco

    2016-06-01

    Castration-resistant prostate cancer (CRPC) is an androgen receptor (AR)-dependent disease expected to cause the death of more than 27,000 Americans in 2015. There are only a few available treatments for CRPC, making the discovery of new drugs an urgent need. We report that CUDC-101 (an inhibitor od HER2/NEU, EGFR and HDAC) inhibits both the full length AR (flAR) and the AR variant AR-V7. This observation prompted experiments to discover which of the known activities of CUDC-101 is responsible for the inhibition of flAR/AR-V7 signaling. We used pharmacologic and genetic approaches, and found that the effect of CUDC-101 on flAR and AR-V7 was duplicated only by other HDAC inhibitors, or by silencing the HDAC isoforms HDAC5 and HDAC10. We observed that CUDC-101 treatment or AR-V7 silencing by RNAi equally reduced transcription of the AR-V7 target gene, PSA, without affecting viability of 22Rv1 cells. However, when cellular proliferation was used as an end point, CUDC-101 was more effective than AR-V7 silencing, raising the prospect that CUDC-101 has additional targets beside AR-V7. In support of this, we found that CUDC-101 increased the expression of the cyclin-dependent kinase inhibitor p21, and decreased that of the oncogene HER2/NEU. To determine if CUDC-101 reduces growth in a xenograft model of prostate cancer, this drug was given for 14 days to castrated male SCID mice inoculated with 22Rv1 cells. Compared to vehicle, CUDC-101 reduced xenograft growth in a statistically significant way, and without macroscopic side effects. These studies demonstrate that CUDC-101 inhibits wtAR and AR-V7 activity and growth of 22Rv1 cells in vitro and in vivo. These effects result from the ability of CUDC-101 to target not only HDAC signaling, which was associated with decreased flAR and AR-V7 activity, but multiple additional oncogenic pathways. These observations raise the possibility that treatment of CRPC may be achieved by using similarly multi-targeted approaches.

  15. ARV Re-Entry Module Aerodynmics And Aerothermodynamics

    NASA Astrophysics Data System (ADS)

    Scheer, Heloise; Tran, Philippe; Berthe, Philippe

    2011-05-01

    Astrium-ST is the prime contractor of ARV phase A and is especially in charge of designing the Reentry Module (RM). The RM aeroshape has been defined following a trade-off. High level system requirements were derived with particular attention paid on minimum lift-over-drag ratio, trim incidence, centre-of-gravity lateral off-set and box size, volumetric efficiency, attitude at parachute deployment, flight heritage and aeroheating. Since moderate cross-range and thus L/D ratio were required, the aeroshape trade-off has been performed among blunt capsule candidates. Two front- shield families were considered: spherical (Apollo/ARD/Soyuz type) and sphero-conical (CTV type) segment front-shield. The rear-cone angle was set to 20° for internal pressurized volume and accommodation purposes. Figures of merit were assessed and a spherical front- shield of ARD type with a 20° rear-cone section was selected and proposed for further investigations. Maximum benefits will be taken from ARD flight heritage. CFD and WTT campaigns plans will be presented including preliminary results.

  16. 75 FR 20561 - Patent Term Extension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... drug products, medical devices, food additives, and color additives are eligible for extension. The..., or a method of manufacturing the approved product. In addition, the application for patent term.... The term of a patent which claims a product, a method of using a product, or a method of...

  17. AR-v7 protein expression is regulated by protein kinase and phosphatase.

    PubMed

    Li, Yinan; Xie, Ning; Gleave, Martin E; Rennie, Paul S; Dong, Xuesen

    2015-10-20

    Failure of androgen-targeted therapy and progression of castration-resistant prostate cancer (CRPC) are often attributed to sustained expression of the androgen receptor (AR) and its major splice variant, AR-v7. Although the new generation of anti-androgens such as enzalutamide effectively inhibits AR activity, accumulating pre-clinical and clinical evidence indicates that AR-v7 remains constitutively active in driving CRPC progression. However, molecular mechanisms which control AR-v7 protein expression remain unclear. We apply multiple prostate cancer cell models to demonstrate that enzalutamide induces differential activation of protein phosphatase-1 (PP-1) and Akt kinase depending on the gene context of cancer cells. The balance between PP-1 and Akt activation governs AR phosphorylation status and activation of the Mdm2 ubiquitin ligase. Mdm2 recognizes phosphorylated serine 213 of AR-v7, and induces AR-v7 ubiquitination and protein degradation. These findings highlight the decisive roles of PP-1 and Akt for AR-v7 protein expression and activities when AR is functionally blocked.

  18. [Global patent overview of Ginkgo biloba preparation].

    PubMed

    Cheng, Xin-Min; Lei, Hai-Min; Liu, Wei

    2013-09-01

    With related global patent data as analysis samples, worldwide patent overview of Ginkgo biloba preparation is analyzed in application, applicant, technical distribution and so on. This research shows that the most important areas of G. biloba preparation are Europe and China. The European applicants start earliest along with developing smoothly, moreover, their patents have best quality. The Chinese applicants start late along with the fastest growing, and have already certain research capabilities, moreover, their patents' quality needs to be improved. This research result provides reference for development of G. biloba preparation. The author suggest that Chinese applicants learn techniques and layout experiences of other's patents fully to enhance the level of new drug development and patent protection.

  19. Are Patents Impeding Medical Care and Innovation?

    PubMed Central

    Gold, E. Richard; Kaplan, Warren; Orbinski, James; Harland-Logan, Sarah; N-Marandi, Sevil

    2010-01-01

    Background to the debate: Pharmaceutical and medical device manufacturers argue that the current patent system is crucial for stimulating research and development (R&D), leading to new products that improve medical care. The financial return on their investments that is afforded by patent protection, they claim, is an incentive toward innovation and reinvestment into further R&D. But this view has been challenged in recent years. Many commentators argue that patents are stifling biomedical research, for example by preventing researchers from accessing patented materials or methods they need for their studies. Patents have also been blamed for impeding medical care by raising prices of essential medicines, such as antiretroviral drugs, in poor countries. This debate examines whether and how patents are impeding health care and innovation. PMID:20052274

  20. 75 FR 17142 - Determination of Regulatory Review Period for Purposes of Patent Extension; LUSEDRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase...

  1. 75 FR 17415 - Determination of Regulatory Review Period for Purposes of Patent Extension; FANAPT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase...

  2. Of patents and patent disputes: The TNFα patent files. Part 1: Humira.

    PubMed

    Storz, Ulrich

    2017-01-01

    This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.

  3. Patenting medical inventions.

    PubMed

    Schwertner, H A

    1994-12-01

    Medical, dental, nursing, and biomedical personnel often perform critical research that can lead to patents. Similarly, patentable discoveries can be made during the normal course of medical practice, e.g., the development of new biocompatible polymers, improved dental materials, new or modified catheters, new laboratory diagnostic tests, and improved medical devices. Many inventions may not be patented in federal organizations due to the lack of information available on the patenting process. In this article, the financial benefits that can be derived from patenting inventions are discussed, as well as the different types of patents that can be obtained, the conditions for patentability, bars or restrictions to obtaining a patent, the importance of proper record keeping, and the steps to take toward getting an invention patented.

  4. Recent survey on nanosuspension: a patent overview.

    PubMed

    Jethara, Sahilhusen I; Patel, Alpesh D; Patel, Mukesh R; Patel, Mukesh S; Patel, Kanu R

    2015-01-01

    The major goals of designing nanosuspension of nanosize materials are increasing due to their tremendous potential as a drug delivery system with the wide range of applications. Nanosuspension is a unique tool for improving the bioavailability of poorly soluble drugs. Nanosuspension drug delivery has wide range of application like oral, injectable, transdermal, inhalation, peroral, ocular, pulmonary and topical etc. by improviing the bioavailability, reducing the dose, gastric irritation, decreasing intra subject variability and increasing adhesivness with intestinal membrane. Recently, nanosuspension has been received much interest as a way to resolve solubility and stability problem because of their cost-effectiveness and technical simplicity compare to other liposome and colloidal drug carriers. Nanosuspensions are engaged to control particle size, surface properties and release of pharmacologically active agents in order to achieve the site-specific action of the drug at the therapeutically optimal rate, improve the bioavaibility of drug with poor solubility and dose regimen. Application and preparation method of nanosuspension has been reported by research articles and patented in different countries. Most of the marketed nanosuspensions are in preclinical and clinical based study for its application. More than 100 patents have been published on nanosuspensions by the recent days. This patent reviews covers different methods of pharmaceutical preparation and applications in drug delivery as well as the recent marketed published or granted patent surveys. This patent review is useful in enhance the knowledge of controlled drug delivery and applications.

  5. Patents, medicine, and the interests of patients: applying general principles to gene patenting.

    PubMed

    2003-01-01

    New technologies and the translation of research into clinical medicine are essential to patient care. Those who develop useful drugs, diagnostic and screening tests, and medical technologies have the right to expect a fair return for their efforts and risks. Current interpretations of patent law (particularly regarding gene patenting), however, have the potential to impede both medical advances and patient care. Patenting policies must balance the open exchange and use of information with making the pursuit of such knowledge financially rewarding. The Committee on Ethics and the Committee on Genetics of the American College of Obstetricians and Gynecologists maintain that patents on medical or surgical procedures are ethically unacceptable. Physicians may obtain patents on surgical and diagnostic instruments that they have developed, but such instruments should be made available to others at a fair and reasonable cost. Patents for genes as "compositions of matter" enable patent holders to control future applications of the genes and should not be granted. Patents should be granted only for specified uses or applications of genes or sequences. If composition-of-matter patents on genes continue to be enforceable, such patents on genes with clinical applications should be subject to federal regulation and oversight to ensure availability on reasonable terms for research and clinical use.

  6. Comprehensive quantitative analysis of Chinese patent drug YinHuang drop pill by ultra high-performance liquid chromatography quadrupole time of flight mass spectrometry.

    PubMed

    Wong, Tin-Long; An, Ya-Qi; Yan, Bing-Chao; Yue, Rui-Qi; Zhang, Tian-Bo; Ho, Hing-Man; Ren, Tian-Jing; Fung, Hau-Yee; Ma, Dik-Lung; Leung, Chung-Hang; Liu, Zhong-Liang; Pu, Jian-Xin; Han, Quan-Bin; Sun, Han-Dong

    2016-06-05

    YinHuang drop pill (YHDP) is a new preparation, derived from the traditional YinHuang (YH) decoction. Since drop pills are one of the newly developed forms of Chinese patent drugs, not much research has been done regarding the quality and efficacy. This study aims to establish a comprehensive quantitative analysis of the chemical profile of YHDP. ultra high-performance liquid chromatography quadrupole time of flight mass spectrometry (UHPLC-Q-TOF-MS/MS) was used to identify 34 non-sugar small molecules including 15 flavonoids, 9 phenolic acids, 5 saponins, 1 iridoid, and 4 iridoid glycosides in YHDP samples, and 26 of them were quantitatively determined. Sugar composition of YHDP in terms of fructose, glucose and sucrose was examined via a high performance liquid chromatography-evaporative light scattering detector on an amide column (HPLC-NH2P-ELSD). Macromolecules were examined by high performance gel permeation chromatography coupled with ELSD (HPGPC-ELSD). The content of the drop pill's skeleton component PEG-4000 was also quantified via ultra-high performance liquid chromatography coupled with charged aerosol detector (UHPLC-CAD). The results showed that up to 73% (w/w) of YHDP could be quantitatively determined. Small molecules accounted for approximately 5%, PEG-4000 represented 68%, while no sugars or macromolecules were found. Furthermore, YHDP showed no significant differences in terms of daily dosage, compared to YinHuang granules and YinHuang oral liquid; however, it has a higher small molecules content compared to YinHuang lozenge.

  7. Modern evaluation of patents

    NASA Astrophysics Data System (ADS)

    Ignat, V.

    2016-08-01

    The number of patents is not so important as the market value. The market value is especially important for licensing of patents, make-or-buy decisions for technology procurement, corporate finance. Patents can be used as collateral for financing. Patents and credit approvals: without patents only 46% and with patents 54%. The value share of knowledge-based components to industrial products already reached 50% and it is still rising. OECD called these developments under the slogan "knowledge economy”. German Norm-DIN 77100 provides a working method for monetary evaluation of a patent. The value of a patent arises from its use. A patent can be used to protect or to earn licensing revenues. An evaluation expertise is required in areas, such as marketing, finance, R & D and strategic planning. As an indicator of the value of a patent is often used the number of citations. The number of a patent citation refers to its meaning and value. Other indicators would be: size of the patent family, validity of the patent, result of objections against patent application, number and quality of claims. The analysis of 9.000 patents resulted that only 7.2% worth over 10 million euro and 68% below 1 million euro. The cost method: it is considered the cost that would be incurred for the development and patenting of a similar invention. The market method: are used the prices that have been achieved in comparable with recently transactions. The Income method: the potential reward is measured, which can arise from a patent. The evaluation will be in the following areas: legal status, technology, market conditions, finance and strategy. Each question relates to a different parameter of a value.

  8. Academic Patents and Access to Medicines in Developing Countries

    PubMed Central

    2009-01-01

    There is a widespread and growing concern that patents hinder access to life-saving drugs in developing countries. Recent student movements and legislative initiatives emphasize the potential role that research universities in developed countries could have in ameliorating this “access gap.” These efforts are based on the assumption that universities own patents on a substantial number of drugs and that patents on these drugs are currently filed in developing countries. I provide empirical evidence regarding these issues and explore the feasibility and desirability of proposals to change university patenting and licensing practices to promote access to medicines in the developing world. PMID:19008514

  9. Whole-genome patenting.

    PubMed

    O'Malley, Maureen A; Bostanci, Adam; Calvert, Jane

    2005-06-01

    Gene patenting is now a familiar commercial practice, but there is little awareness that several patents claim ownership of the complete genome sequence of a prokaryote or virus. When these patents are analysed and compared to those for other biological entities, it becomes clear that genome patents seek to exploit the genome as an information base and are part of a broader shift towards intangible intellectual property in genomics.

  10. [Patenting human genes].

    PubMed

    Brdicka, R

    2002-05-10

    The problem of patenting of human genes, which was discussed at the Workshop organized by OECD, has become very actual due to granted patents that concern testing of genetic disposition for breast cancer. Companies that had made large investments into this research clearly support patenting of their discoveries. But such patents can reduce general accessibility of genetic testing. Existing laws, and namely the Directive of the European Council unfortunately are not unambiguous and allow rather free explanation.

  11. Universities That Litigate Patents

    ERIC Educational Resources Information Center

    Rooksby, Jacob H.

    2012-01-01

    American research universities frequently obtain and license patents to their faculty members' inventions. While university licensing is carefully tracked and thoroughly studied, little is known about university decisions to assertively litigate their patents through filing patent infringement lawsuits in federal court. Which universities…

  12. Antiretroviral drugs: Critical issues and recent advances

    PubMed Central

    Desai, Mira; Iyer, Geetha; Dikshit, R. K.

    2012-01-01

    Human immunodeficiency virus (HIV) infection is now recognized as a chronic illness. Although the success of highly active antiretroviral therapy is beyond question, several issues still persist. Since the drugs cannot eradicate the virus, cure is not yet possible, and patients have to maintain a lifelong adherence with the risk of toxic effects, drug-drug interactions and drug resistance. A clear understanding of the viral replication and its interaction with host cell factors has led to the development of a large number of effective antiretroviral drugs (ARVs). New drugs in the existing class such as apricitabine, elvucitabine and etravirine have shown promising results against HIV isolates resistant to first line drugs. These drugs have offered a new choice for patients with drug resistant disease. However, the impact of their long term use on safety is yet to be assessed. Novel drugs with unique mechanism of action such as CD4 receptor attachment inhibitors, maturation inhibitors, pharmacokinetic enhancers, capsid assembly inhibitors and lens epithelium derived growth factor inhibitors are still under development. Currently, ARVs, especially tenofovir and emtricitabine, are also being evaluated for prevention of sexual transmission of HIV-1. The initial results of an HIV prevention trial network are encouraging and have recommended the use of ARVs for pre-exposure prophylaxis. Thus, ARVs form the key component of HIV prevention and treatment strategy. This article discusses the challenges associated with HIV-1 treatment and updates several major advances in the development of ARVs. PMID:22701234

  13. India: Court finds government has constitutional obligation to provide ARVs to released prisoner.

    PubMed

    Mysko, Barbara

    2004-12-01

    On 5 May 2004 the High Court of Delhi upheld an HIV-positive person's fundamental right to access treatment and medicines. This is a significant decision, given the number of people in India estimated to be infected with HIV. The decision will have implications for the government's rollout of antiretroviral (ARV) therapy.

  14. Mind the gap: access to ARV medication, rights and the politics of scale in South Africa.

    PubMed

    Jones, Peris Sean

    2012-01-01

    Global access to anti-retroviral medication (ARVs) has increased exponentially in recent years. As a relatively recent phenomenon for the global South, much knowledge is being added, but analysis of 'access' to ARVs remains partial. The main research objective of this article is to gain a fuller picture of the range of forces constituting 'access' to ARVs by providing a local community case study from Hammanskraal, South Africa. A qualitative and relational approach situates specific points of 'local' access to ARVs within relations stretched over space. Spatial awareness enables us to consider the reinforcing effects of local geographies upon access to health care but also simultaneously sees this in relation to non-local geographies. The concept of scale is pivotal to creating linkages across space and reveals a number of 'gaps' in access that otherwise might not be shown. Elaborating on the meaning of "access" to treatment produces a more rounded picture of the context that people-living-with-AIDS encounter. A multi-scale and multi-disciplinary analysis of 'access' is therefore also highly informative in a related sense, namely, for closing the gap between human rights standards and actual implementation. A geographical imagination is useful not only to 'mind' but also to close the 'gap' in both senses.

  15. [Patents on life? No patent on life!].

    PubMed

    van Raden, L

    1998-03-01

    Inventions related to living material are in principle patentable as well as inventions in the "classical" fields of technology as long as they are new, industrially applicable and involve an inventive step. A patent gives to its owner for a limited period of time the exclusive right to prevent others from using his patented new technical know-how. Starting point of patent protection in the field of genetic engineering is a genetic information or a genetically induced characteristic of an organism; there is no such thing as a "Patent on Life". As far as inventions relate to genetically modified organisms, patents give to their owners no additional property rights that might exclude the applicability e.g. of the laws on animal protection. Intellectual property like any other property is subject to the limits set up by law. It is neither scientifically correct nor does it help in finding a solution for the conflict within society to shift the--undoubtedly necessary--discussion about research and application in the field of genetic engineering to a discussion about patent law.

  16. 76 FR 36548 - Determination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... patented item (human drug product, animal drug product, medical device, food additive, or color additive... the face and scalp in immunocompetent patients when used in conjunction with lesion preparation in the.... Patent No. 6,034,267) from PhotoCure ASA, and the Patent and Trademark Office requested FDA's...

  17. Droplet Digital PCR Based Androgen Receptor Variant 7 (AR-V7) Detection from Prostate Cancer Patient Blood Biopsies.

    PubMed

    Ma, Yafeng; Luk, Alison; Young, Francis P; Lynch, David; Chua, Wei; Balakrishnar, Bavanthi; de Souza, Paul; Becker, Therese M

    2016-08-04

    Androgen receptor splice variant V7 (AR-V7) was recently identified as a valuable predictive biomarker in metastatic castrate-resistant prostate cancer. Here, we report a new, sensitive and accurate screen for AR-V7 mRNA expression directly from circulating tumor cells (CTCs): We combined EpCAM-based immunomagnetic CTC isolation using the IsoFlux microfluidic platform with droplet digital polymerase chain reaction (ddPCR) to analyze total AR and AR-V7 expression from prostate cancer patients CTCs. We demonstrate that AR-V7 is reliably detectable in enriched CTC samples with as little as five CTCs, even considering tumor heterogeneity, and confirm detection of AR-V7 in CTC samples from advanced prostate cancer (PCa) patients with AR-V7 detection limited to castrate resistant disease status in our sample set. Sensitive molecular analyses of circulating tumor cells (CTCs) or circulating tumor nucleic acids present exciting strategies to detect biomarkers, such as AR-V7 from non-invasive blood samples, so-called blood biopsies.

  18. Patent Deployment Strategies and Patent Value in LED Industry

    PubMed Central

    Wu, Ming-Fu; Chang, Keng-Wei; Zhou, Wei; Hao, Juan; Yuan, Chien-Chung; Chang, Ke-Chiun

    2015-01-01

    This study applies two variables in the measurement of company patent deployment strategies: patent family depth and earn plan ratio. Patent family depth represents the degree to which certain fields and markets are valued by the patent owner. Earn plan ratio defined as the ratio of the number of patent forward citations to patent family size. Earn plan ratio indicates the degree to which a patent family could be cited by later innovators and competitors. This study applies a logistic regression model in the analysis LED industry data. The results demonstrate that patent value has a positive relationship with the patent family depth, and earn plan ratio. PMID:26098313

  19. 37 CFR 1.720 - Conditions for extension of patent term.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... or a veterinary biological product that is not covered by the claims in any other patent that has... patent that claims a new animal drug or a veterinary biological product that is not covered by the...

  20. Patent indicators: a window to pharmaceutical market success.

    PubMed

    Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

    2013-07-01

    Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.

  1. Tubulin inhibitors: a patent survey.

    PubMed

    Nepali, Kunal; Ojha, Ritu; Sharma, Sahil; Bedi, Preet M S; Dhar, Kanaya L

    2014-05-01

    Tubulin is one of the most useful and strategic molecular targets for anticancer drugs. The dynamic process of microtubule assembly and disassembly can be blocked by various agents that bind to distinct sites in the β-tubulin subunit. By interfering with microtubule function in vitro, these agents arrest cells in mitosis, eventually leading to cell death, by both apoptosis and necrosis. So far, three binding domains have been identified a) the colchicine site close to the α/β interface, b) the area where the vinca alkaloids bind, and c) the taxane-binding pocket. This review compiles the patent literature up to 2013 and offers a detailed account of all the advances on Tubulin inhibitors (lead molecules) along with in depth knowledge about the number of novel scaffolds, modified analogs and derivatives of the lead molecules. Colchicine binding site remains the most explored site indicated by the patent survey as majority of the patents revolves around phenstatin and combretastatin based molecules where the key structural feature for tubulin inhibition is an appropriate arrangement of the two aromatic rings at an appropriate distance and optimal dihedral angle maximizing interactions with tubulin. A brief account of promising tubulin inhibitors in stages of clinical development and some strategies for the development of potent molecules overcoming the problem of drug resistance have also been discussed.

  2. Regulation and the circulation of knowledge: penicillin patents in Spain.

    PubMed

    Romero de Pablos, Ana

    2011-01-01

    This paper tells the early history of penicillin patenting in Spain. Patents turn out to be useful instruments for analysing the management of knowledge and its circulation in different professional and geographical domains. They protected knowledge while contributing to standardisation. Patents also ensured quality and guaranteed reliability in manufacturing, delivering and prescribing new drugs. They gained special prominence by allowing the creation of a network in which political, economic and business, industrial power, public health and international cooperation fields came together. The main source of information used for this purpose has been the earliest patent applications for penicillin in Spain between 1948 and 1950, which are kept in the Historical Archives of the Oficina Española de Patentes y Marcas. The study of these patents for penicillin shows their role as agents in introducing this drug in Spain.

  3. AR-V7 and prostate cancer: The watershed for treatment selection?

    PubMed

    Ciccarese, Chiara; Santoni, Matteo; Brunelli, Matteo; Buti, Sebastiano; Modena, Alessandra; Nabissi, Massimo; Artibani, Walter; Martignoni, Guido; Montironi, Rodolfo; Tortora, Giampaolo; Massari, Francesco

    2016-02-01

    The androgen receptor (AR) plays a key role in progression to metastatic castration-resistant prostate cancer (mCRPC). Despite the recent progress in targeting persistent AR activity with the next-generation hormonal therapies (abiraterone acetate and enzalutamide), resistance to these agents limits therapeutic efficacy for many patients. Several explanations for response and/or resistance to abiraterone acetate and enzalutamide are emerging, but growing interest is focusing on importance of AR splice variants (AR-Vs) and in particular of AR-V7. Increasing evidences highlight the concept that variant expression could be used as a potential predictive biomarker and a therapeutic target in advanced prostate cancer. Therefore, understanding the mechanisms of treatment resistance or sensitivity can help to achieve a more effective management of mCRPC, increasing clinical outcomes and representing a promising and engaging area of prostate cancer research.

  4. 37 CFR 1.5 - Identification of patent, patent application, or patent-related proceeding.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Identification of patent, patent application, or patent-related proceeding. 1.5 Section 1.5 Patents, Trademarks, and Copyrights..., the title of the invention, the date of filing the same, and, if known, the group art unit or...

  5. 37 CFR 1.5 - Identification of patent, patent application, or patent-related proceeding.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Identification of patent, patent application, or patent-related proceeding. 1.5 Section 1.5 Patents, Trademarks, and Copyrights..., the title of the invention, the date of filing the same, and, if known, the group art unit or...

  6. 37 CFR 1.5 - Identification of patent, patent application, or patent-related proceeding.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Identification of patent, patent application, or patent-related proceeding. 1.5 Section 1.5 Patents, Trademarks, and Copyrights..., the title of the invention, the date of filing the same, and, if known, the group art unit or...

  7. 37 CFR 1.5 - Identification of patent, patent application, or patent-related proceeding.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Identification of patent, patent application, or patent-related proceeding. 1.5 Section 1.5 Patents, Trademarks, and Copyrights..., the title of the invention, the date of filing the same, and, if known, the group art unit or...

  8. 37 CFR 1.5 - Identification of patent, patent application, or patent-related proceeding.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Identification of patent, patent application, or patent-related proceeding. 1.5 Section 1.5 Patents, Trademarks, and Copyrights..., the title of the invention, the date of filing the same, and, if known, the group art unit or...

  9. 77 FR 20829 - Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of... the extension of patents which claim that human drug product. ADDRESSES: Submit electronic comments to... patented item (human drug product, animal drug product, medical device, food additive, or color...

  10. Environmentally conscious patent histories

    NASA Astrophysics Data System (ADS)

    Crouch, Dennis D.; Crouch, Henry L.

    2004-02-01

    There is a need for investigators, legislators, and business leaders to understand the magnitude of innovation and discovery in the field of environmentally conscious technologies (ECTs). Knowledge of the "big picture" is important to providing a national and global account of actual environmental stewardship over the last twenty-five years. A recitation of the Environmental Protection Agency (EPA) supported Acts which have been enacted into law reveals one facet of the multifaceted dynamic of environmental consciousness. The popular discussion and debate, as well as partisan lobbying, which created the political forces leading to environmentally conscious legislation is another facet. A third facet is the corporate response to the threats and opportunities predicted by CEO"s and others through environmental scanning. This paper examines changes in environmentally conscious inventive effort by comparing data from United States Patents issued from 1976 through 2003. Patents are useful tool for measuring technological innovation because they are publicly available records of innovative activity. Although not all inventions result in patent applications, the monopoly rights granted on the invention give the inventor a strong incentive to obtain patents on any viable product or process. Among the results, we found a significant increase in patents relating to environmentally conscious products and processes during the period in question. Specifically, a dramatic increase in patent activity was seen for the decade of the 1990"s. Surprisingly, the patenting rate from 2000 to 2003 seems to have stabilized. Additionally public discussion of ECTs appears to have a positive impact on patent filings.

  11. Searching bioremediation patents through Cooperative Patent Classification (CPC).

    PubMed

    Prasad, Rajendra

    2016-03-01

    Patent classification systems have traditionally evolved independently at each patent jurisdiction to classify patents handled by their examiners to be able to search previous patents while dealing with new patent applications. As patent databases maintained by them went online for free access to public as also for global search of prior art by examiners, the need arose for a common platform and uniform structure of patent databases. The diversity of different classification, however, posed problems of integrating and searching relevant patents across patent jurisdictions. To address this problem of comparability of data from different sources and searching patents, WIPO in the recent past developed what is known as International Patent Classification (IPC) system which most countries readily adopted to code their patents with IPC codes along with their own codes. The Cooperative Patent Classification (CPC) is the latest patent classification system based on IPC/European Classification (ECLA) system, developed by the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) which is likely to become a global standard. This paper discusses this new classification system with reference to patents on bioremediation.

  12. Transdermal delivery: product and patent update.

    PubMed

    Gupta, Himanshu; Babu, R J

    2013-12-01

    Transdermal drug delivery is an attractive alternative to the oral and parenteral drug delivery. Drugs which are prone to first-pass metabolism can be delivered easily in small doses with sustained blood levels through this method. An update to available products along with a review of clinical trials and patents are discussed in this study. In this review, we have compiled 16 drugs, i.e. Buprenorphine, Clonidine, Estradiol, Fentanyl, Granisetron, Lidocaine, Methylphenidate, Nicotine, Nitroglycerin, Oxybutynin, Rivastigmine, Rotigotine, Scopolamine, Selegiline, Testosterone, Influenza virus vaccine (Microneedle) and covering about 22 marketed products on the transdermal system. We present instrumental information on them along with the compilation of current clinical trials on transdermal systems. We summarize the contents of patents granted in last 5 years under different pharmacological categories. This article serves, accordingly as a source of available information focused on transdermal drug delivery research.

  13. Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

    PubMed Central

    Beall, Reed F.; Nickerson, Jason W.; Kaplan, Warren A.; Attaran, Amir

    2016-01-01

    Background Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. Materials and Methods We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents. Results Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years). Conclusion Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent

  14. Trends in nanotechnology patents applied to the health sector.

    PubMed

    Antunes, Adelaide Maria de Souza; Alencar, Maria Simone de Menezes; da Silva, Cicera Henrique; Nunes, Jeziel; Mendes, Flavia Maria Lins

    2012-01-01

    The aim of the article is to present a method for identifying trends in patent applications for nanotechnology applied to the health sector around the world, based on the International Patent Classification. This classification divides the sector into: dental care, drugs, diagnostic kits, and medical apparatus & medical care. The Derwent database was mined for patent documents using nanotechnology terms associated with the IPC subclasses from the health subsectors. The number of patents was found to be rising, led by the United States, particularly universities and R centers. In the dental care subsector, nanotechnology was found to be used in composite material for manufacturing dental appliances. In drugs, the focus is on the use of nanoparticulate compositions comprising agents that are useful for a variety of diseases. In diagnostic kits, nanostructures have been patented that are capable of detecting target analytes. Meanwhile, in medical apparatus & medical care, patent applications have been made for nanocapsules and/or nanocomposite materials inserted in devices and guide catheters. A study was also made of patents in Brazil, where the same assignees and the same country (United States) as in the survey of global patents were found to be the leading patent applicants / holders.

  15. An empirical analysis of primary and secondary pharmaceutical patents in Chile.

    PubMed

    Abud, María José; Hall, Bronwyn; Helmers, Christian

    2015-01-01

    We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between "primary" (active ingredient) and "secondary" patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate "older" therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents.

  16. Internet Patent Databases: Everyone Is a Patent Searcher Now.

    ERIC Educational Resources Information Center

    Wohrley, Andrew A.; Mitchell, Cindy

    1997-01-01

    Patent information has never been so available, at such low cost, to so many people. Describes patent databases accessible on the Web (Micropatent, Source Translation and Optimization Questel-Orbit QPAT, Internet Patents/Community of Science, and the U.S. Patent and Trademark Office), lists their strengths and weaknesses, and recommends the best…

  17. Ownership of knowledge--the role of patents in pharmaceutical R&D.

    PubMed

    Correa, Carlos María

    2004-10-01

    Both the public and the private sectors contribute to research and development (R&D) in pharmaceuticals. The public sector originates many of the discoveries of new drugs. The private sector, which focuses on development, is heavily reliant on patents. Though patents are presumed to reward genuine inventions, lax rules on patentability and shortcomings in procedures permit protection to be obtained on a myriad of minor developments. These patents, though weak and possibly invalid in many cases, are used to restrain competition and delay the entry of generic competition. Developing countries should design and implement their patent laws so as to prevent strategic patenting and promote competition and access to medicines.

  18. Ownership of knowledge--the role of patents in pharmaceutical R&D.

    PubMed Central

    Correa, Carlos María

    2004-01-01

    Both the public and the private sectors contribute to research and development (R&D) in pharmaceuticals. The public sector originates many of the discoveries of new drugs. The private sector, which focuses on development, is heavily reliant on patents. Though patents are presumed to reward genuine inventions, lax rules on patentability and shortcomings in procedures permit protection to be obtained on a myriad of minor developments. These patents, though weak and possibly invalid in many cases, are used to restrain competition and delay the entry of generic competition. Developing countries should design and implement their patent laws so as to prevent strategic patenting and promote competition and access to medicines. PMID:15643801

  19. Patenting malarial vaccine.

    PubMed

    Wiwanitkit, Viroj

    2008-01-01

    Malaria is an important tropical infection affecting millions of world population each year. Malarial vaccine development is the hope for successful control of malaria. Knowledge on malaria vaccine has been considered patentable subject for decades. Due to the present advance biotechnology, the number of patent applications related to malarial vaccine is growing exponentially. Several malarial vaccine candidates have been recently identified and the genetic manipulation of these candidates is becoming more efficient with the advancement of new biotechnologies. This review summarizes some of the recent published patents on malarial vaccines covering antigens, candidate epitopes and recombinant processing.

  20. Development of AR-V7 as a putative treatment selection marker for metastatic castration-resistant prostate cancer.

    PubMed

    Luo, Jun

    2016-01-01

    Prostate cancer cells demonstrate a remarkable "addiction" to androgen receptor (AR) signaling in all stages of disease progression. As such, suppression of AR signaling remains the therapeutic goal in systemic treatment of prostate cancer. A number of molecular alterations arise in patients treated with AR-directed therapies. These molecular alterations may indicate the emergence of treatment resistance and may be targeted for the development of novel agents for prostate cancer. The presence of functional androgen receptor splice variants may represent a potential explanation for resistance to abiraterone and enzalutamide, newer AR-directed agents developed to treat metastatic castration-resistant prostate cancer (mCRPC). In the last 8 years, many androgen receptor splice variants have been identified and characterized. Among these, androgen receptor splice variant-7 (AR-V7) has been investigated extensively. In AR-V7, the entire COOH-terminal ligand-binding domain of the canonical AR is truncated and replaced with a variant-specific peptide of 16 amino acids. Functionally, AR-V7 is capable of mediating constitutive nuclear localization and androgen receptor signaling in the absence of androgens, or in the presence of enzalutamide. In this review, we will focus on clinical translational studies involving detection/measurement of AR-V7. Methods have been developed to detect AR-V7 in clinical mCRPC specimens. AR-V7 can be reliably measured in both tissue and circulating tumor cells derived from mCRPC patients, making it possible to conduct both cross-sectional and longitudinal clinical correlative studies. Current evidence derived from studies focusing on detection of AR-V7 in mCRPC support its potential clinical utility as a treatment selection marker.

  1. The Impact of Taking or Not Taking ARVs on HIV Stigma as Reported by Persons Living with HIV Infection in Five African Countries

    PubMed Central

    Makoae, Lucy N.; Portillo, Carmen J.; Uys, Leana R.; Dlamini, Priscilla S.; Greeff, Minrie; Chirwa, Maureen; Kohi, Thecla W.; Naidoo, Joanne; Mullan, Joseph; Wantland, Dean; Durrheim, Kevin; Holzemer, William L.

    2009-01-01

    Aim This study examined the impact of taking or not taking antiretroviral (ARV) medications on stigma, as reported by people living with HIV infection in five African countries. Design A two group (taking or not taking ARVs) by three (time) repeated measures analysis of variance examined change in reported stigma in a cohort sample of 1,454 persons living with HIV infection in Lesotho, Malawi, South Africa, Swaziland, and Tanzania. Participants self-reported taking ARV medications and completed a standardized stigma scale validated in the African context. Data were collected at three points in time, from January 2006 to March 2007. Participants taking ARV medications self-reported a mean CD4 count of 273 and those not taking ARV self-reported a mean CD4 count of 418. Results Both groups reported significant decreases in total HIV stigma over time; however, people taking ARVs reported significantly higher stigma at Time 3 compared to those not taking ARVs. Discussion This study documents that this sample of 1,454 HIV infected persons in five countries in Africa reported significantly less HIV stigma over time. In addition, those participants taking ARV medications experienced significantly higher HIV stigma over time compared to those not taking ARVs. This finding contradicts some authors’ opinions that when clients enroll in ARV medication treatment it signifies that they are experiencing less stigma. This work provides caution to health care providers to alert clients new to ARV treatment that they may experience more stigma from their families and communities when they learn they are taking ARV medications. PMID:20024711

  2. Patent ductus arteriosus

    MedlinePlus

    ... the middle Patent ductus arteriosis (PDA) - series References Fraser CD, Carberry KE. Congenital heart disease. In: Townsend ... Read More Heart failure - overview Neonatal respiratory distress syndrome Pediatric heart surgery Premature infant Patient Instructions Pediatric ...

  3. Patent urachus repair

    MedlinePlus

    Patent urachal tube repair ... belly. Next, the surgeon will find the urachal tube and remove it. The bladder opening will be ... surgeon uses the tools to remove the urachal tube and close off the bladder and area where ...

  4. Retrieving Patent Information Online

    ERIC Educational Resources Information Center

    Kaback, Stuart M.

    1978-01-01

    This paper discusses patent information retrieval from online files in terms of types of questions, file contents, coverage, timeliness, and other file variations. CLAIMS, Derwent, WPI, APIPAT and Chemical Abstracts Service are described. (KP)

  5. The Advanced Re-Entry Vehicle (ARV) a Development Step from ATV Toward Manned Transportation Systems

    NASA Astrophysics Data System (ADS)

    Bottacini, M.; Berthe, P.; Vo, X.; Pietsch, K.

    2011-08-01

    The Advanced Re-entry Vehicle (ARV) programme has been undertaken by Europe with the objective to contribute to the preparation of a future European crew transportation system, while providing a valuable logistic support to the ISS through an operational cargo return system. This development would allow: - the early acquisition of critical technologies; - the design, development and testing of elements suitable for the follow up human rated transportation system. These vehicles should also serve future LEO infrastructures and exploration missions. With the aim to satisfy the above objectives a team composed by major European industries and led by EADS Astrium Space Transportation is currently conducting the phase A of the programme under contract with the European Space Agency (ESA). Two vehicle versions are being investigated: a Cargo version, transporting cargo only to/from the ISS, and a Crew version, which will allow the transfer of both crew and cargo to/from the ISS. The ARV Cargo version, in its present configuration, is composed of three modules. The Versatile Service Module (VSM) provides to the system the propulsion/GNC for orbital manoeuvres and attitude control and the orbital power generation. Its propulsion system and GNC shall be robust enough to allow its use for different launch stacks and different LEO missions in the future. The Un-pressurised Cargo Module (UCM) provides the accommodation for about 3000 kg of un-pressurised cargo and is to be sufficiently flexible to ensure the transportation of: - orbital infrastructure components (ORU's); - scientific / technological experiments; - propellant for re-fuelling, re-boost (and deorbiting) of the ISS. The Re-entry Module (RM) provides a pressurized volume to accommodate active/passive cargo (2000 kg upload/1500 kg download). It is conceived as an expendable conical capsule with spherical heat- hield, interfacing with the new docking standard of the ISS, i.e. it carries the IBDM docking system, on a

  6. The Advanced Re-Entry Vehicle (ARV) A Development Step From ATV Toward Manned Transportation Systems

    NASA Astrophysics Data System (ADS)

    Bottacini, Massimiliano; Berthe, Philippe; Vo, Xavier; Pietsch, Klaus

    2011-05-01

    The Advanced Re-entry Vehicle (ARV) programme has been undertaken by Europe with the objective to contribute to the preparation of a future European crew transportation system, while providing a valuable logistic support to the ISS through an operational cargo return system. This development would allow: - the early acquisition of critical technologies; - the design, development and testing of elements suitable for the follow up human rated transportation system. These vehicles should also serve future LEO infrastructures and exploration missions. With the aim to satisfy the above objectives a team composed by major European industries and led by EADS Astrium Space Transportation is currently conducting the phase A of the programme under contract with the European Space Agency (ESA). Two vehicle versions are being investigated: a Cargo version, transporting cargo only to/from the ISS, and a Crew version, which will allow the transfer of both crew and cargo to/from the ISS. The ARV Cargo version, in its present configuration, is composed of three modules. The Versatile Service Module (VSM) provides to the system the propulsion/GNC for orbital manoeuvres and attitude control and the orbital power generation. Its propulsion system and GNC shall be robust enough to allow its use for different launch stacks and different LEO missions in the future. The Un-pressurised Cargo Module (UCM) provides the accommodation for about 3000 kg of unpressurised cargo and is to be sufficiently flexible to ensure the transportation of: - orbital infrastructure components (ORU’s); - scientific / technological experiments; - propellant for re-fuelling, re-boost (and de-orbiting) of the ISS. The Re-entry Module (RM) provides a pressurized volume to accommodate active/passive cargo (2000 kg upload/1500 kg download). It is conceived as an expendable conical capsule with spherical heat-shield, interfacing with the new docking standard of the ISS, i.e. it carries the IBDM docking system, on

  7. [Specificities of patent protection in the pharmaceutical industry: modalities and traits of intellectual property].

    PubMed

    Jannuzzi, Anna Haydée Lanzillotti; Vasconcellos, Alexandre Guimarães; de Souza, Cristina Gomes

    2008-06-01

    Different forms of protection for inventions in the pharmaceutical industry point to strategies for the perpetuation of patent protection. Based on a literature review showing the specificities of patenting in the industry, the article provides a brief history of drug patents in Brazil, a discussion of patentable and non-patentable inventions, and the modalities and traits of patent protection that aim to extend the temporary monopoly granted under the patent. Such strategies include patents targeting polimorphs and optical isomers of drugs and drug combinations and specific clinical preparations, increasingly present in the drug patent claims filed by pharmaceutical companies. The study's objective is to discuss the specificities of drug patent claims in order to help develop expertise in the area and discuss the impact of expanding the scope of patent protection. In conclusion, while the tendency to expand towards more a permissive protective scope could produce opportunities for Brazilian national inventors, it could also be harmful to a policy for access to medicines.

  8. Confocal fluorescence microscopy: An ultra-sensitive tool used to evaluate intracellular antiretroviral nano-drug delivery in HeLa cells

    PubMed Central

    Mandal, Subhra; Zhou, You; Shibata, Annemarie; Destache, Christopher J.

    2015-01-01

    In the last decade, confocal fluorescence microscopy has emerged as an ultra-sensitive tool for real-time study of nanoparticles (NPs) fate at the cellular-level. According to WHO 2007 report, Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) is still one of the world’s major health threats by claiming approximately 7,000 new infections daily worldwide. Although combination antiretroviral drugs (cARV) therapy has improved the life-expectancy of HIV-infected patients, routine use of high doses of cARV has serious health consequences and requires complete adherence to the regimen for success. Thus, our research goal is to fabricate long-acting novel cARV loaded poly(lactide-co-glycolic acid) (PLGA) nanoparticles (cARV-NPs) as drug delivery system. However, important aspects of cARV-NPs that require special emphasis are their cellular-uptake, potency, and sustained drug release efficiency over-time. In this article, ultra-sensitive confocal microscopy is been used to evaluate the uptake and sustained drug release kinetics of cARV-NPs in HeLa cells. To evaluate with the above goal, instead of cARV-drug, Rhodamine6G dye (fluorescent dye) loaded NPs (Rho6G NPs) have been formulated. To correlate the Rhodamin6G release kinetics with the ARV release from NPs, a parallel HPLC study was also performed. The results obtained indicate that Rho6G NPs were efficiently taken up at low concentration (<500 ng/ml) and that release was sustained for a minimum of 4 days of treatment. Therefore, high drug assimilation and sustained release properties of PLGA-NPs make them an attractive vehicle for cARV nano-drug delivery with the potential to reduce drug dosage as well as the number of drug administrations per month. PMID:26221566

  9. Confocal fluorescence microscopy: An ultra-sensitive tool used to evaluate intracellular antiretroviral nano-drug delivery in HeLa cells

    NASA Astrophysics Data System (ADS)

    Mandal, Subhra; Zhou, You; Shibata, Annemarie; Destache, Christopher J.

    2015-08-01

    In the last decade, confocal fluorescence microscopy has emerged as an ultra-sensitive tool for real-time study of nanoparticles (NPs) fate at the cellular-level. According to WHO 2007 report, Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) is still one of the world's major health threats by claiming approximately 7,000 new infections daily worldwide. Although combination antiretroviral drugs (cARV) therapy has improved the life-expectancy of HIV-infected patients, routine use of high doses of cARV has serious health consequences and requires complete adherence to the regimen for success. Thus, our research goal is to fabricate long-acting novel cARV loaded poly(lactide-co-glycolic acid) (PLGA) nanoparticles (cARV-NPs) as drug delivery system. However, important aspects of cARV-NPs that require special emphasis are their cellular-uptake, potency, and sustained drug release efficiency over-time. In this article, ultra-sensitive confocal microscopy is been used to evaluate the uptake and sustained drug release kinetics of cARV-NPs in HeLa cells. To evaluate with the above goal, instead of cARV-drug, Rhodamine6G dye (fluorescent dye) loaded NPs (Rho6G NPs) have been formulated. To correlate the Rhodamin6G release kinetics with the ARV release from NPs, a parallel HPLC study was also performed. The results obtained indicate that Rho6G NPs were efficiently taken up at low concentration (<500 ng/ml) and that release was sustained for a minimum of 4 days of treatment. Therefore, high drug assimilation and sustained release properties of PLGA-NPs make them an attractive vehicle for cARV nano-drug delivery with the potential to reduce drug dosage as well as the number of drug administrations per month.

  10. 75 FR 78714 - Determination of Regulatory Review Period for Purposes of Patent Extension; ANGIOMAX

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... regulatory review period consists of two periods of time: A testing phase and an approval phase. For...

  11. 77 FR 52035 - Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... regulatory review period consists of two periods of time: A testing phase and an approval phase. For...

  12. 77 FR 26289 - Determination of Regulatory Review Period for Purposes of Patent Extension; PRADAXA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... regulatory review period consists of two periods of time: A testing phase and an approval phase. For...

  13. 75 FR 53314 - Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... applicant may receive. A regulatory review period consists of two periods of time: A testing phase and...

  14. 75 FR 17414 - Determination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA...

  15. Anticancer hybrids--a patent survey.

    PubMed

    Nepali, Kunal; Sharma, Sahil; Kumar, Dinesh; Budhiraja, Abhishek; Dhar, Kanaya L

    2014-01-01

    The molecular hybridization (MH) is a strategy of rational design of such ligands or prototypes based on the recognition of pharmacophoric sub-units in the molecular structure of two or more known bioactive derivatives which, through the adequate fusion of these sub-units, lead to the design of new hybrid architectures that maintain pre-selected characteristics of the original templates. The concept of molecular hybridization and the promises/challenges associated with these hybrid molecules along with recent advances on anticancer hybrids and critical discussions on the future aspects of the hybrid drugs have already been presented through a number of reports. However, this article presents the structures of potent hybrids reported during the last two decades along with a detailed account of the patent literature. Significant number of patents on the molecules designed through this valuable drug design technique clearly highlight the present focus of the researchers all around the globe towards hybrid molecules capable of amplifying the effect of individual functionalities through action on another bio target or to interact with multiple targets as one single molecule lowering the risk of drug-drug interactions and minimizing the drug resistance. This review article basically emphasizes the patent literature along with an overview of potent hybrid structures, their IC50 /GI50 values against the various cell lines employed. The present compilation can be utilized as a guide for the medicinal chemists focusing on this area of drug design.

  16. Patents, antibiotics, and autarky in Spain.

    PubMed

    Romero De Pablos, Ana

    2014-01-01

    Patents on antibiotics were introduced in Spain in 1949. Preliminary research reveals diversification in the types of antibiotics: patents relating to penicillin were followed by those relating to streptomycin, erythromycin and tetracycline. There was also diversification in the firms that applied for patents: while Merck & Co. Incorporated and Schenley Industries Inc. were the main partners with Spanish antibiotics manufacturers in the late 1940s, this industrial space also included many others, such as Eli Lilly & Company, Abbott Laboratories, Chas. Pfizer & Co. Incorporated, and American Cyanamid Company in the mid-1970s. The introduction of these drugs in Spain adds new elements to a re-evaluation of the autarkic politics of the early years of the Franco dictatorship.

  17. Antiretroviral drugs in meconium: detection for different gestational periods of exposure

    PubMed Central

    Himes, Sarah K.; Tassiopoulos, Katherine; Yogev, Ram; Huestis, Marilyn A.

    2015-01-01

    Objectives To determine whether antiretroviral (ARV) medications can be detected in meconium from 2nd or 3rd trimester, labor and delivery (L&D), or postnatal exposures. Study design Twenty ARV medications were quantified by LC-MS/MS in 598 meconium samples from uninfected infants born to pregnant women with HIV enrolled in the Pediatric HIV/AIDS Cohort Study. Results ARV detection in meconium following 3rd trimester exposure was 85.7–94.4% for all ARVs except stavudine (0%, n=2), likely due to low doses and a high limit for quantification. Of 107 samples with some 2nd trimester only ARV exposures, meconium was positive for only lopinavir, tenofovir, or efavirenz in 11.8–14.3% of exposed neonates; administration of these ARVs occurred between gestational weeks 25–28 in the positive samples. Days without lopinavir or tenofovir before delivery significantly correlated with decreasing concentrations of tenofovir and lamivudine in meconium. Concentrations significantly correlated with increasing gestational age among infants with continuous 2nd and 3rd trimester exposure. Zidovudine given during L&D or for neonatal prophylaxis was detected in 95.1% and 94.6% of meconium samples, respectively. Conclusions Changes in ARV treatments during pregnancy offered a unique opportunity to investigate ARV detection in meconium. ARVs in meconium primarily reflect 3rd trimester ARV exposures, although 6 of 107 2nd trimester only exposures were detected. Zidovudine administration during L&D was detected in meconium indicating potential urine contamination or rapid incorporation into meconium. These data will improve interpretation of meconium drug test results. PMID:26001315

  18. Preventing and managing antiretroviral drug resistance.

    PubMed

    Kuritzkes, Daniel R

    2004-05-01

    Development of resistance to antiretroviral drugs (ARVs) is a major impediment to optimum treatment of HIV-1 infection. Although resistance testing can help to select subsequent regimens when virologic failure occurs, cross-resistance, which affects all classes of ARVs, may make it more difficult to achieve optimum control of HIV. We have known for some time that our first choice of antiretroviral therapy offers the best chance to control HIV replication and that initial therapy should be selected with an eye on future options. Potency is the first line of defense against the development of resistance. Other factors that affect resistance development include: tolerability, potential for optimum adherence, and genetic and pharmacologic barriers to development of resistance. If resistance emerges, only a single drug may be affected initially, and a rapid change in ARVs may preserve the efficacy of other components. One cautionary note is that we can no longer assume that a patient's HIV is fully susceptible to all ARVs even in the initial regimen. Transmission of drug-resistant HIV means that the genetic composition may be that of an "experienced" virus with reduced susceptibility to ARVs. Resistance testing at the time of transmission is most likely to reveal this resistance, but over time the dominant genetic pattern may revert to wild-type, and be missed by resistance testing. Because "archived" resistant HIV may emerge quickly once treatment is initiated, we need to keep this in mind when selecting initial therapy.

  19. 76 FR 40339 - Patent Prosecution Highway (PPH) Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ... Patent and Trade Mark Office (DPMA), National Board of Patents and Registration of Finland (NBPR), Russian Patent Office (ROSPATENT), Hungarian Patent Office (HPO), Spanish Patent and Trademark...

  20. Selling Complementary Patents: Experimental Investigation

    SciTech Connect

    Bjornstad, David J; Santore, Rudy; McKee, Michael

    2010-02-01

    Production requiring licensing groups of complementary patents implements a coordination game among patent holders, who can price patents by choosing among combinations of fixed and royalty fees. Summed across patents, these fees become the total producer cost of the package of patents. Royalties, because they function as excise taxes, add to marginal costs, resulting in higher prices and reduced quantities of the downstream product and lower payoffs to the patent holders. Using fixed fees eliminates this inefficiency but yields a more complex coordination game in which there are multiple equilibria, which are very fragile in that small mistakes can lead the downstream firm to not license the technology, resulting in inefficient outcomes. We report on a laboratory market investigation of the efficiency effects of coordinated pricing of patents in a patent pool. We find that pool-like pricing agreements can yield fewer coordination failures in the pricing of complementary patents.

  1. Text mining patents for biomedical knowledge.

    PubMed

    Rodriguez-Esteban, Raul; Bundschus, Markus

    2016-06-01

    Biomedical text mining of scientific knowledge bases, such as Medline, has received much attention in recent years. Given that text mining is able to automatically extract biomedical facts that revolve around entities such as genes, proteins, and drugs, from unstructured text sources, it is seen as a major enabler to foster biomedical research and drug discovery. In contrast to the biomedical literature, research into the mining of biomedical patents has not reached the same level of maturity. Here, we review existing work and highlight the associated technical challenges that emerge from automatically extracting facts from patents. We conclude by outlining potential future directions in this domain that could help drive biomedical research and drug discovery.

  2. Paying for On-Patent Pharmaceuticals

    PubMed Central

    Goldfield, Norbert

    2016-01-01

    In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

  3. Generic Drugs

    MedlinePlus

    Generic Drugs: The Same Medicine for Less Money What is a generic drug? A generic is a copy of a brand-name drug. A brand- name drug has a patent. When ... benefit to your health, and you will save money. 7KH IHGHUDO )RRG DQG 'UXJ $GPLQLVWUDWLRQ )'$ UHJXODWHV ERWK ...

  4. Edison's vacuum technology patents

    NASA Astrophysics Data System (ADS)

    Waits, Robert K.

    2003-07-01

    During 1879 Thomas Edison's Menlo Park, New Jersey laboratory developed the means to evacuate glass lamp globes to less than a mTorr in 20 min and in mid-1880 began production of carbon-filament incandescent lamps. Among Edison's nearly 1100 U.S. patents are five for vacuum pump improvements, and at least eight others that are vacuum-related; all applied for between 1880 and 1886. Inspired by an 1878 article by De La Rue and Müller [Philos. Trans. R. Soc. London, Ser. A 169, 155 (1878)] on studies of glow discharges, Edison devised a combination pump using the Geissler pump as a rough pump and the Sprengel pump for continuous exhaustion. Edison's patents described means to control the mercury flow and automate the delivery of the mercury to banks of up to a hundred pumps. Other patents described various means to remove residual gases during lamp processing.

  5. Patent litigation in India continues to throw up new challenges.

    PubMed

    Reddy Thikkavarapu, Prashant

    2016-07-01

    For several years after the reinstitution of a pharmaceutical patent regime in India, most innovator pharmaceutical companies have faced a string of high-profile defeats during litigation in India. In the last 2 years, however, the fortunes of pharmaceutical patentees have changed dramatically. Not only have Indian courts enforced pharmaceutical patents and issued injunctions restraining Indian generic companies from infringing valid patents, but they have also refused to invoke 'public interest' arguments to delay the enforcement of patents. This string of victories for pharmaceutical patents indicates a new era for the innovator industry in India. These victories for the innovator industry demonstrate the objectivity of the Indian judiciary. Even on the issue of compulsory licensing, the Patent Office, which functions as a part of the central government, has been restrained - granting only one compulsory license for a drug owned by Bayer but declining two other similar requests. Similarly, even the Indian judiciary while enforcing patents has also remained sensitive to the flexibilities in the Patents Act, such as the 'Bolar-type' provisions and compulsory licensing provisions.

  6. Biotools: Patenting DNA sequences

    SciTech Connect

    Yablonsky, M.D.; Hone, W.J.

    1995-07-01

    The decision, known as In re Deuel{sup 2}, rejects the PTO`s interpretation of a previous decision of the Federal Circuit and makes it more possible that a {open_quotes}nucleic acid of a particular sequence{close_quotes} - commonly known as a gene sequence - may be patentable. 15 refs.

  7. Framing the patent troll debate.

    PubMed

    Risch, Michael

    2014-02-01

    The patent troll debate has reached a fevered pitch in the USA. This editorial seeks to frame the debate by pointing out the lack of clarity in defining patent trolls and their allegedly harmful actions. It then frames the debate by asking currently unanswered questions: Where do troll patents come from? What are the effects of troll assertions? Will policy changes improve the system?

  8. Biotechnology patents: new move confuses US patents world.

    PubMed

    Budiansky, Stephen

    1983-03-17

    Patent attorneys are perplexed and dismayed over a surprise decision by the U.S. Patent Office to drop its earlier objections to the second Cohen-Boyer patent application, covering basic processes in recombinant DNA technology. The patent proceedings, which were closed to public access at the request of Stanford University, have resulted in confusion over the meaning of the patent law's disclosure requirement as it applies to new organisms. Meanwhile, evidence of a prior Ph.D. thesis has called into question the originality of the Cohen-Boyer process.

  9. Patent Searching for Librarians and Inventors.

    ERIC Educational Resources Information Center

    Wherry, Timothy Lee

    Information on patents is provided for librarians and laypersons requiring an understanding of the system and the processes involved. Chapter 1 discusses successful patents; terms and concepts; patent types; copyright; trademark; requirements; patent examiners; patent pending; expiration; patentee and assignee; and reissued patents. Chapter 2…

  10. Patented herbal formulations and their therapeutic applications.

    PubMed

    Musthaba, Mohamed; Baboota, Sanjula; Athar, Tanwir M D; Thajudeen, Kamal Y; Ahmed, Sayeed; Ali, Javed

    2010-11-01

    Recently, there is a greater global interest in non synthetic, natural medicines derived from plant sources due to better tolerance and minimum adverse drug reactions as compared to synthetic medicines. Herbal products are also commonly used by the patients with certain chronic medical conditions, including breast cancer, liver disease, human immunodeficiency, asthma and rheumatological disorders. WHO estimates that about three-quarters of the world's population currently uses herbs and other forms of traditional medicines for the treatment of various diseases. The herbs are formulated in different modern dosage forms, such as Tablets, Capsules, Topical cream, Gel, Ointment and even some novel drug delivery forms, like extended release, sustained release, and microencapsules dosage forms. Patenting of herbal formulations has increased over the past few years and scientific evidence of therapeutic activity has been reported by performing various in vitro and in vivo experiments. This manuscript deals with various patented herbal formulations with their therapeutic application against various diseases.

  11. Research Tool Patents--Rumours of their Death are Greatly Exaggerated

    ERIC Educational Resources Information Center

    Carroll, Peter G.; Roberts, John S.

    2006-01-01

    Using a patented drug during clinical trials is not infringement [35 U.S.C. 271(e)(1)]. Merck v Integra enlarged this "safe harbour" to accommodate preclinical use of drugs and patented "research tools" if "reasonably related" to FDA approval. The decision allowed lower courts, should they wish, to find any use of a research tool, except for…

  12. 77 FR 26291 - Determination of Regulatory Review Period for Purposes of Patent Extension; LASTACAFT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for LASTACAFT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug...

  13. Humira: the impending patent battles over adalimumab biosimilars.

    PubMed

    Norman, Peter

    2016-05-01

    The world's top selling drug, adalimumab (AbbVie's Humira), generated sales in excess of US$13 billion in 2015. The primary product patent expires in 2016 in the USA and 2018 in Europe. This has resulted in a rush by companies to develop adalimumab biosimilars and Amgen submitted regulatory filings for its product ABP-501 in late 2015 in both the USA and Europe. AbbVie has claimed its patent portfolio provides product protection until 2022, but an increasing number of patent challenges are being made and the filings for approval of biosimilars will see more challenges made over the next few years.

  14. Re-Entry Mission Analysis of the Advanced Re-entry Vehicle (ARV)

    NASA Astrophysics Data System (ADS)

    Bonetti, D.; Haya Ramos, R.; Strauch, H.; Bottacini, M.

    2011-08-01

    This paper presents the results of the DEIMOS Space S.L.U. Re-entry Mission Analysis activities obtained in the frame of the Phase A up to PRR milestone of the Advanced Re-entry Vehicle (ARV) ESA project leaded by ASTRIUM. Results presented show how the trajectory and the vehicle design are strictly related and how a feasible and robust solution can be efficiently obtained by considering since the beginning several constraints limiting the design. The process implemented combines the design of key vehicle and trajectory parameters. Once the vehicle design parameters and the conditions at the EIP are fixed, the Mission Analysis is completed by the definition of the optimal trajectory from the deorbiting to the EIP that allow the correct targeting of the EIP conditions but also a safe separation of the different modules and the correct targeting of the desired landing site.

  15. Re-Entry Mission Analysis Of The Advanced Re-Entry Vehicle (ARV)

    NASA Astrophysics Data System (ADS)

    Bonetti, Davide; Haya Ramos, Rodrigo; Strauch, Hans; Bottacini, Massimiliano

    2011-05-01

    This paper presents the results of the DEIMOS Space S.L.U. Re-entry Mission Analysis activities obtained in the frame of the Phase A up to PRR milestone of the Advanced Re-entry Vehicle (ARV) ESA project leaded by ASTRIUM. Results presented show how the trajectory and the vehicle design are strictly related and how a feasible and robust solution can be efficiently obtained by considering since the beginning several constraints limiting the design. The process implemented combines the design of key vehicle and trajectory parameters. Once the vehicle design parameters and the conditions at the EIP are fixed, the Mission Analysis is completed by the definition of the optimal trajectory from the de- orbiting to the EIP that allow the correct targeting of the EIP conditions but also a safe separation of the different modules and the correct targeting of the desired landing site.

  16. Obstacles in provision of anti-retroviral treatment to drug users in Central and Eastern Europe and Central Asia: a regional overview.

    PubMed

    Bobrova, Natalia; Sarang, Anya; Stuikyte, Raminta; Lezhentsev, Konstantin

    2007-08-01

    Central and Eastern Europe and Central Asia is currently the region with the fastest growing HIV epidemic, mainly among injecting drug users (IDUs). This study explored access to anti-retroviral (ARV) treatment among IDUs and evaluated obstacles to gaining access to treatment. Semi-structured questionnaires were collected from 21 countries from agencies which deliver services to IDUs (N=55), including AIDS centres, drug treatment institutions and Non-governmental Organisations. Results showed that there was poor access to ARV treatment for IDUs. The major obstacles reported were: limited range of institutions for the provision of ARVs, lack of treatment due to high cost of ARVs, lack of clear policies and regulations in providing treatment for IDUs, lack of infrastructure and trained staff to provide treatment, and in some countries, absence of mechanisms such as methadone substitution programmes to support IDUs receiving ARV. There is a need for human and capital resources to bring ARV treatment to IDU populations in the region. Regulations and treatment protocols need to be developed to address this particular group of HIV positive clients to insure better adherence and monitoring of clients with HCV co-infection. Integration of provision of ARV treatment with drug treatment and low-threshold services is advised. Substitution therapy should be advocated for in countries where it is not available or where access is limited. Finally, more research needs to be conducted to understand what will work best in each country, region or setting.

  17. 77 FR 34388 - Determination of Regulatory Review Period for Purposes of Patent Extension; CYSVIEW (Previously...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; CYSVIEW (Previously HEXVIX) AGENCY: Food and Drug Administration, HHS. ACTION:...

  18. 77 FR 34051 - Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR; Correction AGENCY: Food and Drug Administration, HHS. ACTION:...

  19. Towards improved therapies using nanopharmaceuticals: recent patents on pharmaceutical nanoformulations.

    PubMed

    Horstkotte, Elke; Odoerfer, Kathrin I

    2012-12-01

    Pharmaceutical formulations that contain nanosized drugs are perceived as "Nanopharmaceuticals" and offer significant benefit for the patient compared to the conventional formulated drugs. There are several advantages of nanoparticular drug formulations such as enhanced solubility and dissolution rate, enhanced oral bioavailability, improved dose proportionality, reduced food effects, suitability for administration by all routes and possibility of sterile filtration due to decreased particle size range. Several nanopharmaceuticals are successfully marketed. Different patented techniques are commercialized to prepare nanopharmaceuticals such as milling, homogenization and precipitation. The focus of the underlying review is to give an overview of those technologies for nanosizing active pharmaceutical ingredients and recently published patents in the field of nanosized pharmaceutics.

  20. IL-21 and probiotic therapy improve Th17 frequencies, microbial translocation, and microbiome in ARV-treated, SIV-infected macaques.

    PubMed

    Ortiz, A M; Klase, Z A; DiNapoli, S R; Vujkovic-Cvijin, I; Carmack, K; Perkins, M R; Calantone, N; Vinton, C L; Riddick, N E; Gallagher, J; Klatt, N R; McCune, J M; Estes, J D; Paiardini, M; Brenchley, J M

    2016-03-01

    Increased mortality in antiretroviral (ARV)-treated, HIV-infected individuals has been attributed to persistent immune dysfunction, in part due to abnormalities at the gastrointestinal barrier. In particular, the poor reconstitution of gastrointestinal Th17 cells correlates with residual translocation of dysbiotic, immunostimulatory microflora across a compromised intestinal epithelial barrier. We have previously demonstrated that oral probiotics promote increased intestinal CD4(+) T-cell reconstitution during ARV treatment in a non-human primate model of HIV infection; however, essential mucosal T-cell subsets, such as Th17 cells, had limited recovery. Here, we sought to promote Th17 cell recovery by administering interleukin (IL)-21 to a limited number of ARV-treated, probiotic-supplemented, Simian Immunodeficiency Virus (SIV)-infected pigtailed macaques. We demonstrate that probiotic and IL-21 supplementation of ARVs are associated with enhanced polyfunctional Th17 expansion and reduced markers of microbial translocation and dysbiosis as compared with infected controls receiving ARVs alone. Importantly, treatment resulted in fewer morbidities compared with controls, and was independent of increased immune activation or loss of viral suppression. We propose that combining ARVs with therapeutics aimed at restoring intestinal stasis may significantly improve disease prognosis of ARV-treated, HIV-infected individuals.

  1. Antiretroviral drug supply challenges in the era of scaling up ART in Malawi.

    PubMed

    Schouten, Erik J; Jahn, Andreas; Ben-Smith, Anne; Makombe, Simon D; Harries, Anthony D; Aboagye-Nyame, Francis; Chimbwandira, Frank

    2011-07-06

    The number of people receiving antiretroviral treatment (ART) has increased considerably in recent years and is expected to continue to grow in the coming years. A major challenge is to maintain uninterrupted supplies of antiretroviral (ARV) drugs and prevent stock outs. This article discusses issues around the management of ARVs and prevention of stock outs in Malawi, a low-income country with a high HIV/AIDS burden, and a weak procurement and supply chain management system. This system for ARVs, paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, and bypassing the government Central Medical Stores, is in place, using the United Nations Children's Fund's (UNICEF's) procurement services. The system, managed by a handful of people who spend limited time on supply management, is characterized by a centrally coordinated quantification based on verified data from all national ART clinics, parallel procurement through UNICEF, and direct distribution to ART clinics. The model worked well in the first years of the ART programme with a single first-line ARV regimen, but with more regimens becoming available (e.g., alternative first-line, second-line and paediatric regimens), it has become more difficult to administer. Managing supplies through a parallel system has the advantage that weaknesses in the national system have limited influence on the ARV procurement and supply chain management system. However, as the current system operates without a central warehouse and national buffer stock capacity, it diminishes the ability to prevent ARV stock outs. The process of ordering ARVs, from the time that estimates are made to the arrival of supplies in health facilities, takes approximately one year. Addressing the challenges involved in maintaining ARVs through an efficient procurement and supply chain management system that prevents ARV stock outs through the establishment of a dedicated procurement team, a central warehouse and/or national buffer stock is a

  2. An overview of recent patents on nanosuspension.

    PubMed

    Modh, Nirav; Mehta, Dharmik; Parejiya, Punit; Popat, Amirali; Barot, Bhavesh

    2014-01-01

    Pharmaceutical scientists involved in drug discovery and drug development are facing serious problems with newer poorly water soluble drugs with respect to their dissolution and bioavailability. Reducing the particle size of active pharmaceutical ingredient has been an efficient and reliable method for improving the bioavailability of insoluble drugs. Nanosuspension has emerged as an efficient and promising strategy for delivery of insoluble drugs due to its unique advantages such as ease of modification, process flexibility, targeting capabilities, altered pharmacokinetic profile leading to safety and efficacy. These unique features of nanosuspension have enabled its use in various dosage forms, including specialized delivery systems such as oral, parenteral, peroral, ocular and pulmonary routes. Currently, efforts are being directed to extend their applications in site-specific drug delivery. Large numbers of products based on nanosuspension are in the market and few are under clinical trials. The commercialization potential of nanosuspension based formulation for oral route is well established and products for other routes will enter the market within short span. Among the various techniques available, only wet milling technique has been successfully used for commercial production of nanosuspension. Nanosuspension based patents have extensive potential of reaching faster in the market as compared to other nanotechnology based formulations. This review covers various aspects of techniques of preparation, route of administration and commercialization of nanosuspension with main focus on the recent patents granted in the field.

  3. Patents - An Information Resource.

    DTIC Science & Technology

    1980-09-01

    available abstracting services will be compared ard techniques for searching, including automated systems, will be described. Participants, thus having...as they stand or, if use is not permissible, to be avoided. Just as no scientist can keep up with all the articles published in his general subject...field, be It organic chemistry or radio astronomy, so no development engineer can possibly keep up with all the patent literature. Overall something

  4. Patent production is a prerequisite for successful exit of a biopharmaceutical company.

    PubMed

    Saotome, Chikako; Nakaya, Yurie; Abe, Seiji

    2016-03-01

    Patents are especially important for the business of drug discovery; however, their importance for biopharmaceutical companies has not been revealed quantitatively yet. To examine the correlation between patents and long-term business outcome of biopharmaceutical companies we analyze annual number of patent families and business conditions of 123 public-listed biopharmaceutical companies established from 1990 to 1995 in the USA. Our results show the number of patent families per year correlates well with the business condition: average of the bankruptcy group is significantly smaller than those of the continuing and the merger and acquisitions (M&A) groups. In the M&A by big pharma group, the acquisition cost correlates with the number of annual patent families. However, patentability and strategy of foreign patent application are not different among the groups. Therefore, the productivity of invention is the key factor for success of biopharmaceutical companies.

  5. Taxane anticancer agents: a patent perspective

    PubMed Central

    Ojima, Iwao; Lichtenthal, Brendan; Lee, Siyeon; Wang, Changwei; Wang, Xin

    2016-01-01

    Introduction Paclitaxel and docetaxel were two epoch-making anticancer drugs and have been successfully used in chemotherapy for a variety of cancer types. In 2010, a new taxane, cabazitaxel, was approved by FDA for use in combination with prednisone for the treatment of metastatic hormone-refractory prostate cancer. Albumin-bound paclitaxel (nab™-paclitaxel; abraxane) nanodroplet formulation was another notable invention (FDA approval 2005 for refractory, metastatic, or relapsed breast cancer). Abraxane in combination with gemcitabine for the treatment of pancreatic cancer was approved by FDA in 2013. Accordingly, there have been a huge number of patent applications dealing with taxane anticancer agents in the last five years. Thus, it is a good time to review the progress in this area and find the next wave for new developments. Area covered This review article covers the patent literature from 2010 to early 2015 on various aspects of taxane-based chemotherapies and drug developments. Expert opinion Three FDA-approved taxane anticancer drugs will continue to expand their therapeutic applications, especially through drug combinations and new formulations. Inspired by the success of abraxane, new nano-formulations are emerging. Highly potent new-generation taxanes will play a key role in the development of efficacious tumor-targeted drug delivery systems. PMID:26651178

  6. Monitoring and modeling the snowpack dynamics in the Arve upper catchment for hydrological purposes

    NASA Astrophysics Data System (ADS)

    Revuelto, Jesús; Lecourt, Grégoire; Charrois, Luc; Lafaysse, Matthieu; Condom, Thomas; Dumont, Marie; Morin, Samuel; Rabatel, Antoine; Six, Delphine; Vionnet, Vincent; Zin, Isabella

    2016-04-01

    Snow accumulation and its evolution over space and time have major importance for the hydrological cycle, especially at high elevations. The characteristics of mountain valley, such as a wide altitudinal range, large glaciated areas, snow presence all along the year; when combined with specific meteorological conditions like heat waves or extreme rain events, may originate dramatic flash floods, potentially affecting populated areas. Thus, improving snowpack monitoring and forecasting tools are needed to strength the reliability of warning systems. Nowadays, accurately characterising and simulating snowpack evolution over large areas still represents a challenge, and uncertainties arise. The study presented here is focused in analysing two different types of simulation of the snowpack dynamics, performed with different discretization approaches, distributed or semi-distributed, and how these could move forward assimilating remote sensing data from satellites. The considered study area is the Arve catchment at Chamonix, in the French Northern Alps. This valley has the previously mentioned characteristics: it comprises a large elevation range (between 1000 to 4800m asl, with large areas above 2000m asl) and about 32% of its extension (200km2) is glaciated. Thus, the hydrological cycle of this area is highly dependent on the snowpack and the glacier melt dynamics. The snowpack of the Arve catchment has been simulated from 1990 to 2014 with the Crocus model integrated within the SURFEX modelling platform. The input fields are provided by the SAFRAN reanalysis system and the simulations have been performed with both a semi-distributed (classifying terrain by aspect, elevation, slope and land use/land cover) and a distributed (250m spatial resolution grid cells over the study area) approaches. The use of these two approaches using the same snowpack model and same meteorological forcing, enables their comparison in terms of river discharges at several outlets; showing the

  7. Recent Patents, Formulation and Characterization of Nanoliposomes.

    PubMed

    Rohilla, Seema; Dureja, Harish

    2015-01-01

    Nanoliposome has been introduced for nanoscale bilayer lipid vesicles. These are the nano version of liposomes, having cell-specific targeting, required to achieve a desired drug concentration at the target site for optimum therapeutic efficacy, possibly by minimizing the adverse effects on healthy cells and tissues. Nanoliposomes possess impending applications in the fields of nanotechnology, e.g. cancer therapy, cosmetics, diagnosis, gene delivery, agriculture and food technology. Nano liposomes can be formulated by Sonication technique, Extrusion method, Emulsification evaporation method and Lipid layer hydration method. Authors have performed detailed patent and literature survey on PubMed, PubMed Central, Spingerlink and Elsevier based reviews and research articles on nanoliposomes. An attempt has been made to highlight the various formulation methods including the patented technologies, applications and characterization of nanoliposomes.

  8. Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

    PubMed Central

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    Background Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Methods and Findings Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. Significance In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies. PMID:21858138

  9. Pharmacogenomics, genetic tests, and patent-based incentives.

    PubMed

    Meurer, Michael J

    2003-01-01

    Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests should help doctors improve drug safety and efficacy by better matching patients and drugs. This chapter evaluates the effectiveness of patent-based incentives to create genetic tests, and considers the optimal mix of public and private sector pharmacogenomic research and development (R&D). Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be weaker for genetic tests that are used in conjunction with existing drugs. Drug patent owners might gain or lose profit from the introduction of genetic tests into existing drug markets. Profits may fall because of lost sales, or profits may rise because drugs are more valuable to appropriate patients, and because drugs become more differentiated. Public sector R&D should target genetic tests that are likely to be underprovided by the private sector because private returns are low relative to social returns, or private costs are high relative to social costs. Private returns are relatively low when the rate of adoption of a genetic test is apt to be low, when test results increase consumer heterogeneity and consumer bargaining power, and when a test reveals information relevant to the use of more than one drug. Private costs are relatively high when test innovators need to obtain costly patent and trade secret licenses.

  10. The RNA-binding protein Sam68 regulates expression and transcription function of the androgen receptor splice variant AR-V7

    PubMed Central

    Stockley, Jacqueline; Markert, Elke; Zhou, Yan; Robson, Craig N.; Elliott, David J.; Lindberg, Johan; Leung, Hing Y.; Rajan, Prabhakar

    2015-01-01

    Castration-resistant (CR) prostate cancer (PCa) partly arises due to persistence of androgen receptor (AR) transcriptional activity in the absence of cognate ligand. An emerging mechanism underlying the CRPCa phenotype and predicting response to therapy is the expression of the constitutively-active AR-V7 splice variant generated by AR cryptic exon 3b inclusion. Here, we explore the role of the RNA-binding protein (RBP) Sam68 (encoded by KHDRBS1), which is over-expressed in clinical PCa, on AR-V7 expression and transcription function. Using a minigene reporter, we show that Sam68 controls expression of exon 3b resulting in an increase in endogenous AR-V7 mRNA and protein expression in RNA-binding-dependent manner. We identify a novel protein-protein interaction between Sam68 and AR-V7 mediated by a common domain shared with full-length AR, and observe these proteins in the cell nucleoplasm. Using a luciferase reporter, we demonstrate that Sam68 co-activates ligand-independent AR-V7 transcriptional activity in an RNA-binding-independent manner, and controls expression of the endogenous AR-V7-specific gene target UBE2C. Our data suggest that Sam68 has separable effects on the regulation of AR-V7 expression and transcriptional activity, through its RNA-binding capacity. Sam68 and other RBPs may control expression of AR-V7 and other splice variants as well as their downstream functions in CRPCa. PMID:26310125

  11. Patent and product piracy

    NASA Astrophysics Data System (ADS)

    Ignat, V.

    2016-08-01

    Advanced industrial countries are affected by technology theft. German industry annually loses more than 50 billion euros. The main causes are industrial espionage and fraudulent copying patents and industrial products. Many Asian countries are profiteering saving up to 65% of production costs. Most affected are small medium enterprises, who do not have sufficient economic power to assert themselves against some powerful countries. International organizations, such as Interpol and World Customs Organization - WCO - work together to combat international economic crime. Several methods of protection can be achieved by registering patents or specific technical methods for recognition of product originality. They have developed more suitable protection, like Hologram, magnetic stripe, barcode, CE marking, digital watermarks, DNA or Nano-technologies, security labels, radio frequency identification, micro color codes, matrix code, cryptographic encodings. The automotive industry has developed the method “Manufactures against Product Piracy”. A sticker on the package features original products and it uses a Data Matrix verifiable barcode. The code can be recorded with a smartphone camera. The smartphone is connected via Internet to a database, where the identification numbers of the original parts are stored.

  12. Differential regulation of metabolic pathways by androgen receptor (AR) and its constitutively active splice variant, AR-V7, in prostate cancer cells.

    PubMed

    Shafi, Ayesha A; Putluri, Vasanta; Arnold, James M; Tsouko, Efrosini; Maity, Suman; Roberts, Justin M; Coarfa, Cristian; Frigo, Daniel E; Putluri, Nagireddy; Sreekumar, Arun; Weigel, Nancy L

    2015-10-13

    Metastatic prostate cancer (PCa) is primarily an androgen-dependent disease, which is treated with androgen deprivation therapy (ADT). Tumors usually develop resistance (castration-resistant PCa [CRPC]), but remain androgen receptor (AR) dependent. Numerous mechanisms for AR-dependent resistance have been identified including expression of constitutively active AR splice variants lacking the hormone-binding domain. Recent clinical studies show that expression of the best-characterized AR variant, AR-V7, correlates with resistance to ADT and poor outcome. Whether AR-V7 is simply a constitutively active substitute for AR or has novel gene targets that cause unique downstream changes is unresolved. Several studies have shown that AR activation alters cell metabolism. Using LNCaP cells with inducible expression of AR-V7 as a model system, we found that AR-V7 stimulated growth, migration, and glycolysis measured by ECAR (extracellular acidification rate) similar to AR. However, further analyses using metabolomics and metabolic flux assays revealed several differences. Whereas AR increased citrate levels, AR-V7 reduced citrate mirroring metabolic shifts observed in CRPC patients. Flux analyses indicate that the low citrate is a result of enhanced utilization rather than a failure to synthesize citrate. Moreover, flux assays suggested that compared to AR, AR-V7 exhibits increased dependence on glutaminolysis and reductive carboxylation to produce some of the TCA (tricarboxylic acid cycle) metabolites. These findings suggest that these unique actions represent potential therapeutic targets.

  13. Expression of AR-V7 in Circulating Tumour Cells Does Not Preclude Response to Next Generation Androgen Deprivation Therapy in Patients with Castration Resistant Prostate Cancer.

    PubMed

    Bernemann, Christof; Schnoeller, Thomas J; Luedeke, Manuel; Steinestel, Konrad; Boegemann, Martin; Schrader, Andres J; Steinestel, Julie

    2017-01-01

    The androgen receptor splice variant AR-V7 has recently been discussed as a predictive biomarker for nonresponse to next-generation androgen deprivation therapy (ADT) in patients with castration-resistant prostate cancer. However, we recently identified one patient showing a response from abiraterone despite expression of AR-V7 in his circulating tumour cells (CTC). Therefore, we precisely assessed the response in a cohort of 21 AR-V7 positive castration-resistant prostate cancer patients who had received therapy with abiraterone or enzalutamide. We detected a subgroup of six AR-V7 positive patients showing benefit from either abiraterone or enzalutamide. Their progression free survival was 26 d (censored) to 188 d. Four patients displayed a prostate-specific antigen decrease of >50%. When analysing prior therapies, we noticed that only one of the six patients had received next-generation ADT prior to CTC collection. As a result, we conclude that AR-V7 status in CTC cannot entirely predict nonresponse to next generation ADT and AR-V7-positive patients should not be systematically denied abiraterone or enzalutamide treatment, especially as effective alternative treatment options are still limited.

  14. Recent patents on ophthalmic nanoformulations and therapeutic implications.

    PubMed

    Ako-Adounvo, Ann-Marie; Nagarwal, Ramesh C; Oliveira, Lais; Boddu, Sai H S; Wang, Xiang S; Dey, Surajit; Karla, Pradeep K

    2014-01-01

    Nanoformulations (NF) are widely explored as potential alternatives for traditional ophthalmic formulation approaches. The effective treatment of ocular diseases using conventional eye drops is often hampered by factors such as: physiological barriers, rapid elimination, protein binding, and enzymatic drug degradation. Combined, these factors are known to contribute to reduced ocular residence time and poor bioavailability. Recent research studies demonstrated that NF can significantly enhance the therapeutic efficacy and bioavailability of ocular drugs, compared to the established ophthalmic drug delivery strategies. The research studies resulted in a number of patent inventions, reporting a significant increase in therapeutic efficacy for various chronic ocular disease states of both the anterior and posterior ocular segments. This article reviews these patent disclosures in detail and emphasizes the therapeutic advantages conferred by the following nanoformulation approaches: Calcium Phosphate (CaP) nanoparticles, Liposomes, Nanoemulsions, Nanomicelles, and Hydrogels. The nanoformulation approaches were shown to enhance the ocular bioavailability by reducing the drugprotein binding, increasing the corneal resident time, enhancing the drug permeability and providing a sustained drug release. Further, the article discusses United States Food and Drug Administration (USFDA) approved ocular drugs employing nanotechnology and future developments. It should be noted that, despite the potential therapeutic promise demonstrated by nanotechnology for ocular drug delivery, the bench to bed transition from patent inventions to marketed drug products has been insignificant. Majority of the discussed technologies are still in development and testing phase for commercial viability. Further, studies are in progress to assess ocular tolerance and nanotoxicity for prolonged use of NF.

  15. Recent Patents on Ophthalmic Nanoformulations and Therapeutic Implications

    PubMed Central

    Ako-Adounvo, Ann-Marie; Nagarwal, Ramesh C.; Oliveira, Lais; Boddu, Sai H.S.; Wang, Xiang S.; Dey, Surajit; Karla, Pradeep K.

    2015-01-01

    Nanoformulations (NF) are widely explored as potential alternatives for traditional ophthalmic formulation approaches. The effective treatment of ocular diseases using conventional eye drops is often hampered by factors such as: physiological barriers, rapid elimination, protein binding, and enzymatic drug degradation. Combined, these factors are known to contribute to reduced ocular residence time and poor bioavailability. Recent research studies demonstrated that NF can significantly enhance the therapeutic efficacy and bioavailability of ocular drugs, compared to the established ophthalmic drug delivery strategies. The research studies resulted in a number of patent inventions, reporting a significant increase in therapeutic efficacy for various chronic ocular disease states of both the anterior and posterior ocular segments. This article reviews these patent disclosures in detail and emphasizes the therapeutic advantages conferred by the following nanoformulation approaches: Calcium Phosphate (CaP) nanoparticles, Liposomes, Nanoemulsions, Nanomicelles, and Hydrogels. The nanoformulation approaches were shown to enhance the ocular bioavailability by reducing the drugprotein binding, increasing the corneal resident time, enhancing the drug permeability and providing a sustained drug release. Further, the article discusses United States Food and Drug Administration (USFDA) approved ocular drugs employing nanotechnology and future developments. It should be noted that, despite the potential therapeutic promise demonstrated by nanotechnology for ocular drug delivery, the bench to bed transition from patent inventions to marketed drug products has been insignificant. Majority of the discussed technologies are still in development and testing phase for commercial viability. Further, studies are in progress to assess ocular tolerance and nanotoxicity for prolonged use of NF. PMID:25262835

  16. Recent patents on molecular cytogenetics.

    PubMed

    Iourov, Ivan Y; Vorsanova, Svetlana G; Yurov, Yuri B

    2008-01-01

    The questions surrounding patenting of DNA sequences encoding specific proteins are relatively well reviewed in the available literature. However, neither applications nor molecular cytogenetic techniques, which use these sequences as a probe, have been reviewed in the light of the patenting. Furthermore, the patenting of the use of numerous probes, which are produced on different types of repetitive genome elements (i.e. satellite DNA or telomeric DNA sequences) and those generated by chromosome microdissection has not been reviewed. Molecular cytogenetic techniques are one of the most applied in current bioscience (as to June 2007, over 40,000 papers in browseable scientific databases mention one or several molecular cytogenetic techniques). Therefore, reviewing recent patents in this field is of general interest for numerous researchers in different areas of biology and medicine. Here, we address world-wide patents on DNA sequences used as molecular cytogenetic probes and molecular cytogenetic techniques to define current state and perspectives of this biomedical direction.

  17. [Patent rights and biotechnological inventions].

    PubMed

    Lobato García-Miján, M

    1998-01-01

    In spite of all the controversy surrounding it and the problems encountered in the process leading to its adoption, the Directive on the legal protection of biotechnology inventions does not feature anything substantially new compared to the criteria used by patent offices in determining whether inventions of this type can be patented. The Directive's originality stems not so much from the interpretation given of patenting requirements but rather from the legal importance attached to issues of public policy or morality. It sets out and interprets for the member states of the European Union what is meant by the term. However, in our opinion this regulation of morality reflects above all else an attempt to satisfy the views of sectors opposed to the Directive. Clearly, there is some doubt as to whether in practice patents for genetic material can be turned down because they run counter to morality, except in blatant cases of immorality (applications for patents for human embryos, etc).

  18. 76 FR 31349 - Determination of Regulatory Review Period for Purposes of Patent Extension; ACTEMRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for ACTEMRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological...

  19. Patent Pools: Intellectual Property Rights and Competition

    PubMed Central

    Rodriguez, Victor

    2010-01-01

    Patent pools do not correct all problems associated with patent thickets. In this respect, patent pools might not stop the outsider problem from striking pools. Moreover, patent pools can be expensive to negotiate, can exclude patent holders with smaller numbers of patents or enable a group of major players to form a cartel that excludes new competitors. For all the above reasons, patent pools are subject to regulatory clearance because they could result in a monopoly. The aim of this article is to present the relationship between patents and competition in a broad context. PMID:20200607

  20. Automated mapping system patented

    NASA Astrophysics Data System (ADS)

    A patent on a satellite system dubbed Mapsat, which would be able to map the earth from space and would thereby reduce the time and cost of mapping on a smaller scale, has been issued to the U.S. Geological Survey.The Mapsat concept, invented by Alden F. Colvocoresses, a research cartographer at the USGS National Center, is based on Landsat technology but uses sensors that acquire higher-resolution image data in either a stereo or monoscopic mode. Stereo data can be processed relatively simply with automation to produce images for interpretation or to produce maps. Monoscopic and multispectral data can be processed in a computer to derive information on earth resources. Ground control, one of the most expensive phases of mapping, could be kept to a minimum.

  1. Patent foramen ovale and cryptogenic stroke: the hole story.

    PubMed

    Furlan, Anthony J; Jauss, Marek

    2013-09-01

    Despite 3 recent randomized clinical trials, the management of patients with cryptogenic stroke and patent foramen ovale remains unsettled. The primary results of Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale (CLOSURE), Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Stroke (PC), and Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) were the same; the intent to treat analysis for the primary end point in all 3 trials failed to demonstrate superiority of device closure compared with medical therapy. CLOSURE put the brakes on indiscriminate device closure of patent foramen ovales in patients with cryptogenic stroke or transient ischemic attack. RESPECT suggested, but did not prove, that highly selected patients without vascular risk factors, with a cortical infarct on baseline magnetic resonance imaging and a substantial patent foramen ovale shunt may benefit from the Amplatzer device during a multiple-year period. In the absence of definitive clinical trial results, the precise definition of which patient subgroups should be considered for patent foramen ovale device closure should be agreed to by the stakeholder societies and the Food and Drug Administration.

  2. Patenting the Life Sciences at the European Patent Office

    PubMed Central

    Gates, Christina

    2014-01-01

    The European patent system is very much like those of the United States and other major countries. Patent applications can be filed as a first filing, as a priority application, or as a national phase of a Patent Cooperation Treaty application. The applications are searched, rigorously examined, and ultimately granted, with the time periods varying somewhat depending on the application type. The object of this article is to highlight some of the differences between the U.S. and European systems, particularly as they relate to life sciences. PMID:25342060

  3. SureChEMBL: a large-scale, chemically annotated patent document database

    PubMed Central

    Papadatos, George; Davies, Mark; Dedman, Nathan; Chambers, Jon; Gaulton, Anna; Siddle, James; Koks, Richard; Irvine, Sean A.; Pettersson, Joe; Goncharoff, Nicko; Hersey, Anne; Overington, John P.

    2016-01-01

    SureChEMBL is a publicly available large-scale resource containing compounds extracted from the full text, images and attachments of patent documents. The data are extracted from the patent literature according to an automated text and image-mining pipeline on a daily basis. SureChEMBL provides access to a previously unavailable, open and timely set of annotated compound-patent associations, complemented with sophisticated combined structure and keyword-based search capabilities against the compound repository and patent document corpus; given the wealth of knowledge hidden in patent documents, analysis of SureChEMBL data has immediate applications in drug discovery, medicinal chemistry and other commercial areas of chemical science. Currently, the database contains 17 million compounds extracted from 14 million patent documents. Access is available through a dedicated web-based interface and data downloads at: https://www.surechembl.org/. PMID:26582922

  4. Law-medicine interfacing: patenting of human genes and mutations.

    PubMed

    Fialho, Arsenio M; Chakrabarty, Ananda M

    2011-08-01

    Mutations, Single Nucleotide Polymorphisms (SNPs), deletions and genetic rearrangements in specific genes in the human genome account for not only our physical characteristics and behavior, but can lead to many in-born and acquired diseases. Such changes in the genome can also predispose people to cancers, as well as significantly affect the metabolism and efficacy of many drugs, resulting in some cases in acute toxicity to the drug. The testing of the presence of such genetic mutations and rearrangements is of great practical and commercial value, leading many of these genes and their mutations/deletions and genetic rearrangements to be patented. A recent decision by a judge in the Federal District Court in the Southern District of New York, has created major uncertainties, based on the revocation of BRCA1 and BRCA2 gene patents, in the eligibility of all human and presumably other gene patents. This article argues that while patents on BRCA1 and BRCA2 genes could be challenged based on a lack of utility, the patenting of the mutations and genetic rearrangements is of great importance to further development and commercialization of genetic tests that can save human lives and prevent suffering, and should be allowed.

  5. Negotiation Strategies for Antiretroviral Drug Purchasers in the United States.

    PubMed

    Linnemayr, Sebastian; Ryan, Gery W; Karir, Veena; Liu, Jenny; Palar, Kartika

    2012-01-01

    Antiretroviral treatment has transformed HIV from a death sentence to a chronic condition, allowing people with HIV to live longer and healthier lives. However, they face significant barriers to accessing and affording life-saving-but expensive-antiretroviral (ARV) medications. These barriers are particularly severe for low-income patients, and they disproportionately affect racial and ethnic minorities. High ARV prices create pressure for government insurers to contain costs either by rationing care or by restricting eligibility for public programs. Limited funding, coupled with a growing demand for HIV care and treatment, is likely to make programmatic decisions about who is covered become more difficult over time. Therefore, it is important to identify options for reducing the cost of providing ARVs to allow more people to receive treatment. This study examines a variety of options for negotiating lower ARV procurement costs in U.S. markets. A case-study approach is used to assess options that different stakeholders could use in negotiating ARV price discounts with drug manufacturers given the regulatory and market constraints that exist in the United States.

  6. Developing a Systematic Patent Search Training Program

    ERIC Educational Resources Information Center

    Zhang, Li

    2009-01-01

    This study aims to develop a systematic patent training program using patent analysis and citation analysis techniques applied to patents held by the University of Saskatchewan. The results indicate that the target audience will be researchers in life sciences, and aggregated patent database searching and advanced search techniques should be…

  7. Patenting drought tolerance in organisms.

    PubMed

    Somvanshi, Vishal S

    2009-01-01

    Dehydration is a major form of osmotic stress in cells. Physiological and molecular basis of dehydration stress responses in cells and organisms has been intensively researched over past years. Almost all of the patented dehydration stress tolerance genes from different organisms were used in engineering drought tolerance in crop plants. In spite of the moral, religious and ethical controversies surrounding use of foreign DNA sequences in crop plants, the numbers of such patents has grown tremendously in recent years. In future, we might witness another rise in patents on use of dehydration stress related gene sequences in creating environmental stress tolerant biological control agents for plant disease and insect pest management in agriculture. This review summarizes some of the recent published patents related to drought tolerance genes and their use.

  8. Embryonic stem cell patents and human dignity.

    PubMed

    Resnik, David B

    2007-09-01

    This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells.

  9. Embryonic Stem Cell Patents and Human Dignity

    PubMed Central

    Resnik, David B.

    2009-01-01

    This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells. PMID:17922198

  10. Are DNA patents bad for medicine?

    PubMed

    Resnik, David B

    2003-08-01

    This paper considers the potential benefits and harms of DNA patenting for biomedical research and medical practice. It argues that, all things considered, the benefits of patenting DNA outweigh the harms, although societies should adopt policies designed to prevent or mitigate the harms associated with patenting. Some of these policies include: (1) reinforcing the research exemption for academic researchers, (2) raising the "bar" for the criteria of patentability, (3) restricting the scope of patents, (4) disclosing conflicts of interest related to DNA patents, (5) sharing the economic benefits of patenting with patients, and (6) providing insurance coverage for some types of genetic tests.

  11. The patenting of novel biotech products.

    PubMed

    Webber, Philip M

    2007-07-01

    Patent laws covering NCEs are well established in most developed countries. For such entities to be patentable, they must be novel, inventive and have some practical use. Furthermore, the patent applications must describe how to make the entities, and provide data to support the patent claims. The same criteria are being applied by Patent Offices to the patenting of the new generation of biotech products: genes, proteins, microorganisms, transgenic plants and transgenic animals. This feature review focuses on the patenting of these novel products.

  12. Recent patents in food nanotechnology.

    PubMed

    Pérez-Esteve, Edgar; Bernardos, Andrea; Martínez-Mañez, Ramón; Barat, José M

    2011-09-01

    Nanotechnology is a multidisciplinary field of current interest. The huge possibilities in most industries are making nanoscience grow at a rapid pace, but what is the real impact of nanotechnology in a traditional industry such as food? The study of patents published in the last 20 years provides the answer, and the results are quite surprising; the food industry is the fifth largest sector in terms of patents related to nanotechnology.

  13. The patenting of medical treatment.

    PubMed

    Loughlan, P L

    1995-04-03

    The Full Federal Court of Australia recently held, in a decisive break with long-established legal principle, that methods of medical treatment are patentable inventions. The judgment signals the advent of monopolies and therefore monopoly prices on new therapeutic procedures until now made freely available to the medical profession. It also heralds delays in the dissemination of information about discoveries of such procedures through teaching and publication until a patent application can be prepared for and made.

  14. Rightpollex: From Patent To Startup

    NASA Astrophysics Data System (ADS)

    Leba, Monica; Ionica, Andreea Cristina; Dobra, Remus

    2015-07-01

    RightPollex is an innovative product patented and developed by a multidisciplinary team from the University of Petrosani. The paper presents not only the idea and implementation possibilities of this patent, but also the current stage on the path towards the development of startups, an initiative of our university together with a private investor. The result of this initiative is JV Sensor Ventures that supports several startups.

  15. Universities and Patent Demands

    PubMed Central

    Cordova, Andrew K.; Feldman, Robin

    2015-01-01

    Research universities have made enormous contributions to the field of medicine and the treatment of human disease. Alone or in collaboration with pharmaceutical companies, academic researchers have added to the store of knowledge that has led to numerous life science breakthroughs. A new chapter may be opening for academic researchers, however, that could lead to a darker tale. ‘The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research, by Bubela et al., chronicles one such tale.’ The authors do an excellent job of bringing to life the twisting saga that engulfed numerous academic and non-profit Alzheimer's researchers over many years. The authors note that the story is an outlier, but sadly, that may not be the case. There are increasing signs that academic researchers and their institutions are being caught up in the rush for gold that is accompanying the proliferation of the non-practicing entity business model. As I have noted before, academic institutions have a dual role, as keepers of the academic flame and guardians of the public monies entrusted to them through state and federal research funding. The specter of taxpayer money being used, not to advance research and for the betterment of society, but as part of schemes to extract money from productive companies may not sit well with voters, and ultimately, with legislators. In that case, researchers and institutions themselves may have much to lose. PMID:27774221

  16. Universities and Patent Demands.

    PubMed

    Cordova, Andrew K; Feldman, Robin

    2015-11-01

    Research universities have made enormous contributions to the field of medicine and the treatment of human disease. Alone or in collaboration with pharmaceutical companies, academic researchers have added to the store of knowledge that has led to numerous life science breakthroughs. A new chapter may be opening for academic researchers, however, that could lead to a darker tale. 'The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research, by Bubela et al., chronicles one such tale.' The authors do an excellent job of bringing to life the twisting saga that engulfed numerous academic and non-profit Alzheimer's researchers over many years. The authors note that the story is an outlier, but sadly, that may not be the case. There are increasing signs that academic researchers and their institutions are being caught up in the rush for gold that is accompanying the proliferation of the non-practicing entity business model. As I have noted before, academic institutions have a dual role, as keepers of the academic flame and guardians of the public monies entrusted to them through state and federal research funding. The specter of taxpayer money being used, not to advance research and for the betterment of society, but as part of schemes to extract money from productive companies may not sit well with voters, and ultimately, with legislators. In that case, researchers and institutions themselves may have much to lose.

  17. Disclosing in utero HIV/ARV exposure to the HIV-exposed uninfected adolescent: is it necessary?

    PubMed Central

    Jao, Jennifer; Hazra, Rohan; Mellins, Claude A; Remien, Robert H; Abrams, Elaine J

    2016-01-01

    Introduction The tremendous success of antiretroviral therapy has resulted in a diminishing population of perinatally HIV-infected children on the one hand and a mounting number of HIV-exposed uninfected (HEU) children on the other. As the oldest of these HEU children are reaching adolescence, questions have emerged surrounding the implications of HEU status disclosure to these adolescents. This article outlines the arguments for and against disclosure of a child's HEU status. Discussion Disclosure of a child's HEU status, by definition, requires disclosure of maternal HIV status. It is necessary to weigh the benefits and harms which could occur with disclosure in each of the following domains: psychosocial impact, long-term physical health of the HEU individual and the public health impact. Does disclosure improve or worsen the psychological health of the HEU individual and extended family unit? Do present data on the long-term safety of in utero HIV/ARV exposure reveal potential health risks which merit disclosure to the HEU adolescent? What research and public health programmes or systems need to be in place to afford monitoring of HEU individuals and which, if any, of these require disclosure? Conclusions At present, it is not clear that there is sufficient evidence on whether long-term adverse effects are associated with in utero HIV/ARV exposures, making it difficult to mandate universal disclosure. However, as more countries adopt electronic medical record systems, the HEU status of an individual should be an important piece of the health record which follows the infant not only through childhood and adolescence but also adulthood. Clinicians and researchers should continue to approach the dialogue around mother–child disclosure with sensitivity and a cogent consideration of the evolving risks and benefits as new information becomes available while also working to maintain documentation of an individual's perinatal HIV/ARV exposures as a vital part of his

  18. Patent Law for Computer Scientists

    NASA Astrophysics Data System (ADS)

    Closa, Daniel; Gardiner, Alex; Giemsa, Falk; Machek, Jörg

    More than five centuries ago the first patent statute was passed by the Venetian senate. It already had most of the features of modern patent law, recognizing the public interest in innovation and granting exclusive right in exchange for a full disclosure. Some 350 years later the industrial revolution led to globalisation. The wish to protect intellectual property on a more international level evolved and supranational treaties were negotiated. Patent laws are still different in many countries, however, and inventors are sometimes at a loss to understand which basic requirements should be satisfied if an invention is to be granted a patent. This is particularly true for inventions implemented on a computer. While roughly a third of all applications (and granted patents) relate, in one way or another, to a computer, applications where the innovation mainly resides in software or in a business method are treated differently by the major patent offices. The procedures at the USPTO, JPO and EPO and, in particular, the differences in the treatment of applications centring on software are briefly explained. In later sections of this book, a wealth of examples will be presented. The methodology behind the treatment of these examples is explained.

  19. Antiretroviral Drugs-Loaded Nanoparticles Fabricated by Dispersion Polymerization with Potential for HIV/AIDS Treatment

    PubMed Central

    Ogunwuyi, Oluwaseun; Kumari, Namita; Smith, Kahli A.; Bolshakov, Oleg; Adesina, Simeon; Gugssa, Ayele; Anderson, Winston A.; Nekhai, Sergei; Akala, Emmanuel O.

    2016-01-01

    Highly active antiretroviral (ARV) therapy (HAART) for chronic suppression of HIV replication has revolutionized the treatment of HIV/AIDS. HAART is no panacea; treatments must be maintained for life. Although great progress has been made in ARV therapy, HIV continues to replicate in anatomical and intracellular sites where ARV drugs have restricted access. Nanotechnology has been considered a platform to circumvent some of the challenges in HIV/AIDS treatment. Dispersion polymerization was used to fabricate two types (PMM and ECA) of polymeric nanoparticles, and each was successfully loaded with four ARV drugs (zidovudine, lamivudine, nevirapine, and raltegravir), followed by physicochemical characterization: scanning electron microscope, particle size, zeta potential, drug loading, and in vitro availability. These nanoparticles efficiently inhibited HIV-1 infection in CEM T cells and peripheral blood mononuclear cells; they hold promise for the treatment of HIV/AIDS. The ARV-loaded nanoparticles with polyethylene glycol on the corona may facilitate tethering ligands for targeting specific receptors expressed on the cells of HIV reservoirs. PMID:27013886

  20. ACOG Committee Opinion. Number 364 May 2007. Patents, medicine, and the interests of patients.

    PubMed

    2007-05-01

    Many basic scientists and clinicians support the right to obtain and enforce patents on drugs, diagnostic tests, medical devices, and most recently, genes. Although those who develop useful drugs, diagnostic and screening tests, and medical technologies have the right to expect a fair return for their efforts and risks, current interpretations of patent law have the potential to impede rather than promote scientific and medical advances. Policies regarding the patenting of scientific inventions, discoveries, and improvements must balance the need for the open exchange and use of information with the need ot make the pursuit of such knowledge financially rewarding.

  1. Considerations on patent valuation based on patent classification and citation in biotechnological field

    NASA Astrophysics Data System (ADS)

    Mihara, Kenji

    Regarding innovation measurement utilizing patent information, a number of researchers are making great efforts to measure a "patent value (patent quality)." For patent valuation, patent classification and citation are often utilized as patent information. Also, biotechnological field is attracting attention from the viewpoint of application to environmental or medical study, and considerable researches on patent valuation are ongoing in this technical field. However, it is not enough recognized that researchers cannot be too careful when they deal with classification information in the biotech field because patent classification structure in this field is not well-established. And also, it is not known enough that citation patterns of both academic papers and patent documents are so complicated that the patterns cannot be easily generalized. In this article, the issues above were verified from a position based on working experiences of biotech patent examiner at Japan Patent Office, and considerations and implications were given on what patent valuation should be.

  2. 37 CFR 1.315 - Delivery of patent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Delivery of patent. 1.315 Section 1.315 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF... Patent § 1.315 Delivery of patent. The patent will be delivered or mailed upon issuance to...

  3. 37 CFR 1.315 - Delivery of patent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Delivery of patent. 1.315 Section 1.315 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF... Patent § 1.315 Delivery of patent. The patent will be delivered or mailed upon issuance to...

  4. Patent cliff mitigation strategies: giving new life to blockbusters.

    PubMed

    Kakkar, Ashish Kumar

    2015-01-01

    With several blockbuster drugs on the brink of another significant patent expiry cliff, innovator pharmaceutical firms are at risk of losing billions of dollars in sales to generic competition. With issues such as staggering R&D costs, reduced productivity and increasing governmental emphasis on pharmacoeconomics, timely planning and implementation of product lifecycle management strategies is becoming indispensable. A variety of strategies designed to mitigate the post-patent expiry revenue loss exist. These approaches range from fairly straightforward measures, such as strategic price cuts and launching own or authorized generics, to complex and lengthy ones, such as new formulations and indications that require companies to reinvent their pharmaceuticals. As patent expiries loom and product pipelines continue to remain thin, proactive planning for generic entry will be critical for pharma companies to drive growth and earnings in a sustainable manner.

  5. Antiepileptic drug selection for people with HIV/AIDS: evidence-based guidelines from the ILAE and AAN.

    PubMed

    Birbeck, Gretchen L; French, Jacqueline A; Perucca, Emilio; Simpson, David M; Fraimow, Henry; George, Jomy M; Okulicz, Jason F; Clifford, David B; Hachad, Houda; Levy, René H

    2012-01-01

    A joint panel of the American Academy of Neurology (AAN) and the International League Against Epilepsy (ILAE) convened to develop guidelines for selection of antiepileptic drugs (AEDs) among people with HIV/AIDS. The literature was systematically reviewed to assess the global burden of relevant comorbid entities, to determine the number of patients who potentially utilize AEDs and antiretroviral agents (ARVs), and to address AED-ARV interactions. Key findings from this literature search included the following: AED-ARV administration may be indicated in up to 55% of people taking ARVs. Patients receiving phenytoin may require a lopinavir/ritonavir dosage increase of approximately 50% to maintain unchanged serum concentrations (Level C). Patients receiving valproic acid may require a zidovudine dosage reduction to maintain unchanged serum zidovudine concentrations (Level C). Coadministration of valproic acid and efavirenz may not require efavirenz dosage adjustment (Level C). Patients receiving ritonavir/atazanavir may require a lamotrigine dosage increase of approximately 50% to maintain unchanged lamotrigine serum concentrations (Level C). Coadministration of raltegravir/atazanavir and lamotrigine may not require lamotrigine dosage adjustment (Level C). Coadministration of raltegravir and midazolam may not require midazolam dosage adjustment (Level C). Patients may be counseled that it is unclear whether dosage adjustment is necessary when other AEDs and ARVs are combined (Level U). It may be important to avoid enzyme-inducing AEDs in people on ARV regimens that include protease inhibitors or nonnucleoside reverse transcriptase inhibitors because pharmacokinetic interactions may result in virologic failure, which has clinical implications for disease progression and development of ARV resistance. If such regimens are required for seizure control, patients may be monitored through pharmacokinetic assessments to ensure efficacy of the ARV regimen (Level C).

  6. HIV-1 Antiretroviral Drug Resistance Mutations in Treatment Naïve and Experienced Panamanian Subjects: Impact on National Use of EFV-Based Schemes

    PubMed Central

    Mendoza, Yaxelis; Castillo Mewa, Juan; Martínez, Alexander A.; Zaldívar, Yamitzel; Sosa, Néstor; Arteaga, Griselda; Armién, Blas; Bautista, Christian T.; García-Morales, Claudia; Tapia-Trejo, Daniela; Ávila-Ríos, Santiago; Reyes-Terán, Gustavo; Bello, Gonzalo; Pascale, Juan M.

    2016-01-01

    The use of antiretroviral therapy in HIV infected subjects prevents AIDS-related illness and delayed occurrence of death. In Panama, rollout of ART started in 1999 and national coverage has reached 62.8% since then. The objective of this study was to determine the level and patterns of acquired drug resistance mutations of clinical relevance (ADR-CRM) and surveillance drug resistance mutations (SDRMs) from 717 HIV-1 pol gene sequences obtained from 467 ARV drug-experienced and 250 ARV drug-naïve HIV-1 subtypes B infected subjects during 2007–2013, respectively. The overall prevalence of SDRM and of ADR-CRM during the study period was 9.2% and 87.6%, respectively. The majority of subjects with ADR-CRM had a pattern of mutations that confer resistance to at least two classes of ARV inhibitors. The non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations K103N and P225H were more prevalent in both ARV drug-naïve and ARV drug-experienced subjects. The nucleoside reverse transcriptase inhibitor (NRTI) mutation M184V was more frequent in ARV drug-experienced individuals, while T215YFrev and M41L were more frequent in ARV drug-naïve subjects. Prevalence of mutations associated to protease inhibitors (PI) was lower than 4.1% in both types of subjects. Therefore, there is a high level of resistance (>73%) to Efavirenz/Nevirapine, Lamivudine and Azidothymidine in ARV drug-experienced subjects, and an intermediate to high level of resistance (5–10%) to Efavirenz/Nevirapine in ARV drug-naïve subjects. During the study period, we observed an increasing trend in the prevalence of ADR-CRM in subjects under first-line schemes, but not significant changes in the prevalence of SDRM. These results reinforce the paramount importance of a national surveillance system of ADR-CRM and SDRM for national management policies of subjects living with HIV. PMID:27119150

  7. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670... (human drug product, animal drug product, medical device, food additive, or color additive) was subject... regulatory review period consists of two periods of time: A testing phase and an approval phase. For...

  8. 77 FR 26288 - Determination of Regulatory Review Period for Purposes of Patent Extension; HALAVEN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; HALAVEN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers...

  9. 77 FR 20827 - Determination of Regulatory Review Period for Purposes of Patent Extension; TEFLARO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670... (human drug product, animal drug product, medical device, food additive, or color additive) was subject... regulatory review period consists of two periods of time: A testing phase and an approval phase. For...

  10. 78 FR 6826 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670... (human drug product, animal drug product, medical device, food additive, or color additive) was subject... regulatory review period consists of two periods of time: A testing phase and an approval phase. For...

  11. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers...

  12. 77 FR 26554 - Determination of Regulatory Review Period for Purposes of Patent Extension; GILENYA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; GILENYA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for GILENYA and...

  13. Farnesyl pyrophosphate synthase modulators: a patent review (2006 - 2010)

    PubMed Central

    Sun, Shuting; McKenna, Charles E.

    2012-01-01

    Introduction Farnesyl pyrophosphosphate synthase (FPPS (also known as farnesyl diphosphate synthase, FDPS)) is one of the key enzymes involved in the mevalonate pathway and as such is widely expressed. FPPS modulators, specifically FPPS inhibitors, are useful in treating a number of diseases, including bone related disorders characterized by excessive bone resorption e.g. osteoporosis, cancer metathesis to bone and infectious diseases caused by certain parasites. Areas covered This review covers structures and applications of novel FPPS modulators described in the patent literature from 2006 to 2010. Patents disclosing new formulations and uses of existing FPPS inhibitors are also reviewed. Thirty-three patents retrieved from the USPTO, EP and WIPO databases are examined with the goal of defining current trends in drug discovery related to FPPS inhibition, and its therapeutic effects. Expert opinion Bisphosphonates continue to dominate in this area, although other types of modulator are making their appearance. Remarkable for their high bone mineral affinity, bisphosphonates are structural mimics of the dimethylallyl pyrophosphate (DMAPP) substrate of FPPS, and constitute the major type of FPPS inhibitor currently used in the clinic for treatment of bone-related diseases. Lipophilic bisphosphonates and new classes of non-bisphosphonate FPPS inhibitors (salicylic acid and quinoline derivatives) have been introduced as possible alternatives for treatment of soft tissue diseases, such as some cancers. Novel formulations, fluorescent diagnostic probes and new therapeutic applications of existing FPPS inhibitors are also areas of significant patent activity, demonstrating growing recognition of the versatility and underdeveloped potential of these drugs. PMID:21702715

  14. Recent Patents in Oncolytic Virotherapy.

    PubMed

    Ahmad, Tauqeer; Venkataraman, Srividhya; AbouHaidar, Mounir; Hefferon, Kathleen L

    2016-01-01

    Recent innovative and advanced developments in the diagnosis and treatment of human diseases as well as enhanced in-depth understanding of virus molecular biology have opened novel avenues with respect to the patent landscape. Included are viruses utilized in the development of anticancer agents, agents that are employed against the spread of infectious viral diseases, RNA silencing agents and virus-derived expression vectors that can be used for over-expression of therapeutic proteins or as gene therapy vehicles. The current review describes several recent patents pertaining to virus sequences and their medical and biotechnological applications.

  15. Patent Abstract Digest. Volume I.

    DTIC Science & Technology

    1979-04-30

    COMMAND United States Patent ij fill 4,102,610 Taboada et al. [45] Jul. 25,1i978 154] CONSTANT VOLUME SEAL-FREE 3.522,794 7/1970 DNJl................318...MATCHING [561 Rafaree. Cited SPACER U.S. PATENT DOCUMENTS [751 Inventors: Sidney Michael Cole. Waved 7; Paul 3.533.607 1/1971 Lehrreld . ...... 331/34 tA...Schwadron 11) let. CV ....................... F16K 21/18; FI7C 13/02; Aiistant Examiner-A. Michael Chambers GOlF 23/24 Attorney Agent, orFirm-Joseph E

  16. Impact of bioethics on patentability of inventions.

    PubMed

    Devaiah, Vishwas H

    2010-01-01

    This paper examines the impact of bioethics on patent claims. The increase in research activities involving human biological materials, and the rush to commercialise inventions derived from such biological materials, can at times result in unethical conduct of research. Questions arise as to whether patent law should concern itself with tainted research that has resulted in an invention or whether it should grant patent rights solely on the basis of the technical improvements resulting from such research. This paper highlights the significance of ethical practice in biomedical research, an issue that may influence the decision to grant patents on inventions. It explores the relation between morality, bioethics and patents from the perspective of the objectives of the patent system and current developments in the law on patents. The inclusion of the morality provision in patent law introduces a mechanism through which inventions derived from tainted research can be filtered at an early stage.

  17. 48 CFR 1327.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Patent and copyright... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1327.201 Patent and copyright infringement liability....

  18. 48 CFR 27.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Patent and copyright... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 27.201 Patent and copyright infringement liability....

  19. 48 CFR 1427.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Patent and copyright... INTERIOR GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1427.201 Patent and copyright infringement liability....

  20. 48 CFR 1327.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Patent and copyright... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1327.201 Patent and copyright infringement liability....

  1. 48 CFR 1327.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Patent and copyright... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1327.201 Patent and copyright infringement liability....

  2. 48 CFR 27.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Patent and copyright... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 27.201 Patent and copyright infringement liability....

  3. 7 CFR 1210.367 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Patents, copyrights, inventions, and publications....367 Patents, copyrights, inventions, and publications. Any patents, copyrights, inventions, product... such patents, copyrights, inventions, product formulations, or publications shall be considered...

  4. 7 CFR 1210.367 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Patents, copyrights, inventions, and publications....367 Patents, copyrights, inventions, and publications. Any patents, copyrights, inventions, product... such patents, copyrights, inventions, product formulations, or publications shall be considered...

  5. 48 CFR 1327.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent and copyright... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1327.201 Patent and copyright infringement liability....

  6. 48 CFR 27.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patent and copyright... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 27.201 Patent and copyright infringement liability....

  7. 48 CFR 1327.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Patent and copyright... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1327.201 Patent and copyright infringement liability....

  8. 7 CFR 1210.367 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Patents, copyrights, inventions, and publications....367 Patents, copyrights, inventions, and publications. Any patents, copyrights, inventions, product... such patents, copyrights, inventions, product formulations, or publications shall be considered...

  9. 48 CFR 1427.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Patent and copyright... INTERIOR GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1427.201 Patent and copyright infringement liability....

  10. 48 CFR 27.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Patent and copyright... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 27.201 Patent and copyright infringement liability....

  11. 48 CFR 1427.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent and copyright... INTERIOR GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1427.201 Patent and copyright infringement liability....

  12. 7 CFR 1210.367 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Patents, copyrights, inventions, and publications....367 Patents, copyrights, inventions, and publications. Any patents, copyrights, inventions, product... such patents, copyrights, inventions, product formulations, or publications shall be considered...

  13. 48 CFR 27.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Patent and copyright... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 27.201 Patent and copyright infringement liability....

  14. 48 CFR 1427.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Patent and copyright... INTERIOR GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1427.201 Patent and copyright infringement liability....

  15. 48 CFR 1427.201 - Patent and copyright infringement liability.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Patent and copyright... INTERIOR GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1427.201 Patent and copyright infringement liability....

  16. 7 CFR 1210.367 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Patents, copyrights, inventions, and publications....367 Patents, copyrights, inventions, and publications. Any patents, copyrights, inventions, product... such patents, copyrights, inventions, product formulations, or publications shall be considered...

  17. 37 CFR 1.740 - Formal requirements for application for extension of patent term; correction of informalities.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... number, the date of issue, and the date of expiration; (7) A copy of the patent for which an extension is... information pursuant to 35 U.S.C. 156(g) in order to enable the Secretary of Health and Human Services or the...: (i) For a patent claiming a human drug, antibiotic, or human biological product: (A) The...

  18. 77 FR 4509 - Patent Public Advisory Committee Public Hearings on the Proposed Patent Fee Schedule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    .... Dated: January 24, 2012. David J. Kappos, Under Secretary of Commerce for Intellectual Property and... United States Patent and Trademark Office 37 CFR Chapter I Patent Public Advisory Committee Public Hearings on the Proposed Patent Fee Schedule AGENCY: United States Patent and Trademark Office,...

  19. The patentability of human beings: the effect of a proposed exclusion in the Patents Act 1953.

    PubMed

    MacBean, Alexandra

    2002-11-01

    The author critically examines the debate over whether "human beings" ought to be patentable. The article outlines the choices between excluding just the patenting of whole organisms or parts of organisms. After considering New Zealand, Canadian, and European Union Patent law, the author concludes that at very least New Zealand must statutorily prevent the patenting of whole organisms.

  20. HIV Type 2 Protease, Reverse Transcriptase, and Envelope Viral Variation in the PBMC and Genital Tract of ARV-Naive Women in Senegal

    PubMed Central

    Hawes, Stephen E.; Wong, Kim G.; Raugi, Dana N.; Agne, Habibatou D.; Critchlow, Cathy W.; Kiviat, Nancy B.; Sow, Papa Salif

    2008-01-01

    Abstract Unique viral variants and resistance mutations may occur in the genital tract of HIV-2 ARV-naive infected women. We sequenced and phylogenetically analyzed protease (PR), reverse transcriptase (RT), and envelope (ENV) from PBMC and genital tract samples from four ARV-naive women in Senegal. HIV-2 protease polymorphisms that predict HIV-1 protease inhibitor (PI) resistance were common. Two subjects had protease mutations (T77I and I64V) in genital tract samples that were not found in PBMCs. One subject had the HIV-2 reverse transcriptase M184I mutation in CVL DNA (but not PBMCs) that is known to confer 3TC/FTC resistance in HIV-2. In another subject, the reverse transcriptase A62V mutation was also found in CVL-RNA but not PBMCs. We found no significant difference in ENV variants between PBMCs and the genital tract. HIV-2 RT and PR mutations in the genital tract of ARV-naive females may have implications for transmitted HIV-2 resistance and ARV therapy. PMID:18544024

  1. "It's important to take your medication everyday okay?" An evaluation of counselling by lay counsellors for ARV adherence support in the Western Cape, South Africa.

    PubMed

    Dewing, S; Mathews, C; Schaay, N; Cloete, A; Louw, J; Simbayi, L

    2013-01-01

    There is growing interest in standard care programmes for antiretroviral (ARV) adherence support. In South Africa, individual counselling following ARV initiation is a main strategy for supporting adherence in the public sector. Egan's client-centred "Skilled Helper" counselling model is the predominant model used in HIV counselling in this context. This study evaluated counselling delivered by lay ARV adherence counsellors in Cape Town in terms of adherence to Egan's model. Thirty-eight transcripts of counselling sessions with non-adherent patients were analysed based on the methods of content analysis. These sessions were conducted by 30 counsellors. Generally counsellors' practice adhered neither to Egan's model nor a client-centred approach. Inconsistent with evidence-based approaches to counselling for ARV adherence support, counsellors mainly used information-giving and advice as strategies for addressing clients' non-adherence. Recommendations for improving practice are made. The question as to how appropriate strategies from developed countries are for this setting is also raised.

  2. [Gene and gene sequence patenting].

    PubMed

    Bergel, S D

    1998-01-01

    According to the author, the patenting of elements isolated or copied from the human body boils down to the issue of genes and gene sequences. He describes the current situation from the comparative law standpoint (U.S. and Spanish law mainly) and then esamines the biotechnology industry's position.

  3. The US patent system is broken.

    PubMed

    Pieczenik, George

    2013-08-01

    In discussions in this issue of RBM Online relating to a patent granted to Auxogyn, Professor Renee Reijo Pera claims this is not about a "broken patent system". I shall demonstrate how dysfunctional the patent system has become and how much in denial 'inventor' Renee Reijo Pera is about her invention differing from a naturally occurring phenomenon.

  4. Patents and human rights: a heterodox analysis.

    PubMed

    Gold, E Richard

    2013-01-01

    Much international debate over access to medicines focuses on whether patent law accords with international human rights law. This article argues that this is the wrong question to ask. Following an analysis of both patent and human rights law, this article suggests that the better approach is to focus on national debates over the best calibration of patent law to achieve national objectives.

  5. Abstract Journals: A Survey of Patent Coverage.

    ERIC Educational Resources Information Center

    Rimmer, Brenda M.

    1988-01-01

    Describes a survey of 33 British, French, German, and U.S. abstract journals that examined their coverage of patent specifications. The standards for the identification of patent documents developed by the World Intellectual Property Organization are discussed, and an appendix provides a listing of the patent coverage by the country of each…

  6. 14 CFR 1274.911 - Patent rights.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Patent rights. 1274.911 Section 1274.911... FIRMS Other Provisions and Special Conditions § 1274.911 Patent rights. Patent Rights July 2002 (a... through 121.911 will be used.) (8) Subject Invention means any invention of a Recipient and/or...

  7. 14 CFR 1274.911 - Patent rights.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Patent rights. 1274.911 Section 1274.911... FIRMS Other Provisions and Special Conditions § 1274.911 Patent rights. Patent Rights July 2002 (a... through 121.911 will be used.) (8) Subject Invention means any invention of a Recipient and/or...

  8. 14 CFR 1274.911 - Patent rights.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Patent rights. 1274.911 Section 1274.911... FIRMS Other Provisions and Special Conditions § 1274.911 Patent rights. Patent Rights July 2002 (a... through 121.911 will be used.) (8) Subject Invention means any invention of a Recipient and/or...

  9. 48 CFR 35.012 - Patent rights.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patent rights. 35.012 Section 35.012 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.012 Patent rights. For a discussion of patent rights,...

  10. 48 CFR 970.2703 - Patent rights.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Patent rights. 970.2703 Section 970.2703 Federal Acquisition Regulations System DEPARTMENT OF ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2703 Patent rights....

  11. 48 CFR 970.2703 - Patent rights.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent rights. 970.2703 Section 970.2703 Federal Acquisition Regulations System DEPARTMENT OF ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2703 Patent rights....

  12. 48 CFR 970.2703 - Patent rights.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Patent rights. 970.2703 Section 970.2703 Federal Acquisition Regulations System DEPARTMENT OF ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2703 Patent rights....

  13. 48 CFR 970.2703 - Patent rights.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Patent rights. 970.2703 Section 970.2703 Federal Acquisition Regulations System DEPARTMENT OF ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2703 Patent rights....

  14. 48 CFR 970.2703 - Patent rights.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Patent rights. 970.2703 Section 970.2703 Federal Acquisition Regulations System DEPARTMENT OF ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2703 Patent rights....

  15. Laccases and their applications: a patent review.

    PubMed

    Kunamneni, Adinarayana; Plou, Francisco J; Ballesteros, Antonio; Alcalde, Miguel

    2008-01-01

    Laccases are an interesting group of multi copper enzymes, which have received much attention of researchers in last decades due to their ability to oxidize both phenolic and non-phenolic lignin related compounds as well as highly recalcitrant environmental pollutants. This makes these biocatalysts very useful for their application in several biotechnological processes. Such applications include the detoxification of industrial effluents, mostly from the paper and pulp, textile and petrochemical industries, polymer synthesis, bioremediation of contaminated soils, wine and beverage stabilization. Laccases are also used as catalysts for the manufacture of anti-cancer drugs and even as ingredients in cosmetics. Recently, the utility of laccases has also been applied to nanobiotechnology. This paper reviews recent and important patents related to the properties, heterologous production, molecular cloning, and applications of laccases within different industrial fields as well as their potential extension to the nanobiotechnology area.

  16. The importance of patents to innovation: updated cross-industry comparisons with biopharmaceuticals.

    PubMed

    Cockburn, Iain; Long, Genia

    2015-07-01

    Patents have long been considered essential incentives to foster innovation, particularly the development of new prescription drugs, due to the lengthy, costly, and risky nature of the research and development (R&D) process as compared to the lower levels of investment and risk associated with generic drug entry. Compared with other forms of intellectual property protection (such as trade secrets, trademarks, and copyrights) and strategic complementary assets (such as lead time, sales and service, and manufacturing advantages), researchers focused on the US since the 1980s consistently have found patents to be relatively more important to R&D in pharmaceuticals than in other industries. Despite many changes in the market and patent landscape, the most recent data from government surveys and annual surveys of licensing professionals continue to find differential and high importance of patents to biopharmaceutical innovation.

  17. ACOG. Committee opinion: number 277, November 2002. Patients, medicine and the interests of patients: applying general principles to gene patenting.

    PubMed

    2002-11-01

    New technologies and the translation of research into clinical medicine are essential to patient care. Those who develop useful drugs, diagnostic and screening tests, and medical technologies have the right to expect a fair return for their efforts and risks. Current interpretations of patent law (particularly regarding gene patenting), however, have the potential to impede both medical advances and patient care. Patenting policies must balance the open exchange and use of information with making the pursuit of such knowledge financially rewarding. The Committee on Ethics and the Committee on Genetics of the American College of Obstetricians and Gynecologists maintain that patents on medical or surgical procedures are ethically unacceptable. Physicians may obtain patents on surgical and diagnostic instruments that they have developed, but such instruments should be made available to others at a fair and reasonable cost. Patents for genes as "compositions of matter" enable patent holders to control future applications of the genes and should not be granted. Patents should be granted only for specified uses or applications of genes or sequences. If composition-of-matter patents on genes continue to be enforceable, such patents on genes with clinical application is should be subject to federal regulation and oversight to ensure availability on reasonable terms for research and clinical use.

  18. 37 CFR 1.740 - Formal requirements for application for extension of patent term; correction of informalities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... patent claiming a new animal drug: (A) The date a major health or environmental effects test on the drug...) In the case of a drug product, an identification of each active ingredient in the product and as to... or use under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the...

  19. New drug applications and abbreviated new drug applications; technical amendment. Final rule; technical amendment.

    PubMed

    2009-03-06

    The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications and to correct an inaccurate cross-reference. This action is being taken to ensure accuracy and clarity in the agency's regulations.

  20. Patent data mining method and apparatus

    DOEpatents

    Boyack, Kevin W.; Grafe, V. Gerald; Johnson, David K.; Wylie, Brian N.

    2002-01-01

    A method of data mining represents related patents in a multidimensional space. Distance between patents in the multidimensional space corresponds to the extent of relationship between the patents. The relationship between pairings of patents can be expressed based on weighted combinations of several predicates. The user can select portions of the space to perceive. The user also can interact with and control the communication of the space, focusing attention on aspects of the space of most interest. The multidimensional spatial representation allows more ready comprehension of the structure of the relationships among the patents.

  1. DNA patenting: implications for public health research.

    PubMed Central

    Dutfield, Graham

    2006-01-01

    I weigh the arguments for and against the patenting of functional DNA sequences including genes, and find the objections to be compelling. Is an outright ban on DNA patenting the right policy response? Not necessarily. Governments may wish to consider options ranging from patent law reforms to the creation of new rights. There are alternative ways to protect DNA sequences that industry may choose if DNA patenting is restricted or banned. Some of these alternatives may be more harmful than patents. Such unintended consequences of patent bans mean that we should think hard before concluding that prohibition is the only response to legitimate concerns about the appropriateness of patents in the field of human genomics. PMID:16710549

  2. DNA patenting: implications for public health research.

    PubMed

    Dutfield, Graham

    2006-05-01

    I weigh the arguments for and against the patenting of functional DNA sequences including genes, and find the objections to be compelling. Is an outright ban on DNA patenting the right policy response? Not necessarily. Governments may wish to consider options ranging from patent law reforms to the creation of new rights. There are alternative ways to protect DNA sequences that industry may choose if DNA patenting is restricted or banned. Some of these alternatives may be more harmful than patents. Such unintended consequences of patent bans mean that we should think hard before concluding that prohibition is the only response to legitimate concerns about the appropriateness of patents in the field of human genomics.

  3. US photovoltaic patents: 1991--1993

    SciTech Connect

    Pohle, L

    1995-03-01

    This document contains US patents on terrestrial photovoltaic (PV) power applications, including systems, components, and materials as well as manufacturing and support functions. The patent entries in this document were issued from 1991 to 1993. The entries were located by searching USPA, the database of the US Patent Office. The final search retrieved all patents under the class ``Batteries, Thermoelectric and Photoelectric`` and the subclasses ``Photoelectric,`` ``Testing,`` and ``Applications.`` The search also located patents that contained the words ``photovoltaic(s)`` or ``solar cell(s)`` and their derivatives. After the initial list was compiled, most of the patents on the following subjects were excluded: space photovoltaic technology, use of the photovoltaic effect for detectors, and subjects only peripherally concerned with photovoltaic. Some patents on these three subjects were included when ft appeared that those inventions might be of use in terrestrial PV power technologies.

  4. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  5. Enforcement costs: some humanitarian alternatives to stronger patent rights.

    PubMed

    Trotter, Andrew

    2012-01-01

    Diseases that cause comparatively few problems in developed countries kill millions of people in the Third World each year. In many cases, people die because they cannot afford the medication needed to save their lives. In others, there are simply no drugs available because there are no wealthy western patients to justify pharmaceutical companies investing in a cure. This reveals a deep-seated problem within the patent system and the pharmaceutical industry that emphasises markets and profits at the expense of health and global welfare. Global efforts have seen substantial improvements in access to medicines in isolated areas, but with international agreements driving towards stronger patent protection and the expiry date for the TRIPS grace period fast approaching, it is time to consider alternatives which will allow the patent system to work for the humanitarian cause rather than against it. This paper considers two such problems in the patent system and pharmaceutical industry - prohibitive pricing and misdirected incentives - to offer a mode of regulation and enforcement that will support both a viable pharmaceutical industry and the human right to health and medication.

  6. The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.

    PubMed

    Panattoni, Laura E

    2011-01-01

    This purpose of this paper is to investigate the impact of Paragraph IV patent infringement decisions on brand drug pharmaceutical firms. Paragraph IV decisions determine whether a generic firm can enter before the period of exclusivity ends. I construct a novel dataset of all Paragraph IV decisions and find that they disproportionately involve the highest revenue drugs, significant periods of patent protection, and a non-trivial portion of all brand drugs facing generic entry. I also estimate the impact of Paragraph IV decisions on brand firm profitability and find they have large value consequences.

  7. A Case Study of Pharmaceutical Pricing in China: Setting the Price for Off-Patent Originators.

    PubMed

    Hu, Shanlian; Zhang, Yabing; He, Jiangjiang; Du, Lixia; Xu, Mingfei; Xie, Chunyan; Peng, Ying; Wang, Linan

    2015-08-01

    This article aims to define a value-based approach to pricing and reimbursement for off-patent originators using a multiple criteria decision analysis (MCDA) approach centered on a systematic analysis of current pricing and reimbursement policies in China. A drug price policy review was combined with a quantitative analysis of China's drug purchasing database. Policy preferences were identified through a MCDA performed by interviewing well-known academic experts and industry stakeholders. The study findings indicate that the current Chinese price policy includes cost-based pricing and the establishment of maximum retail prices and premiums for off-patent originators, whereas reference pricing may be adopted in the future. The literature review revealed significant differences in the dissolution profiles between originators and generics; therefore, dissolution profiles need to be improved. Market data analysis showed that the overall price ratio of generics and off-patent originators was around 0.54-0.59 in 2002-2011, with a 40% price difference, on average. Ten differentiating value attributes were identified and MCDA was applied to test the impact of three pricing policy scenarios. With the condition of implementing quality consistency regulations and controls, a reduction in the price gap between high-quality off-patent products (including originator and generics) seemed to be the preferred policy. Patents of many drugs will expire within the next 10 years; thus, pricing will be an issue of importance for off-patent originators and generic alternatives.

  8. 75 FR 54887 - Determination of Regulatory Review Period for Purposes of Patent Extension; REPEL-CV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; REPEL-CV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  9. 75 FR 79381 - Determination of Regulatory Review Period for Purposes of Patent Extension; FOLOTYN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; FOLOTYN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  10. 76 FR 37128 - Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  11. 75 FR 54344 - Determination of Regulatory Review Period for Purposes of Patent Extension; EFFIENT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; EFFIENT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  12. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  13. 75 FR 54888 - Determination of Regulatory Review Period for Purposes of Patent Extension; IXIARO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; IXIARO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  14. 78 FR 13684 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  15. 76 FR 37127 - Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  16. 78 FR 13685 - Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  17. 76 FR 25357 - Determination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  18. 76 FR 12974 - Determination of Regulatory Review Period for Purposes of Patent Extension; AMPYRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; AMPYRA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  19. 75 FR 9227 - Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  20. 75 FR 76740 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEPREVE

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; BEPREVE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  1. 75 FR 18213 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOZOBIL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; MOZOBIL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  2. 75 FR 76739 - Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  3. 77 FR 34389 - Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant AGENCY: Food and Drug Administration, HHS....

  4. 75 FR 32951 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  5. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  6. 75 FR 32479 - Determination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  7. Patent first, ask questions later: morality and biotechnology in patent law.

    PubMed

    Bagley, Margo A

    2003-12-01

    This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article

  8. Antibody-drug conjugates: Intellectual property considerations.

    PubMed

    Storz, Ulrich

    2015-01-01

    Antibody-drug conjugates are highly complex entities that combine an antibody, a linker and a toxin. This complexity makes them demanding both technically and from a regulatory point of view, and difficult to deal with in their patent aspects. This article discusses different issues of patent protection and freedom to operate with regard to this promising new class of drugs.

  9. Antibody-drug conjugates: Intellectual property considerations

    PubMed Central

    Storz, Ulrich

    2015-01-01

    Antibody-drug conjugates are highly complex entities that combine an antibody, a linker and a toxin. This complexity makes them demanding both technically and from a regulatory point of view, and difficult to deal with in their patent aspects. This article discusses different issues of patent protection and freedom to operate with regard to this promising new class of drugs. PMID:26292154

  10. Inventions and patents: a practical tutorial.

    PubMed

    Tidwell, J Lille; Liotta, Lance A

    2012-01-01

    Patents are designed to protect and encourage creativity and innovation. Patenting a biomedical discovery can be a requirement before a pharmaceutical company or biotech entity will invest in the lengthy and costly clinical testing necessary to achieve patient benefit. Although scientists and clinicians are well versed in research publication requirements, patent descriptions and claims are formatted in a manner quite different from a research paper. Patents require (a) a series of logical statements clearly delineating the boundaries of the novel aspects of the invention and (b) sufficient disclosure of the invention so that it can be reproduced by others. Patents are granted only for inventions that meet three conditions: novelty, nonobviousness, and usefulness. This chapter provides basic guidelines and definitions of technology transfer: inventions, inventorship, and patent filing, which are summarized using a question and answer format.

  11. PATENTS IN GENOMICS AND HUMAN GENETICS

    PubMed Central

    Cook-Deegan, Robert; Heaney, Christopher

    2010-01-01

    Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts---and sometimes fails to adapt---to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive postdiscovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims. PMID:20590431

  12. Writing reports to facilitate patent applications.

    SciTech Connect

    Libman, George H.; Doerry, Armin Walter

    2004-06-01

    Brief disclosures may often be sufficient for the filing of a Technical Advance with Sandia's Intellectual Property Center, but still be inadequate to facilitate an optimum patent application where more detail and explanation are required. Consequently, the crafting of a patent application may require considerably more additional interaction between the application preparer and the inventors. This inefficiency can be considerably mitigated if the inventors address some critical aspects of a patent application when they write a technical report.

  13. Persistent Confusion and Controversy Surrounding Gene Patents

    PubMed Central

    Guerrini, Christi J.; Majumder, Mary A.; McGuire, Amy L.

    2016-01-01

    There is persistent confusion and controversy surrounding basic issues of patent law relevant to the genomics industry. Uncertainty and conflict can lead to the adoption of inefficient practices and exposure to liability. The development of patent-specific educational resources for industry members, as well as the prompt resolution of patentability rules unsettled by recent U.S. Supreme Court decisions, are therefore urgently needed. PMID:26849516

  14. 78 FR 72872 - Notice of Intent To Grant Partially Exclusive Patent License; ICAP Patent Brokerage, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... exclusive license in the United States to practice the Government-Owned inventions described in U.S. Patent...//U.S. Patent No. 8,073,804: System and Method For Type 2 KASER (Knowledge Amplification by...

  15. 78 FR 51177 - Notice of Intent To Grant Partially Exclusive Patent License; ICAP Patent Brokerage, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ....//U.S. Patent No. 7,925,496: Method for Summarizing Natural Language Text.//U.S. Patent No. 8,217,382: Optical-Powered Flexible Photonic Bandgap Sensor Device. DATES: Anyone wishing to object to the grant...

  16. Early Initiation of ARV During Pregnancy to Move towards Virtual Elimination of Mother-to-Child-Transmission of HIV-1 in Yunnan, China

    PubMed Central

    Meyers, Kathrine; Qian, Haoyu; Wu, Yingfeng; Lao, Yunfei; Chen, Qingling; Dong, Xingqi; Li, Huiqin; Yang, Yiqing; Jiang, Chengqin; Zhou, Zengquan

    2015-01-01

    Objective To identify factors associated with mother-to-child-transmission and late access to prevention of maternal to child transmission (PMTCT) services among HIV-infected women; and risk factors for infant mortality among HIV-exposed infants in order to assess the feasibility of virtual elimination of vertical transmission and pediatric HIV in this setting. Design Observational study evaluating the impact of a provincial PMTCT program. Methods The intervention was implemented in 26 counties of Yunnan Province, China at municipal and tertiary health care settings. Log linear regression models with generalized estimating equations were used to identify unadjusted and adjusted correlates for late ARV intervention and MTCT. Cox proportional hazard models with robust sandwich estimation were applied to examine correlates of infant mortality. Results Mother-to-child- transmission rate of HIV was controlled to 2%, with late initiation of maternal ARV showing a strong association with vertical transmission and infant mortality. Risk factors for late initiation of maternal ARV were age, ethnicity, education, and having a husband not tested for HIV. Mortality rate among HIV-exposed infants was 2.9/100 person-years. In addition to late initiation of maternal ARV, ethnicity, low birth weight and preterm birth were associated with infant mortality. Conclusions This PMTCT program in Yunnan achieved low rates of MTCT. However the infant mortality rate in this cohort of HIV-exposed children was almost three times the provincial rate. Virtual elimination of MTCT of HIV is an achievable goal in China, but more attention needs to be paid to HIV-free survival. PMID:26407096

  17. Careers in Patent Law for Physics Majors

    NASA Astrophysics Data System (ADS)

    Oliver, Douglas L.

    2010-11-01

    An important question that many undergraduate physics students ask is, "What can one do with a physics degree?" Of course there are many answers to this question. Often a general reference to becoming a lawyer is given as a possible answer. This paper is intended to explain the field of patent law and how a physics degree can lead to an interesting and potentially lucrative career as a patent examiner, a patent agent, or a patent attorney. This information may be of interest to physics students as well as those who recruit or counsel physics students.

  18. US Photovoltaic Patents, 1988--1990

    SciTech Connect

    Not Available

    1991-12-01

    This document contains US patents on terrestrial photovoltaic (PV) power applications, including systems, components, and materials, as well as manufacturing and support functions. The patent entries in this document were issued from 1988 through 1990. The entries were located by searching USPA, the data base of the US Patent Office. The final search retrieved all patents under the class ``Batteries, Thermoelectric and Photoelectric`` and the subclasses ``Photoelectric,`` ``Testing,`` and ``Applications.`` The search also located patents that contained the words ``photovoltaic(s)`` or ``solar cell(s)`` and their derivatives. A manual search of the patents in the Solar Energy Research Institute (SERI) patent file augmented the data base search. After the initial list was compiled, most of the patents on the following subjects were excluded: space photovoltaic technology, use of the photovoltaic effect for detectors and subjects only peripherally concerned with photovoltaics. Some patents on these three subjects were included when it appeared that those inventions might be of use in terrestrial PV power technologies.

  19. US Photovoltaic Patents, 1988--1990

    SciTech Connect

    Not Available

    1991-12-01

    This document contains US patents on terrestrial photovoltaic (PV) power applications, including systems, components, and materials, as well as manufacturing and support functions. The patent entries in this document were issued from 1988 through 1990. The entries were located by searching USPA, the data base of the US Patent Office. The final search retrieved all patents under the class Batteries, Thermoelectric and Photoelectric'' and the subclasses Photoelectric,'' Testing,'' and Applications.'' The search also located patents that contained the words photovoltaic(s)'' or solar cell(s)'' and their derivatives. A manual search of the patents in the Solar Energy Research Institute (SERI) patent file augmented the data base search. After the initial list was compiled, most of the patents on the following subjects were excluded: space photovoltaic technology, use of the photovoltaic effect for detectors and subjects only peripherally concerned with photovoltaics. Some patents on these three subjects were included when it appeared that those inventions might be of use in terrestrial PV power technologies.

  20. The History of Patenting Genetic Material.

    PubMed

    Sherkow, Jacob S; Greely, Henry T

    2015-01-01

    The US Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, "products of nature" were not eligible to be patented unless they were "isolated and purified" from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply patent-law logic to genes themselves. These patents, along with other biological patents, generated substantial social and political criticism. Myriad Genetics, a company with patents on BRCA1 and BRCA2, two genes critical to assessing early-onset breast and ovarian cancer risk, and with a particularly controversial business approach, became the antagonist in an ultimately successful campaign to overturn gene patents in court. Despite Myriad's defeat, some questions concerning the rights to monopolize genetic information remain. The history leading to that defeat may be relevant to these future issues.

  1. Patent law in dentistry: an overview.

    PubMed

    Bijle, Mohammed Nadeem A

    2011-01-01

    Dentistry in recent years has developed interest in the field of intellectual property rights (IPR) and Patents due to extensive research in the fraternity and existing competition. There have been various patent applications and grants in the field of dentistry abroad due to better understanding of IPR but India still has very few patent grants and applications on the subject matter. This review article in particular deals with the understanding of IPR and Patents as a whole, especially for dental professionals involved in research and development. Hence, this would also act as an asset for dental researchers to explore and expand their scope of activities, with special privileges empowered for their work.

  2. Patenting Stem Cell Technologies in Europe

    PubMed Central

    Sheard, Andrew

    2015-01-01

    European patent law as it applies to stem cell technologies is complex. The complexities have developed from different supranational sources of law during the last 50 years and from the various levels of exceptions to patentability embodied in the law. In relation to stem cells of human embryonic origin, the definition of a human embryo, although broad, is still in some respects unclear; and the definition of what constitutes the use of a human embryo for industrial or commercial purposes, which is excluded from patentability in Europe, is also remarkably broad. Further clarification is awaited from the courts and from the Boards of Appeal of the European Patent Office. PMID:25395376

  3. Patenting and licensing in genetic testing.

    PubMed

    Aymé, S; Matthijs, G; Soini, S

    2008-04-01

    Patents for inventions can be beneficial for society, if they drive innovation and promote progress. In most areas, the patenting system works satisfactorily. However, it must be recognized that in some instances it can also be problematic; this is the case in the field of genetics, and particularly in the area of genetic testing. As patents should serve their original purpose (promoting innovation through a fair reward system for the inventors), the European Society of Human Genetics (ESHG) suggests ways to improve the mechanisms that already form part of the patents system as a whole. In brief, the ESHG recommends limiting the breadth of the claims in genetic patents and, more practically, to reduce the number of patents by limiting the patentable subject matter, thereby improving the quality of the patents that will eventually be granted. There is also a suggestion to redefine the concept of utility in patent law, by taking account of downstream clinical experience. The ESHG sees no harm in the patenting of novel technical tools for genetic testing (eg PCR or chip technologies), as they can promote investment and still allow for invention around them. Many disputes between supporters of the patenting system and the public revolve around ethical issues. The European Patent Office should consider the benefit of having an ethics committee to consider issues of major interest, such as patents applied to genes. The problem of licensing should also be addressed. Practically, this means supporting the Organisation for Economic Co-operation and Development guidelines, which prescribe that licenses should be non-exclusive and easily obtainable, both in practical and in financial terms. To promote this, the practical exploration of alternative models for licensing, like patent pools and clearinghouses, is a prerequisite. To better track developments in this field, the establishment of a voluntary reporting system, whereby geneticists could report on any issues related to

  4. 78 FR 19416 - Revisions to Patent Term Adjustment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... United States Patent and Trademark Office 37 CFR Part 1 RIN 0651-AC84 Revisions to Patent Term Adjustment... changes to the patent term adjustment provisions in section 1(h) of the Act to correct and improve certain... patent term adjustment period is measured, and clarifies the date from which the three-year patent...

  5. 37 CFR 1.177 - Issuance of multiple reissue patents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Issuance of multiple reissue patents. 1.177 Section 1.177 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Reissues §...

  6. Enhancing the DNA Patent Database

    SciTech Connect

    Walters, LeRoy B.

    2008-02-18

    Final Report on Award No. DE-FG0201ER63171 Principal Investigator: LeRoy B. Walters February 18, 2008 This project successfully completed its goal of surveying and reporting on the DNA patenting and licensing policies at 30 major U.S. academic institutions. The report of survey results was published in the January 2006 issue of Nature Biotechnology under the title “The Licensing of DNA Patents by US Academic Institutions: An Empirical Survey.” Lori Pressman was the lead author on this feature article. A PDF reprint of the article will be submitted to our Program Officer under separate cover. The project team has continued to update the DNA Patent Database on a weekly basis since the conclusion of the project. The database can be accessed at dnapatents.georgetown.edu. This database provides a valuable research tool for academic researchers, policymakers, and citizens. A report entitled Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health was published in 2006 by the Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, Board on Science, Technology, and Economic Policy at the National Academies. The report was edited by Stephen A. Merrill and Anne-Marie Mazza. This report employed and then adapted the methodology developed by our research project and quoted our findings at several points. (The full report can be viewed online at the following URL: http://www.nap.edu/openbook.php?record_id=11487&page=R1). My colleagues and I are grateful for the research support of the ELSI program at the U.S. Department of Energy.

  7. Using Patent Classification to Discover Chemical Information in a Free Patent Database: Challenges and Opportunities

    ERIC Educational Resources Information Center

    Ha¨rtinger, Stefan; Clarke, Nigel

    2016-01-01

    Developing skills for searching the patent literature is an essential element of chemical information literacy programs at the university level. The present article creates awareness of patents as a rich source of chemical information. Patent classification is introduced as a key-component in comprehensive search strategies. The free Espacenet…

  8. 37 CFR 1.33 - Correspondence respecting patent applications, patent reexamination proceedings, and other...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Correspondence respecting... Attorney Or Agent § 1.33 Correspondence respecting patent applications, patent reexamination proceedings, and other proceedings. (a) Correspondence address and daytime telephone number. When filing...

  9. 37 CFR 1.33 - Correspondence respecting patent applications, patent reexamination proceedings, and other...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Correspondence respecting... Attorney Or Agent § 1.33 Correspondence respecting patent applications, patent reexamination proceedings, and other proceedings. (a) Correspondence address and daytime telephone number. When filing...

  10. Antiretroviral drug expenditure, pricing and judicial demand: an analysis of federal procurement data in Brazil from 2004–2011

    PubMed Central

    2014-01-01

    Background Previous studies have described expenditures for antiretroviral (ARV) medicines in Brazil through 2005. While prior studies examined overall expenditures, they have not have analyzed drug procurement data in order to describe the role of court litigation on access and pricing. Methods ARV drug procurement from private sector sources for the years 2004–2011 was obtained through the general procurement database of the Brazilian Federal Government (SIASG). Procurement was measured in Defined Daily Doses (DDD) per 1000 persons-under-treatment per day. Expenditures and price per DDD were calculated and expressed in U.S. Dollars. Justifications for ARV purchases were examined in order to determine the relationship between health litigation and incorporation into Brazil’s national treatment guidelines. Results Drug procurement of ARVs from private sources underwent marked expansion in 2005, peaked in 2009, and stabilized to 2008 levels by 2011. Expenditures followed procurement curves. Medications which were procured for the first time after 2007 cost more than medicines which were introduced before 2007. Judicial actions initially resulted in purchases of newer medications for a select number of patients in Brazil but ultimately expanded availability to a larger population through incorporation into the national treatment guidelines. Conclusions Drug procurement and expenditures for ARVs in Brazil varied between 2004–2011. The procurement of some drugs from the private sector ceased after public manufacturers started producing them locally. Judicial demand has resulted in the incorporation of newer drugs into the national treatment guidelines. In order for the AIDS treatment program to remain sustainable, efforts should be pursued to reduce prices through generic drugs, price negotiation and other public health flexibilities such as compulsory licensing. PMID:24735589

  11. Recent patents in flavor microencapsulation.

    PubMed

    Feng, Tao; Xiao, Zuobing; Tian, Huaixiang

    2009-11-01

    Many aroma compounds, used to flavor food products, are used in a solid state, after encapsulation. Synthetic or natural polymers are the common matrices used to entrap these volatiles. This paper reviews the recent patents of versatile matrices and methods used in flavor microencapsulation. The encapsulation ratio depends on both the carriers' physicochemical properties and the characteristics of the aroma compound. The patents about flavor encapsulation methods are spray drying, fluidized bed coating, melt extrusion, complex coacervation, aqueous diffusion and novel fat-coating etc. All these methods have both advantages and disadvantages. In brief, spray drying is very convenient but unsuitable for heat sensitive flavor and stored with moisture instability. Fluidized bed coating is costly but having better storage stability. Melt extrusion is suitable for large-scale production but having bad particle size distribution. Complex coacervation has good capsule size uniformity but controversial safety. Aqueous diffusion has excellent safety but low efficient encapsulation. Novel fat-coating has good encapsulation efficiency but uncontrollable size distribution.

  12. 77 FR 14766 - Patents for Humanity Program (Formerly Humanitarian Program)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... Humanitarian Technologies and Licensing Through the Intellectual Property System'' published September 20, 2010... United States Patent and Trademark Office Patents for Humanity Program (Formerly Humanitarian Program) ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark...

  13. Grant Patents on Animals? An Ethical and Legal Battle Looms.

    ERIC Educational Resources Information Center

    Wheeler, David L.

    1987-01-01

    Rulings on applications for animal patents being considered by the U.S. Patent and Trademark Office could profoundly influence university patent and research income. Many animal-rights advocates have expressed philosophical objections to genetic engineering of animals. (MLW)

  14. 77 FR 37879 - Cooperative Patent Classification External User Day

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE Patent and Trademark Office Cooperative Patent Classification External User Day AGENCY: United States... Office (USPTO) is hosting a Cooperative Patent Classification (CPC) External User Day event at...

  15. Behavioral Economics Matters for HIV Research: The Impact of Behavioral Biases on Adherence to Antiretrovirals (ARVs)

    PubMed Central

    Stecher, Chad

    2016-01-01

    Behavioral economics (BE) has been used to study a number of health behaviors such as smoking and drug use, but there is little knowledge of how these insights relate to HIV prevention and care. We present novel evidence on the prevalence of the common behavioral decision-making errors of present-bias, overoptimism, and information salience among 155 Ugandan HIV patients, and analyze their association with subsequent medication adherence. 36 % of study participants are classified as present-biased, 21 % as overoptimistic, and 34 % as having salient HIV information. Patients displaying present-bias were 13 % points (p = 0.006) less likely to have adherence rates above 90 %, overoptimistic clients were 9 % points (p = 0.04) less likely, and those not having salient HIV information were 17 % points (p < 0.001) less likely. These findings indicate that BE may be used to screen for future adherence problems and to better design and target interventions addressing these behavioral biases and the associated suboptimal adherence. PMID:25987190

  16. Behavioral Economics Matters for HIV Research: The Impact of Behavioral Biases on Adherence to Antiretrovirals (ARVs).

    PubMed

    Linnemayr, Sebastian; Stecher, Chad

    2015-11-01

    Behavioral economics (BE) has been used to study a number of health behaviors such as smoking and drug use, but there is little knowledge of how these insights relate to HIV prevention and care. We present novel evidence on the prevalence of the common behavioral decision-making errors of present-bias, overoptimism, and information salience among 155 Ugandan HIV patients, and analyze their association with subsequent medication adherence. 36 % of study participants are classified as present-biased, 21 % as overoptimistic, and 34 % as having salient HIV information. Patients displaying present-bias were 13 % points (p = 0.006) less likely to have adherence rates above 90 %, overoptimistic clients were 9 % points (p = 0.04) less likely, and those not having salient HIV information were 17 % points (p < 0.001) less likely. These findings indicate that BE may be used to screen for future adherence problems and to better design and target interventions addressing these behavioral biases and the associated suboptimal adherence.

  17. Patent Office Hands Blackboard a Setback

    ERIC Educational Resources Information Center

    Mangan, Katherine

    2008-01-01

    In March the U.S. Patent and Trademark Office issued a preliminary decision that could have significant ramifications for universities that use course-management software, as well as for the companies that make it. The "nonfinal" decision rejects all 44 claims Blackboard Inc. made for its controversial patent of an online-learning system.…

  18. Investigation of At-Risk Patent Filings

    ERIC Educational Resources Information Center

    Livne, O.

    2003-01-01

    The author presents an investigation of patent-application filings made without external financial support, or "at-risk", based on inventions disclosed to the University of California from fiscal years 1991 to 2000. The success of the at-risk patent applications filed on these invention disclosures is examined from the perspective of…

  19. 43 CFR 402.10 - Patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 1 2014-10-01 2014-10-01 false Patent. 402.10 Section 402.10 Public Lands: Interior Regulations Relating to Public Lands BUREAU OF RECLAMATION, DEPARTMENT OF THE INTERIOR SALE OF LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied...

  20. 43 CFR 402.10 - Patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Patent. 402.10 Section 402.10 Public Lands: Interior Regulations Relating to Public Lands BUREAU OF RECLAMATION, DEPARTMENT OF THE INTERIOR SALE OF LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied...

  1. 43 CFR 402.10 - Patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Patent. 402.10 Section 402.10 Public Lands: Interior Regulations Relating to Public Lands BUREAU OF RECLAMATION, DEPARTMENT OF THE INTERIOR SALE OF LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied...

  2. Clearing a path through the patent thicket.

    PubMed

    Holman, Chris

    2006-05-19

    Patents do not always promote innovation, particularly when they restrict access to fundamental scientific discoveries and the tools of basic research. However, there are legal and policy approaches that may help to ameliorate problems associated with patenting these sorts of inventions.

  3. Recognizing chemicals in patents: a comparative analysis.

    PubMed

    Habibi, Maryam; Wiegandt, David Luis; Schmedding, Florian; Leser, Ulf

    2016-01-01

    Recently, methods for Chemical Named Entity Recognition (NER) have gained substantial interest, driven by the need for automatically analyzing todays ever growing collections of biomedical text. Chemical NER for patents is particularly essential due to the high economic importance of pharmaceutical findings. However, NER on patents has essentially been neglected by the research community for long, mostly because of the lack of enough annotated corpora. A recent international competition specifically targeted this task, but evaluated tools only on gold standard patent abstracts instead of full patents; furthermore, results from such competitions are often difficult to extrapolate to real-life settings due to the relatively high homogeneity of training and test data. Here, we evaluate the two state-of-the-art chemical NER tools, tmChem and ChemSpot, on four different annotated patent corpora, two of which consist of full texts. We study the overall performance of the tools, compare their results at the instance level, report on high-recall and high-precision ensembles, and perform cross-corpus and intra-corpus evaluations. Our findings indicate that full patents are considerably harder to analyze than patent abstracts and clearly confirm the common wisdom that using the same text genre (patent vs. scientific) and text type (abstract vs. full text) for training and testing is a pre-requisite for achieving high quality text mining results.

  4. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... employee may request rights in that country subject to the conditions stated in § 501.7(b) that may be... UNIFORM PATENT POLICY FOR RIGHTS IN INVENTIONS MADE BY GOVERNMENT EMPLOYEES § 501.9 Patent protection. (a... States by or on behalf of the agency for such invention. A controversy over the respective rights of...

  5. Nanotechnology and patents in agriculture, food technology, nutrition and medicine - advantages and risks: worldwide patented nano- and absorber particles in food nutrition and agriculture.

    PubMed

    Benckiser, Gero

    2012-12-01

    The keywords nanotechnology, super absorber, agriculture, nutrition, and food technology exhibited 28,149 positive matches under more than 68 million patents worldwide. A closer look at the first 500 nanotechnology, agriculture, nutrition and biotechnology related patents, published during 2011-2012, unveiled that 64% are parts of machines and control devices while about 36% comprise metal oxides, fertilizers, pesticides and drugs, which are compounds and often applied in combination with inorganic or organic super absorbing polymeric structures. The latter compounds are in the focus of this special issue.

  6. Patent foramen ovale: clinical manifestations and treatment.

    PubMed

    Kedia, Gautam; Tobis, Jonathan; Lee, Michael S

    2008-01-01

    A persistent patent foramen ovale produces an intermittent intra-atrial right-to-left shunt and occurs in approximately 25% of the general population. Although the vast majority of people with patent foramen ovale are asymptomatic, a patent foramen ovale is believed to act as a pathway for chemicals or thrombus that can result in a variety of clinical manifestations, including stroke, migraine headache, decompression sickness, high-altitude pulmonary edema, and platypnea-orthodeoxia syndrome. The optimal management of patients with patent foramen ovale who experience cryptogenic stroke is unclear. Percutaneous closure appears to have a low risk profile and has been considered in high-risk patients who are not candidates for randomized clinical trials. Randomized clinical trials that are underway should help define the best management of patent foramen ovale, as well as the true safety and efficacy of percutaneous closure devices.

  7. Recent patents on nano flavor preparation and its application.

    PubMed

    Feng, Tao; Xiao, Zuobing; Tian, Huaixiang

    2010-11-01

    Nano flavor preparation and its application have been reviewed in this paper. Nano flavor could be prepared by physical methods such as spray drying with microfluidization and ultrasonication, physical adsorption and so on, chemical methods such as complex formation, nano-sized self-structured liquid, and nano emulsification and so on. Different preparation technology could produce nano particles with different physical properties, thus they could be used in different occasions such as food, drug, cosmetics and so on. The article presents some promising patents on nano flavor preparation and its application.

  8. The therapeutic applications of antimicrobial peptides (AMPs): a patent review.

    PubMed

    Kang, Hee-Kyoung; Kim, Cheolmin; Seo, Chang Ho; Park, Yoonkyung

    2017-01-01

    Antimicrobial peptides (AMPs) are small molecules with a broad spectrum of antibiotic activities against bacteria, yeasts, fungi, and viruses and cytotoxic activity on cancer cells, in addition to anti-inflammatory and immunomodulatory activities. Therefore, AMPs have garnered interest as novel therapeutic agents. Because of the rapid increase in drug-resistant pathogenic microorganisms, AMPs from synthetic and natural sources have been developed using alternative antimicrobial strategies. This article presents a broad analysis of patents referring to the therapeutic applications of AMPs since 2009. The review focuses on the universal trends in the effective design, mechanism, and biological evolution of AMPs.

  9. Impact of gene patents on diagnostic testing: a new patent landscaping method applied to spinocerebellar ataxia

    PubMed Central

    Berthels, Nele; Matthijs, Gert; Van Overwalle, Geertrui

    2011-01-01

    Recent reports in Europe and the United States raise concern about the potential negative impact of gene patents on the freedom to operate of diagnosticians and on the access of patients to genetic diagnostic services. Patents, historically seen as legal instruments to trigger innovation, could cause undesired side effects in the public health domain. Clear empirical evidence on the alleged hindering effect of gene patents is still scarce. We therefore developed a patent categorization method to determine which gene patents could indeed be problematic. The method is applied to patents relevant for genetic testing of spinocerebellar ataxia (SCA). The SCA test is probably the most widely used DNA test in (adult) neurology, as well as one of the most challenging due to the heterogeneity of the disease. Typically tested as a gene panel covering the five common SCA subtypes, we show that the patenting of SCA genes and testing methods and the associated licensing conditions could have far-reaching consequences on legitimate access to this gene panel. Moreover, with genetic testing being increasingly standardized, simply ignoring patents is unlikely to hold out indefinitely. This paper aims to differentiate among so-called ‘gene patents' by lifting out the truly problematic ones. In doing so, awareness is raised among all stakeholders in the genetic diagnostics field who are not necessarily familiar with the ins and outs of patenting and licensing. PMID:21811306

  10. Summary of trends in photovoltaic patent activity

    NASA Astrophysics Data System (ADS)

    Levine, L. C.

    1984-06-01

    Information on patent activity for inventions concerning photovoltaic cell technology is given. Such information can aid in the assessment of the status and direction of technological development. A total of 729 US patents that issued between mid-1962 and the end of 1982, were individually examined and classified into several technical categories. Computerized analysis of trends in patent activity among major technical categories was performed. The level of inventive activity increased dramatically in the mid-1970's. It appears to have peaked in 1978 and remained steady through 1980. The data indicates that, beginning in 1978, an increasing proportion of inventions were among approaches other than the conventional Cz type cells, specifically thin film and concentrator cells. Thin film and Cz type photovoltaic cells represent two thirds of the patents analyzed. Among thin film patents, silicon and cadmium containing cells represent about two thirds of the patents analyzed. Further insight into recent trends could be obtained by adding more recently issued patents to the data base.

  11. AVC/H.264 patent portfolio license

    NASA Astrophysics Data System (ADS)

    Horn, Lawrence A.

    2005-08-01

    MPEG LA, LLC offers a joint patent license for the AVC (a/k/a H.264) Standard (ISO/IEC IS 14496-10:2004). Like MPEG LA's other licenses, the AVC Patent Portfolio License is offered for the convenience of the marketplace as an alternative enabling users to access essential intellectual property owned by many patent holders under a single license rather than negotiating licenses with each of them individually. The AVC Patent Portfolio License includes essential patents owned by Electronics and Telecommunications Research Institute (ETRI); France Telecom, societe anonyme; Fujitsu Limited; Koninklijke Philips Electronics N.V.; LG Electronics Inc.; Matsushita Electric Industrial Co., Ltd.; Microsoft Corporation; Mitsubishi Electric Corporation; Robert Bosch GmbH; Samsung Electronics Co., Ltd.; Sedna Patent Services, LLC; Sharp Kabushiki Kaisha; Siemens AG; Sony Corporation; The Trustees of Columbia University in the City of New York; Toshiba Corporation; and Victor Company of Japan, Limited. MPEG LA's objective is to provide worldwide access to as much AVC essential intellectual property as possible for the benefit of AVC users. Therefore, any party that believes it has essential patents is welcome to submit them for evaluation of their essentiality and inclusion in the License if found essential.

  12. AVC/H.264 patent portfolio license

    NASA Astrophysics Data System (ADS)

    Skandalis, Dean A.

    2006-08-01

    MPEG LA, LLC offers a joint patent license for the AVC (a/k/a H.264) Standard (ISO/IEC IS 14496-10:2004). Like MPEG LA's other licenses, the AVC Patent Portfolio License is offered for the convenience of the marketplace as an alternative enabling users to access essential intellectual property owned by many patent holders under a single license rather than negotiating licenses with each of them individually. The AVC Patent Portfolio License includes essential patents owned by DAEWOO Electronics Corporation; Electronics and Telecommunications Research Institute (ETRI); France Telecom, societe anonyme; Fujitsu Limited; Hitachi, Ltd.; Koninklijke Philips Electronics N.V.; LG Electronics Inc.; Matsushita Electric Industrial Co., Ltd.; Microsoft Corporation; Mitsubishi Electric Corporation; Robert Bosch GmbH; Samsung Electronics Co., Ltd.; Sedna Patent Services, LLC; Sharp Kabushiki Kaisha; Siemens AG; Sony Corporation; The Trustees of Columbia University in the City of New York; Toshiba Corporation; UB Video Inc.; and Victor Company of Japan, Limited. Another is expected also to join as of August 1, 2006. MPEG LA's objective is to provide worldwide access to as much AVC essential intellectual property as possible for the benefit of AVC users. Therefore, any party that believes it has essential patents is welcome to submit them for evaluation of their essentiality and inclusion in the License if found essential.

  13. A new model for gene patents

    SciTech Connect

    Not Available

    1993-04-02

    When the National Institutes of Health (NIH) filed for patents on thousands of gene fragments in 1991, it created a furor because it was attempting to assert broad rights to sequences whose functions were unknown. The cDNA fragments NIH researchers had discovered were simply short stretches of presumably expressed genes, yet the patent the agency was seeking would give it rights both to the full genes themselves and to all their possible future uses. If NIH prevailed, researchers argued, it would potentially discourage further work on those genes. Now the head of the genome project at the Department of Energy (DOE) - NIH's partner in the program - has proposed an alternative approach to gene patenting. At a meeting last week of a congressional Office of Technology Assessment panel that is preparing a report on this issue, DOE's David Galas revealed that University of Washington genome researcher Leroy Hood is preparing to file a patent application that could serve as a model for such patents in the future. Hood's team has been sequencing the genes encoding the beta chain of the human T cell receptor. Mutations in the T cell receptor genes may lead to any of a number of autoimmune diseases, including rheumatoid arthritis and multiple sclerosis. A broad patent on the genes could therefore conceivably cover not only techniques for diagnosing autoimmune diseases but also of therapies for the conditions, and indeed anything involving T cell activity. But Hood's patent application won't make such broad claims. Instead, Hood, with DOE's support, will not seek to patent the genes but will claim only the specific uses of developing the diagnostic and therapeutic tools for dealing with specific autoimmune diseases. By restricting patents just to known uses the problems of gene ownership are neatly avoided.

  14. Whither ink jet? Current patent trends

    NASA Astrophysics Data System (ADS)

    Pond, Stephen F.; Karz, Robert S.

    1995-04-01

    The status and potential of ink jet technology is discernible in its major technical literature forum: worldwide patents. Most ink jet technical activity is focused in commercial research and development laboratories where proprietary considerations make patents the norm for publication. Currently there are about 2,000 ink jet disclosures issued annually with over 200 enterprises represented. Ink jet patent activity is increasing about 25% per year driven by a rapidly expanding base of products, applications, and revenue. An analysis of the ink jet patent literature reveals a few major themes (i.e. continuous ink jet, piezoelectric drop-on-demand, and thermal ink jet) and numerous minor ones (i.e. electrohydro-dynamic extraction, magnetic drop-on-demand, Hertz continuous, acoustic ink printing). Patents bear witness to transformations in the industry as dominant players of the 1970's have given way to new leaders in the 1990's. They also foretell important commercial developments in ink jet's near term future. When studied in aggregate, the patent record reveals patterns for the industry in general as well as for individual companies. It becomes possible to use the patent data base not only to identify technical approaches and problems for specific firms, but also to track progress and monitor changing strategies. In addition, international filing patterns can provide insights into industry priorities. This paper presents an overview of ink jet technology as revealed by the patent literature. It will include a 25 year perspective, a review of trends over the past five years, and a survey of today's most active companies and their technical approaches. With this analysis, it will be shown that the information inherent in the patent record is more than the sum of its individual disclosures. Indeed, by using it, we can outlook whither goes ink jet.

  15. 76 FR 35899 - Determination of Regulatory Review Period for Purposes of Patent Extension; MYFORTIC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... [Federal Register Volume 76, Number 118 (Monday, June 20, 2011)] [Notices] [Page 35899] [FR Doc No: 2011-15197] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-E-0267 (formerly) 2004E-0325] Determination of Regulatory Review Period for Purposes of Patent...

  16. 76 FR 28235 - Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ; Correction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ; Correction and Reopening of the Comment Period AGENCY: Food and...

  17. 75 FR 54345 - Determination of Regulatory Review Period for Purposes of Patent Extension; BRYAN CERVICAL DISC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... Patent Extension; BRYAN CERVICAL DISC SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice... CERVICAL DISC SYSTEM and is publishing this notice of that determination as required by law. FDA has made... device BRYAN CERVICAL DISC SYSTEM. BRYAN CERVICAL DISC SYSTEM is indicated in skeletally mature...

  18. Efflux transporters- and cytochrome P-450-mediated interactions between drugs of abuse and antiretrovirals☆

    PubMed Central

    Pal, Dhananjay; Kwatra, Deep; Minocha, Mukul; Paturi, Durga K.; Budda, Balasubrahmanyam; Mitra, Ashim K.

    2010-01-01

    Multidrug regimens and corresponding drug interactions cause many adverse reactions and treatment failures. Drug efflux transporters: P-gp, MRP, BCRP in conjunction with metabolizing enzymes (CYPs) are major factors in such interactions. Most effective combination antiretrovirals (ARV) therapy includes a PI or a NNRTI or two NRTI. Coadministration of such ARV may induce efflux transporters and/or CYP3A4 resulting in sub-therapeutic blood levels and therapeutic failure due to reduced absorption and/or increased metabolism. A similar prognosis is true for ARV-compounds and drugs of abuse combinations. Morphine and nicotine enhance CYP3A4 and MDR1 expression in vitro. A 2.5 fold rise of cortisol metabolite was evident in smokers relative to nonsmokers. Altered functions of efflux transporters and CYPs in response to ARV and drugs of abuse may result in altered drug absorption and metabolism. Appropriate in vitro models can be employed to predict such interactions. Influence of genetic polymorphism, SNP and inter-individual variation in drug response has been discussed. Complexity underlying the relationship between efflux transporters and CYP makes it difficult to predict the outcome of HAART as such, particularly when HIV patients taking drugs of abuse do not adhere to HAART regimens. HIV+ pregnant women on HAART medications, indulging in drugs of abuse, may develop higher viral load due to such interactions and lead to increase in mother to child transmission of HIV. A multidisciplinary approach with clear understanding of mechanism of interactions may allow proper selection of regimens so that desired therapeutic outcome of HAART can be reached without any side effects. PMID:20932495

  19. A Review of the Toxicity of HIV Medications II: Interactions with Drugs and Complementary and Alternative Medicine Products.

    PubMed

    Stolbach, Andrew; Paziana, Karolina; Heverling, Harry; Pham, Paul

    2015-09-01

    For many patients today, HIV has become a chronic disease. For those patients who have access to and adhere to lifelong antiretroviral (ARV) therapy, the potential for drug-drug interactions has become a real and life-threatening concern. It is known that most ARV drug interactions occur through the cytochrome P450 (CYP) pathway. Medications for comorbid medical conditions, holistic supplements, and illicit drugs can be affected by CYP inhibitors and inducers and have the potential to cause harm and toxicity. Protease inhibitors (PIs) tend to inhibit CYP3A4, while most non-nucleoside reverse transcriptase inhibitors (NNRTIs) tend to induce the enzyme. As such, failure to adjust the dose of co-administered medications, such as statins and steroids, may lead to serious complications including rhabdomyolysis and hypercortisolism, respectively. Similarly, gastric acid blockers can decrease several ARV absorption, and warfarin doses may need to be adjusted to maintain therapeutic concentrations. Illicit drugs such as methylenedioxymethamphetamine (MDMA, "ecstasy") in combination with PIs lead to increased toxicity, while the concomitant administration of sedative drugs such as midazolam and alprazolam in patients taking PIs can result in prolonged sedation, delayed recovery, and increased length of stay. Even supplements like St. John's Wort can alter PI concentrations. In theory, any drug that is metabolized by CYP has potential for a pharmacokinetic drug-drug interaction with all PIs, cobicistat, and most NNRTIs. When adding a new medication to an ARV regimen, use of a drug-drug interaction software and/or consultation with a clinical pharmacist/pharmacologist or HIV specialist is recommended.

  20. Modeling HIV Vaccines in Brazil: Assessing the Impact of a Future HIV Vaccine on Reducing New Infections, Mortality and Number of People Receiving ARV

    PubMed Central

    Fonseca, Maria Goretti P.; Forsythe, Steven; Menezes, Alexandre; Vuthoori, Shilpa; Possas, Cristina; Veloso, Valdiléa; de Fátima Lucena, Francisca; Stover, John

    2010-01-01

    Background The AIDS epidemic in Brazil remains concentrated in populations with high vulnerability to HIV infection, and the development of an HIV vaccine could make an important contribution to prevention. This study modeled the HIV epidemic and estimated the potential impact of an HIV vaccine on the number of new infections, deaths due to AIDS and the number of people receiving ARV treatment, under various scenarios. Methods and Findings The historical HIV prevalence was modeled using Spectrum and projections were made from 2010 to 2050 to study the impact of an HIV vaccine with 40% to 70% efficacy, and 80% coverage of adult population, specific groups such as MSM, IDU, commercial sex workers and their partners, and 15 year olds. The possibility of disinhibition after vaccination, neglecting medium- and high-risk groups, and a disease-modifying vaccine were also considered. The number of new infections and deaths were reduced by 73% and 30%, respectively, by 2050, when 80% of adult population aged 15–49 was vaccinated with a 40% efficacy vaccine. Vaccinating medium- and high-risk groups reduced new infections by 52% and deaths by 21%. A vaccine with 70% efficacy produced a great decline in new infections and deaths. Neglecting medium- and high-risk population groups as well as disinhibition of vaccinated population reduced the impact or even increased the number of new infections. Disease-modifying vaccine also contributed to reducing AIDS deaths, the need for ART and new HIV infections. Conclusions Even in a country with a concentrated epidemic and high levels of ARV coverage, such as Brazil, moderate efficacy vaccines as part of a comprehensive package of treatment and prevention could have a major impact on preventing new HIV infections and AIDS deaths, as well as reducing the number of people on ARV. Targeted vaccination strategies may be highly effective and cost-beneficial. PMID:20668523

  1. Patent border wars: defining the boundary between scientific discoveries and patentable inventions.

    PubMed

    Holman, Christopher M

    2007-12-01

    Drawing an appropriate boundary between unpatentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle. Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headline-grabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that Congress and/or the courts will address the issue, and perhaps substantially shift the boundary.

  2. Gene and genetic diagnostic method patent claims: a comparison under current European and US patent law.

    PubMed

    Huys, Isabelle; Van Overwalle, Geertrui; Matthijs, Gert

    2011-10-01

    The paper focuses on the fundamental debate that is going on in Europe and the United States about whether genes and genetic diagnostic methods are to be regarded as inventions or subject matter eligible for patent protection, or whether they are discoveries or principles of nature and thus excluded from patentability. The study further explores some possible scenarios of American influences on European patent applications with respect to genetic diagnostic methods. Our analysis points out that patent eligibility for genes and genetic diagnostic methods, as discussed in the United States in the Association of Molecular Pathology versus US Patent and Trademark Office decision, is based on a different reasoning compared with the European Patent Convention.

  3. 7 CFR 1220.254 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Patents, copyrights, inventions, and publications... Miscellaneous § 1220.254 Patents, copyrights, inventions, and publications. (a) Any patents, copyrights..., franchising, or other uses of such patents, copyrights, inventions, or publications, inure to the benefit...

  4. 7 CFR 1250.542 - Patents, copyrights, trademarks, and information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Patents, copyrights, trademarks, and information... AGRICULTURE EGG RESEARCH AND PROMOTION Rules and Regulations Patents, Copyrights, Trademarks, and Information § 1250.542 Patents, copyrights, trademarks, and information. Patents, copyrights, trademarks,...

  5. 7 CFR 1250.542 - Patents, copyrights, trademarks, and information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Patents, copyrights, trademarks, and information... AGRICULTURE EGG RESEARCH AND PROMOTION Rules and Regulations Patents, Copyrights, Trademarks, and Information § 1250.542 Patents, copyrights, trademarks, and information. Patents, copyrights, trademarks,...

  6. 7 CFR 1220.254 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Patents, copyrights, inventions, and publications... Miscellaneous § 1220.254 Patents, copyrights, inventions, and publications. (a) Any patents, copyrights..., franchising, or other uses of such patents, copyrights, inventions, or publications, inure to the benefit...

  7. 7 CFR 1220.254 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Patents, copyrights, inventions, and publications... Miscellaneous § 1220.254 Patents, copyrights, inventions, and publications. (a) Any patents, copyrights..., franchising, or other uses of such patents, copyrights, inventions, or publications, inure to the benefit...

  8. 7 CFR 1220.254 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Patents, copyrights, inventions, and publications... Miscellaneous § 1220.254 Patents, copyrights, inventions, and publications. (a) Any patents, copyrights..., franchising, or other uses of such patents, copyrights, inventions, or publications, inure to the benefit...

  9. 7 CFR 1250.542 - Patents, copyrights, trademarks, and information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Patents, copyrights, trademarks, and information... AGRICULTURE EGG RESEARCH AND PROMOTION Rules and Regulations Patents, Copyrights, Trademarks, and Information § 1250.542 Patents, copyrights, trademarks, and information. Patents, copyrights, trademarks,...

  10. 7 CFR 1250.542 - Patents, copyrights, trademarks, and information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Patents, copyrights, trademarks, and information... AGRICULTURE EGG RESEARCH AND PROMOTION Rules and Regulations Patents, Copyrights, Trademarks, and Information § 1250.542 Patents, copyrights, trademarks, and information. Patents, copyrights, trademarks,...

  11. 7 CFR 1250.542 - Patents, copyrights, trademarks, and information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Patents, copyrights, trademarks, and information... AGRICULTURE EGG RESEARCH AND PROMOTION Rules and Regulations Patents, Copyrights, Trademarks, and Information § 1250.542 Patents, copyrights, trademarks, and information. Patents, copyrights, trademarks,...

  12. 37 CFR 11.9 - Limited recognition in patent matters.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Limited recognition in patent matters. 11.9 Section 11.9 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE... application is filed as provided in PCT Art. 49, Rule 90 and § 1.455 of this subchapter, or before...

  13. 37 CFR 11.9 - Limited recognition in patent matters.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Limited recognition in patent matters. 11.9 Section 11.9 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE... office with which the international application is filed as provided in PCT Art. 49, Rule 90 and §...

  14. 37 CFR 11.9 - Limited recognition in patent matters.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Limited recognition in patent matters. 11.9 Section 11.9 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE... office with which the international application is filed as provided in PCT Art. 49, Rule 90 and §...

  15. 37 CFR 11.9 - Limited recognition in patent matters.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Limited recognition in patent matters. 11.9 Section 11.9 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE... application is filed as provided in PCT Art. 49, Rule 90 and § 1.455 of this subchapter, or before...

  16. Report of the AD HOC Committee on Patent Documentation.

    ERIC Educational Resources Information Center

    Urbach, Peter; And Others

    The Committee was established in September 1967 to study and make recommendations on Recommendation XXIX and XXX of the Report of the President's Commission on the Patent System. Based on interviews with Patent Office officials, patent examiners and classifiers and a review of Patent Office studies and documents, the Committee concluded that the…

  17. Preliminary analysis of patent trends for magnetic fusion technology

    SciTech Connect

    Levine, L.O.; Ashton, W.B.; Campbell, R.S.

    1984-02-01

    This study presents a preliminary analysis of development trends in magnetic fusion technology based on data from US patents. The research is limited to identification and description of general patent activity and ownership characteristics for 373 patents. The results suggest that more detailed studies of fusion patents could provide useful R and D planning information.

  18. 37 CFR 1.46 - Assigned inventions and patents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Assigned inventions and... for A Patent § 1.46 Assigned inventions and patents. In case the whole or a part interest in the invention or in the patent to be issued is assigned, the application must still be made or authorized to...

  19. 43 CFR 3864.1-1 - Application for patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Application for patent. 3864.1-1 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) MINERAL PATENT APPLICATIONS Millsite Patents § 3864.1-1 Application for patent. (a) Land entered as a millsite must be shown to be...

  20. 37 CFR 1.215 - Patent application publication.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... publication. 1.215 Section 1.215 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Publication of Applications § 1.215 Patent application publication. (a) The publication of an application...

  1. 37 CFR 1.215 - Patent application publication.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... publication. 1.215 Section 1.215 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Publication of Applications § 1.215 Patent application publication. (a) The publication of an application...

  2. 37 CFR 1.215 - Patent application publication.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... publication. 1.215 Section 1.215 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Publication of Applications § 1.215 Patent application publication. (a) The publication of an application...

  3. 75 FR 30773 - United States Patent Applicant Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... Patent and Trademark Office United States Patent Applicant Survey ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing effort... United States Patent Applicant Survey as part of the continuing effort to better predict the...

  4. 43 CFR 3862.8 - Patents for mining claims.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patents for mining claims. 3862.8 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) MINERAL PATENT APPLICATIONS Lode Mining Claim Patent Applications § 3862.8 Patents for mining claims....

  5. 43 CFR 3862.8 - Patents for mining claims.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patents for mining claims. 3862.8 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) MINERAL PATENT APPLICATIONS Lode Mining Claim Patent Applications § 3862.8 Patents for mining claims....

  6. 43 CFR 3862.8 - Patents for mining claims.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patents for mining claims. 3862.8 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) MINERAL PATENT APPLICATIONS Lode Mining Claim Patent Applications § 3862.8 Patents for mining claims....

  7. 43 CFR 3862.8 - Patents for mining claims.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patents for mining claims. 3862.8 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) MINERAL PATENT APPLICATIONS Lode Mining Claim Patent Applications § 3862.8 Patents for mining claims....

  8. 48 CFR 1852.227-84 - Patent rights clauses.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Patent rights clauses. 1852... 1852.227-84 Patent rights clauses. The contracting officer shall insert the following provision as prescribed in 1827.303-70(e): Patent Rights Clauses (DEC 1989) This solicitation contains the patent...

  9. 77 FR 14686 - Claims for Patent and Copyright Infringement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... history of each patent, if it is available to the claimant. Indicate whether the patent has been the... corresponding foreign patents and patent applications and full copies of the same. (11) Pertinent prior art known to the claimant not contained in the USPTO file, for example, publications and foreign prior...

  10. 43 CFR 3862.8-1 - Land descriptions in patents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Land descriptions in patents. 3862.8-1 Section 3862.8-1 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND... Claim Patent Applications § 3862.8-1 Land descriptions in patents. The land description in a patent...

  11. 78 FR 62367 - Changes To Implement the Patent Law Treaty

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-21

    ...The Patent Law Treaties Implementation Act of 2012 (PLTIA) amends the patent laws to implement the provisions of the Hague Agreement Concerning International Registration of Industrial Designs (Hague Agreement) in title I, and the Patent Law Treaty (PLT) in title II. The PLT harmonizes and streamlines formal procedures pertaining to the filing and processing of patent applications. This final......

  12. ACTA Technology Presents EPA with Patent Copy

    EPA Pesticide Factsheets

    US EPA SBIR awardee, ACTA Technology, presented James H. Johnson, Director of the US EPA National Center for Environmental Research, and April Richards, Program Manager of the US EPA's SBIR Program, with a copy of their Red Ribbon patent.

  13. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... rights as are specified in § 501.6(a)(2), but this shall be without prejudice to acquiring the rights... filing of an application for patent, take the rights specified in that paragraph without prejudice to...

  14. Patenting genes: a fast and furious primer.

    PubMed

    Askland, Andrew

    2003-01-01

    Patents have been issued in the United States for genes and gene sequences since 1980. Patent protection has provided incentives to aggressively probe the genome of humans and non-humans alike in search of profitable applications. Yet it is not clear that patent protection should have been afforded to genes and gene sequences and it is increasingly clear that patent protection, as currently formulated, is not an appropriate means to realize the full benefits of genetic research. As we stand on the threshold of a genetically enhanced future, in which we shall have the power to consciously steer our evolution as a species, we need to carefully consider how to shape the benefits of genetic research and how to recognize and contain its detriments.

  15. Genomic patenting and the utility requirement.

    PubMed

    Calvert, Jane

    2004-12-01

    This paper analyses the ways in which genomic knowledge is portrayed as useful knowledge in gene patenting in order to fulfil the 'utility'/'industrial applicability' requirement for patentability. It gives examples of utility claims in gene patents and asks whether genomics (as opposed to genetics) changes our ideas about what is useful and what can be patented. It puts forward a provisional classification of different types of utility and argues that merely identifying the physiological function of a gene diverges radically from our commonsense understanding of what it is for an invention to be useful. Furthermore, social, political and ethical issues inevitably arise when discussing the utility requirement, because an invention cannot be useful in isolation from a social context.

  16. Recent patents on electrophoretic displays and materials.

    PubMed

    Christophersen, Marc; Phlips, Bernard F

    2010-11-01

    Electrophoretic displays (EPDs) have made their way into consumer products. EPDs enable displays that offer the look and form of a printed page, often called "electronic paper". We will review recent apparatus and method patents for EPD devices and their fabrication. A brief introduction into the basic display operation and history of EPDs is given, while pointing out the technological challenges and difficulties for inventors. Recently, the majority of scientific publications and patenting activity has been directed to micro-segmented EPDs. These devices exhibit high optical reflectance and contrast, wide viewing angle, and high image resolution. Micro-segmented EPDs can also be integrated with flexible transistors technologies into flexible displays. Typical particles size ranges from 200 nm to 2 micrometer. Currently one very active area of patenting is the development of full-color EPDs. We summarize the recent patenting activity for EPDs and provide comments on perceiving factors driving intellectual property protection for EPD technologies.

  17. Ethico-legal issues in biomedicine patenting: a patent professional viewpoint.

    PubMed

    Crespi, R Stephen

    2005-01-01

    Over the last two decades, the ethical implications of patents for biological materials and processes have been the subject of spirited public debate between the many individuals and groups on which the patent system impacts. Whereas copyright, trade marks, and other species of Intellectual Property Rights (IPR) are widely acceptable, the patent system evokes criticism from many quarters, especially in relation to the legal protection of inventions in the Life Sciences. Some of these criticisms expressed by prestigious public organisations are addressed here from the patent professional standpoint.

  18. 75 FR 21298 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT --NDA 22-253 AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  19. 75 FR 21299 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT--NDA 22-254 AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  20. Patents | NCI Technology Transfer Center | TTC

    Cancer.gov

    Timely reporting of discoveries is critical, because patent protection may be lost if an invention is publicly disclosed prior to filing a patent application. A public disclosure may include Talks, presentations, posters; Publications, including titles and abstracts posted on websites; Internet postings; Graduate student theses, job interviews; andDiscussions with non-NIH personnel without a Confidential Disclosure Agreement (CDA) in place. | [google6f4cd5334ac394ab.html

  1. Competition policy in patent cases and antitrust.

    PubMed

    Sobel, Gerald

    2003-01-01

    The article that follows examines the competition policy reflected in the decisions of the Court of Appeals for the Federal Circuit in its patent cases. The court's views on this subject have been manifested most plainly in decisions that have transformed the law concerning infringement under the doctrine of equivalents and claim construction. In both categories, the court narrowed patent scope by reason of its desire to protect competitors. The article argues that the court's premise in prescribing narrower claim scope reflected an incomplete view of competition policy. The court's analysis overlooked the benefits to competition provided by patents, which stimulate inventions and their development. The article traces the development of antitrust jurisprudence and demonstrates how respect for the contribution of patents to competition and skepticism of free-riding has evolved, particularly beginning in the 1970s. The article draws a parallel between the Court's reasoning about competition policy, on the one hand, and the rejected views of Justices Hugo Black and William O. Douglas and abandoned patent-antitrust jurisprudence, on the other. The Federal Circuit's decision in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 234 F.3d 558 (Fed. Cir. 2000), on the subject of equivalents is considered in the paper. In that decision, the majority adopted a new rule that completely barred infringement under the doctrine of equivalents of any claim limitation where, in prosecution, there had been a narrowing amendment relating to patentability. In the past, prosecution estoppel foreclosing equivalents had been subject to a "flexible bar," which, in some circumstances, allowed for equivalence notwithstanding such an amendment. The article points out that because almost all patents are amended during prosecution, the effect would be to allow widespread copying of patented inventions by trivial modifications of any narrowed claim limitation. The incentive to innovate

  2. Patenting human genes and stem cells.

    PubMed

    Martin-Rendon, Enca; Blake, Derek J

    2007-01-01

    Cell lines and genetically modified single cell organisms have been considered patentable subjects for the last two decades. However, despite the technical patentability of genes and stem cell lines, social and legal controversy concerning their 'ownership' has surrounded stem cell research in recent years. Some granted patents on stem cells with extremely broad claims are casting a shadow over the commercialization of these cells as therapeutics. However, in spite of those early patents, the number of patent applications related to stem cells is growing exponentially. Both embryonic and adult stem cells have the ability to differentiate into several cell lineages in an organism as a result of specific genetic programs that direct their commitment and cell fate. Genes that control the pluripotency of stem cells have been recently identified and the genetic manipulation of these cells is becoming more efficient with the advance of new technologies. This review summarizes some of the recent published patents on pluripotency genes, gene transfer into stem cells and genetic reprogramming and takes the hematopoietic and embryonic stem cell as model systems.

  3. Genetic engineering and the patent office

    SciTech Connect

    Sheldon, J.G.; Anderson, D.L.

    1987-10-01

    Higher life forms created through genetic engineering are now recognized as potentially patentable. On 7 April 1987, the US Patent and Trademark Office announced that it now considers non-naturally occurring non-human multi-cellular living organisms, including animals, to be patentable subject matter. The response to this announcement has been an emotion controversy centering on the patent office. The announcement has become the lightning rod for all of the practical and moral questions surrounding the overwhelming potential of genetic engineering. Environmentalists claim that genetic engineering will ruin the ecology. The Humane Society of the US, headquartered in Washington, DC, claims that genetic engineering will cause undo suffering to animals produced through genetic experiments and may ultimately lead to the demise of overly engineered animal species. Religious fundamentalists claim that genetic engineering is wrongfully tinkering with the handiwork of the Almighty. While it may be good that such questions are being raised, the patent office is being wrongly singled out as the source of the problem. This paper discusses the legal problems that patents on new lifeforms have caused.

  4. AVC/H.264 patent portfolio license

    NASA Astrophysics Data System (ADS)

    Horn, Lawrence A.

    2004-11-01

    MPEG LA, LLC recently announced terms of a joint patent license for the AVC (a/k/a H.264) Standard (ISO/IEC IS 14496-10: Information technology -- Coding of audio-visual objects -- Part 10: Advanced Video Coding | ITU-T Rec. H.264: Series H: Audiovisual and Multimedia Systems: Infrastructure of audiovisual services -- Coding of moving video: Advanced video coding for generic audiovisual services). Like MPEG LA"s other licenses, the AVC Patent Portfolio License is offered for the convenience of the marketplace as an alternative enabling users to access essential intellectual property owned by many patent holders under a single license rather than negotiating licenses with each of them individually. The AVC Patent Portfolio License includes essential patents owned by Columbia Innovation Enterprises; Electronics and Telecommunications Research Institute (ETRI); France Télécom, société anonyme; Fujitsu Limited; Koninklijke Philips Electronics N.V.; Matsushita Electric Industrial Co., Ltd.; Microsoft Corporation; Mitsubishi Electric Corporation; Robert Bosch GmbH; Samsung Electronics Co., Ltd.; Sharp Kabushiki Kaisha; Sony Corporation; Toshiba Corporation; and Victor Company of Japan, Limited. MPEG LA"s objective is to provide worldwide access to as much AVC essential intellectual property as possible for the benefit of AVC users. Therefore, any party that believes it has essential patents is welcome to submit them for evaluation of their essentiality and inclusion in the License if found essential.

  5. [Trends in the development of research in the field of liposomes (review of patent literature)].

    PubMed

    Nesytova, N Iu; Paleva, N S; Il'ina, E V; Shenk, P; Bendas, F; Nun, P

    1990-01-01

    The review embraces major trends and tendencies in liposome studies and is based on the statistical and qualitative analysis of patent information issued in the period 1970-1988. Special attention is devoted to the analysis of patents in liposome production techniques, their lipid composition, and application in pharmaceutical and cosmetic industries and also for the diagnostic and therapeutic purposes. Liposomal preparations are shown to be superior to common drugs as concerns, in particular, liposomes containing medicinal agents for prolonged use (including hormones, antibiotics, cytostatics, and immunostimulants) and liposomes used in dermatological practice. Liposome-based assessment of application prospects is given.

  6. Liquid membranes. (Latest citations from the US Patent Bibliographic file with exemplary claims). Published Search

    SciTech Connect

    Not Available

    1994-04-01

    The bibliography contains citations of selected patents concerning liquid membranes (LM) and LM processes. Included are patents for LM formulations and compositions, separation of aqueous and gas mixtures, and LM type electrodes. Applications are discussed, including use in drug release control, water and wastewater treatment, metal recovery, high temperature and high pressure LM processes, artificial LM lung and LM red cells, and LM scale removal from oil and gas production equipment. Citations concerning ion exchange resins are excluded and examined in a separate bibliography. (Contains a minimum of 99 citations and includes a subject term index and title list.)

  7. Liquid membranes. (Latest citations from the US Patent database). Published Search

    SciTech Connect

    Not Available

    1992-12-01

    The bibliography contains citations of selected patents concerning liquid membranes (LM) and LM processes. Included are patents for LM formulations and compositions, separation of aqueous and gas mixtures, and LM type electrodes. Applications are discussed, including use in drug release control, water and wastewater treatment, metal recovery, high temperature and high pressure LM processes, artificial LM lung and LM red cells, and LM scale removal from oil and gas production equipment. Citations concerning ion exchange resins are excluded and examined in a separate bibliography. (Contains a minimum of 92 citations and includes a subject term index and title list.)

  8. Factor XIa inhibitors: A review of patent literature

    PubMed Central

    Al-Horani, Rami A.; Desai, Umesh R.

    2016-01-01

    Introduction Anticoagulants are the mainstay for prevention and/or treatment of thrombotic disorders. Each clinically used anticoagulant is associated with significant adverse consequences, especially bleeding. Factor XIa (FXIa), a key factor involved in the amplification of procoagulation signal, has been suggested as a major target for anticoagulant drug discovery because of reduced risk of bleeding. Areas covered Our literature search uncovered dozens of industrial and academic patents on the discovery of novel FXIa/FXI inhibitors. Small peptidomimetics, sulfated glycosaminoglycan mimetics, polypeptides, antisense oligonucleotides, and monoclonal antibodies have been developed as inhibitors of FXIa. Although many agents are in early discovery/development phases, the activity and safety of a few have been evaluated in various animal models and in humans. Expert opinion FXIa is a promising drug target for development of effective anticoagulants with limited bleeding complications. Literature reveals a major trend in the number of patent applications over the last three years. These inhibitors exploit different approaches for target inhibition. Allosteric modulation of FXIa and biosynthetic inhibition of FXI are mechanistically unique. Despite initial results in patients undergoing knee anthroplasty as with antisense oligonucleotides, major advances should be realized, particularly with respect to pharmacokinetics, for FXI/FXIa inhibitors to enter the clinic. PMID:26881476

  9. Unanticipated Effects of New Drug Availability on Antiretroviral Durability: Implications for Comparative Effectiveness Research.

    PubMed

    Eaton, Ellen F; Tamhane, Ashutosh R; Burkholder, Greer A; Willig, James H; Saag, Michael S; Mugavero, Michael J

    2016-04-01

    Background.  Durability of antiretroviral (ARV) therapy is associated with improved human immunodeficiency virus (HIV) outcomes. Data on ARV regimen durability in recent years and clinical settings are lacking. Methods.  This retrospective follow-up study included treatment-naive HIV-infected patients initiating ARV therapy between January 2007 and December 2012 in a university-affiliated HIV clinic in the Southeastern United States. Outcome of interest was durability (time to discontinuation) of the initial regimen. Durability was evaluated using Kaplan-Meier survival analyses. Cox proportional hazard analyses was used to evaluate the association among durability and sociodemographic, clinical, and regimen-level factors. Results.  Overall, 546 patients were analyzed. Median durability of all regimens was 39.5 months (95% confidence interval, 34.1-44.4). Commonly prescribed regimens were emtricitabine and tenofovir with efavirenz (51%; median duration = 40.1 months) and with raltegravir (14%; 47.8 months). Overall, 67% of patients had an undetectable viral load at the time of regimen cessation. Discontinuation was less likely with an integrase strand transfer inhibitor (adjusted hazards ratio [aHR] = 0.35, P = .001) or protease inhibitor-based regimen (aHR = 0.45, P = .006) and more likely with a higher pill burden (aHR = 2.25, P = .003) and a later treatment era (aHR = 1.64, P < .001). Conclusions.  Initial ARV regimen longevity declined in recent years contemporaneous with the availability of several new ARV drugs and combinations. Reduced durability mostly results from a preference for newly approved regimens rather than indicating failing therapy, as indicated by viral suppression observed in a majority of patients (67%) prior to regimen cessation. Durability is influenced by extrinsic factors including new drug availability and provider preference. Medication durability must be interpreted carefully in the context of a dynamic treatment landscape.

  10. Morphinan derivatives--A review of the recent patent literature.

    PubMed

    Gagliardi, Stefania; Dondio, Giulio; Giardina, Giuseppe A M

    2003-02-01

    Alkaloids extracted from the Papaverum somniferum are among the most powerfully acting and clinically used drugs for diseases of the central nervous system, in particular for pain. The basic ring system, common to these opiate alkaloids, is the morphinan skeleton, which in the last 50 years has been chemically manipulated to obtain compounds with improved potency and increased selectivity toward different populations of opioid receptors. Despite a huge amount of research, interest surrounding these compounds is still high. This review will discuss the patent applications published from January 2001 to June 2002, focusing on new chemical entities that could become drugs over the next few years, new chemical processes for the production of the morphinans currently used in therapy, novel formulations and combined compositions.

  11. 37 CFR 1.704 - Reduction of period of adjustment of patent term.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... adjustment of patent term. 1.704 Section 1.704 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND... of Patent Term Adjustment of Patent Term Due to Examination Delay § 1.704 Reduction of period of adjustment of patent term. (a) The period of adjustment of the term of a patent under §§ 1.703(a) through...

  12. Should the patent system for pharmaceuticals be replaced? A theoretical approach.

    PubMed

    Antoñanzas, Fernando; Rodríguez-Ibeas, Roberto; Juárez-Castelló, Carmelo A

    2014-10-01

    This paper acknowledges the difficulties of providing access to innovative drugs in some jurisdictions under the patent system and it contributes to the current debate on mechanisms aimed at facilitating such access. We employ a highly stylized static model of two markets (North and South) to analyse the conditions under which a new system based on royalty payments would be preferred to a patent system for pharmaceuticals. In the welfare calculations we have considered explicitly the influence of marketing activities by the patent owner as well as the shadow price of public funds needed to finance the royalties. The bargaining power of the firm in terms of obtaining higher compensation is also considered. The result: are not unambiguously conclusive being heavily dependent on the relevant values of the parameters. Nevertheless, it seems that for realistic parameter values, the new system could be preferred by all the parties involved.

  13. Use of optical storage for patent image retrieval: the U.S. Patent and Trademark Office's automated patent system

    NASA Astrophysics Data System (ADS)

    Jacobson, Stephen R.

    1990-08-01

    The Automated Patent System (APS) was designed, among other things, to assist the patent examiner in performing the patent search. It is a fully distributed system that uses custom-built high-resolution dual-display intelligent workstations, optical file servers, mainframes, and support computers networked together using Ethernet technology. The system is composed of two parts which are highly integrated: a full text search system and a patent image retrieval system. When fully deployed, APS will have an image data base of up to 30 terabytes being accessed from over 1000 workstations. The U.S. Patent and Trademark Office (PTO) has had problems with their optical drives, and although they are fairly stable today, we still experience a moderately high hardware failure rate. The optical drive problems include media instability, hardware design errors, vendor problems, and configuration control failures. We intend to purchase additional drives in the future, and are re-evaluating the exclusive use of optical storage in light of recent advances in magnetic storage technology.

  14. HIV-1 Antiretroviral Drug Resistance in Pregnant Women in Jamaica A Preliminary Report

    PubMed Central

    Amarakoon, II; Ramkissoon, A; Pierre, R; Eyzaguirre, LM; Carr, JK; Blattner, WA; Roye, ME

    2014-01-01

    ABSTRACT This preliminary report sought to provide insight into the genetic diversity of human immunodeficiency virus drug resistance (HIVDR) in Jamaica. This was done by investigating the genetic diversity associated with drug resistance in pregnant women living with HIV attending antenatal clinics in Kingston, Jamaica. Blood samples were collected and viral RNA were extracted and analysed. The protease and reverse transcriptase (Pro-RT) genes were amplified using the nested polymerase chain reaction (PCR) method. Polymerase chain reaction amplicons were obtained for nine (56%) of 16 patients, of which five (55%) were antiretroviral (ARV) drug naïve and four (45%) were treatment experienced. Three minor protease inhibitor resistant-conferring mutations (A71AT, A71V, A71T) and five mutations conferring high to low-level resistance (K219EK, T69S, K103S, G190A and K103N) were detected in the RT region. More than 50% of the resistance mutations found were detected in ARV drug naïve individuals, implying that viruses are being transmitted with the ARV resistance. These preliminary results will inform the health practitioners of the level of drug resistance that is being transmitted as well as strengthen the need to initiate a national baseline survey on HIVDR in Jamaica. PMID:25803373

  15. A Moral Economy of Patents: Case of Finnish Research Universities' Patent Policies

    ERIC Educational Resources Information Center

    Kauppinen, Ilkka

    2014-01-01

    The primary objective of this paper is to demonstrate the usefulness of the concept of moral economy for higher education studies through a study of Finnish research universities' patent policies. Patent policies not only stimulate the commercialization of research, they also set norms for behavior and aim to clarify how to distribute rights and…

  16. How do public health safeguards in Indian patent law affect pharmaceutical patenting in practice?

    PubMed

    Sampat, Bhaven N; Amin, Tahir

    2013-08-01

    The 1995 Trade Related Intellectual Property Rights (TRIPS) agreement required developing countries to grant product patents in pharmaceuticals. Developing countries have since explored various measures to ameliorate potential negative effects of the new laws on public health. A prominent example is India, whose post-TRIPS patent laws include a provision, section 3(d), that restricts patents on incremental pharmaceutical innovations. Its critics and supporters alike suggest that this provision makes Indian patent law very different from that in other jurisdictions. Yet there are concerns that given resource constraints facing the Indian patent office, this novel feature of Indian patent laws on the books may not have an effect on Indian patent prosecution in practice. We test this by examining the prosecution outcomes of 2,803 applications filed in both India and Europe, coded by whether they include claims that trigger 3(d) considerations. We find that having the 3(d) provision on the books does not translate into very different patent outcomes in practice in India, relative to Europe, a jurisdiction without this provision.

  17. Can patents prohibit research? On the social epistemology of patenting and licensing in science.

    PubMed

    Biddle, Justin B

    2014-03-01

    A topic of growing importance within philosophy of science is the epistemic implications of the organization of research. This paper identifies a promising approach to social epistemology--nonideal systems design--and uses it to examine one important aspect of the organization of research, namely the system of patenting and licensing and its role in structuring the production and dissemination of knowledge. The primary justification of patenting in science and technology is consequentialist in nature. Patenting should incentivize research and thereby promote the development of knowledge, which in turn facilitates social progress. Some have disputed this argument, maintaining that patenting actually inhibits knowledge production. In this paper, I make a stronger argument; in some areas of research in the US--in particular, research on GM seeds--patents and patent licenses can be, and are in fact being, used to prohibit some research. I discuss three potential solutions to this problem: voluntary agreements, eliminating patents, and a research exemption. I argue against eliminating patents, and I show that while voluntary agreements and a research exemption could be helpful, they do not sufficiently address the problems of access that are discussed here. More extensive changes in the organization of research are necessary.

  18. Biological Diversity in the Patent System

    PubMed Central

    Oldham, Paul; Hall, Stephen; Forero, Oscar

    2013-01-01

    Biological diversity in the patent system is an enduring focus of controversy but empirical analysis of the presence of biodiversity in the patent system has been limited. To address this problem we text mined 11 million patent documents for 6 million Latin species names from the Global Names Index (GNI) established by the Global Biodiversity Information Facility (GBIF) and Encyclopedia of Life (EOL). We identified 76,274 full Latin species names from 23,882 genera in 767,955 patent documents. 25,595 species appeared in the claims section of 136,880 patent documents. This reveals that human innovative activity involving biodiversity in the patent system focuses on approximately 4% of taxonomically described species and between 0.8–1% of predicted global species. In this article we identify the major features of the patent landscape for biological diversity by focusing on key areas including pharmaceuticals, neglected diseases, traditional medicines, genetic engineering, foods, biocides, marine genetic resources and Antarctica. We conclude that the narrow focus of human innovative activity and ownership of genetic resources is unlikely to be in the long term interest of humanity. We argue that a broader spectrum of biodiversity needs to be opened up to research and development based on the principles of equitable benefit-sharing, respect for the objectives of the Convention on Biological Diversity, human rights and ethics. Finally, we argue that alternative models of innovation, such as open source and commons models, are required to open up biodiversity for research that addresses actual and neglected areas of human need. The research aims to inform the implementation of the 2010 Nagoya Protocol on Access to Genetic Resources and the Equitable Sharing of Benefits Arising from their Utilization and international debates directed to the governance of genetic resources. Our research also aims to inform debates under the Intergovernmental Committee on Intellectual

  19. Analysis of Patent Databases Using VxInsight

    SciTech Connect

    BOYACK,KEVIN W.; WYLIE,BRIAN N.; DAVIDSON,GEORGE S.; JOHNSON,DAVID K.

    2000-12-12

    We present the application of a new knowledge visualization tool, VxInsight, to the mapping and analysis of patent databases. Patent data are mined and placed in a database, relationships between the patents are identified, primarily using the citation and classification structures, then the patents are clustered using a proprietary force-directed placement algorithm. Related patents cluster together to produce a 3-D landscape view of the tens of thousands of patents. The user can navigate the landscape by zooming into or out of regions of interest. Querying the underlying database places a colored marker on each patent matching the query. Automatically generated labels, showing landscape content, update continually upon zooming. Optionally, citation links between patents may be shown on the landscape. The combination of these features enables powerful analyses of patent databases.

  20. The ethics of patenting human embryonic stem cells.

    PubMed

    Chapman, Audrey R

    2009-09-01

    Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison's intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns.

  1. Should patents for antiretrovirals be waived in the developing world? Annual varsity medical debate - London, 21 January 2011

    PubMed Central

    2011-01-01

    The 2011 Varsity Medical Debate, between Oxford and Cambridge Universities, brought students and faculty together to discuss the waiving of patents for antiretroviral therapies in the developing world. With an estimated 29.5 million infected by Human Immunodeficiency Virus (HIV) in low- and middle-income countries and only 5.3 million of those being treated, the effective and equitable distribution of anti-retroviral therapy (ART) is an issue of great importance. The debate centred around three areas of contention. Firstly, there was disagreement about whether patents were the real barrier to the access of anti-retroviral therapy in the developing world. Secondly, there were differing views on the effectiveness of a patent pool. Thirdly, concerns were raised over the impact of waiving patents on research to produce new and better anti retro-viral drugs. PMID:21740573

  2. Protecting new ideas and inventions in nanomedicine with patents.

    PubMed

    Bawa, Raj; Bawa, S R; Maebius, Stephen B; Flynn, Ted; Wei, Chiming

    2005-06-01

    New paradigms are shrinking our world. Tiny is in and patents are essential for success in nanomedicine. In fact, patents are already shaping this nascent and rapidly evolving field. For the past decade a swarm of patent applications pertaining to nanomedicine has been arriving at the US Patent and Trademark Office (PTO). As companies develop products and processes and begin to seek commercial applications for their inventions, securing valid and defensible patent protection will be vital to their long-term survival. As we enter the "golden era" of medicine, or nanomedicine, in the next decade with the field maturing and the promised breakthroughs accruing, patents will generate licensing revenue, provide leverage in deals and mergers, and reduce the likelihood of infringement. Because development of nanobiotechnology- and nanomedicine-related products is extremely research intensive, without the market exclusivity offered by a US patent, development of these products and their commercial viability in the marketplace will be significantly hampered. In this article, we highlight critical issues relating to patenting nanomedicine products. Effects of the "nanopatent land grab" that is underway in nanomedicine by "patent prospectors" are examined as startups and corporations compete to lock up broad patents in these critical early days. Because nanomedicine is multidisciplinary, patenting presents unique opportunities and poses numerous challenges. Although patents are being sought more actively and enforced more vigorously, the entire patent system is under greater scrutiny and strain, with the PTO continuing to struggle with evaluating nanomedicine-related patent applications.

  3. A consideration of the patentability of enantiomers in the pharmaceutical industry in the United States.

    PubMed

    Miller, Chris P; Ullrich, John W

    2008-06-01

    During the last thirty years, concern over stereoselectivity of drug action has drawn a great deal of interest within the pharmaceutical field due to an improved understanding of the pharmacology and pharmacokinetics of enantiomers. Developing single enantiomers versus racemates or introducing a single enantiomer following the development of the racemic mixture appears to be the new trend. The intellectual property status of single enantiomers from racemates may be unclear. Drug discoverers and patent attorneys must examine the examples of the past to establish an appropriate pathway towards the development and intellectual property protection of chiral drugs. The review will focus on the patenting of an enantiomer in view of the prior art disclosure for the racemic mixture.

  4. Metastasizing patent claims on BRCA1.

    PubMed

    Kepler, Thomas B; Crossman, Colin; Cook-Deegan, Robert

    2010-05-01

    Many patents make claims on DNA sequences; some include claims on oligonucleotides related to the primary patented gene. We used bioinformatics to quantify the reach of one such claim from patent 4,747,282 on BRCA1. We find that human chromosome 1 (which does not contain BRCA1) contains over 300,000 oligonucleotides covered by this claim, and that 80% of cDNA and mRNA sequences contributed to GenBank before the patent application was filed also contain at least one claimed oligonucleotide. Any "isolated" DNA molecules that include such 15 bp nucleotide sequences would fall under the claim as granted by the US Patent and Trademark Office. Anyone making, using, selling, or importing such a molecule for any purpose within the United States would thus be infringing the claim. This claim and others like it turn out, on examination, to be surprisingly broad, and if enforced would have substantial implications for medical practice and scientific research.

  5. Gene patents, patenting life and the impact of court rulings on US stem cell patents and research.

    PubMed

    Matthews, Kirstin R W; Cuchiara, Maude L

    2014-03-01

    In June 2013, the US Supreme Court ruled that naturally occurring genes were unpatentable in the case Association for Molecular Pathology v. Myriad Genetics. Up until this decision, Myriad Genetics was the only company in the USA that could legally conduct diagnostic testing for BRCA1 and 2, genes that are linked to familial breast and ovarian cancer. The court case and rulings garnered discussion in public about patenting biological materials. This paper will describe the progression of the Myriad Genetics case, similar US rulings and biological intellectual property policies. In addition, it will discuss the impact of the case on biological patents - specifically those for human embryonic stem cells.

  6. Digital pathology: A systematic evaluation of the patent landscape

    PubMed Central

    Cucoranu, Ioan C.; Parwani, Anil V.; Vepa, Suryanarayana; Weinstein, Ronald S.; Pantanowitz, Liron

    2014-01-01

    Introduction: Digital pathology is a relatively new field. Inventors of technology in this field typically file for patents to protect their intellectual property. An understanding of the patent landscape is crucial for companies wishing to secure patent protection and market dominance for their products. To our knowledge, there has been no prior systematic review of patents related to digital pathology. Therefore, the aim of this study was to systematically identify and evaluate United States patents and patent applications related to digital pathology. Materials and Methods: Issued patents and patent applications related to digital pathology published in the United States Patent and Trademark Office (USPTO) database (www.uspto.gov) (through January 2014) were searched using the Google Patents search engine (Google Inc., Mountain View, California, USA). Keywords and phrases related to digital pathology, whole-slide imaging (WSI), image analysis, and telepathology were used to query the USPTO database. Data were downloaded and analyzed using the Papers application (Mekentosj BV, Aalsmeer, Netherlands). Results: A total of 588 United States patents that pertain to digital pathology were identified. In addition, 228 patent applications were identified, including 155 that were pending, 65 abandoned, and eight rejected. Of the 588 patents granted, 348 (59.18%) were specific to pathology, while 240 (40.82%) included more general patents also usable outside of pathology. There were 70 (21.12%) patents specific to pathology and 57 (23.75%) more general patents that had expired. Over 120 unique entities (individual inventors, academic institutions, and private companies) applied for pathology specific patents. Patents dealt largely with telepathology and image analysis. WSI related patents addressed image acquisition (scanning and focus), quality (z-stacks), management (storage, retrieval, and transmission of WSI files), and viewing (graphical user interface (GUI

  7. The impact of patent eligibility on biotech patents: A flow chart for determining patent eligibility and an immune therapy case study

    PubMed Central

    Chang, Bao-Chi; Wang, Shyh-Jen

    2015-01-01

    US common law recites a natural law, natural phenomenon or abstract idea as exceptions to the 4 statutory patentable categories to guard against the wholesale preemption of fundamental principles. The very recent evolutions of patent exceptions in the US may increase the difficulty of patenting and may create uncertainty in determining patent eligibility. To solve the thorny problem of eligibility, this study presents a flow chart based on the courts’ decisions that can serve as a set of guidelines for determining patent eligibility. A case related to prostate cancer immune therapy is presented for discussion. PMID:25714661

  8. Patent information - towards simplicity or complexity?

    NASA Astrophysics Data System (ADS)

    Shenton, Written By Kathleen; Norton, Peter; Onodera, Translated By Natsuo

    Since the advent of online services, the ability to search and find chemical patent information has improved immeasurably. Recently, integration of a multitude of files (through file merging as well as cross-file/simultaneous searches), 'intelligent' interfaces and optical technology for large amounts of data seem to achieve greater simplicity and convenience in the retrieval of patent information. In spite of these progresses, there is more essential problem which increases complexity. It is a tendency to expand indefinitely the range of claim for chemical substances by a ultra-generic description of structure (overuse of optional substituents, variable divalent groups, repeating groups, etc.) and long listing of prophetic examples. Not only does this tendency worry producers and searchers of patent databases but also prevents truly worthy inventions in future.

  9. Biomedical patents and ethics: a Canadian solution.

    PubMed

    Gold, E R

    2000-05-01

    World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.

  10. From flood-event to climate in an alpine context (Arve valley, France): methodological issues toward the confrontation of historical documentation and geological records

    NASA Astrophysics Data System (ADS)

    Mélo, Alain; Ployon, Estelle; Wilhelm, Bruno; Arnaud, Fabien

    2014-05-01

    Floods are complex multifactor events. As it can occur randomly on a given region, a given singular event does not clearly inform about climate variations. On the contrary, long-time series of well documented events, each one being replaced in its historical and geographical context, should bring valuable information. Such successions can be built-up using heterogeneous historical documentation taken from various social contexts. This is the case of small drainage basin of river Arve and its tributaries (Northern French Alps), on which this paper will focus. We used a plentiful and rich documentation which was elaborated quite exclusively to report damages in the aim of claiming tax abatement. As a consequence each text requires a hard critic to reach the necessary objectivity. The analysis of 18th century treasury archives led first to a geographical reconstruction of floods impacts and second to an unambiguous chronology of events. The contrasted morphology of river Arve drainage basin generates various types of floods, depending on geographical situations: summer flash-floods in the higher parts of valleys (Chamonix, Sixt) or torrential tributaries (Borne); autumn large floods in lower parts (Bonneville); some unusual events concern the whole basin (1733, 1778...). The constitution of long continuous series was thus possible. However, this does not allow evidencing any trend because most of the events are randomly-distributed flash-floods. In return, meteorological contextualization of each event replaces it in a larger climatic perception. Using this way (meteorological archives, comparisons with recently well-documented event) led us to corroborate connections between flood events and changing patterns. In order to go a step further, we led a pilot-study aiming at representing our data in space-time information system using concepts and tools of time geography. This study was limited to year 1930 AD which was rich in various meteorological events leading to

  11. Deubiquitinases (DUBs) and DUB inhibitors: a patent review

    PubMed Central

    Nwankwo, Joseph O.; Arkwright, Richard T.; Cvek, Boris; Liu, Jinbao; Dou, Q. Ping

    2016-01-01

    Introduction Deubiquitinating-enzymes (DUBs) are key components of the ubiquitin-proteasome-system (UPS). The fundamental role of DUBs is specific removal of ubiquitin from substrates. DUBs contribute to activation/deactivation, recycling and localization of numerous regulatory-proteins, thus playing major roles in diverse cellular-processes. Altered DUB activity is associated with multitudes of pathologies including cancer. Therefore, DUBs represent novel candidates for target-directed drug development. Areas covered The article is a thorough review/accounting of patented compounds targeting DUBs stratifying/classifying the patented compounds based on: chemical-structures, nucleic-acid compositions, modes-of-action and targeting-sites. The review provides a brief background on the UPS and DUBs involvement. Furthermore, methods for assessing efficacy and potential pharmacological utility of DUB inhibitor (DUBi) are discussed. Expert opinion The FDA’s approval of the 20S proteasome inhibitors: bortezomib and carfilzomib for treatment of hematological malignancies established the UPS as an anti-cancer target. Unfortunately, many patients are inherently resistant or develop resistance to proteasome inhibitors (PIs). One potential strategy to combat PI resistance is targeting upstream components of the UPS such as DUBs. DUBs represent a promising potential therapeutic target due to their critical roles in various cellular processes including protein-turnover, localization and cellular homeostasis. While considerable efforts have been undertaken to develop DUB modulators, significant advancement is necessary move DUB inhibitors into the clinic. PMID:26077642

  12. Bio-patents, development and society: on the patentability of human genes.

    PubMed

    Myszczuk, Ana Paula; de Meirelles, Jussara Maria Leal

    2012-01-01

    This study discusses the possibility of patenting inventions based on human genes and the need for an effective adaptation of the Patent Law system to enable the patenting of material derived from human genes. Furthermore, to allow for the inclusion of human gene-based inventions in the current patent system, many more amendments are required than those that have already become law during and since the twentieth century. It should be emphasized that one of the main characteristics of Patent Law is this changeability that requires the law to constantly respond to economic needs, advances in science and their resulting challenges in order to protect the product of human ingenuity. Therefore, new adaptations are required. In this context, the present paper adopts the understanding that human genes may serve as a basis for patentable inventions provided that the traditional requirements of novelty, inventiveness, utility and descriptive adequacy are adapted to the specific nature of living human matter. They should also be in line with the principles of legality and morality and not infringe human dignity, personality rights and should fulfill their social and environmental functions. Therefore, a bio-patent has a threefold function: economic, social and environmental. The economic function lies in the exclusive right to exploit an invention; the social function is implicit because there is no reason for the existence of a patent that solely benefits, its owner without society also enjoying its benefits and; the environmental function is that which guarantees that a bio-patent should preserve biodiversity and social diversity.

  13. Nanocellulose patents trends: a comprehensive review on patents on cellulose nanocrystals, microfibrillated and bacterial cellulose.

    PubMed

    Charreau, Hernan; Foresti, Maria L; Vazquez, Analia

    2013-01-01

    Cellulose nanoparticles (i.e. cellulose elements having at least one dimension in the 1-100 nm range) have received increasing attention during the last decade. This is not only evident in academic articles, but it is also manifested by the increasing number of nanocellulose patents that are published every year. In the current review, nanocellulose patents are reviewed using specific software which provides valuable information on the annual number of patents that have been published throughout the years, main patent owners, most prolific inventors, and patents on the field that have received more citations. Patent statistics on rod-like cellulose nanoparticles extracted from plants by acid hydrolysis (nanocrystals), mechanical treatment leading to microfibrillated cellulose (MFC), and microbially produced nanofibrils (bacterial cellulose, BC) are analyzed in detail. The aim of the current review is to provide researchers with patent information which may help them in visualizing the evolution of nanocellulose technology, both as a whole and also divided among the different nanosized particles that are currently the subject of outstanding scientific attention. Then, patents are not only analyzed by their content, but also by global statistics which will reveal the moment at which different cellulose nanoparticles technologies achieved a breakthrough, the relative interest received by different nanocellulose particles throughout the years, the companies that have been most interested in this technology, the most prolific inventors, and the patents that have had more influence in further developments. It is expected that the results showing the explosion that nanocellulose technology is experiencing in current days will still bring more research on the topic and contribute to the expansion of nanocellulosics applications.

  14. Longer patents for increased generic competition in the US. The Waxman-Hatch Act after one decade.

    PubMed

    Grabowski, H; Vernon, J

    1996-01-01

    The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act's existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act.

  15. 48 CFR 970.3102-05-30 - Patent costs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent costs. 970.3102-05... SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Contract Cost Principles and Procedures 970.3102-05-30 Patent costs....

  16. 48 CFR 970.3102-05-30 - Patent costs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Patent costs. 970.3102-05... SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Contract Cost Principles and Procedures 970.3102-05-30 Patent costs....

  17. 48 CFR 27.204 - Patented technology under trade agreements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Patented technology under trade agreements. 27.204 Section 27.204 Federal Acquisition Regulations System FEDERAL ACQUISITION... Patented technology under trade agreements....

  18. 48 CFR 27.204 - Patented technology under trade agreements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Patented technology under trade agreements. 27.204 Section 27.204 Federal Acquisition Regulations System FEDERAL ACQUISITION... Patented technology under trade agreements....

  19. 48 CFR 27.204 - Patented technology under trade agreements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Patented technology under trade agreements. 27.204 Section 27.204 Federal Acquisition Regulations System FEDERAL ACQUISITION... Patented technology under trade agreements....

  20. 48 CFR 27.204 - Patented technology under trade agreements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patented technology under trade agreements. 27.204 Section 27.204 Federal Acquisition Regulations System FEDERAL ACQUISITION... Patented technology under trade agreements....

  1. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent Term... by: (1) The fee set forth in § 1.18(f); and (2) A showing to the satisfaction of the Director...

  2. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent Term... by: (1) The fee set forth in § 1.18(f); and (2) A showing to the satisfaction of the Director...

  3. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent Term... showing to the satisfaction of the Director that, in spite of all due care, the applicant was unable...

  4. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent Term... showing to the satisfaction of the Director that, in spite of all due care, the applicant was unable...

  5. 48 CFR 27.204 - Patented technology under trade agreements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Patented technology under trade agreements. 27.204 Section 27.204 Federal Acquisition Regulations System FEDERAL ACQUISITION... Patented technology under trade agreements....

  6. An advanced search engine for patent analytics in medicinal chemistry.

    PubMed

    Pasche, Emilie; Gobeill, Julien; Teodoro, Douglas; Gaudinat, Arnaud; Vishnykova, Dina; Lovis, Christian; Ruch, Patrick

    2012-01-01

    Patent collections contain an important amount of medical-related knowledge, but existing tools were reported to lack of useful functionalities. We present here the development of TWINC, an advanced search engine dedicated to patent retrieval in the domain of health and life sciences. Our tool embeds two search modes: an ad hoc search to retrieve relevant patents given a short query and a related patent search to retrieve similar patents given a patent. Both search modes rely on tuning experiments performed during several patent retrieval competitions. Moreover, TWINC is enhanced with interactive modules, such as chemical query expansion, which is of prior importance to cope with various ways of naming biomedical entities. While the related patent search showed promising performances, the ad-hoc search resulted in fairly contrasted results. Nonetheless, TWINC performed well during the Chemathlon task of the PatOlympics competition and experts appreciated its usability.

  7. DNA Dilemma: A Perspective on Current U.S. Patent and Trademarh Office Philosophy Concerning Life Patents

    SciTech Connect

    Franz, K.; Faletra, P.

    2002-01-01

    The lack of a solid set of criteria for determining patentability of subject matter - particularly subject matter dealing with life - has recently been of increasing public concern in the United States. Alarm for patent practices related to life systems ranges from patents being granted on biochemical processes and the knowledge of these processes to the patenting of entire organisms. One of the most volatile concerns is the patenting of human genes or parts of genes since this genetic material is the basic informational molecule for all life. Current patent law, legislated in 1952, has been interpreted by the U.S. Supreme Court to allow broad patents of DNA, biochemical processes, and what are generally considered 'inventions' of life systems. Several issues are addressed in this paper regarding the unsound reasoning underlying both the interpretation and execution of patent law. Lapses in logic provide a gateway for businesses and individuals to take patenting to an illogical and unworkable extreme. Patent Office disorder of this magnitude is unnecessary and has great potential for harming the mission that the patent office was designed to serve. Recently disclosed patent-granting guidelines suggest the United States Patent and Trademark Office is not upholding its Constitutional responsibility of promoting the progress of science.

  8. Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

    DTIC Science & Technology

    2005-05-06

    patent life with respect to an unrelated product has been termed a “ wild card ” term extension.87 Under this regime, a countermeasure innovator could...for an additional period of six months to two years. Supporters of a wild card patent term extension urge that patent-based incentives on profitable...particular illnesses or medical conditions.89 S. 975 appears to employ this “ wild card ” patent term extension concept. That bill stipulates that

  9. Contribution of rainfall, snow and ice melt to the hydrological regime of the Arve upper catchment and to severe flood events

    NASA Astrophysics Data System (ADS)

    Lecourt, Grégoire; Revuelto, Jesús; Morin, Samuel; Zin, Isabella; Lafaysse, Matthieu; Condom, Thomas; Six, Delphine; Vionnet, Vincent; Charrois, Luc; Dumont, Marie; Gottardi, Frédéric; Laarman, Olivier; Coulaud, Catherine; Esteves, Michel; Lebel, Thierry; Vincent, Christian

    2016-04-01

    In Alpine catchments, the hydrological response to meteorological events is highly influenced by the precipitation phase (liquid or solid) and by snow and ice melt. It is thus necessary to simulate accurately the snowpack evolution and its spatial distribution to perform relevant hydrological simulations. This work is focused on the upper Arve Valley (Western Alps). This 205 km2 catchment has large glaciated areas (roughly 32% of the study area) and covers a large range of elevations (1000-4500 m a.s.l.). Snow presence is significant year-round. The area is also characterized by steep terrain and strong vegetation heterogeneity. Modelling hydrological processes in such a complex catchment is therefore challenging. The detailed ISBA land surface model (including the Crocus snowpack scheme) has been applied to the study area using a topography based discretization (classifying terrain by aspect, elevation, slope and presence of glacier). The meteorological forcing used to run the simulations is the reanalysis issued from the SAFRAN model which assimilates meteorological observations from the Meteo-France networks. Conceptual reservoirs with calibrated values of emptying parameters are used to represent the underground water storage. This approach has been tested to simulate the discharge on the Arve catchment and three sub-catchments over 1990-2015. The simulations were evaluated with respect to observed water discharges for several headwaters with varying glaciated areas. They allow to quantify the relative contribution of rainfall, snow and ice melt to the hydrological regime of the basin. Additionally, we present a detailed analysis of several particular flood events. For these events, the ability of the model to correctly represent the catchment behaviour is investigated, looking particularly to the relevance of the simulated snowpack. Particularly, its spatial distribution is evaluated using MODIS snow cover maps, punctual snowpack observations and summer

  10. 78 FR 60256 - Initial Patent Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... should be directed to the attention of Raul Tamayo, Senior Legal Advisor, Office of Patent Legal... them will be submitted. The recordkeeping costs associated with keeping a copy of the electronically... suggests, but does not require, that applicants keep copies of their electronically-filed applications....

  11. Careers in Patent Law for Physics Majors

    ERIC Educational Resources Information Center

    Oliver, Douglas L.

    2010-01-01

    An important question that many undergraduate physics students ask is, "What can one do with a physics degree?" Of course there are many answers to this question. Often a general reference to becoming a lawyer is given as a possible answer. This paper is intended to explain the field of patent law and how a physics degree can lead to an…

  12. 76 FR 72000 - Patent, Trademark & Copyright Acts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR Geological Survey Patent, Trademark & Copyright Acts AGENCY: U.S. Geological Survey, Interior. ACTION: Notice of Prospective Intent to Award Exclusive License. SUMMARY: The United States Geological Survey...

  13. Patent foramen ovale presenting as visual loss

    PubMed Central

    Liu, Xiaoxuan; Calvert, Patrick A; Arif, Sayqa; Keane, Pearse A

    2016-01-01

    Retinal artery occlusion in an otherwise healthy, young patient is rare. In this context it is important to consider patent foramen ovale as a differential. Early referral to a cardiology specialist for diagnosis and treatment is important for preventing further ocular and non-ocular events. PMID:28203381

  14. Patent and Copyright Policies at Selected Universities.

    ERIC Educational Resources Information Center

    National Association of College and University Business Officers, Washington, DC.

    Gathered are statements of copyright and patent policies in effect at 13 universities. In some cases policies concerning publication and sponsored research are included. The statements are reproduced exactly as received from the institutions, without interpretation. The universities participating are: Boston University (Massachusetts); California…

  15. Stem cell technologies: regulation, patents and problems.

    PubMed

    Then, Shih-Ning

    2004-11-01

    Human embryonic stem cell research promises to deliver in the future a whole range of therapeutic treatments, but currently governments in different jurisdictions must try to regulate this burgeoning area. Part of the problem has been, and continues to be, polarised community opinion on the use of human embryonic stem cells for research. This article compares the approaches of the Australian, United Kingdom and United States governments in regulating human embryonic stem cell research. To date, these governments have approached the issue through implementing legislation or policy to control research. Similarly, the three jurisdictions have viewed the patentability of human embryonic stem cell technologies in their own ways with different policies being adopted by the three patent offices. This article examines these different approaches and discusses the inevitable concerns that have been raised due to the lack of a universal approach in relation to the regulation of research; the patenting of stem cell technologies; and the effects patents granted are having on further human embryonic stem cell research.

  16. Glidden's Patent Application for Barbed Wire.

    ERIC Educational Resources Information Center

    Ray, Emily; Schamel, Wynell

    1997-01-01

    Describes a series of teaching activities to be used in conjunction with a reproduction of Joseph Glidden's patent for barbed wire fencing. These include document analysis, creative interpretation, and personal experience. Presents a brief history of the social and economic effects of the introduction of barbed wire to the West. (MJP)

  17. Savannah River Site Patented Technologies Summaries

    SciTech Connect

    Rabold, D.E.

    1995-07-18

    This information represents SRS`s contribution of the DOE technology information network, an internet service coordinated out of Los Alamos. The information provided is strictly DOE-SR-titled and-issued patented technologies including environmental remediation, robotics, sensors, materials science, biomedical applications, hydrogen, and consumer products.

  18. The Applicability of Patented Technologies to Sonobuoys

    DTIC Science & Technology

    1989-06-30

    to Navy suppliers. F. Contact: Darryl Mexic, Esquire Patent Counsel Sughrue, Mion, Zinn , Macpeak & Seas 2100 Pennsylvania Avenue, NW Washington, DC...Bovernack Auoney, Agent. or Firm- Howard P. Terry; Seymour (75) Inventor: D d H. MeMa , Carlisle, Mass. Levine [73] Assignee: Sperry Corporatloin, New York

  19. Vehicle Technologies Program Awards and Patents

    SciTech Connect

    2011-12-13

    Award-winning technologies and processes are hallmarks of the programs funded by the U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, and industrial partners. Awards, patents, and other recognition validate the products of research undertaken as part of the Vehicle Technologies Program.

  20. 77 FR 4887 - DOE Patent Licensing Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY 10 CFR..., Department of Energy. ACTION: Final rule. SUMMARY: The Department of Energy (DOE) is amending its patent... for Technology Transfer and Procurement shall hear and decide appeals relating to licensing...

  1. Update on Brazil's pharma patent landscape.

    PubMed

    Gosain, Rana

    2016-09-01

    Brazil's Pharma market is a dynamic and promising one. It ranks within the top ten market. There are peculiar hurdles that patentees have to overcome, such as, a two-tier examination, a serious backlog at the Brazilian Patent and Trademark Office. Several measures to accelerate examination have been adopted given the meager number of Examiners.

  2. 75 FR 17380 - Patents Ombudsman Pilot Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE... and Trademark Office, Commerce. ACTION: Notice. SUMMARY: The United States Patent and Trademark Office... satisfaction level of the participants will be monitored. If a participant is not satisfied with the...

  3. 77 FR 269 - Matters Related to Patent Appeals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-04

    ... United States Patent and Trademark Office Matters Related to Patent Appeals ACTION: Proposed collection...: Email: InformationCollection@uspto.gov . Include ``0651- 00xx Matters Related to Patent Appeals comment... protection to which he or she is entitled. Where the differences of opinion on such matters concern...

  4. 48 CFR 31.205-30 - Patent costs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patent costs. 31.205-30... CONTRACTING REQUIREMENTS CONTRACT COST PRINCIPLES AND PROCEDURES Contracts With Commercial Organizations 31.205-30 Patent costs. (a) The following patent costs are allowable to the extent that they are...

  5. 48 CFR 31.205-30 - Patent costs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Patent costs. 31.205-30... CONTRACTING REQUIREMENTS CONTRACT COST PRINCIPLES AND PROCEDURES Contracts With Commercial Organizations 31.205-30 Patent costs. (a) The following patent costs are allowable to the extent that they are...

  6. Biotechnology Firms Gird for Clash over Patent Claims.

    ERIC Educational Resources Information Center

    Webber, David

    1984-01-01

    Examines issues and trends related to biotechnology patents, providing data that show that foreign concerns have gained a large share of United States patents. Also lists the number of patents assigned to companies, foreign countries, and universities during 1983 and 1984. (JN)

  7. 77 FR 48755 - Office Patent Trial Practice Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ...The Leahy-Smith America Invents Act (AIA) establishes several new trial proceedings to be conducted by the Patent Trial and Appeal Board (Board) including inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings. In separate rulemakings, the United States Patent and Trademark Office (Office or USPTO) is revising the rules......

  8. 7 CFR 1230.88 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Patents, copyrights, inventions, and publications... Information Order Miscellaneous § 1230.88 Patents, copyrights, inventions, and publications. Any patents, copyrights, trademarks, inventions, or publications developed through the use of funds collected under...

  9. 7 CFR 1160.505 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 9 2011-01-01 2011-01-01 false Patents, copyrights, inventions and publications. 1160... PROGRAM Fluid Milk Promotion Order Miscellaneous § 1160.505 Patents, copyrights, inventions and publications. (a) Any patents, copyrights, trademarks, inventions or publications developed through the use...

  10. 7 CFR 1230.88 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Patents, copyrights, inventions, and publications... Information Order Miscellaneous § 1230.88 Patents, copyrights, inventions, and publications. Any patents, copyrights, trademarks, inventions, or publications developed through the use of funds collected under...

  11. 7 CFR 1260.215 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Patents, copyrights, inventions and publications..., copyrights, inventions and publications. (a) Any patents, copyrights, inventions or publications developed... patents, copyrights, inventions, or publications, ensure to the benefit of the Board. Upon termination...

  12. 7 CFR 1160.505 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 9 2013-01-01 2013-01-01 false Patents, copyrights, inventions and publications. 1160... PROGRAM Fluid Milk Promotion Order Miscellaneous § 1160.505 Patents, copyrights, inventions and publications. (a) Any patents, copyrights, trademarks, inventions or publications developed through the use...

  13. 7 CFR 1260.215 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Patents, copyrights, inventions and publications..., copyrights, inventions and publications. (a) Any patents, copyrights, inventions or publications developed... patents, copyrights, inventions, or publications, ensure to the benefit of the Board. Upon termination...

  14. 7 CFR 1160.505 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 9 2012-01-01 2012-01-01 false Patents, copyrights, inventions and publications. 1160... PROGRAM Fluid Milk Promotion Order Miscellaneous § 1160.505 Patents, copyrights, inventions and publications. (a) Any patents, copyrights, trademarks, inventions or publications developed through the use...

  15. 7 CFR 1230.88 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Patents, copyrights, inventions, and publications... Information Order Miscellaneous § 1230.88 Patents, copyrights, inventions, and publications. Any patents, copyrights, trademarks, inventions, or publications developed through the use of funds collected under...

  16. 7 CFR 1150.184 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 9 2014-01-01 2013-01-01 true Patents, copyrights, inventions and publications. 1150... Dairy Promotion and Research Order Miscellaneous § 1150.184 Patents, copyrights, inventions and publications. Any patents, copyrights, trademarks, inventions or publications developed through the use...

  17. 7 CFR 1150.184 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 9 2011-01-01 2011-01-01 false Patents, copyrights, inventions and publications. 1150... Dairy Promotion and Research Order Miscellaneous § 1150.184 Patents, copyrights, inventions and publications. Any patents, copyrights, trademarks, inventions or publications developed through the use...

  18. 7 CFR 1150.184 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 9 2013-01-01 2013-01-01 false Patents, copyrights, inventions and publications. 1150... Dairy Promotion and Research Order Miscellaneous § 1150.184 Patents, copyrights, inventions and publications. Any patents, copyrights, trademarks, inventions or publications developed through the use...

  19. 7 CFR 1150.184 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 9 2012-01-01 2012-01-01 false Patents, copyrights, inventions and publications. 1150... Dairy Promotion and Research Order Miscellaneous § 1150.184 Patents, copyrights, inventions and publications. Any patents, copyrights, trademarks, inventions or publications developed through the use...

  20. 7 CFR 1160.505 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 9 2014-01-01 2013-01-01 true Patents, copyrights, inventions and publications. 1160... PROGRAM Fluid Milk Promotion Order Miscellaneous § 1160.505 Patents, copyrights, inventions and publications. (a) Any patents, copyrights, trademarks, inventions or publications developed through the use...

  1. 7 CFR 1260.215 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 10 2012-01-01 2012-01-01 false Patents, copyrights, inventions and publications..., copyrights, inventions and publications. (a) Any patents, copyrights, inventions or publications developed... patents, copyrights, inventions, or publications, ensure to the benefit of the Board. Upon termination...

  2. 7 CFR 1260.215 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 10 2013-01-01 2013-01-01 false Patents, copyrights, inventions and publications..., copyrights, inventions and publications. (a) Any patents, copyrights, inventions or publications developed... patents, copyrights, inventions, or publications, ensure to the benefit of the Board. Upon termination...

  3. 7 CFR 1230.88 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Patents, copyrights, inventions, and publications... Information Order Miscellaneous § 1230.88 Patents, copyrights, inventions, and publications. Any patents, copyrights, trademarks, inventions, or publications developed through the use of funds collected under...

  4. Invisible genomes: the genomics revolution and patenting practice.

    PubMed

    Bostanci, Adam; Calvert, Jane

    2008-03-01

    In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney's case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a 'genome', and the ways in which it may be different from a 'gene', played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences.

  5. 45 CFR 650.2 - National Science Foundation patent policy.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false National Science Foundation patent policy. 650.2 Section 650.2 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PATENTS § 650.2 National Science Foundation patent policy. As authorized by the National...

  6. 45 CFR 650.2 - National Science Foundation patent policy.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false National Science Foundation patent policy. 650.2 Section 650.2 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PATENTS § 650.2 National Science Foundation patent policy. As authorized by the National...

  7. Annotated chemical patent corpus: a gold standard for text mining.

    PubMed

    Akhondi, Saber A; Klenner, Alexander G; Tyrchan, Christian; Manchala, Anil K; Boppana, Kiran; Lowe, Daniel; Zimmermann, Marc; Jagarlapudi, Sarma A R P; Sayle, Roger; Kors, Jan A; Muresan, Sorel

    2014-01-01

    Exploring the chemical and biological space covered by patent applications is crucial in early-stage medicinal chemistry activities. Patent analysis can provide understanding of compound prior art, novelty checking, validation of biological assays, and identification of new starting points for chemical exploration. Extracting chemical and biological entities from patents through manual extraction by expert curators can take substantial amount of time and resources. Text mining methods can help to ease this process. To validate the performance of such methods, a manually annotated patent corpus is essential. In this study we have produced a large gold standard chemical patent corpus. We developed annotation guidelines and selected 200 full patents from the World Intellectual Property Organization, United States Patent and Trademark Office, and European Patent Office. The patents were pre-annotated automatically and made available to four independent annotator groups each consisting of two to ten annotators. The annotators marked chemicals in different subclasses, diseases, targets, and modes of action. Spelling mistakes and spurious line break due to optical character recognition errors were also annotated. A subset of 47 patents was annotated by at least three annotator groups, from which harmonized annotations and inter-annotator agreement scores were derived. One group annotated the full set. The patent corpus includes 400,125 annotations for the full set and 36,537 annotations for the harmonized set. All patents and annotated entities are publicly available at www.biosemantics.org.

  8. 7 CFR 1220.254 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Patents, copyrights, inventions, and publications... Miscellaneous § 1220.254 Patents, copyrights, inventions, and publications. (a) Any patents, copyrights, inventions, or publications developed through the use of funds remitted to the Board under the provisions...

  9. 34 CFR 6.1 - Publication or patenting of inventions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Publication or patenting of inventions. 6.1 Section 6.1 Education Office of the Secretary, Department of Education INVENTIONS AND PATENTS (GENERAL) § 6.1 Publication or patenting of inventions. It is the general policy of the Department that the results...

  10. 7 CFR 1230.88 - Patents, copyrights, inventions, and publications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Patents, copyrights, inventions, and publications... Information Order Miscellaneous § 1230.88 Patents, copyrights, inventions, and publications. Any patents, copyrights, trademarks, inventions, or publications developed through the use of funds collected under...

  11. 77 FR 71004 - Patents and Inventions; Delegation of Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... HUMAN SERVICES Centers for Disease Control and Prevention Patents and Inventions; Delegation of... administer and make decisions regarding the invention and patent program of CDC and the authority to make determinations of rights in inventions and patents in which CDC and the Department have an interest....

  12. 50 CFR 82.19 - Patents and inventions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Patents and inventions. 82.19 Section 82...-IN-AID (MARINE MAMMAL PROTECTION ACT OF 1972) Administration § 82.19 Patents and inventions. Determination of the patent rights in any inventions or discoveries resulting from work under...

  13. 7 CFR 1160.505 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 9 2010-01-01 2009-01-01 true Patents, copyrights, inventions and publications. 1160... PROGRAM Fluid Milk Promotion Order Miscellaneous § 1160.505 Patents, copyrights, inventions and publications. (a) Any patents, copyrights, trademarks, inventions or publications developed through the use...

  14. 50 CFR 401.21 - Patents and inventions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Patents and inventions. 401.21 Section 401... CONSERVATION, DEVELOPMENT AND ENHANCEMENT § 401.21 Patents and inventions. Determination of the patent rights in any inventions or discoveries resulting from work under project agreements entered into...

  15. 7 CFR 1260.215 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Patents, copyrights, inventions and publications..., copyrights, inventions and publications. (a) Any patents, copyrights, inventions or publications developed... patents, copyrights, inventions, or publications, ensure to the benefit of the Board. Upon termination...

  16. 7 CFR 1150.184 - Patents, copyrights, inventions and publications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 9 2010-01-01 2009-01-01 true Patents, copyrights, inventions and publications. 1150... Dairy Promotion and Research Order Miscellaneous § 1150.184 Patents, copyrights, inventions and publications. Any patents, copyrights, trademarks, inventions or publications developed through the use...

  17. Glidden's Patent Application for Barbed Wire. Teaching with Documents.

    ERIC Educational Resources Information Center

    National Archives and Records Administration, Washington, DC.

    Life in the western United States was reshaped by a series of patents for a simple tool that helped ranchers tame the land: barbed wire. Nine patents for improvements to wire fencing were granted by the U.S. Patent Office to U.S. inventors beginning with Michael Kelly in 1868 and ending with Joseph Glidden in 1874. Vast and undefined prairies and…

  18. 25 CFR 152.5 - Issuance of patent in fee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Issuance of patent in fee. 152.5 Section 152.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER ISSUANCE OF PATENTS IN FEE, CERTIFICATES OF COMPETENCY, REMOVAL OF RESTRICTIONS, AND SALE OF CERTAIN INDIAN LANDS Issuing Patents in...

  19. 48 CFR 52.227-3 - Patent Indemnity.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 2 2014-10-01 2014-10-01 false Patent Indemnity. 52.227-3... AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 52.227-3 Patent Indemnity. As prescribed in 27.201-2(c)(1), insert the following clause: Patent Indemnity (APR 1984) (a)...

  20. 25 CFR 152.5 - Issuance of patent in fee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 1 2014-04-01 2014-04-01 false Issuance of patent in fee. 152.5 Section 152.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER ISSUANCE OF PATENTS IN FEE, CERTIFICATES OF COMPETENCY, REMOVAL OF RESTRICTIONS, AND SALE OF CERTAIN INDIAN LANDS Issuing Patents in...