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Sample records for arv drug patents

  1. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India.

    PubMed

    Satyanarayana, Kanikaram; Srivastava, Sadhana

    2010-01-01

    The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable

  2. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) – A Strategic Option for India

    PubMed Central

    Satyanarayana, Kanikaram; Srivastava, Sadhana

    2010-01-01

    The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable

  3. 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

  4. Nanoparticle-Based ARV Drug Combinations for Synergistic Inhibition of Cell-Free and Cell-Cell HIV Transmission.

    PubMed

    Jiang, Yonghou; Cao, Shijie; Bright, Danielle K; Bever, Alaina M; Blakney, Anna K; Suydam, Ian T; Woodrow, Kim A

    2015-12-01

    Nanocarrier-based drug delivery systems are playing an emerging role in human immunodeficiency virus (HIV) chemoprophylaxis and treatment due to their ability to alter the pharmacokinetics and improve the therapeutic index of various antiretroviral (ARV) drug compounds used alone and in combination. Although several nanocarriers have been described for combination delivery of ARV drugs, measurement of drug-drug activities facilitated by the use of these nanotechnology platforms has not been fully investigated for topical prevention. Here, we show that physicochemically diverse ARV drugs can be encapsulated within polymeric nanoparticles to deliver multidrug combinations that provide potent HIV chemoprophylaxis in relevant models of cell-free, cell-cell, and mucosal tissue infection. In contrast to existing approaches that coformulate ARV drug combinations together in a single nanocarrier, we prepared single-drug-loaded nanoparticles that were subsequently combined upon administration. ARV drug-nanoparticles were prepared using emulsion-solvent evaporation techniques to incorporate maraviroc (MVC), etravirine (ETR), and raltegravir (RAL) into poly(lactic-co-glycolic acid) (PLGA) nanoparticles. We compared the antiviral potency of the free and formulated drug combinations for all pairwise and triple drug combinations against both cell-free and cell-associated HIV-1 infection in vitro. The efficacy of ARV-drug nanoparticle combinations was also assessed in a macaque cervicovaginal explant model using a chimeric simian-human immunodeficiency virus (SHIV) containing the reverse transcriptase (RT) of HIV-1. We observed that our ARV-NPs maintained potent HIV inhibition and were more effective when used in combinations. In particular, ARV-NP combinations involving ETR-NP exhibited significantly higher antiviral potency and dose-reduction against both cell-free and cell-associated HIV-1 BaL infection in vitro. Furthermore, ARV-NP combinations that showed large dose

  5. Can drug patents be morally justified?

    PubMed

    Sterckx, Sigrid

    2005-01-01

    This paper offers a few elements of an answer to the question to what extent drug patents can be morally justified. Justifications based on natural rights, distributive justice and utilitarian arguments are discussed and criticized. The author recognizes the potential of the patents to benefit society but argues that the system is currently evolving in the wrong direction, particularly in the field of drugs. More than a third of the world's population has no access to essential drugs. The working of the patent system is an important determinant of access to drugs. This paper argues that drug patents are not easily justified and that the 'architecture' of the patent system should be rethought in view of its mission of benefiting society. PMID:15727003

  6. 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. PMID:12886793

  7. [The patents game. Generic and biosimilar drugs].

    PubMed

    Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

    2016-01-01

    The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. PMID:26542789

  8. 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. PMID:25640303

  9. Understanding the Impact of Hazardous and Harmful Use of Alcohol and/or Other Drugs on ARV Adherence and Disease Progression

    PubMed Central

    Kader, Rehana; Govender, Rajen; Seedat, Soraya; Koch, John Randy; Parry, Charles

    2015-01-01

    The objective of this study was to understand the impact of hazardous and harmful use of alcohol and/or other drugs on ARV adherence and disease progression among HIV patients. A cross-sectional study design was used. A total of 1503 patients attending HIV clinics in Cape Town, South Africa were screened for problematic substance use. A sub-sample of 607 patients (303 patients who screened positive for problematic substance use and 304 who did not) participated in this study. Hazardous or harmful alcohol use and problematic drug use predicted missing and stopping ARVs which, in turn, was associated with a decrease in CD4 counts and more rapid HIV-disease progression and poorer health outcomes in people living with HIV/AIDS (PLWHA). The findings of this study underscore the need for an integrated approach to managing substance-use disorders in PLWHA. PMID:25933422

  10. 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

  11. [Drug patents and other ways to protect pharmaceutical research].

    PubMed

    Ohana, Patrick; Tardieu, Sophie; Blin, Olivier; Tassy, Sébastien; Sambuc, Roland

    2004-01-01

    Pharmaceutical research constitutes a significant cost for pharmaceutical companies. Because of the importance of the financial investment in research projects, companies must protect their discoveries. There are multiple ways to do this. First, the legal avenue can be divided into three parts: a pharmaceutical company can protect a new drug by a patent, then an additional patent or a secondary patent; moreover, since 1992 in Europe, the pharmaceutical industry has been able to extend a patent by the "Supplementary Protection Certificate" (le Certificat Complémentaire de Protection [CCP]). The nonjuridical way is to use the chiral "switch", which can extend patents close to expiring, thus enhancing profitability. PMID:15359623

  12. 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.: PMID:24981938

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

    PubMed Central

    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. PMID:26870716

  14. Secondary patenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades.

    PubMed

    Amin, Tahir; Kesselheim, Aaron S

    2012-10-01

    Pharmaceutical manufacturers rely on patents to protect their intellectual property and often seek to extend market exclusivity for their products to maximize their return on investment. One method is by obtaining patents on features other than the original active drug ingredient, including secondary patents on alternate formulations of the drug or on methods of administration. This article examines how secondary patents can extend market exclusivity and thus delay generic competition, using as an example two key antiretroviral drugs for the management of HIV: ritonavir (Norvir) and lopinavir/ritonavir (Kaletra). We identified 108 patents, which together could delay generic competition until at least 2028--twelve years after the expiration of the patents on the drugs' base compounds and thirty-nine years after the first patents on ritonavir were filed. Some of the secondary patents that were reviewed were found to be of questionable inventiveness. We argue that increased transparency for existing patents, stricter patentability standards, and increased opportunities to challenge patent applications and patents could reduce inappropriate market exclusivity extensions on brand-name drugs and open the door to lower-cost generics. PMID:23048110

  15. Arv1 lipid transporter function is conserved between pathogenic and nonpathogenic fungi

    PubMed Central

    Gallo-Ebert, Christina; McCourt, Paula C.; Donigan, Melissa; Villasmil, Michelle L.; Chen, WeiWei; Pandya, Devanshi; Franco, Judith; Romano, Desiree; Chadwick, Sean; Gygax, Scott; Nickels, Joseph T.

    2011-01-01

    The lipid transporter Arv1 regulates sterol trafficking, and glycosylphosphatidylinositol and sphingolipid biosyntheses in Saccharomyces cerevisiae. ScArv1 contains an Arv1 homology domain (AHD) that is conserved at the amino acid level in the pathogenic fungal species, Candida albicans and Candida glabrata. Here we show S. cerevisiae cells lacking Arv1 are highly susceptible to antifungal drugs. In the presence of drug, Scarv1 cells are unable to induce ERG gene expression, have an altered pleiotrophic drug response, and are defective in multi-drug resistance efflux pump expression. All phenotypes are remediated by ectopic expression of CaARV1 or CgARV1. The AHDs of these pathogenic fungi are required for specific drug tolerance, demonstrating conservation of function. In order to understand how Arv1 regulates antifungal susceptibility, we examined sterol trafficking. CaARV1/CgARV1 expression suppressed the sterol trafficking defect of Scarv1 cells. Finally, we show that C. albicans arv1/arv1 cells are avirulent using a BALB/c disseminated mouse model. We suggest that overall cell survival in response to antifungal treatment requires the lipid transporter function of Arv1. PMID:22142782

  16. '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. PMID:27140984

  17. 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

  18. 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

  19. [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. PMID:24066606

  20. 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

  1. 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. PMID:21327122

  2. Recent patents survey on self emulsifying drug delivery system.

    PubMed

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

    2014-01-01

    Self-Emulsifying Drug Delivery System is a unique feasible approach to overcome low oral bioavailability problem which is associated with the hydrophobic drugs due to their unparalleled potential as a drug delivery with the broad range of application. The estimated 40% of active pharmaceuticals are poorly water soluble. Now recently, formulation containing oral SEDDS has received much interest as it solve problems related to oral bioavailability, intra and inter-subject variability and lack of dose proportionality of hydrophobic drugs. Now a days, it is the first way to investigate the development of any kind of innovative dosage forms. Many important in-vitro characteristics such as surfactant concentration, oil/surfactant ratio, emulsion polarity, droplet size and zeta potential play an important role in oral absorption of drug from SEEDS. It can be orally administered in the form of SGC or HGC and also enhances bioavailability of drugs to increase solubility and minimizes the gastric irritation. After administration the drug remains entrapped in the oily droplets (inside the droplet or in the surfactant`s film at the interface) of the emulsion that are formed in the GIT upon self-emulsification process. It is also a bit problematic to say that the drug is being released from SMEDDS, it would be more precise to say that it diffuses out of oily droplets into the GIT media resulting in the formation of an equilibrium between the drug dissolved in oily droplets and the outer dispersed media (e.g. GIT fluids). Many of the application and preparation methods of SEDDS are reported by research articles and patents in different countries. We present an exhaustive and updated account of numerous literature reports and more than 150 patents published on SEDDS in the recent period. This current patent review is useful in knowledge of SEDDS for its preparations and patents in different countries with emphasis on their formulation, characterization and systematic optimization

  3. Patent term extension systems differentiate Japanese and US drug lifecycle management.

    PubMed

    Yamanaka, Takayuki; Kano, Shingo

    2016-01-01

    Drug lifecycle management (LCM) contributes to maximizing drug discovery investment returns. After initial drug approval, additional approvals can be sought for novel indications and formulations to extend product marketability. Patents provide additional barriers to entry and patent term extension systems facilitate extension of these. Several aspects of the US and Japanese patent term extension systems differ. Therefore, we compared both systems using a drug LCM case study to highlight the differences. Our findings indicate that the extension of multiple drug patents on multiple occasions in Japan produces a more complicated range of extended patent protections, compared with the US system. PMID:26360052

  4. 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... drug or human biological product is eligible for extension, the term shall be extended by the time...

  5. 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... drug or human biological product is eligible for extension, the term shall be extended by the time...

  6. 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... drug or human biological product is eligible for extension, the term shall be extended by the time...

  7. 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... drug or human biological product is eligible for extension, the term shall be extended by the time...

  8. 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... drug or human biological product is eligible for extension, the term shall be extended by the time...

  9. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  10. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  11. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  12. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  13. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  14. 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

  15. 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

  16. A brief literature and patent review of nanosuspensions to a final drug product.

    PubMed

    Chin, William Wei Lim; Parmentier, Johannes; Widzinski, Michael; Tan, En Hui; Gokhale, Rajeev

    2014-10-01

    Particle size reduction can be used for enhancing the dissolution of poorly water-soluble drugs in order to enhance bioavailability. In nanosuspensions, the particle size of the drug is reduced to nanometer size. Nanosuspensions after downstream processing into drug products have successfully shown its impact on formulation design, the augmentation of product life cycle, patent life, and therapeutic efficacy. Formulation considerations for the nanosuspension formulation, its processing into a solid form, and aspects of material characterization are discussed. Technology assessments and feasibility of upstream processes for nanoparticle creation, and subsequently transformation into a drug product via the downstream processes have been reviewed. This paper aims to bridge formulation and process considerations along with patent reviews and may provide further insight into understanding the science and the white space. An analysis of current patent outlook and future trends is described to fully understand the limitations and opportunities in intellectual property generation. PMID:25099918

  17. Vulnerable infected populations and street markets for ARVs: Potential implications for PrEP rollout in the USA.

    PubMed

    Kurtz, Steven P; Buttram, Mance E; Surratt, Hilary L

    2014-04-01

    Widespread diversion of antiretroviral (ARV) medications to illicit markets has recently been documented among indigent patients in South Florida. The recent approval of ARVs for pre-exposure prophylaxis (PrEP) has the potential to broaden these illicit markets, as high-risk individuals seek ARVs without a prescription or medical supervision. Nonadherence among diverters and unsupervised use of ARVs for treatment or PrEP increase risks of treatment failure, drug resistance, and disease transmission. We report the scope of ARV diversion among substance-using men who have sex with men in South Florida. Structured interviews (N = 515) queried demographics, HIV status, mental distress, substance dependence, and sexual risks. HIV-positive participants answered questions about medical care, treatment, and ARV adherence and diversion. Median age was 39. Of 46.4% who were HIV-positive, 79.1% were prescribed ARVs. Of these, 27% reported selling/trading ARVs. Reasons for diversion were sharing/trading with friends, sale/trade for money/drugs, and sale/trade of unused medications. ARV diverters, compared to nondiverters, were more likely to be substance dependent (74.5% vs. 58.7%, p = 0.046) and have traded sex for money/drugs (60.8% vs. 32.6%, p < 0.001), and less likely to be adherent to ARVs (54.9% vs. 73.9%, p = 0.012). ARV diversion should be a particular concern in communities of high-risk men who have sex with men as uninfected men in such communities are likely to benefit most from PrEP but unlikely to have access to PrEP and necessary ancillary services through the health-care system. The implications of diversion for increased risks of treatment failure, disease transmission, and PrEP failure should be carefully considered in developing policy and behavioral supports to scaling up treatment as prevention and PrEP. PMID:24033118

  18. Streptokinase-A Drug for Thrombolytic Therapy: A Patent Review.

    PubMed

    Kunamneni, Adinarayana; Durvasula, Ravi

    2014-01-01

    Accumulation of fibrin in blood vessels significantly increases thrombosis, leading to myocardial infraction and other cardiovascular diseases. Microbial enzymes are one option for curing this pathological condition. Fibrinolytic enzymes such as urokinase (UK), tissue type plasminogen activator (t-PA) and streptokinase (SK) attracted much attention for thrombolytic therapy. Among them SK is preferable in low-resource settings because it is cost-effective. Therefore, the purpose of this review is to summarize recent patents related to the occurrence, mechanism of action, physico-chemical properties, cloning and expression, production, structure, immunogenicity, chemical modification, in vivo application and clinical trials of SK. This patent review considers the properties and characteristics of SK that make it a preferred agent for thrombolytic therapy. PMID:26497671

  19. 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. PMID:24700981

  20. Pharmacogenetic & Pharmacokinetic Biomarker for Efavirenz Based ARV and Rifampicin Based Anti-TB Drug Induced Liver Injury in TB-HIV Infected Patients

    PubMed Central

    Yimer, Getnet; Ueda, Nobuhisa; Habtewold, Abiy; Amogne, Wondwossen; Suda, Akira; Riedel, Klaus-Dieter; Burhenne, Jürgen; Aderaye, Getachew; Lindquist, Lars; Makonnen, Eyasu; Aklillu, Eleni

    2011-01-01

    Background Implication of pharmacogenetic variations and efavirenz pharmacokinetics in concomitant efavirenz based antiviral therapy and anti-tubercular drug induced liver injury (DILI) has not been yet studied. We performed a prospective case-control association study to identify the incidence, pharmacogenetic, pharmacokinetic and biochemical predictors for anti-tubercular and antiretroviral drugs induced liver injury (DILI) in HIV and tuberculosis (TB) co-infected patients. Methods and Findings Newly diagnosed treatment naïve TB-HIV co-infected patients (n = 353) were enrolled to receive efavirenz based ART and rifampicin based anti-TB therapy, and assessed clinically and biochemically for DILI up to 56 weeks. Quantification of plasma efavirenz and 8-hydroxyefaviernz levels and genotyping for NAT2, CYP2B6, CYP3A5, ABCB1, UGT2B7 and SLCO1B1 genes were done. The incidence of DILI and identification of predictors was evaluated using survival analysis and the Cox Proportional Hazards Model. The incidence of DILI was 30.0%, or 14.5 per 1000 person-week, and that of severe was 18.4%, or 7.49 per 1000 person-week. A statistically significant association of DILI with being of the female sex (p = 0.001), higher plasma efavirenz level (p = 0.009), efavirenz/8-hydroxyefavirenz ratio (p = 0.036), baseline AST (p = 0.022), ALT (p = 0.014), lower hemoglobin (p = 0.008), and serum albumin (p = 0.007), NAT2 slow-acetylator genotype (p = 0.039) and ABCB1 3435TT genotype (p = 0.001). Conclusion We report high incidence of anti-tubercular and antiretroviral DILI in Ethiopian patients. Between patient variability in systemic efavirenz exposure and pharmacogenetic variations in NAT2, CYP2B6 and ABCB1 genes determines susceptibility to DILI in TB-HIV co-infected patients. Close monitoring of plasma efavirenz level and liver enzymes during early therapy and/or genotyping practice in HIV clinics is recommended for early identification of patients

  1. 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

  2. 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. PMID:27009132

  3. 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

  4. 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. PMID:17125881

  5. Nanosuspensions in drug delivery: recent advances, patent scenarios, and commercialization aspects.

    PubMed

    Chavhan, Sandip S; Petkar, Kailash C; Sawant, Krutika K

    2011-01-01

    The interest in the preparation and application of nanometer-sized materials is increasing due to their tremendous potential as a drug delivery system with wide range of applications. Recently, nanoscale systems have received much interest as a way to resolve solubility issues because of their cost-effectiveness and technical simplicity compared to liposomes and other colloidal drug carriers. Nanosuspensions have proven to be a better alternative over other approaches currently available for improving bioavailability of number of drugs with low solubility. Nanosuspensions have been extensively developed for a wide range of drugs and have been evaluated for in vitro and in vivo applications by various routes: parenteral, oral, pulmonary, topical. They have also been used for drug targeting. Different preparation methods for nanosuspensions and their application are being reported and patented. In fact, the number of products based on nanosuspension in the market and under clinical study is higher than that of other nanotechnology-based applications. This article reviews the research and recent advances in formulation, characterization, application of nanosuspensions as well as patents on nanosuspension methods. PMID:22077201

  6. International patenting in ophthalmology: An analysis of its structure and relevance for the development of drugs and diagnostics

    PubMed Central

    Mucke, Hermann AM; Mucke, Peter; Mucke, Eva

    2009-01-01

    While investigative ophthalmologists access peer-reviewed journals as part of their daily routine, and while they regularly visit scientific congresses, they rarely peruse patent documents as an information source. Among the reasons for this negligence are the incompatibility of patent search algorithms with those known from journal databases, a legalistic and frequently redundant language, and misconceptions about the nature of the patenting system. Here we present key data and analyses from the ophthalmology module of a patent database system that we are developing to address some of these problems. We show that international patent applications consistently reflect developer interest in the ocular drug and diagnostics field; that they are technically focused lead indicators of developments that frequently feature in peer-reviewed patenting only much later; and that patenting targets are well aligned with the unmet therapeutic needs of populations in industrialized countries. Most applications (74%–78% in years since 2006) are supported with experimental data, and most (on average, 80%–90%) faced at least one objection to patentability during their initial stage of examination. In contrast to the peer-reviewed scenery that is highly diverse, the corresponding patenting arena shows a pronounced focus on the United States. PMID:19668552

  7. Analysis of drugs illegally added into Chinese traditional patent medicine using surface-enhanced Raman scattering.

    PubMed

    Zhang, Yan; Huang, Xiaoyan; Liu, Wenfang; Cheng, Zeneng; Chen, Chuanpin; Yin, Lihui

    2013-01-01

    Illegal chemicals, which could cause unpredictable side effects, may be added into traditional Chinese medicine (TCM) for a rapid healing effect. In this report, a surface-enhanced Raman scattering (SERS) analysis method for five kinds of illegally added drugs (rosiglitazone maleate, phenformin hydrochloride, metformin hydrochloride, pioglitazone hydrochloride and sibutramine hydrochloride) in Chinese traditional patent medicine (CTPM) has been demonstrated, including simultaneous detections of drug mixtures with CTPM. Silver colloidal, prepared by a sodium citrate reaction, was used as a SERS substrate. The optimum pH condition for each drug has also been explored because of its combined effect on protonation, surface charge, repulsion of an analyte and nanoparticles. Furthermore, the simultaneous detection of two or three kinds of these chemicals has been carried out. Characteristic peaks are employed for qualitative analysis. This is the first research using SERS for the analysis of drug mixtures in CTPM without any separation process. PMID:24107564

  8. Whole organism based techniques and approaches in early stage oncology drug discovery-patents and trends.

    PubMed

    Hampson, Richard J; Wyatt, Michael D

    2011-09-01

    Discovery of new cancer drugs is important for the improvement of disease treatment and management. In addition to the clear medical needs there are also economic considerations: Much drug discovery is performed in the private sector. The high cost of some drug treatments, which can run to tens of thousands of US$ per patient for single courses of therapy has led to the perception of high profitability in the industry. But drug discovery and development is a very expensive and lengthy process, with an ongoing trend of fewer drugs brought to market per dollar invested in R&D Biochemical-based in vitro screens for hosts of targets have produced early stage drug candidates and led to drugs reaching the market, but there remains a great need to evaluate in vivo efficacy, toxicity and potential off-target effects as early as possible in the discovery process. Using whole organisms much earlier in cancer (and other) drug discovery is a potential approach to improve R&D productivity. Here, we provide an overview of recent patenting activity and take a brief look at possible new developments in the field. PMID:21913888

  9. 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. PMID:25853470

  10. Modified alginate beads for mucoadhesive drug delivery system: an updated review of patents.

    PubMed

    Swain, Suryakanta; Behera, Aurobinda; Beg, Sarwar; Patra, Chinam N; Dinda, Subash C; Sruti, Jammula; Rao, Muddana E B

    2012-12-01

    Pharmaceutical research and inventions are increasingly developed for the design of an ideal dosage regimen in drug therapy of many diseases, which attains therapeutic concentration of drug in plasma and maintains it constant for the entire duration of treatment and also minimizes the side effects. Recent trends in pharmaceutical technology indicated that mucoadhesive micro particle and modified alginate beads as drug delivery system especially suitable for achieving delivery of drug in a predetermined rate locally or systemically for a prolonged period of time. The release of drug from microparticle depends on a variety of factors including carrier used to form the micro particle and amount of drug contained in them. The main aim of the present review is to explain the various theories, mechanisms, advanced mucoadhesive polymers, various delivery approaches, methodologies for developing a mucoadhesive micro-particle and modified alginate beads formulation, in vitro, ex vivo and in vivo characterization. Apart from this, an innovative test method that is biacore is highlighted in this review to measure the mucoadhesive strength. This review is also briefly explained about the updated patenting system for the development of micro-particle and modified alginate beads as drug delivery system. PMID:22734868

  11. The ARV roll out and the disability grant: a South African dilemma?

    PubMed Central

    2012-01-01

    Background Prior to the antiretroviral (ARV) drug roll out in 2004, people living with HIV (PLHIV) in South Africa received disability grants when they were defined as "AIDS-sick". In the absence of available and effective medication, a diagnosis of AIDS portended disability. The disability grant is a critical component of South Africa's social security system, and plays an important role in addressing poverty among PLHIV. Given the prevalence of unemployment and poverty, disability grants ensure access to essential resources, like food, for PLHIV. Following the ARV roll out in South Africa, PLHIV experienced improved health that, in turn, affected their grant eligibility. Our aim is to explore whether PLHIV reduced or stopped treatment to remain eligible for the disability grant from the perspectives of both PLHIV and their doctors. Methods A mixed-methods design with concurrent triangulation was applied. We conducted: (1) in-depth semi-structured interviews with 29 PLHIV; (2) in-depth semi-structured interviews with eight medical doctors working in the public sector throughout the Cape Peninsula; (3) three focus group discussions with programme managers, stakeholders and community workers; and (4) a panel survey of 216 PLHIV receiving ARVs. Results Unemployment and poverty were the primary concerns for PLHIV and the disability grant was viewed as a temporary way out of this vicious cycle. Although loss of the disability grant significantly affected the well-being of PLHIV, they did not discontinue ARVs. However, in a number of subtle ways, PLHIV "tipped the scales" to lower the CD4 count without stopping ARVs completely. Grant criteria were deemed ad hoc, and doctors struggled to balance economic and physical welfare when assessing eligibility. Conclusions It is crucial to provide sustainable economic support in conjunction with ARVs in order to make "positive living" a reality for PLHIV. A chronic illness grant, a basic income grant or an unemployment grant

  12. 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. PMID:26205680

  13. "ARVs" as sickness and medicine: examining children's knowledge and experience in the HIV era in urban Zambia.

    PubMed

    Hunleth, Jean

    2013-01-01

    Since the roll out of no cost antiretroviral drugs (ARVs) in health centers in Zambia in 2004, the number of Zambians receiving treatment has substantially increased. While research has addressed adult responses to ARVs in Zambia and elsewhere, there is little known about how children experience and respond to the presence of treatment in their communities and households. The increasing acknowledgment that children provide care and treatment support to people with HIV in their households demands a better understanding of children's knowledge of HIV and ARVs. To examine children's ARV knowledge, this article focuses on three children's workshops carried out with 38 children ages 8-12, who participated in a yearlong ethnographic study in 2007 and 2008. All children lived in a low-income and heavily HIV-affected residential area in Lusaka, and many children lived with parents or guardians who had HIV. Findings suggest that, when the children discussed ARVs, they made two intersecting points: (1) local conditions make living with HIV, even while on antiretroviral therapy (ART), difficult; and (2) children face particular challenges, concerns, and insecurities when caring for and living with the ill. Children's discussions about ARVs offer a deeper understanding of experiences of HIV and childhood in a disproportionately HIV-affected and low-resource area. Such insights might productively inform future programming and research aimed at assisting children and adults. PMID:23256500

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

    PubMed

    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

  15. 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. PMID:25310477

  16. FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).

    PubMed

    Hui, Yuk Fung

    2003-01-01

    In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry. PMID:12856462

  17. 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

  18. 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

  19. 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

  20. The social construction of ARVs in South Africa.

    PubMed

    Sember, R

    2008-01-01

    An estimated 5.5 million people are currently living with HIV/AIDS in South Africa, 4.9 million of them between the ages of 15-49, 18.8% of the total population in that age bracket (Department of Health, Republic of South Africa 2006). The potential medical and social benefits of anti-retroviral drugs (ARVs) would be substantial, but South Africa's leaders have faulted in their response to AIDS from the very beginning, particularly President Thabo Mbeki, who, in concert with the Minister of Health, has questioned the basic science of AIDS, and has condemned ARVs as poisonous. President Mbeki has created a false distinction between social causes and disease agents in his analysis that it is poverty, rather than HIV, that causes AIDS. He has made his arguments using post-colonial rhetoric to condemn pharmaceutical imperialism and medical experimentation on African populations. Opponents, most notably the pro-treatment social movement group, Treatment Action Campaign, claim that because poverty increases the risk of infection, illness and death due to HIV access to anti-retroviral medication is a social justice issue - justice demands the medications be available at all government clinics at no cost. In 2003 a government-sponsored treatment programme was launched, and by mid-2006 it was treating 140 000 persons with HIV/AIDS, less than 25% of the number estimated to require treatment. Treatment access, for all who need it in South Africa, is an ambitious but achievable goal. A new president will be elected in 2008, and many hope that this will result in a national treatment programme unshackled from the "AIDS denialism" of the current leaders. Former deputy president, Jacob Zuma, is likely to be the next president. His record on AIDS, and his patriarchal attitudes towards women, are troubling, however. One can only hope that the provincial health systems, which operate with a fair level of autonomy from the national Department of Health, will not be further hampered

  1. Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064.

    PubMed

    Chen, Iris; Clarke, William; Ou, San-San; Marzinke, Mark A; Breaud, Autumn; Emel, Lynda M; Wang, Jing; Hughes, James P; Richardson, Paul; Haley, Danielle F; Lucas, Jonathan; Rompalo, Anne; Justman, Jessica E; Hodder, Sally L; Eshleman, Susan H

    2015-01-01

    Antiretroviral (ARV) drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009-2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2%) of 1,806 participants: 27/181 (15%) in Baltimore, MD and 12/179 (7%) in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1-4 drugs/sample). These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals. PMID:26445283

  2. Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064

    PubMed Central

    Chen, Iris; Clarke, William; Ou, San-San; Marzinke, Mark A.; Breaud, Autumn; Emel, Lynda M.; Wang, Jing; Hughes, James P.; Richardson, Paul; Haley, Danielle F.; Lucas, Jonathan; Rompalo, Anne; Justman, Jessica E.; Hodder, Sally L.; Eshleman, Susan H.

    2015-01-01

    Antiretroviral (ARV) drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009–2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2%) of 1,806 participants: 27/181 (15%) in Baltimore, MD and 12/179 (7%) in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1–4 drugs/sample). These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals. PMID:26445283

  3. Will changes to patent infringements attract drug research in the UK?

    PubMed

    Snodin, Mike

    2015-01-01

    Ever since the introduction of the 'Bolar' exemption into the national laws of the EU Member States, the UK has been perceived to be a relatively difficult territory in which to conduct clinical trials, as compared to EU territories having very broad 'Bolar' exemptions, such as France and Germany. This problem for the UK has now been comprehensively eliminated by an amendment to UK patent law that came into force on 1 October 2014. However, whilst addressing a problem faced by the pharmaceutical industry in connection with conducting clinical trials, the manner in which UK patent law has been amended raises important but as yet unanswered questions about the knock-on effects for enforcement of European patents having unitary effect, if and when the laws governing such patents come into force. PMID:25813963

  4. 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

  5. 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. PMID:25092512

  6. 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

  7. PEDF as an anticancer drug and new treatment methods following the discovery of its receptors: A patent perspective

    PubMed Central

    Manalo, Katrina B.; Choong, Peter F.M.; Becerra, S. Patricia; Dass, Crispin R.

    2014-01-01

    Background Traditional forms of cancer therapy, which includes chemotherapy, have largely been overhauled due to the significant degree of toxicity they pose to normal, otherwise healthy tissue. It is hoped that use of biological agents, most of which are endogenously present in the body, will lead to safer treatment outcomes, without sacrificing efficacy. Objective The finding that PEDF, a naturally-occurring protein, was a potent angiogenesis inhibitor became the basis for studying the role of PEDF in tumours that are highly resistant to chemotherapy. The determination of the direct role of PEDF against cancer paved the way for understanding and developing PEDF as a novel drug. This review focuses on the patent applications behind testing the anticancer therapeutic effect of PEDF via its receptors as an antiangiogenic agent and as a direct anticancer agent. Conclusions The majority of the PEDF patents describe its and/or its fragments’ antiangiogenic ability and the usage of recombinant vectors as the mode of treatment delivery. PEDF’s therapeutic potential against different diseases and the discovery of its receptors opens possibilities for improving PEDF-based peptide design and drug delivery modes. PMID:21204726

  8. 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…

  9. Drugmakers struggle with Indian patents.

    PubMed

    2012-12-01

    Pharmaceutical companies continue their legal battles for intellectual property protection for their drugs in India after the country's patent office revoked Pfizer's local patent for Sutent (sunitinib malate). PMID:23230206

  10. Making tenofovir accessible in the brazilian public health system: patent conflicts and generic production.

    PubMed

    Veras, Juliana

    2014-08-01

    In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the 'Brazilian model' of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. PMID:24889312

  11. The mechanism by which the phenothiazine thioridazine contributes to cure problematic drug-resistant forms of pulmonary tuberculosis: recent patents for "new use".

    PubMed

    Amaral, Leonard; Martins, Ana; Spengler, Gabriella; Hunyadi, Attila; Molnar, Joseph

    2013-12-01

    At this moment, over half million patients suffer from multi-drug resistant tuberculosis (MDR-TB) according to the data from the WHO. A large majority is terminally ill with essentially incurable pulmonary tuberculosis. This herein mini-review provides the experimental and observational evidence that a specific phenothiazine, thioridazine, will contribute to cure any form of drug-resistant tuberculosis. This antipsychotic agent is no longer under patent protection for its initial use. The reader is informed on the recent developments in patenting this compound for "new use" with a special emphasis on the aspects of drug-resistance. Given that economic motivation can stimulate the use of this drug as an antitubercular agent, future prospects are also discussed. PMID:24320229

  12. Advances in recent patent and clinical trial drug development for Alzheimer’s disease

    PubMed Central

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

    2015-01-01

    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. PMID:25291315

  13. 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

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

    PubMed

    Hoen, Ellen 't; Berger, Jonathan; Calmy, Alexandra; Moon, Suerie

    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 a

  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. PMID:25310755

  16. Dual Therapy Treatment Strategies for the Management of Patients Infected with HIV: A Systematic Review of Current Evidence in ARV-Naive or ARV-Experienced, Virologically Suppressed Patients

    PubMed Central

    Baril, Jean-Guy; Angel, Jonathan B.; Gill, M. John; Gathe, Joseph; Cahn, Pedro; van Wyk, Jean; Walmsley, Sharon

    2016-01-01

    Objective We reviewed the current literature regarding antiretroviral (ARV)-sparing therapy strategies to determine whether these novel regimens can be considered appropriate alternatives to standard regimens for the initial treatment of ARV-naive patients or as switch therapy for those patients with virologically suppressed HIV infection. Methods A search for studies related to HIV dual therapy published from January 2000 through April 2014 was performed using Biosis, Derwent Drug File, Embase, International Pharmaceutical Abstracts, Medline, Pascal, SciSearch, and TOXNET databases; seven major trial registries, and the abstracts of major conferences. Using predetermined criteria for inclusion, an expert review committee critically reviewed and qualitatively evaluated all identified trials for efficacy and safety results and potential limitations. Results Sixteen studies of dual therapy regimens were critiqued for the ARV-naive population. Studies of a protease inhibitor/ritonavir in combination with the integrase inhibitor raltegravir or the nucleoside reverse transcriptase inhibitor lamivudine provided the most definitive evidence supporting a role for dual therapy. In particular, lopinavir/ritonavir or darunavir/ritonavir combined with raltegravir and lopinavir/ritonavir combined with lamivudine demonstrated noninferiority to standard of care triple therapy after 48 weeks of treatment. Thirteen trials were critiqued in ARV-experienced, virologically suppressed patients. The virologic efficacy outcomes were mixed. Although overall data regarding toxicity are limited, when compared with standard triple therapy, certain dual therapy regimens may offer advantages in renal function, bone mineral density, and limb fat changes; however, some dual combinations may elevate lipid or bilirubin levels. Conclusions The potential benefits of dual therapy regimens include reduced toxicity, improved tolerability and adherence, and reduced cost. Although the data reviewed here

  17. 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

  18. Investigative Approaches for Oral Delivery of Anticancer Drugs: A Patent Review.

    PubMed

    Tariq, Mohammad; Singh, Anu T; Iqbal, Zeenat; Ahmad, Farhan J; Talegaonkar, Sushama

    2016-01-01

    Typically, chemotherapy has been dominated by intravenous administration. Though, inclination towards oral ingestion of chemotherapeutics is increasing since it offers ample of fascinating opportunities including better quality of life, treatment advantages and low healthcare cost. However, low or moderate bioavailability along with significant inter-patient variability and narrow therapeutic window challenges their oral administration. Thus, optimization of oral route with maximized efficacy and miniminal adverse events is a challenging area. To surmount the challenges, a number of strategies like P-glycoprotein (P-gp) modulation, colloidal carrier etc. have been under investigation and scientists are exploring the utility of solid dispersions, prodrugs, biconjugates, complexes, microparticulate, and nanoparticulate systems (liposome, SLN, dendrimers, SEDDS, nanoparticles). Among these, nanoparticulate systems have shown promising results due to their targeting potential and ability to alter absorption pathways. Functional excipients with P-gp modulating activity are also being explored for more effective oral delivery of chemotherapeutics. This article explores the encouraging reports, recent patents and inventions on the feasibility and applicability of oral administration of chemotherapeutics. PMID:26310247

  19. Trends in nanopharmaceutical patents.

    PubMed

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

    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

  20. 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

  1. 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

  2. Patent protection strategies.

    PubMed

    Gupta, Himanshu; Kumar, Suresh; Roy, Saroj Kumar; Gaud, R S

    2010-01-01

    It is widely recognized that the pharmaceutical industry faces serious financial challenges. Large numbers of blockbuster drugs are losing patent protection and going generic. The pipeline of new drugs is too sparse to fill the gap and generate a platform for future growth. Moreover, many of the new products are biologics with much narrower target patient populations and comparatively higher prices relative to traditional pharmaceuticals. So now the time has come 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. Facing this scenario, the pharmaceutical industry has moved to accelerate drug development process and to adopt at the same time different strategies to extend the life time of the patent monopoly to provide the economic incentives and utilizing it for drug discovery and development. This review covers the need of patent protection and various strategies to extend the patent. PMID:21814422

  3. Patent protection strategies

    PubMed Central

    Gupta, Himanshu; Kumar, Suresh; Roy, Saroj Kumar; Gaud, R. S.

    2010-01-01

    It is widely recognized that the pharmaceutical industry faces serious financial challenges. Large numbers of blockbuster drugs are losing patent protection and going generic. The pipeline of new drugs is too sparse to fill the gap and generate a platform for future growth. Moreover, many of the new products are biologics with much narrower target patient populations and comparatively higher prices relative to traditional pharmaceuticals. So now the time has come 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. Facing this scenario, the pharmaceutical industry has moved to accelerate drug development process and to adopt at the same time different strategies to extend the life time of the patent monopoly to provide the economic incentives and utilizing it for drug discovery and development. This review covers the need of patent protection and various strategies to extend the patent. PMID:21814422

  4. 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.…

  5. Patent urachus repair

    MedlinePlus

    ... Drugs & Supplements Videos & Tools About MedlinePlus Show Search Search MedlinePlus GO GO About MedlinePlus Site Map FAQs Contact Us Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Patent urachus repair URL of this page: //medlineplus.gov/ ...

  6. Patent urachus repair - slideshow

    MedlinePlus

    ... Drugs & Supplements Videos & Tools About MedlinePlus Show Search Search MedlinePlus GO GO About MedlinePlus Site Map FAQs Contact Us Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Patent urachus repair - series—Normal anatomy URL of this ...

  7. Patent quality.

    PubMed

    Sklan, Alexandra

    2014-01-01

    Against a backdrop of a rising generics market and increasing patent expiries, the 'quality' of patents has become an ever more significant topic of debate. Pharmaceutical Patent Analyst has brought together a group of leading attorneys and IP specialists to disentangle the issue of patent quality, including its definition and importance to the field of pharmaceutical and medical science, and what steps could be taken to improve understanding of this important yet fluid concept. Interviews conducted by Alexandra Sklan, Commissioning Editor. PMID:24354975

  8. 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. PMID:27039667

  9. 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

  10. Antiretroviral (ARV) Therapy in Resource Poor Countries: What do we Need in Real Life?

    PubMed Central

    Castelli, Francesco; Pietra, Virginio; Diallo, Ismael; Schumacher, Richard F.; Simpore, Jacques

    2010-01-01

    Significant progresses have been made in the last 5 years towards the ultimate goal to provide universal access to care for all HIV/AIDS patients needing antiretroviral treatment in resource-poor countries. However, many barriers are still to be overcome, including (●) cost of care for the individual, (●) stigma, (●) lack of qualified human resources and infrastructure, especially in the rural setting, (●) rescue drugs for failing patients and (●) pediatric formulations. Priority actions to be promoted if the fight against HIV/AIDS is to be successful include: (i) promoting access to care in the rural areas, (ii) strengthening of basic health infrastructures, (iii) waiving of users’ fee to get ARV, (iv) a larger variety of drugs, with particular regard to fixed dose combination third line drugs and pediatric formulations, (v) local quality training and (vi) high quality basic and translational research. While the universal access to HIV care is crucial in developing countries, a strong emphasis on prevention should be maintained along. PMID:20148089

  11. Parenteral patent drug S/GSK1265744 has the potential to be an effective agent in pre-exposure prophylaxis against HIV infection.

    PubMed

    Taha, Huda; Morgan, James; Das, Archik; Das, Satyajit

    2013-12-01

    The continuing HIV epidemic has driven advancements in antiretroviral therapy. New therapeutic targets have been identified over the past years, one of which has been the Integrase enzyme. This is responsible for integrating HIV pro-DNA into the host cell genome and has proved a successful drug target. Efforts have also been made to improve the pharmacokinetic parameters of current drug therapy and utilise these techniques in maximising drug therapeutic effect whilst minimising adverse events. An exciting example of new technologies is that of nanotechnology where drugs can be specifically targeted to certain tissues and drug delivery can be improved by utilising biological molecules and structures. Pre-exposure prophylaxis is also an area of much interest currently both on an individual and population level. Compliance is however a major issue with daily medication to prevent HIV acquisition as has been demonstrated with contraceptive agents. However if long acting compounds can be developed, compliance can be improved. The patent drug currently being developed through nanotechnology as an analogue of Dolutegravir, GSK1265744 LAP (Long Acting Parenteral) has shown promise as a Long Acting Integrase Inhibitor with potential action both as a therapeutic agent but also in pre-exposure prophylaxis. The favourable pharmacokinetic profile and therapeutic efficacy in comparison to other compounds of the same class demonstrate it to be a promising advance. However given current limitations in study material, further randomised studies with long term follow up are required to fully evaluate the value of the patent drug GSK1265744 LAP in action in both seropositive and seronegative individuals. PMID:24738551

  12. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-18

    ... Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040 AGENCY: Food and Drug Administration... has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug...

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

    PubMed

    Bian, Henry; McCourt, Conor

    2015-06-01

    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. PMID:25573772

  14. Quality patents.

    PubMed

    Sinclair, K

    1994-01-01

    Watermark Patent and Trademark Attorneys has recently been accepted by the Council of National Association of Testing Authorities, Australia as operating a Quality Management System that complies with the requirements of AS3901/ISO9001 for the creation and servicing of Australian and overseas patents, trademarks and designs and provision of related advice. It is believed that Watermark is the first firm of Patent Attorneys in the world to achieve this. PMID:7765675

  15. Arv1 promotes cell division by recruiting IQGAP1 and myosin to the cleavage furrow.

    PubMed

    Sundvold, Hilde; Sundvold-Gjerstad, Vibeke; Malerød-Fjeld, Helle; Haglund, Kaisa; Stenmark, Harald; Malerød, Lene

    2016-03-01

    Cell division is strictly regulated by a diversity of proteins and lipids to ensure proper duplication and segregation of genetic material and organelles. Here we report a novel role of the putative lipid transporter ACAT-related protein required for viability 1 (Arv1) during telophase. We observed that the subcellular localization of Arv1 changes according to cell cycle progression and that Arv1 is recruited to the cleavage furrow in early telophase by epithelial protein lost in neoplasm (EPLIN). At the cleavage furrow Arv1 recruits myosin heavy chain 9 (MYH9) and myosin light chain 9 (MYL9) by interacting with IQ-motif-containing GTPase-activating protein (IQGAP1). Consequently the lack of Arv1 delayed telophase-progression, and a strongly increased incidence of furrow regression and formation of multinuclear cells was observed both in human cells in culture and in follicle epithelial cells of egg chambers of Drosophila melanogaster in vivo. Interestingly, the cholesterol-status at the cleavage furrow did not affect the recruitment of either IQGAP1, MYH9 or MYL. These results identify a novel function for Arv1 in regulation of cell division through promotion of the contractile actomyosin ring, which is independent of its lipid transporter activity. PMID:27104745

  16. Patent profiles

    SciTech Connect

    Not Available

    1980-01-01

    This report presents profiles of US patents in the area of solar energy technology, and in the related areas of wind, geothermal and tide and wave energy. Each profile is divided into three parts. The first part identifies the area which is examined, lists the pertinent US Patent Classification(s), and graphically illustrates patent activity across a designated 10-year span. The second part tabulates the data upon which the graphs of the first part were based, provides a list of assignees for the period 1969 to 1978 both by the number of patents and alphabetically, and presents on alphabetical listing of inventors of unassigned patents. The third part updates the preceding material for the period January-October 1979. (SPH)

  17. 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. PMID

  18. Geopolitical and cultural factors affecting ARV adherence on the US-Mexico border.

    PubMed

    Shedlin, Michele G; Decena, Carlos Ulises; Beltran, Oscar

    2013-10-01

    The data discussed represent the findings from a study by the NIH-funded Hispanic Health Disparities Research Center, exploring the influence of institutional and psychosocial factors on adherence to antiretroviral medications by Mexican-origin persons living with AIDS on the US-Mexico Border. A qualitative approach was utilized consisting of clinic observations, baseline and follow-up interviews with patients (N = 113), key informant interviews (N = 9) and focus groups (5) with patients and health providers. Findings include the social-normative, institutional and geo-political factors affecting treatment and service delivery as well as individual variation and culturally patterned behaviors. ARV adherence and retention were found to depend on complex interactions and negotiation of co-occurring factors including the experience of medications and side-effects, patient/provider relationships, cultural norms and the changing dynamics of international borders. We note effects of drug-related violence which created border-crossing obstacles influencing mobility, access to services and adherence. PMID:22797951

  19. 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. PMID:25201433

  20. Patents pending

    NASA Astrophysics Data System (ADS)

    2012-01-01

    Technology-transfer activities have surged since the 1980s, but only few inventions are bound to become a commercial success. Academic patenting requires professional strategies and should be motivated by goals beyond licensing revenue.

  1. Patent controversies and court cases

    PubMed Central

    Fialho, Arsenio M.; Chakrabarty, Ananda M.

    2012-01-01

    Patents are issued essentially by all countries on inventions that are deemed novel, non-obvious, clearly described and of significant utility or industrial application. The only exceptions to patenting an invention are abstract ideas, laws of nature and natural phenomena, although the exceptions vary depending on countries where moral, public order or human rights considerations are also taken into account. Although patent laws are updated over decades, the rapid progress of science creates situations that the patent laws on the book cannot address, leading to contentious legal issues. This is often true for life saving drugs, particularly drugs for cancers or HIV/AIDS, which are expensive and beyond the reach of poor people because of the proprietary positions of these patented drugs. Another contentious issue is the patent eligibility of human genes and mutations that are often thought of nature's contribution to human health and propagation and should be beyond the reach of patentability. In this review, we address some of these current legal issues and their implications for the development of diagnostic methods, therapeutic interventions and even prevention for cancer, a scourge of mankind. PMID:22954683

  2. Clinical Pharmacology Quality Assurance (CPQA) Program: Models for Longitudinal Analysis of Antiretroviral (ARV) Proficiency Testing for International Laboratories

    PubMed Central

    DiFrancesco, Robin; Rosenkranz, Susan L.; Taylor, Charlene R.; Pande, Poonam G.; Siminski, Suzanne M.; Jenny, Richard W.; Morse, Gene D.

    2013-01-01

    Among National Institutes of Health (NIH) HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals (ARV). Drug assay data are, in turn, entered into study-specific datasets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semi-annual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance (CPQA) program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1)assess the precision and accuracy of concentrations reported by individual CPLs; (2)determine factors associated with round-specific and long-term assay accuracy, precision and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21)drug concentration results reported for clinical trial samples by multiple CPLs).Using the CLIA acceptance of meeting criteria for ≥2/3 consecutive rounds, all ten laboratories that participated in three or more rounds per analyte maintained CLIA proficiency. Significant associations were present between magnitude of error and CPL (Kruskal Wallis [KW]p<0.001), and ARV (KW p<0.001). PMID:24052065

  3. Extending the market exclusivity of therapeutic antibodies through dosage patents.

    PubMed

    Storz, Ulrich

    2016-07-01

    Dosage patents are one way to extend the market exclusivity of an approved drug beyond the lifetime of the patent that protects the drug as such. Dosage patents may help to compensate the applicant for the long period where the active pharmaceutical ingredient as such is already under patent prosecution, but not on the market yet, due to lengthy development and approval procedures. This situation erodes part of the time the drug is marketed under patent protection. Dosage patents filed at a later date can provide remedy for this problem. Examples of successful and unsuccesful attempts, and the reasons for the respective outcomes, are provided in this article. PMID:27115842

  4. 75 FR 19407 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAVELLA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... Patent Extension; SAVELLA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may...

  5. The UNITAID Patent Pool Initiative: Bringing Patents Together for the Common Good.

    PubMed

    Bermudez, Jorge; 't Hoen, Ellen

    2010-01-01

    Developing and delivering appropriate, affordable, well-adapted medicines for HIV/AIDS remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of ARVs are not available in pediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking. UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property (IP) rights - a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the IP related to their inventions to the patent pool. Any company that wants to use the IP to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their IP to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all. PMID:20309404

  6. Recent patents and patented technology platforms for pharmaceutical taste masking.

    PubMed

    Kaushik, Deepak; Dureja, Harish

    2014-04-01

    Taste masking is an important factor in the development of oral dosage forms containing bitter active pharmaceutical ingredients. Currently numerous techniques are being applied to overcome this problem. Realizing this, several researchers and pharmaceutical companies are now engaged in developing novel techniques to address the problem of taste masking evident by numerous patents filed in this area in recent times. In this review the most recent patents for taste masking are discussed and how these patents overcome the limitations of conventional approaches of taste masking is also highlighted. Novel techniques based on some recent patents such as nanohybrid, melt extrusion, non-complex cyclodextrin compositions and off taste masking are providing new realms to taste masking of bitter drugs. The present article also provides an overview of various patented platform technologies based on different techniques/mechanisms employed for taste masking. The unique features and principles of taste-masking approaches used in various patented technologies are also discussed. A better understanding of these new patents and patented technologies will help researchers and pharmaceutical industries to select the appropriate platform, or to develop innovative products with improved taste masking properties. PMID:24499438

  7. Using patent data to assess the value of pharmaceutical innovation.

    PubMed

    Kesselheim, Aaron S; Avorn, Jerry

    2009-01-01

    Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development. PMID:19493065

  8. Undisclosed Antiretroviral Drug Use in a Multinational Clinical Trial (HIV Prevention Trials Network 052)

    PubMed Central

    Fogel, Jessica M.; Wang, Lei; Parsons, Teresa L.; Ou, San-San; Piwowar-Manning, Estelle; Chen, Ying; Mudhune, Victor O.; Hosseinipour, Mina C.; Kumwenda, Johnstone; Hakim, James G.; Chariyalertsak, Suwat; Panchia, Ravindre; Sanne, Ian; Kumarasamy, Nagalingeswaran; Grinsztejn, Beatriz; Makhema, Joseph; Pilotto, Jose; Santos, Breno R.; Mayer, Kenneth H.; McCauley, Marybeth; Gamble, Theresa; Bumpus, Namandjé N.; Hendrix, Craig W.; Cohen, Myron S.; Eshleman, Susan H.

    2013-01-01

    The HIV Prevention Trials Network 052 study enrolled serodiscordant couples. Index participants infected with human immunodeficiency virus reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45 of 96 participants (46.9%) with an undetectable viral load, 2 of 48 (4.2%) with a low viral load, and 1 of 65 (1.5%) with a high viral load (P < .0001); they were also detected in follow-up samples from participants who were not receiving study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings. PMID:23908493

  9. 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 noting country…

  10. Spectroscopic classification of Gaia16arv as Type Ia supernova with the SEDM

    NASA Astrophysics Data System (ADS)

    Blagorodnova, N.; Neill, D.; Walters, R.

    2016-07-01

    The Caltech Time Domain Astronomy group reports the classification of Gaia16arv, discovered by the Gaia ESA survey. This transient was also reported by MASTER as OT J220727.43-053121.8, with discovery date 2016-06-16.09813 UT (Atel #9161).

  11. Role and modulation of drug transporters in HIV-1 therapy.

    PubMed

    Alam, Camille; Whyte-Allman, Sana-Kay; Omeragic, Amila; Bendayan, Reina

    2016-08-01

    Current treatment of human immunodeficiency virus type-1 (HIV-1) infection involves a combination of antiretroviral drugs (ARVs) that target different stages of the HIV-1 life cycle. This strategy is commonly referred to as highly active antiretroviral therapy (HAART) or combined antiretroviral therapy (cART). Membrane-associated drug transporters expressed ubiquitously in mammalian systems play a crucial role in modulating ARV disposition during HIV-1 infection. Members of the ATP-binding cassette (ABC) and solute carrier (SLC) transporter superfamilies have been shown to interact with ARVs, including those that are used as part of first-line treatment regimens. As a result, the functional expression of drug transporters can influence the distribution of ARVs at specific sites of infection. In addition, pathological factors related to HIV-1 infection and/or ARV therapy itself can alter transporter expression and activity, thus further contributing to changes in ARV disposition and the effectiveness of HAART. This review summarizes current knowledge on the role of drug transporters in regulating ARV transport in the context of HIV-1 infection. PMID:27181050

  12. Stirling engine patents: international patent inventory

    SciTech Connect

    Newman, B.K.

    1983-09-01

    One hundred seventy-five years (1817-1982) of research and development (R and D) in Stirling-cycle engines is represented in this international inventory of patent applications. The following lists are included: assignor, assignee, patent numbers, US patent classification, and international patent classification. (MHR)

  13. Women and ARV-based HIV prevention – challenges and opportunities

    PubMed Central

    Geary, Cynthia W; Bukusi, Elizabeth A

    2014-01-01

    ARV-based HIV prevention methods available in pill, gel or ring formulations (broadly referred to as microbicides) offer the possibility of protection against HIV for women who find it difficult because they cannot ask their partners to use condoms or even refuse sex. Partial efficacy of ARV-based medications has been demonstrated in a number of clinical trials around the world among various populations, building the evidence that ARV-based technologies will contribute to reducing the AIDS epidemic worldwide. Disappointing results, however, from two trials in sub-Saharan Africa, where poor adherence contributed to study closure due to futility, have raised questions about whether women at the centre of the epidemic are able to effectively use products that require routine use. Also, there are fears by some of risk compensation by decreased condom use because of the availability of microbicides when only partial efficacy has been demonstrated in microbicide trials to date. Of note, sub-analyses of biologic measures of adherence in trials where this was possible have shown a strong correlation between good adherence and efficacy, reinforcing the necessity of good adherence. Research conducted in conjunction with clinical trials and post-trials in advance of possible rollout of ARV-based products have examined social and cultural factors, gender-related and otherwise, influencing adherence and other aspects of women's use of products. These include HIV stigma, women's perception of risk, partner and community influences and the differing needs of women in various stages of life and in different circumstances. It is the purpose of this supplement to give voice to the needs of women who can benefit from woman-initiated methods by presenting research results and commentary to contribute to the global conversation about optimizing women's experience with ARV-based prevention. PMID:25224621

  14. 75 FR 32479 - Determination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... Patent Extension; ABLAVAR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Patents and Trademarks, Department of Commerce, for the extension of a patent which claims the human drug... Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic...

  15. 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...

  16. 75 FR 17414 - Determination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ

    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...

  17. 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...

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

    PubMed Central

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

    2016-01-01

    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. PMID:27527157

  19. Arv1 regulates PM and ER membrane structure and homeostasis but is dispensable for intracellular sterol transport

    PubMed Central

    Georgiev, Alexander G.; Johansen, Jesper; Ramanathan, Vidhya D.; Sere, Yves Y.; Beh, Christopher T.; Menon, Anant K.

    2013-01-01

    The pan-eukaryotic endoplasmic reticulum (ER) membrane protein Arv1 has been suggested to play a role in intracellular sterol transport. We tested this proposal by comparing sterol traffic in wild-type and Arv1-deficient Saccharomyces cerevisiae. We used fluorescence microscopy to track the retrograde movement of exogenously supplied dehydroergosterol (DHE) from the plasma membrane (PM) to the ER and lipid droplets and high performance liquid chromatography to quantify, in parallel, the transport-coupled formation of DHE esters. Metabolic labeling and subcellular fractionation were used to assay anterograde transport of ergosterol from the ER to the PM. We report that sterol transport between the ER and PM is unaffected by Arv1 deficiency. Instead, our results indicate differences in ER morphology and the organization of the PM lipid bilayer between wild-type and arv1Δ cells suggesting a distinct role for Arv1 in membrane homeostasis. In arv1Δ cells, specific defects affecting single C-terminal transmembrane domain proteins suggest that Arv1 might regulate membrane insertion of tail-anchored proteins involved in membrane homoeostasis. PMID:23668914

  20. The International Patent Situation

    ERIC Educational Resources Information Center

    Helliwell, B. F. M.

    1974-01-01

    Highlights the differences in patent laws in different countries to illustrate the importance of searching foreign patents, indicates how patent searches should be tackled and what assistance is available from patent offices, searching organizations and commercial patent documentation services, and considers the probable effect of the Europatent…

  1. 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

    ... Patent Extension; VIMPAT--NDA 22-254 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may...

  2. [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. PMID:24380318

  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. PMID:26827690

  4. Patents and patent office resources in biotechnology.

    PubMed

    Koniarek, J P; Coleman, K D

    1988-02-01

    Patents play an increasingly important role in the dissemination of information in many fast moving fields such as biotechnology and semiconductors. Quite a few new developments are introduced as patents, and only later, if at all, do they find their way into the scientific literature. In spite of this, patents lack wide acceptance as a source of information among scientists in academia and, to a lesser degree, industry. Patents share many similarities with scientific papers. They both are organized in a similar way and are carefully reviewed by experts in the field. Both can be effective and timely sources of information. Patents can be accessed through data bases, library collections, the "Official Gazette of the Patent and Trademark Office," or directly in the Patent and Trademark Office. This article is designed to serve as a guide to the type of information which can be found in patents, and alternatives for obtaining this information. PMID:3273180

  5. 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

    2016-06-01

    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. PMID:27131804

  6. 77 FR 20827 - Determination of Regulatory Review Period for Purposes of Patent Extension; TEFLARO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Patent Extension; TEFLARO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L....

  7. 77 FR 20830 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Patent Extension; VIIBRYD AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub....

  8. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Patent Extension; Victoza AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  9. 75 FR 55332 - Determination of Regulatory Review Period for Purposes of Patent Extension; ULORIC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... Patent Extension; ULORIC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to http..., 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act...

  10. 77 FR 20829 - Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Patent Extension; NATROBA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub....

  11. 76 FR 36929 - Determination of Regulatory Review Period for Purposes of Patent Extension; DEXILANT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Patent Extension; DEXILANT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  12. 76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... Patent Extension; VPRIV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to http..., 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act...

  13. 77 FR 26557 - Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Patent Extension; FERAHEME AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  14. 75 FR 9227 - Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... Patent Extension; FIRMAGON AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments.... SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law...

  15. 77 FR 26554 - Determination of Regulatory Review Period for Purposes of Patent Extension; GILENYA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Patent Extension; GILENYA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  16. 76 FR 24034 - Determination of Regulatory Review Period for Purposes of Patent Extension; CONVENIA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... Patent Extension; CONVENIA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that animal drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  17. 77 FR 26556 - Determination of Regulatory Review Period for Purposes of Patent Extension; EQUIDONE GEL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Patent Extension; EQUIDONE GEL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The..., for the extension of a patent which claims that animal drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  18. 75 FR 19406 - Determination of Regulatory Review Period for Purposes of Patent Extension; AFINITOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... Patent Extension; AFINITOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments.... SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law...

  19. 75 FR 77877 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIBATIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... Patent Extension; VIBATIV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub....

  20. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... Patent Extension; ISTODAX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  1. 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

    ... Patent Extension; CYSVIEW (Previously HEXVIX) AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  2. 75 FR 75679 - Determination of Regulatory Review Period for Purposes of Patent Extension; BESIVANCE

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... Patent Extension; BESIVANCE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  3. 77 FR 52035 - Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Patent Extension; TORISEL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  4. 77 FR 20644 - Determination of Regulatory Review Period for Purposes of Patent Extension; FLECTOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ... Patent Extension; FLECTOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  5. 76 FR 36548 - Determination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Patent Extension; METVIXIA AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  6. 76 FR 36928 - Determination of Regulatory Review Period for Purposes of Patent Extension; BROVANA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Patent Extension; BROVANA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  7. 76 FR 36927 - Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Patent Extension; Fusilev, Levoleucovorin AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  8. 75 FR 76990 - Determination of Regulatory Review Period for Purposes of Patent Extension; COARTEM

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... Patent Extension; COARTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  9. Detection and characterization of two co-infection variant strains of avian orthoreovirus (ARV) in young layer chickens using next-generation sequencing (NGS)

    PubMed Central

    Tang, Yi; Lin, Lin; Sebastian, Aswathy; Lu, Huaguang

    2016-01-01

    Using next-generation sequencing (NGS) for full genomic characterization studies of the newly emerging avian orthoreovirus (ARV) field strains isolated in Pennsylvania poultry, we identified two co-infection ARV variant strains from one ARV isolate obtained from ARV-affected young layer chickens. The de novo assembly of the ARV reads generated 19 contigs of two different ARV variant strains according to 10 genome segments of each ARV strain. The two variants had the same M2 segment. The complete genomes of each of the two variant strains were 23,493 bp in length, and 10 dsRNA segments ranged from 1192 bp (S4) to 3958 bp (L1), encoding 12 viral proteins. Sequence comparison of nucleotide (nt) and amino acid (aa) sequences of all 10 genome segments revealed 58.1–100% and 51.4–100% aa identity between the two variant strains, and 54.3–89.4% and 49.5–98.1% aa identity between the two variants and classic vaccine strains. Phylogenetic analysis revealed a moderate to significant nt sequence divergence between the two variant and ARV reference strains. These findings have demonstrated the first naturally occurring co-infection of two ARV variants in commercial young layer chickens, providing scientific evidence that multiple ARV strains can be simultaneously present in one host species of chickens. PMID:27089943

  10. 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. PMID:25354346

  11. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical... dated February 17, 2011, FDA advised the Patent and Trademark Office that this medical device had... Patent Extension; Alair Bronchial Thermoplasty System AGENCY: Food and Drug Administration, HHS....

  12. 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

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

    PubMed Central

    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. PMID:27174161

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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

  19. How to successfully patent therapeutic antibodies.

    PubMed

    Lahrtz, Fritz

    2015-04-01

    Therapeutic antibodies have become an established class of drugs for the treatment of a variety of diseases, especially cancer and autoimmune/inflammatory disorders, and a sufficient patent protection is a prerequisite for their successful commercialization. As monoclonal antibodies and their therapeutic potential have been well known for decades, the mere production of yet another therapeutic antibody is in many jurisdictions not considered a patentable invention. In contrast, antibodies with novel structural features and/or improved properties may be patentable. When drafting the claims, care should be taken to obtain a broad patent scope that protects both the antibody of interest and related antibodies having the same functional features, thereby preventing competitors from marketing a functionally equivalent antibody. Furthermore, the application should contain experimental evidence showing the improved properties of the claimed antibody. After the filing of a priority patent application, patent protection should be initiated at least in countries that are of particular commercial importance. Subsequent inventions relating to novel uses, formulations, dosage regimens, and combinations with other treatment modalities should be protected by further patent applications to extend patent term. PMID:25614506

  20. 76 FR 15323 - Determination of Regulatory Review Period for Purposes of Patent Extension; ATRYN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... Patent Extension; ATRYN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... extension of a patent which claims that human biological product. ADDRESSES: Submit electronic comments to... 20993-0002. 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  1. 78 FR 13685 - Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... Patent Extension; LAVIV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... extension of a patent which claims that human biological product. ADDRESSES: Submit electronic comments to... 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  2. 77 FR 26017 - Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Patent Extension; KALBITOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... the extension of a patent which claims that human biological product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  3. 76 FR 12975 - Determination of Regulatory Review Period for Purposes of Patent Extension; CERVARIX

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... Patent Extension; CERVARIX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food..., for the extension of a patent which claims that human biological product. ADDRESSES: Submit electronic..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent...

  4. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ..., MD 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... candidates for phototherapy or systemic therapy. Subsequent to this approval, the Patent and Trademark...

  5. Challenges in oral drug delivery of antiretrovirals and the innovative strategies to overcome them.

    PubMed

    Sosnik, Alejandro; Augustine, Robin

    2016-08-01

    Development of novel drug delivery systems (DDS) represents a promising opportunity to overcome the various bottlenecks associated with the chronic antiretroviral (ARV) therapy of the human immunodeficiency virus (HIV) infection. Oral drug delivery is the most convenient and simplest route of drug administration that involves the swallowing of a pharmaceutical compound with the intention of releasing it into the gastrointestinal tract. In oral delivery, drugs can be formulated in such a way that they are protected from digestive enzymes, acids, etc. and released in different regions of the small intestine and/or the colon. Not surprisingly, with the exception of the subcutaneous enfuvirtide, all the marketed ARVs are administered orally. However, conventional (marketed) and innovative (under investigation) oral delivery systems must overcome numerous challenges, including the acidic gastric environment, and the poor aqueous solubility and physicochemical instability of many of the approved ARVs. In addition, the mucus barrier can prevent penetration and subsequent absorption of the released drug, a phenomenon that leads to lower oral bioavailability and therapeutic concentration in plasma. Moreover, the frequent administration of the cocktail (ARVs are administered at least once a day) favors treatment interruption. To improve the oral performance of ARVs, the design and development of more efficient oral drug delivery systems are called for. The present review highlights various innovative research strategies adopted to overcome the limitations of the present treatment regimens and to enhance the efficacy of the oral ARV therapy in HIV. PMID:26772138

  6. 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

  7. 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…

  8. 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. PMID:23611022

  9. 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 UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN...

  10. 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 UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN...

  11. 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 UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN...

  12. 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 UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN...

  13. 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 UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN...

  14. 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. PMID:22332464

  15. 21 CFR 314.52 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., agent, or authorized official may be obtained from the Orange Book Staff, Office of Generic Drugs, 7500... noninfringement of a patent. 314.52 Section 314.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Applications § 314.52 Notice of certification of invalidity or noninfringement of a patent....

  16. 21 CFR 314.52 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., agent, or authorized official may be obtained from the Orange Book Staff, Office of Generic Drugs, 7500... noninfringement of a patent. 314.52 Section 314.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Applications § 314.52 Notice of certification of invalidity or noninfringement of a patent....

  17. 21 CFR 314.52 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., agent, or authorized official may be obtained from the Orange Book Staff, Office of Generic Drugs, 7500... noninfringement of a patent. 314.52 Section 314.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Applications § 314.52 Notice of certification of invalidity or noninfringement of a patent....

  18. 21 CFR 314.52 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., agent, or authorized official may be obtained from the Orange Book Staff, Office of Generic Drugs, 7500... noninfringement of a patent. 314.52 Section 314.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Applications § 314.52 Notice of certification of invalidity or noninfringement of a patent....

  19. 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.

  20. 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.

  1. 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

  2. Patent Deployment Strategies and Patent Value in LED Industry.

    PubMed

    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

  3. Trends in the human embryonic stem cell patent field.

    PubMed

    Karlsson, Ulrika; Hyllner, Johan; Runeberg, Kristina

    2007-01-01

    The successful derivation of human embryonic stem (hES) cell lines in late 1990s marks the birth of a new era in biomedical research. In the USA, this landmark invention is protected by granted composition-of-matter patents. In addition to these patents, several others have been granted on further development of hES cell research, such as on differentiated cell types and in vitro and in vivo use aspects. In Europe, there is presently no consensus pertaining to the patentability of hES cells, and all patent applications pending at the European patent office are therefore awaiting a principal decision by the Enlarged Board of Appeal. The authors argue that it will be of importance to the stem cell industry that patents are granted on inventions downstream in the value chain, e.g on specialised cell types derived from hES cells and different drug discovery applications. Patents and patent applications on such inventions for the three germ layers ectoderm/neuro, endoderm/hepato and mesoderm/cardio have been examined. The number of patents increased in the period 2001 to 2006 for all three lineages with ectoderm/neuro as the most patent intensive field. There where 9-13 times more US patent applications filed related to the three lineages compared to in Europe. PMID:19076035

  4. 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. PMID:24025130

  5. IL-21 and Probiotic Therapy Improve TH17 Frequencies, Microbial Translocation, and Microbiome in ARV-Treated, SIV-Infected Macaques

    PubMed Central

    Ortiz, Alexandra M.; Klase, Zachary A.; DiNapoli, Sarah R.; Vujkovic-Cvijin, Ivan; Carmack, Kirby; Perkins, Molly R.; Calantone, Nina; Vinton, Carol L.; Riddick, Nadeene E.; Gallagher, John; Klatt, Nichole R.; McCune, Joseph M.; Estes, Jacob D.; Paiardini, Mirko; Brenchley, Jason M.

    2015-01-01

    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 IL-21 to a limited number of ARV-treated, probiotic-supplemented, SIV-infected pigtailed macaques. We demonstrate that probiotic and IL-21 supplementation of ARVs is associated with enhanced polyfunctional TH17 expansion and reduced markers of microbial translocation and dysbiosis as compared to infected controls receiving ARVs alone. Importantly, treatment resulted in fewer morbidities compared to 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. PMID:26286233

  6. 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

    2011-01-01

    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

  7. An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile

    PubMed Central

    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. PMID:25915050

  8. 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. PMID:25915050

  9. 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

  10. What Is Patent Ductus Arteriosus?

    MedlinePlus

    ... page from the NHLBI on Twitter. What Is Patent Ductus Arteriosus? Patent ductus arteriosus (PDA) is a ... the lung arteries. Normal Heart and Heart With Patent Ductus Arteriosus Figure A shows the interior of ...

  11. 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. PMID:21875404

  12. 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

    ..., for the extension of a patent which claims that medical device. ADDRESSES: Submit electronic comments... 17, 2010, FDA advised the Patent and Trademark Office that this medical device had undergone a... Patent Extension; REPEL-CV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  13. 75 FR 54152 - Determination of Regulatory Review Period for Purposes of Patent Extension; NEURX DIAPHRAGM...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES... dated February 17, 2010, FDA advised the Patent and Trademark Office that this medical device had... Patent Extension; NEURX DIAPHRAGM PACING SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION:...

  14. Patent holdings of US biotherapeutic companies in major markets.

    PubMed

    Sebastian, Teena E; Yerram, Chandra Bindu; Saberwal, Gayatri

    2009-05-01

    In previous studies we examined the (United States, US) patent holdings of 109 largely North American biotech companies developing therapeutics that, in particular, have an interest in discovery stage science. There appears little correlation between the number of patents and the number of products of individual companies. Here we quantified and compared the 103 US-headquartered companies' patent holdings in Australia, Canada, Europe, Japan and the US. The companies demonstrate variable and surprising patterns of patent holdings across these countries or regions. For most companies, patent holdings are not in proportion to the importance of the country as a biotech or pharma market. These results have implications for the patenting strategies of small biotech companies involved in drug discovery. PMID:19429502

  15. 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

  16. 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

  17. 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...

  18. 77 FR 26291 - Determination of Regulatory Review Period for Purposes of Patent Extension; LASTACAFT

    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...

  19. 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...

  20. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    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...

  1. 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...

  2. 75 FR 53315 - Determination of Regulatory Review Period for Purposes of Patent Extension; ONGLYZA

    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...

  3. 77 FR 26288 - Determination of Regulatory Review Period for Purposes of Patent Extension; HALAVEN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... 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... indicated for the treatment of patients with metastatic breast cancer who have previously received at...

  4. 78 FR 6826 - Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... 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... indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer...

  5. 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.

  6. Managing your patent assets.

    PubMed

    Di Nunzio, Mary Catherine

    2014-01-01

    This article includes tips to manage your patent assets effectively and efficiently. I have provided "real world" examples in the form of case studies to support my advice. My goal is to arm you with sufficient knowledge so as to enable you to devise a patent strategy that suits your company's business and scientific needs. PMID:23920435

  7. Problem Solving with Patents

    ERIC Educational Resources Information Center

    Moore, Jerilou; Sumrall, William J.

    2008-01-01

    Exploring our patent system is a great way to engage students in creative problem solving. As a result, the authors designed a teaching unit that uses the study of patents to explore one avenue in which scientists and engineers do science. Specifically, through the development of an idea, students learn how science and technology are connected.…

  8. A Patent Dilemma

    ERIC Educational Resources Information Center

    Downes, Stephen

    2007-01-01

    When Blackboard unveiled its U.S. patent for 44 features of learning management systems and then filed a patent infringement suit against Design2Learn, the response of the educational technology community was negative and swift. Stephen Downes discusses why many educators oppose Blackboard's proprietary claims to technologies long considered in…

  9. Patenting After GATT.

    ERIC Educational Resources Information Center

    Blumenstyk, Goldie

    1995-01-01

    Effective June 8, 1995, new patent laws resulting from the General Agreement on Tariffs and Trade (GATT) will become effective. Some would protect researcher rights to intellectual property. Others may make it harder for institutions to commercialize on faculty and graduate student research due to shortened patent terms. (MSE)

  10. 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. PMID:26812756

  11. [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. PMID:18545747

  12. [Socio-economic impact of one decade of ARV therapy for people living with HIV in Senegal].

    PubMed

    Coutherut, J

    2014-10-01

    A retrospective biographical survey was conducted based on a patient sample whose median ARV treatment duration was nine years (within the framework of ANRS Cohort 1215 in Dakar) in order to document the long-term socio-economic outcomes for PLHIV. The study shows that, overall, socio-economic indicators did not significantly deteriorate since treatment initiation. The patients' socioeconomic profile-defined by their type of employment and wages, by gender-is identical to that of the general population. Medical care through ARV therapy has helped limit the disease's negative social impact. However, the economic insecurity experienced by these patients, comparable to that of the general population, is a threat to their medical care over the long term. PMID:25103748

  13. 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

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

    PubMed

    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

  15. 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

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

    PubMed Central

    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.

    2015-01-01

    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. PMID:26378018

  18. 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. PMID:26054209

  19. 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)

  20. Patent foramen ovale

    MedlinePlus

    PFO ... close, it is called a patent foramen ovale (PFO). The cause of a PFO is unknown. There are no known risk factors. ... An echocardiogram can be done to diagnose a PFO. If the PFO is not easily seen, a ...

  1. 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

  2. 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. PMID:27179985

  3. ARV robotic technologies (ART): a risk reduction effort for future unmanned systems

    NASA Astrophysics Data System (ADS)

    Jaster, Jeffrey F.

    2006-05-01

    The Army's ARV (Armed Robotic Vehicle) Robotic Technologies (ART) program is working on the development of various technological thrusts for use in the robotic forces of the future. The ART program will develop, integrate and demonstrate the technology required to advance the maneuver technologies (i.e., perception, mobility, tactical behaviors) and increase the survivability of unmanned platforms for the future force while focusing on reducing the soldiers' burden by providing an increase in vehicle autonomy coinciding with a decrease in the total number user interventions required to control the unmanned assets. This program will advance the state of the art in perception technologies to provide the unmanned platform an increasingly accurate view of the terrain that surrounds it; while developing tactical/mission behavior technologies to provide the Unmanned Ground Vehicle (UGV) the capability to maneuver tactically, in conjunction with the manned systems in an autonomous mode. The ART testbed will be integrated with the advanced technology software and associated hardware developed under this effort, and incorporate appropriate mission modules (e.g. RSTA sensors, MILES, etc.) to support Warfighter experiments and evaluations (virtual and field) in a military significant environment (open/rolling and complex/urban terrain). The outcome of these experiments as well as other lessons learned through out the program life cycle will be used to reduce the current risks that are identified for the future UGV systems that will be developed under the Future Combat Systems (FCS) program, including the early integration of an FCS-like autonomous navigation system onto a tracked skid steer platform.

  4. The new patent regime and disease priorities in India.

    PubMed

    Gupta, Indrani; Guin, Pradeep; Trivedi, Mayur

    2013-01-01

    The World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS), which made product patents compulsory for countries to follow, meant that the entire market for generic drugs was out of bounds for manufacturing till the time the products went off-patent. The TRIPS has generated widespread discussions and debates around the costs and benefits of new patent regimes on countries such as India. This article analyses whether the post-WTO system was consistent with, and conducive to, improved public health in India. It is a first-of-its-kind effort in which the data on pharmaceutical patents applications were collected, collated, cleaned and classified according to IPC codes, to enable preliminary understanding of the nature and type of the applications. The patent applications that are filed in India are not found to be consistent with the disease burden of the country. PMID:22845021

  5. 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.

  6. 75 FR 76740 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEPREVE

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for BEPREVE 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...

  7. 76 FR 25357 - Determination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for VOTRIENT 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...

  8. 76 FR 35899 - Determination of Regulatory Review Period for Purposes of Patent Extension; MYFORTIC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for MYFORTIC 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...

  9. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for SABRIL 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...

  10. 77 FR 26555 - Determination of Regulatory Review Period for Purposes of Patent Extension; EGRIFTA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for EGRIFTA 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for AMPYRA 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 drug...

  13. Evaluation of Risk for Late Language Emergence after In Utero Antiretroviral Drug Exposure in HIV-exposed Uninfected Infants

    PubMed Central

    Rice, Mabel L.; Zeldow, Bret; Siberry, George K.; Purswani, Murli; Malee, Kathleen; Hoffman, Howard J.; Frederick, Toni; Buchanan, Ashley; Sirois, Patricia A.; Allison, Susannah M.; Williams, Paige L

    2013-01-01

    Background Combination antiretroviral (cARV) regimens are recommended for pregnant women with HIV to prevent perinatal HIV transmission. Safety is a concern for infants who were HIV-exposed but uninfected (HEU), particularly for neurodevelopmental problems, such as language delays. Methods We studied late language emergence (LLE) in HEU children enrolled in a US-based prospective cohort study. LLE was defined as a caregiver-reported score ≤ 10th percentile in any of 4 domains of the MacArthur-Bates Communicative Development Inventory for one-year-olds and as ≥1 standard deviation below age-specific norms for the Ages and Stages Questionnaire for two-year-olds. Logistic regression models were used to evaluate associations of in utero cARV exposure with LLE, adjusting for infant, maternal, and environmental characteristics. Results 1,129 language assessments were conducted among 792 one- and two-year-olds (50% male, 62% black, and 37% Hispanic). Overall, 86% had in utero exposure to cARV and 83% to protease inhibitors. LLE was identified in 26% of one-year-olds and 23% of two-year-olds, with higher rates among boys. In adjusted models, LLE was not associated with maternal cARV or ARV drug classes in either age group. Among cARV-exposed one-year-olds, increased odds of LLE was observed for those exposed to atazanavir (aOR=1.83, 95% CI=1.10-3.04), particularly after the first trimester (aOR=3.56, p=0.001), compared to atazanavir-unexposed infants. No associations of individual ARV drugs with LLE were observed among two-year-olds. Conclusions In utero cARV exposure showed little association with LLE, except for a higher risk of language delay observed in one-year-old infants with atazanavir exposure. PMID:24067563

  14. 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. PMID:27348790

  15. TVA fertilizer patents

    SciTech Connect

    Mackey, J.J.; Aldridge, J.W.

    1980-12-01

    Fertilizer research has been an important function of the Tennessee Valley Authority from the time it was established in 1933 to the present. During this period there have been extensive changes in the fertilizer industry. New and improved products have been developed and more efficient manufacturing methods have emerged. Products and processes developed by TVA are in widespread use today in the fertilizer industry. This bulletin is a collection of abstracts of patents granted to TVA on fertilizer technology and related topics over about 45 years. It contains 200 abstracts of patents. The abstracts have been divided into 13 major sections. Each section reflects the improved technology through this period of time. Abstracts of some of the patents issued to TVA since 1968 have already appeared in Fertilizer Abstracts, a journal published monthly since 1968. Inventor and subject indexes are provided in this bulletin.

  16. Genome patent fight erupts

    SciTech Connect

    Roberts, L.

    1991-10-11

    At a Congressional briefing while describing a new project to sequence partially every gene active in the human brain, it was made known that the National Institutes of Health was planning to file patent applications on 1,000 of these sequences a month. The scheme has engendered a firestorm of criticism from genome scientists and project officials alike. The critics argue that these sequences probably can't be patented in the first place - and even if they can, they shouldn't be. The plan would undercut patent protection for those who labor long and hard at the real task of elucidating the function of the proteins encoded by the genes, thereby driving industry away from developing inventions based on that work.

  17. 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. PMID:27087201

  18. [Treatment of senile diseases should prescribe Chinese patent medicine scientifically].

    PubMed

    Zhao, Xin-Xiang

    2014-04-01

    Treatment of senile diseases by Chinese patent medicine should prescribe according to physiological and pathological specialty of the aged. It's necessary for treatment according to syndrome differentiation associating with the disease,reasonable combination of drugs avoiding adverse reactions,gentle medicine character but not fierce,small medicine quantity but not great, the use of Chinese patent medicine mild and tonic used properly but not excessively. PMID:24812911

  19. Patent pools and diagnostic testing.

    PubMed

    Verbeure, Birgit; van Zimmeren, Esther; Matthijs, Gert; Van Overwalle, Geertrui

    2006-03-01

    There is increasing concern that overlapping patents in the field of genetics will create a costly and legally complex situation known as a patent thicket, which, along with the associated issues of accumulating royalty payments, can act as a disincentive for innovation. One potential means of preventing this is for the patent holders to enter into a so-called patent pool, such as those established in the electronics and telecommunications industries. Precedents for these also exist in the field of genetics, notably with the patents pertaining to the SARS genome. In this review, we initially address the patent pool concept in general and its application in genetics. Following this, we will explore patent pools in the diagnostic field in more detail, and examine some existing and novel examples of patent pools in genetics. PMID:16443296

  20. 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

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

    PubMed

    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

  2. The Perils of Gene Patents

    PubMed Central

    Salzberg, SL

    2013-01-01

    I argue here that gene patents, and patented genetic tests based on them, are a very bad idea. First, I discuss whether genes can reasonably be the subject of patents in the first place; I maintain that the answer is no. Second, I explain how gene patents interfere with scientific progress, slowing down the development of new cures and treatments for genetic diseases. PMID:22609909

  3. Patents protect deepwater platform concepts

    SciTech Connect

    Khurana, S.

    1998-06-22

    Numerous deepwater platform concepts have patents that provide an inventor protection for his new ideas. But an inventor should not be discouraged by the fact that many patents exist. In fact, it may be advantageous to build on existing patents and prior art, and patent new ideas and concepts for reducing costs. Challenges still remain such as for optimizing drilling and production operations simultaneously on deepwater platforms for accessing and producing oil and gas reserves.

  4. Trends in Decline of Antiretroviral Resistance among ARV-Experienced Patients in the HIV Outpatient Study: 1999–2008

    PubMed Central

    Buchacz, Kate; Baker, Rose; Ward, Douglas J.; Palella, Frank J.; Chmiel, Joan S.; Young, Benjamin; Yangco, Bienvenido G.; Novak, Richard M.; Brooks, John T.

    2012-01-01

    Background. Little is known about temporal trends in frequencies of clinically relevant ARV resistance mutations in HIV strains from U.S. patients undergoing genotypic testing (GT) in routine HIV care. Methods. We analyzed cumulative frequency of HIV resistance among patients in the HIV Outpatient Study (HOPS) who, during 1999–2008 and while prescribed antiretrovirals, underwent GT with plasma HIV RNA >1,000 copies/mL. Exposure ≥4 months to each of three major antiretroviral classes (NRTI, NNRTI and PI) was defined as triple-class exposure (TCE). Results. 906 patients contributed 1,570 GT results. The annual frequency of any major resistance mutations decreased during 1999–2008 (88% to 79%, P = 0.05). Resistance to PIs decreased among PI-exposed patients (71% to 46%, P = 0.010) as exposure to ritonavir-boosted PIs increased (6% to 81%, P < 0.001). Non-significant declines were observed in resistance to NRTIs among NRTI-exposed (82% to 67%), and triple-class-resistance among TCE patients (66% to 41%), but not to NNRTIs among NNRTI-exposed. Conclusions. HIV resistance was common but declined in HIV isolates from subgroups of ARV-experienced HOPS patients during 1999–2008. Resistance to PIs among PI-exposed patients decreased, possibly due to increased representation of patients whose only PI exposures were to boosted PIs. PMID:22611484

  5. 21 CFR 314.52 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Notice of certification of invalidity or noninfringement of a patent. 314.52 Section 314.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.52 Notice...

  6. 21 CFR 314.95 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Notice of certification of invalidity or noninfringement of a patent. 314.95 Section 314.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Abbreviated Applications § 314.95...

  7. 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. PMID:24758487

  8. 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…

  9. 37 CFR 3.21 - Identification of patents and patent applications.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Identification of patents and patent applications. 3.21 Section 3.21 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND... for Recording § 3.21 Identification of patents and patent applications. An assignment relating to...

  10. 37 CFR 3.21 - Identification of patents and patent applications.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Identification of patents and patent applications. 3.21 Section 3.21 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND... for Recording § 3.21 Identification of patents and patent applications. An assignment relating to...

  11. 37 CFR 3.21 - Identification of patents and patent applications.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Identification of patents and patent applications. 3.21 Section 3.21 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND... for Recording § 3.21 Identification of patents and patent applications. An assignment relating to...

  12. 37 CFR 3.21 - Identification of patents and patent applications.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Identification of patents and patent applications. 3.21 Section 3.21 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND... for Recording § 3.21 Identification of patents and patent applications. An assignment relating to...

  13. 37 CFR 3.21 - Identification of patents and patent applications.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Identification of patents and patent applications. 3.21 Section 3.21 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND... for Recording § 3.21 Identification of patents and patent applications. An assignment relating to...

  14. 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. PMID:26721189

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

    PubMed

    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

  16. 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

  17. [Analyses on positive influence of harmonous development of traditional Chinese medicine compounds' researchs and patent protection].

    PubMed

    Yang, Xujie; Xiao, Shiying; Guo, Zan; Wang, Zhimin; You, Yun

    2012-01-01

    Current patent protection of traditional Chinese medicine (TCM) compounds is far from being satisfactory with increasing research and development achievements. As patent protection of traditional Chinese medicine compounds is closely related with many fields such as research and development of new TCM drugs, industrial development and TCM internationalization, the development of research and harmonious development of TCM compounds and their patent protection is bound to have a far-reaching influence on domestic and even international societies. PMID:22741453

  18. Recent patents on flavonoids.

    PubMed

    Mamta, Gokhale; Bansal, Y K; Sandhu, S S

    2013-12-01

    Flavonoids are substances which are widely distributed in the plant kingdom. They occur in considerable quantities in common food products, spices and beverages. Interest of researchers has been greatly enhanced towards therapeutic potential of flavonoids in last some years. This review summarizes important patents pertaining to recent biotechnological techniques applied for the production, analysis of biosynthetic pathways, effects and applications of different flavonoids. For systematic studies investigations which have been published in the form of patents, are classified in different sectors like biosynthesis, medical application, antimicrobial activity, alteration of flower color, industrial application, cosmetics, food and plant tissue culture. A number of activities have been observed in each sector with vast area of research on flavonoids. PMID:24182323

  19. Dental stem cell patents.

    PubMed

    Morsczeck, Christian; Frerich, Bernhard; Driemel, Oliver

    2009-01-01

    A complex human tissue harbors stem cells that are responsible for its maintenance or repair. These stem cells have been isolated also from dental tissues such as the periodontal ligament, dental papilla or dental follicle and they may offer novel applications in dentistry. This following review summarizes patents about dental stem cells for dental tissue engineering and considers their value for regenerative dentistry. PMID:19149737

  20. Pharmaceutical patent challenges--time for reassessment?

    PubMed

    Glass, Gregory

    2004-12-01

    For nearly 15 years after the passage of the Hatch-Waxman Act in 1984, generics drug companies took little advantage of its provisions, which provided financial incentives to them for challenging the patents of branded pharmaceutical products. However, during the past 3-5 years, generics manufacturers have dramatically increased the number of patent challenges. Although these challenges can certainly benefit consumers and payers, the number of challenges puts many innovator companies at risk, which they argue is detrimental to future R&D spending. If many of the challenges are successful, then the increase in challenges could in turn be detrimental to generics, and the system itself might therefore be due for a re-balance. PMID:15573104

  1. Africa, access, and patents: moving fast.

    PubMed

    James, J S

    1999-07-01

    In the United States, all scientifically proven HIV treatments are patented, and pricing of these drugs is often set too high for developing countries to access them. Similar problems are expected to occur with medications for other diseases. As the public is becoming more aware of the issue, demonstrations are being held against Vice President Gore, who had a role in its development, and the issue is now being discussed by members of Congress and journalists worldwide. Two statements are presented that address the patent/access issue. The first is a compassionate plea to end the restricted access. The second is an open letter to Vice President Gore expressing opposition to trade pressures being brought against the South African people over their struggle to gain access to essential medicines. PMID:11366567

  2. Determinants of HIV drug resistance and public health implications in low- and middle-income countries.

    PubMed

    Bertagnolio, Silvia; De Luca, Andrea; Vitoria, Marco; Essajee, Shaffiq; Penazzato, Martina; Hong, Steven Y; McClure, Craig; Duncombe, Chris; Jordan, Michael R

    2012-01-01

    Global scale-up of antiretroviral therapy (ART) in low- and middle-income countries (LMICs) is an unprecedented public health achievement. With planned efforts of expanded ART access including earlier treatment initiation and the use of antiretroviral (ARV) drugs for prophylaxis, increasing levels of HIV drug resistance (HIVDR) are expected.Several factors may lead to selection and transmission of significant HIVDR in LMICs, which will lead to decreased population-level efficacy of standard first- and second-line ART regimens. These factors include low genetic barrier of some ARVs to resistance development, drug-drug interactions, inappropriate prescribing practices, interruption of drug supply, poor retention in care and lack of routine viral load monitoring.To maximize long-term effectiveness of available ARVs, policy makers and programme managers in LMICs should routinely monitor programme factors associated with emergence and transmission of HIVDR and implement routine HIVDR surveillance following standardized methods. When surveillance results suggest the need for action, specific public health interventions must be taken to adjust ART programme functioning to minimize further emergence and transmission of HIVDR.In this paper, we review ARV drug, HIV, patient and programme-related determinants of HIVDR. Additionally, we summarize the World Health Orgnization's global HIVDR surveillance and prevention strategy and describe resulting public health and policy implications. PMID:22898622

  3. Recreational Drugs and HIV

    MedlinePlus

    ... when used with didanosine (Videx, fact_sheet 413 ) Cocaine Although interactions between cocaine and ARVs are unlikely to increase cocaine toxicity, the cocaine use may decrease ARV effectiveness ...

  4. 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. PMID:25262835

  5. 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

  6. Patent dispute: Delhi High Court gives a boost to access to affordable medicines.

    PubMed

    Menghaney, Leena

    2010-01-01

    The Delhi High Court has rejected the petition filed by Bayer Corporation seeking to stop the Drugs Controller of India (DCGI) from registering a generic version of a patented cancer drug. The case was filed in 2008 by Bayer to try and introduce "patent linkage" which involves linking the registration (marketing approval) of drugs with their patent status. If Bayer's plea for "patent linkage" had been accepted by the court, it would have undermined public health safeguards contained in India's patent legislation. This comment discusses the Bayer case in the context of efforts by multinational pharmaceutical companies to introduce barriers to generic competition, the only proven means of reducing the prices of medicines to make them affordable to those in need. Bayer has filed an appeal in the Supreme Court, indicating that it does not intend to give up. PMID:20432882

  7. 21 CFR 314.95 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... be obtained from the Orange Book Staff, Office of Generic Drugs, 7500 Standish Pl., Rockville, MD... noninfringement of a patent. 314.95 Section 314.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Abbreviated Applications § 314.95 Notice of certification of invalidity or noninfringement of...

  8. 21 CFR 314.95 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... be obtained from the Orange Book Staff, Office of Generic Drugs, 7500 Standish Pl., Rockville, MD... noninfringement of a patent. 314.95 Section 314.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Abbreviated Applications § 314.95 Notice of certification of invalidity or noninfringement of...

  9. 21 CFR 314.95 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... be obtained from the Orange Book Staff, Office of Generic Drugs, 7500 Standish Pl., Rockville, MD... noninfringement of a patent. 314.95 Section 314.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Abbreviated Applications § 314.95 Notice of certification of invalidity or noninfringement of...

  10. 21 CFR 314.95 - Notice of certification of invalidity or noninfringement of a patent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... be obtained from the Orange Book Staff, Office of Generic Drugs, 7500 Standish Pl., Rockville, MD... noninfringement of a patent. 314.95 Section 314.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DRUG Abbreviated Applications § 314.95 Notice of certification of invalidity or noninfringement of...

  11. 75 FR 76739 - Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ...The Food and Drug Administration (FDA) has determined the regulatory review period for ILARIS 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 biological...

  12. 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...

  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

    .... 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory... 20993-0002, 301-796-3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term... years of age and older. Subsequent to this approval, the Patent and Trademark Office received a...

  14. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Patent protection. 501.9 Section 501.9 Patents, Trademarks, and Copyrights UNDER SECRETARY FOR TECHNOLOGY, DEPARTMENT OF COMMERCE UNIFORM PATENT POLICY FOR RIGHTS IN INVENTIONS MADE BY GOVERNMENT EMPLOYEES § 501.9 Patent protection....

  15. 43 CFR 6.52 - Patents.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Patents. 6.52 Section 6.52 Public Lands: Interior Office of the Secretary of the Interior PATENT REGULATIONS Licenses § 6.52 Patents. Patents in... sublicenses, are classified as follows: (a) Class A. Patents, other than those referred to in paragraph (c)...

  16. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patent protection. 501.9 Section 501.9 Patents, Trademarks, and Copyrights UNDER SECRETARY FOR TECHNOLOGY, DEPARTMENT OF COMMERCE UNIFORM PATENT POLICY FOR RIGHTS IN INVENTIONS MADE BY GOVERNMENT EMPLOYEES § 501.9 Patent protection....

  17. 75 FR 17380 - Patents Ombudsman Pilot Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... procedure. See Request for Comments on Patents Ombudsman Pilot Program, 74 FR 55212 (Oct. 27, 2009), 1348... United States Patent and Trademark Office Patents Ombudsman Pilot Program AGENCY: United States Patent and Trademark Office, Commerce. ACTION: Notice. SUMMARY: The United States Patent and Trademark...

  18. 43 CFR 6.52 - Patents.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Patents. 6.52 Section 6.52 Public Lands: Interior Office of the Secretary of the Interior PATENT REGULATIONS Licenses § 6.52 Patents. Patents in... sublicenses, are classified as follows: (a) Class A. Patents, other than those referred to in paragraph (c)...

  19. 43 CFR 6.52 - Patents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 1 2014-10-01 2014-10-01 false Patents. 6.52 Section 6.52 Public Lands: Interior Office of the Secretary of the Interior PATENT REGULATIONS Licenses § 6.52 Patents. Patents in... sublicenses, are classified as follows: (a) Class A. Patents, other than those referred to in paragraph (c)...

  20. 43 CFR 6.52 - Patents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Patents. 6.52 Section 6.52 Public Lands: Interior Office of the Secretary of the Interior PATENT REGULATIONS Licenses § 6.52 Patents. Patents in... sublicenses, are classified as follows: (a) Class A. Patents, other than those referred to in paragraph (c)...

  1. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Patent protection. 501.9 Section 501.9 Patents, Trademarks, and Copyrights UNDER SECRETARY FOR TECHNOLOGY, DEPARTMENT OF COMMERCE UNIFORM PATENT POLICY FOR RIGHTS IN INVENTIONS MADE BY GOVERNMENT EMPLOYEES § 501.9 Patent protection....

  2. 43 CFR 6.52 - Patents.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Patents. 6.52 Section 6.52 Public Lands: Interior Office of the Secretary of the Interior PATENT REGULATIONS Licenses § 6.52 Patents. Patents in... sublicenses, are classified as follows: (a) Class A. Patents, other than those referred to in paragraph (c)...

  3. 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? PMID:24354803

  4. Gastroretentive carrier systems in the delivery of therapeutic actives: an updated patent review.

    PubMed

    Pathak, Kamla; Akhtar, Nida; Singh, Sonam

    2015-01-01

    Gastroretentive drug-delivery systems have the potential to prolong the gastric retention time and provide controlled/sustained release of a drug at the absorption site, thereby improving the bioavailability. Advantageous features include reduction in dose, side effects and dosing frequency. Research inputs have led to exploration of novel gastroretentive systems. The present review explores various patents issued on gastroretentive drug delivery on the basis of the therapeutic category of drugs. It traces US, EP and WIPO patents issued in the last 10 years. Various patents have revealed that gastrocarriers can effectively enhance therapeutic activity of a drug. Drugs acting on the CNS have been prominently investigated, followed by antimicrobials and locally acting drugs. Areas of future research can be drugs acting on the cardiovascular system. PMID:26580994

  5. Two-Drug Treatment Approaches in HIV: Finally Getting Somewhere?

    PubMed

    Kelly, Sean G; Nyaku, Amesika N; Taiwo, Babafemi O

    2016-04-01

    The advent of combination antiretroviral therapy (ART) has significantly decreased AIDS-related morbidity and mortality. Nevertheless, the benefits of ART are only realized through adherence to lifelong treatment. Though contemporary antiretroviral (ARV) drugs have fewer adverse effects in comparison to older ARV drugs, many agents are associated with negative or unknown long-term effects. There is increasing evidence that two-drug (dual-therapy) regimens may be an effective alternative to the currently recommended three-drug (triple-therapy) regimens. In this review, we provide a comprehensive and critical review of recently completed and ongoing trials of dual-therapy regimens in treatment-naïve and treatment-experienced HIV-1-infected patients. We also review current HIV/AIDS society recommendations regarding dual therapy as well as future therapeutic possibilities. PMID:26886135

  6. Effects of Hormonal Contraception on Anti-Retroviral Drug Metabolism, Pharmacokinetics and Pharmacodynamics

    PubMed Central

    Thurman, Andrea Ries; Anderson, Sharon; Doncel, Gustavo F

    2014-01-01

    Among women, human immunodeficiency virus type 1 (HIV-1) infection is most prevalent in those of reproductive age. These women are also at risk of unintended or mistimed pregnancies. Hormonal contraceptives (HCs) are one of the most commonly used methods of family planning world-wide. Therefore concurrent use of HC among women on anti-retroviral medications (ARVs) is increasingly common. ARVs are being investigated and have been approved for pre-exposure prophylaxis (PrEP), and therefore drug-drug interactions must also be considered in HIV-1 negative women who want to prevent both unintended pregnancy and HIV-1 infection. This article will review four main interactions: (1) the effect of HCs on ARV pharmacokinetics (PK) and pharmacodynamics (PD) during therapy, (2) the effect of ARVs on HC PK and PD, (3) the role of drug transporters on drug-drug interactions and (4) ongoing research into the effect of HCs on pre-exposure prophylaxis PK and PD. PMID:24521428

  7. Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents

    PubMed Central

    2012-01-01

    Background While there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents. Methodology/Principal Findings We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents). We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs. Conclusions/Significance Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active

  8. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patents subject to extension of the patent term. 1.710 Section 1.710 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and...

  9. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Patents subject to extension of the patent term. 1.710 Section 1.710 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and...

  10. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Patents subject to extension of the patent term. 1.710 Section 1.710 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and...

  11. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Patents subject to extension of the patent term. 1.710 Section 1.710 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and...

  12. 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

    ... 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, Department... (AIA), the United States Patent and Trademark Office (USPTO) may set or adjust by rule any patent...

  13. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Patents subject to extension of the patent term. 1.710 Section 1.710 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and...

  14. Achieving clinical equality in an influenza pandemic: patent realities.

    PubMed

    Kane, Eileen M

    2009-01-01

    A twenty-first century novel influenza A (H1N1) pandemic is currently unfolding, and the eventual scope of this public health crisis is not clear. In addition, ongoing surveillance of the avian influenza A (H5N1) virus reveals outbreaks of human-to-human transmission of the virus, with significant mortality. Effective pandemic management depends on pharmaceutical intervention with two different clinical objectives: the generation of an immune response to specific viral strains (vaccination) and the reduction of viral replication in an infected individual (antiviral administration). The ability to offer pharmaceutical interventions for a public health crisis depends on three factors: development, capacity, and access. Pharmaceutical measures must be developed, capacity must be established, and access must be ensured. The article discusses the three nodes of patenting that influence the availability of pharmaceutical countermeasures in an influenza pandemic. Identification of the causative influenza virus is the first step in pandemic management and precedes vaccine design, and the virus and its RNA sequence are both knowledge assets and inputs for vaccine design. Vaccine development, therefore, will be influenced by any patents on the genetic sequences or proteins of the pandemic virus, as well as on novel methods for vaccine production, the actual vaccine or adjuvant technology, all of which are relevant to the assembly of a working vaccine on short notice. Pharmaceutical treatment of influenza infection during a pandemic could also rely on use of patented antiviral drugs, whose efficacy may be revealed as the pandemic unfolds. Unlike vaccines, these are not generally developed de novo for a pandemic, but their availability could be dependent on the exercise of patent rights by market incumbents. Patent rights could control capacity, which may determine access. Pandemic planning must consider how patenting can influence development, capacity and access to

  15. Formulation and Characterization of Polymeric Films Containing Combinations of Antiretrovirals (ARVs) for HIV Prevention

    PubMed Central

    Akil, Ayman; Agashe, Hrushikesh; Dezzutti, Charlene S.; Moncla, Bernard J.; Hillier, Sharon L.; Devlin, Brid; Shi, Yuan; Uranker, Kevin; Rohan, Lisa Cencia

    2014-01-01

    Purpose To develop polymeric films containing dual combinations of anti-HIV drug candidate tenofovir, maraviroc and dapivirine for vaginal application as topical microbicides. Methods A solvent casting method was used to manufacture the films. Solid phase solubility was used to identify potential polymers for use in the film formulation. Physical and chemical properties (such as water content, puncture strength and in vitro release) and product stability were determined. The bioactivity of the film products against HIV was assessed using the TZM-bl assay and a cervical explant model. Results Polymers identified from the solid phase solubility study maintained tenofovir and maraviroc in an amorphous state and prevented drug crystallization. Three combination film products were developed using cellulose polymers and polyvinyl alcohol. The residual water content in all films was < 10% (w/w). All films delivered the active agents with release of > 50% of film drug content within 30 minutes. Stability testing confirmed that the combination film products were stable for 12 months at ambient temperature and 6 months under stressed conditions. Antiviral activity was confirmed in TZM-bl and cervical explant models. Conclusions Polymeric films can be used as a stable dosage form for the delivery of antiretroviral combinations as microbicides. PMID:25079391

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

    PubMed

    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

  17. 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

  18. Online Patent Searching: The Realities.

    ERIC Educational Resources Information Center

    Kaback, Stuart M.

    1983-01-01

    Considers patent subject searching capabilities of major online databases, noting patent claims, "deep-indexed" files, test searches, retrieval of related references, multi-database searching, improvements needed in indexing of chemical structures, full text searching, improvements needed in handling numerical data, and augmenting a subject search…

  19. Gene patents on the line.

    PubMed

    Carlson, Bob

    2009-10-01

    Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Patent Statute (USC 35, Part II, Chapter 10, Section 101). PMID:22478783

  20. Gene Patents on the Line

    PubMed Central

    Carlson, Bob

    2009-01-01

    Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Patent Statute (USC 35, Part II, Chapter 10, Section 101). PMID:22478783

  1. Obsolescence of the Patent Literature

    ERIC Educational Resources Information Center

    Clark, C. V.

    1976-01-01

    Here the year by year issue of U.S. patents since 1836 is used to correct for growth their apparent aging, as obtained by a synchronous study of citations made by (a) U.S. patent examiners and (b) periodicals. Apparent and corrected aging are treated in terms of conditional probabilities. (Author)

  2. Patent pools: intellectual property rights and competition.

    PubMed

    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

  3. 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

  4. Patenting and Academic Research: Historical Case Studies.

    ERIC Educational Resources Information Center

    Weiner, Charles

    1987-01-01

    Presents historical accounts of patenting and past experiments in academic patent management. These cases highlight the motivations, expectations, and results for scientists, their institutions, and the public. (ML)

  5. Potential drug–drug interactions in HIV-perinatally infected adolescents on antiretroviral therapy in Buenos Aires, Argentina

    PubMed Central

    Cordova, Ezequiel; Cecchini, Diego; Rodriguez, Claudia

    2014-01-01

    Introduction An increasing number of treatment-experienced perinatally HIV-infected adolescents (PHA) are being transitioned from paediatric centres to adult HIV-care [1]. Most of them had been heavily exposed to antiretroviral drugs (ARVs), harbour drug-resistant viruses and require non-antiretroviral medication due to comorbidities [2]. This may predispose for clinically significant drug–drug interactions (CSDDIs) [3]. There are no studies concerning CSDDIs in PHA. We aimed to evaluate the prevalence of concomitant medications and CSDDIs in PHA who were transitioned for adult HIV-care to the Infectious Diseases Unit, Cosme Argerich Hospital, Buenos Aires City, Argentina. Materials and Methods Descriptive pilot cross-sectional study (March to June 2014). PHA under ARVs at the time of the study were assessed for concomitant medication. CSDDIs were screened and categorized using the University of Liverpool Drug Interactions Program (www.hiv-druginteractions.org) [4]. Results Forty-five patients were included. Female sex: 53%. Median (IQR) age: 20 years (18–22). CDC-stage C was observed in 27 (79%); 50% had ≥1 comorbidities including 3 with HCV co-infection. Drug abuse was observed in 6 (13%). The median of prior ARV regimens was 3 (3–5). Current ARV regimen included: PI: 87%, NNRTI: 27%, INSTI: 20%, enfuvirtide: 7% and CCR5 inhibitor: 4%. Median CD4 T-cell count: 568 cells/mL (279–771). Viral load <50 copies/mL: 80%. Sixty percent (27/45) had ≥1 co-medications (median 1). The most frequent co-medications were NSAIDs (40%), hormonal therapy (19%) and antimicrobials (19%). Use of herbal supplements was observed in 10 (22%). Overall, 23 (51%) had ≥ 1 CSDDIs: 19/27 (70%) with co-medication (orange flag=18 and red flag=1); and 2/10 (20%) with herbal supplements. ARV–ARV interactions were observed in 4/45 (9%): unboosted atazanavir+tenofovir (n=2), unboosted atazanavir+efavirenz (n=1) and lopinavir/ritonavir+efavirenz (n=1) (all orange flag). Considering

  6. Patent arterial duct

    PubMed Central

    Forsey, Jonathan T; Elmasry, Ola A; Martin, Robin P

    2009-01-01

    Patent arterial duct (PAD) is a congenital heart abnormality defined as persistent patency in term infants older than three months. Isolated PAD is found in around 1 in 2000 full term infants. A higher prevalence is found in preterm infants, especially those with low birth weight. The female to male ratio is 2:1. Most patients are asymptomatic when the duct is small. With a moderate-to-large duct, a characteristic continuous heart murmur (loudest in the left upper chest or infraclavicular area) is typical. The precordium may be hyperactive and peripheral pulses are bounding with a wide pulse pressure. Tachycardia, exertional dyspnoea, laboured breathing, fatigue or poor growth are common. Large shunts may lead to failure to thrive, recurrent infection of the upper respiratory tract and congestive heart failure. In the majority of cases of PAD there is no identifiable cause. Persistence of the duct is associated with chromosomal aberrations, asphyxia at birth, birth at high altitude and congenital rubella. Occasional cases are associated with specific genetic defects (trisomy 21 and 18, and the Rubinstein-Taybi and CHARGE syndromes). Familial occurrence of PAD is uncommon and the usual mechanism of inheritance is considered to be polygenic with a recurrence risk of 3%. Rare families with isolated PAD have been described in which the mode of inheritance appears to be dominant or recessive. Familial incidence of PAD has also been linked to Char syndrome, familial thoracic aortic aneurysm/dissection associated with patent arterial duct, and familial patent arterial duct and bicuspid aortic valve associated with hand abnormalities. Diagnosis is based on clinical examination and confirmed with transthoracic echocardiography. Assessment of ductal blood flow can be made using colour flow mapping and pulsed wave Doppler. Antenatal diagnosis is not possible, as PAD is a normal structure during antenatal life. Conditions with signs and symptoms of pulmonary overcirculation

  7. Patent arterial duct.

    PubMed

    Forsey, Jonathan T; Elmasry, Ola A; Martin, Robin P

    2009-01-01

    Patent arterial duct (PAD) is a congenital heart abnormality defined as persistent patency in term infants older than three months. Isolated PAD is found in around 1 in 2000 full term infants. A higher prevalence is found in preterm infants, especially those with low birth weight. The female to male ratio is 2:1. Most patients are asymptomatic when the duct is small. With a moderate-to-large duct, a characteristic continuous heart murmur (loudest in the left upper chest or infraclavicular area) is typical. The precordium may be hyperactive and peripheral pulses are bounding with a wide pulse pressure. Tachycardia, exertional dyspnoea, laboured breathing, fatigue or poor growth are common. Large shunts may lead to failure to thrive, recurrent infection of the upper respiratory tract and congestive heart failure. In the majority of cases of PAD there is no identifiable cause. Persistence of the duct is associated with chromosomal aberrations, asphyxia at birth, birth at high altitude and congenital rubella. Occasional cases are associated with specific genetic defects (trisomy 21 and 18, and the Rubinstein-Taybi and CHARGE syndromes). Familial occurrence of PAD is uncommon and the usual mechanism of inheritance is considered to be polygenic with a recurrence risk of 3%. Rare families with isolated PAD have been described in which the mode of inheritance appears to be dominant or recessive. Familial incidence of PAD has also been linked to Char syndrome, familial thoracic aortic aneurysm/dissection associated with patent arterial duct, and familial patent arterial duct and bicuspid aortic valve associated with hand abnormalities. Diagnosis is based on clinical examination and confirmed with transthoracic echocardiography. Assessment of ductal blood flow can be made using colour flow mapping and pulsed wave Doppler. Antenatal diagnosis is not possible, as PAD is a normal structure during antenatal life. Conditions with signs and symptoms of pulmonary overcirculation

  8. Patenting the life sciences at the European Patent Office.

    PubMed

    Gates, Christina

    2014-12-01

    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

  9. Expression of Genes for Drug Transporters in the Human Female Genital Tract and Modulatory Effect of Antiretroviral Drugs

    PubMed Central

    Hijazi, Karolin; Cuppone, Anna M.; Smith, Kieron; Stincarelli, Maria A.; Ekeruche-Makinde, Julia; De Falco, Giulia; Hold, Georgina L.; Shattock, Robin; Kelly, Charles G.; Pozzi, Gianni; Iannelli, Francesco

    2015-01-01

    Anti-retroviral (ARV) –based microbicides are one of the strategies pursued to prevent HIV-1 transmission. Delivery of ARV drugs to subepithelial CD4+ T cells at concentrations for protection is likely determined by drug transporters expressed in the cervicovaginal epithelium. To define the role of drug transporters in mucosal disposition of topically applied ARV-based microbicides, these must be tested in epithelial cell line-based biopharmaceutical assays factoring the effect of relevant drug transporters. We have characterised gene expression of influx and efflux drug transporters in a panel of cervicovaginal cell lines and compared this to expression in cervicovaginal tissue. We also investigated the effect of dapivirine, darunavir and tenofovir, currently at advanced stages of microbicides development, on expression of drug transporters in cell lines. Expression of efflux ABC transporters in cervical tissue was best represented in HeLa, Ect1/E6E7 and End1/E6E7 cell lines. Expression of influx OCT and ENT transporters in ectocervix matched expression in Hela while expression of influx SLCO transporters in vagina was best reflected in VK2/E6E7 cell line. Stimulation with darunavir and dapivirine upregulated MRP transporters, including MRP5 involved in transport of tenofovir. Dapivirine also significantly downregulated tenofovir substrate MRP4 in cervical cell lines. Treatment with darunavir and dapivirine showed no significant effect on expression of BCRP, MRP2 and P-glycoprotein implicated in efflux of different ARV drugs. Darunavir strongly induced expression in most cell lines of CNT3 involved in cell uptake of nucleotide/nucleoside analogue reverse transcriptase inhibitors and SLCO drug transporters involved in cell uptake of protease inhibitors. This study provides insight into the suitability of cervicovaginal cell lines for assessment of ARV drugs in transport kinetics studies. The modulatory effect of darunavir and dapivirine on expression of drug

  10. Valley heat deficit as a bulk measure of wintertime particulate air pollution in the Arve River Valley

    NASA Astrophysics Data System (ADS)

    Chemel, Charles; Arduini, Gabriele; Staquet, Chantal; Largeron, Yann; Legain, Dominique; Tzanos, Diane; Paci, Alexandre

    2016-03-01

    Urbanized valleys are particularly vulnerable to particulate air pollution during the winter, when ground-based stable layers or cold-air pools persist over the valley floor. We examine whether the temporal variability of PM10 concentration in the section of the Arve River Valley between Cluses and Servoz in the French Alps can be explained by the temporal variability of the valley heat deficit, a bulk measure of atmospheric stability within the valley. We do this on the basis of temperature profile and ground-based PM10 concentration data collected during wintertime with a temporal resolution of 1 h or finer, as part of the Passy-2015 field campaign conducted around Passy in this section of valley. The valley heat deficit was highly correlated with PM10 concentration on a daily time scale. The hourly variability of PM10 concentrations was more complex and cannot be explained solely by the hourly variability of the valley heat deficit. The interplay of the diurnal cycles of emissions and local dynamics is demonstrated and a drainage mechanism for observed nocturnal dilution of near-surface PM10 concentrations is proposed.

  11. 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

  12. Patent urachus repair

    MedlinePlus

    ... of the urachus VCUG (voiding cystourethrogram), a special x-ray to make sure the bladder is working Always tell your child's health care provider: What drugs your child is taking. Include drugs, herbs, vitamins, or any other supplements you bought without a ...

  13. 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...

  14. 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...

  15. Patenting genetic diagnostic methods: NGS, GWAS, SNPs and patents.

    PubMed

    Lawson, Charles

    2015-06-01

    This article reviews the problems posed by patent claims to genetic diagnostic methods associated with genome-wide association studies (GWAS) adopting methodologies using next-generation sequencing (NGS) and single nucleotide polymorphisms (SNP). These problems are essentially about experimental reproducibility and the credibility and veracity of reported developments. An analysis of the relevant law demonstrates that the current Australian and United States laws about suitable patentable subject matter differ, and that the current reproducibility (sufficiency, enablement and inutility) standards are unlikely to address these problems. The article concludes that following the United States approach excluding these genetic diagnostic method claims from patenting is one solution. Failing this, improving analysis and quality controls that are now being adopted in the basic research will reduce the nature of the problems, although this will remain problematic for patent examiners and the broader public. PMID:26349382

  16. 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…

  17. 43 CFR 2544.5 - Patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patent. 2544.5 Section 2544.5 Public Lands...: Louisiana § 2544.5 Patent. Upon the submission of satisfactory proof, the Bureau will, if no protest or contest is pending, issue patent, such patent to contain a stipulation that all the minerals in the...

  18. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Patent protection. 501.9 Section 501.9 Patents, Trademarks, and Copyrights NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE UNIFORM PATENT POLICY FOR RIGHTS IN INVENTIONS MADE BY GOVERNMENT EMPLOYEES §...

  19. 43 CFR 2741.9 - Patent provisions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patent provisions. 2741.9 Section 2741.9... Public Purposes Act: Requirements § 2741.9 Patent provisions. (a) All patents under the act shall provide... management plan. (b) Patents shall also provide that the Secretary of the Interior may take action to...

  20. 43 CFR 2544.5 - Patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patent. 2544.5 Section 2544.5 Public Lands...: Louisiana § 2544.5 Patent. Upon the submission of satisfactory proof, the Bureau will, if no protest or contest is pending, issue patent, such patent to contain a stipulation that all the minerals in the...

  1. 37 CFR 501.9 - Patent protection.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Patent protection. 501.9 Section 501.9 Patents, Trademarks, and Copyrights NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE UNIFORM PATENT POLICY FOR RIGHTS IN INVENTIONS MADE BY GOVERNMENT EMPLOYEES §...

  2. 43 CFR 2544.5 - Patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patent. 2544.5 Section 2544.5 Public Lands...: Louisiana § 2544.5 Patent. Upon the submission of satisfactory proof, the Bureau will, if no protest or contest is pending, issue patent, such patent to contain a stipulation that all the minerals in the...

  3. 78 FR 7759 - Patent Cooperation Treaty

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... Patent and Trademark Office Patent Cooperation Treaty ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce...: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States Patent...

  4. 43 CFR 2544.5 - Patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patent. 2544.5 Section 2544.5 Public Lands...: Louisiana § 2544.5 Patent. Upon the submission of satisfactory proof, the Bureau will, if no protest or contest is pending, issue patent, such patent to contain a stipulation that all the minerals in the...

  5. 43 CFR 2741.9 - Patent provisions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patent provisions. 2741.9 Section 2741.9... Public Purposes Act: Requirements § 2741.9 Patent provisions. (a) All patents under the act shall provide... management plan. (b) Patents shall also provide that the Secretary of the Interior may take action to...

  6. 76 FR 72000 - Patent, Trademark & Copyright Acts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... Geological Survey Patent, Trademark & Copyright Acts AGENCY: U.S. Geological Survey, Interior. ACTION: Notice...., Suite 200, Kennesaw, GA 30144, on U.S. Patent Application Serial No. 12/133,666, and a divisional patent application to be filed shortly at the Patent and Trademark Office, both entitled ``Anaerobic...

  7. 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: The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce...: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States Patent...

  8. 43 CFR 2741.9 - Patent provisions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patent provisions. 2741.9 Section 2741.9... Public Purposes Act: Requirements § 2741.9 Patent provisions. (a) All patents under the act shall provide... management plan. (b) Patents shall also provide that the Secretary of the Interior may take action to...

  9. 78 FR 60256 - Initial Patent Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... Patent and Trademark Office Initial Patent Applications ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing efforts to..., United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. Federal...

  10. 78 FR 67339 - Initial Patent Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... Patent and Trademark Office Initial Patent Applications ACTION: Proposed collection; Extension of Comment Period. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing efforts... Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. Federal Rulemaking Portal:...

  11. 75 FR 23227 - Initial Patent Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-03

    ... Patent and Trademark Office Initial Patent Applications ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing efforts to..., Records Officer, Office of the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box...

  12. 77 FR 16813 - Patent Processing (Updating)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

    ... United States Patent and Trademark Office Patent Processing (Updating) ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing... Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450....

  13. 43 CFR 2741.9 - Patent provisions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patent provisions. 2741.9 Section 2741.9... Public Purposes Act: Requirements § 2741.9 Patent provisions. (a) All patents under the act shall provide... management plan. (b) Patents shall also provide that the Secretary of the Interior may take action to...

  14. 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 patent applications, patent reexamination proceedings, and other proceedings. 1.33 Section 1.33 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES...

  15. 43 CFR 3815.8 - Notation required in application for patent; conditions required in patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... patent; conditions required in patent. 3815.8 Section 3815.8 Public Lands: Interior Regulations Relating... Notation required in application for patent; conditions required in patent. (a) Every application for patent for any minerals located subject to this Act must bear on its face, before being executed by...

  16. 43 CFR 3815.8 - Notation required in application for patent; conditions required in patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... patent; conditions required in patent. 3815.8 Section 3815.8 Public Lands: Interior Regulations Relating... Notation required in application for patent; conditions required in patent. (a) Every application for patent for any minerals located subject to this Act must bear on its face, before being executed by...

  17. 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 patent applications, patent reexamination proceedings, and other proceedings. 1.33 Section 1.33 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES...

  18. 43 CFR 3815.8 - Notation required in application for patent; conditions required in patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... patent; conditions required in patent. 3815.8 Section 3815.8 Public Lands: Interior Regulations Relating... Notation required in application for patent; conditions required in patent. (a) Every application for patent for any minerals located subject to this Act must bear on its face, before being executed by...

  19. 43 CFR 3815.8 - Notation required in application for patent; conditions required in patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... patent; conditions required in patent. 3815.8 Section 3815.8 Public Lands: Interior Regulations Relating... Notation required in application for patent; conditions required in patent. (a) Every application for patent for any minerals located subject to this Act must bear on its face, before being executed by...

  20. 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

  1. 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. PMID:26372691

  2. The extraterritoriality of US patents on the pharmaceutical industry.

    PubMed

    Park, Hyunseok

    2014-09-01

    As pharmaceutical industries have rapidly modernized and globalized, borders have been blurred and multiple entities in different countries are now involved with the manufacture, supply, distribution, dispensing and administration of even a single drug in the pharmaceutical industry. The cross jurisdictional nature of the modern pharmaceutical industry presents new challenges to limitations on the extraterritorial reach of US patents. The enforcement of US patents outside the jurisdictional boundaries of the USA has judicially evolved through cases such as Deep South, Microsoft, Bayer AG, Union Carbide, AT&T, Cardiac Pacemakers and others. This article explores the effects of recent cases on the extraterritorial enforcement of US pharmaceutical patents, particularly when different types of claims are involved. PMID:25374318

  3. 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. PMID:26292154

  4. 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

  5. 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. PMID:23013408

  6. 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.

  7. Considerations in vaccine patent protection.

    PubMed

    Brazell, Lorna

    2010-12-01

    This feature article discusses the basic principles of patentability as related to vaccine research, and outlines recent cases in the US and EU in which vaccine patents have been considered. Issues regarding eligibility for supplementary protection, as currently being considered by the Court of Justice of the EU, are also outlined, as well as the implications of such issues in protecting future vaccine research. PMID:21154148

  8. Patent perspectives for corticosteroids based ophthalmic therapeutics.

    PubMed

    Suresh, Preeti K; Sah, Abhishek K

    2014-01-01

    Eye inflammation, if untreated at right time poses the risk of vision loss. Several categories of drugs are available in the global market, but corticosteroids are still used for the treatment of ocular inflammation including anterior/ posterior uveitis, age related macular degeneration (AMD) and post cataract surgery inflammation. Although corticosteroids have well-documented side effects as compared to non steroidal anti-inflammatory drugs (NSAIDs), but they are still regarded as better anti-inflammatory agents for treating ocular inflammations. The prime concern with conventional formulations such as (ophthalmic solutions, suspensions, ointments) is low drug bioavailability due to precorneal barrier of the eye, tear turnover and rapid drainage of drug via nasolacrimal drainage and drug induced systemic toxicity. To overcome these limitations, various novel formulations of corticosteroids have been explored. These include nanoparticles, solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC), nanomicelles, in-situ gels, iontophoresis, liposomes, nanoemulsions, microemulsions and ocular implants for the effective ophthalmic delivery of the corticosteroids. Topical nanocarriers have also been demonstrated to be promising vectors with potential application in the ophthalmic therapeutics. This review summarizes the clinical findings and patents on various corticosteroids as ocular pharmacotherapeutics. PMID:25020063

  9. 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.

  10. Radiological instrument. Patent Application

    SciTech Connect

    Kronenberg, S.; McLaughlin, W.L.; Siebentritt, C.R.

    1985-10-10

    This patent application discloses a radiological measuring instrument including an angularly variable radiation-sensitive structure comprised of two blocks of material having a different index of refraction with one of the materials comprising a radiochromic substance whose refractive index changes through anomolous dispersion as a result of being exposed to radiation. The ratio of the two indices of refraction is selected to be close to unity, with the radiation-sensitive structure being pivotally adjusted so that light is directed into one end of the block comprising the material having the greater index of refraction. This element, moreover, is selected to be clear and transparent with the incident angle being close to the critical angle where total reflection of all incident light occurs. A portion of the incident light is furthermore projected through the clear transparent block without reflection, with the two beams emerging from the other end of the block, where they are detected. Exposure to radiation changes the index of refraction of the radiochromic block and accordingly the reflected energy emerging therefrom. Calibrated readjustment of the angle of incidence provides a measure of the sensed radiation.

  11. Patent foramen ovale.

    PubMed

    Homma, Shunichi; Messé, Steven R; Rundek, Tatjana; Sun, Yee-Ping; Franke, Jennifer; Davidson, Karina; Sievert, Horst; Sacco, Ralph L; Di Tullio, Marco R

    2016-01-01

    Patent foramen ovale (PFO) is the most common congenital heart abnormality of fetal origin and is present in approximately ∼25% of the worldwide adult population. PFO is the consequence of failed closure of the foramen ovale, a normal structure that exists in the fetus to direct blood flow directly from the right to the left atrium, bypassing the pulmonary circulation. PFO has historically been associated with an increased risk of stroke, the mechanism of which has been attributed to the paradoxical embolism of venous thrombi that shunt through the PFO directly to the left atrium. However, several studies have failed to show an increased risk of stroke in asymptomatic patients with a PFO, and the risk of stroke recurrence is low in patients who have had a stroke that may be attributed to a PFO. With the advent of transoesophageal and transthoracic echocardiography, as well as transcranial Doppler, a PFO can be routinely detected in clinical practice. Medical treatment with either antiplatelet or anticoagulation therapy is recommended. At the current time, closure of the PFO by percutaneous interventional techniques does not appear to reduce the risk of stroke compared to conventional medical treatment, as shown by three large clinical trials. Considerable controversy remains regarding the optimal treatment strategy for patients with both cryptogenic stroke and PFO. This Primer discusses the epidemiology, mechanisms, pathophysiology, diagnosis, screening, management and effects on quality of life of PFO. PMID:27188965

  12. 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.

  13. Should ANVISA be permitted to reject pharmaceutical patent applications in Brazil?

    PubMed

    Mueller, Lisa L; Taketsuma Costa, Silvia Moreira

    2014-01-01

    Pharmaceutical manufacturers who seek new markets for expansion are particularly attracted to Brazil given its potential for growth and the expectation that it will be the fifth largest drug market by 2015. Given the significance of Brazil in the marketplace, strong patent protection for pharmaceutical products and processes is critical. In April 2013, a new workflow came into effect in Brazil which allows the National Sanitary Vigilance Agency (ANVISA), a government agency whose function is to protect public health, to examine and reject any patent application that claims a pharmaceutical product or process before any examination of the application by the Brazilian Patent Office. If a patent application is rejected by ANVISA, the application is returned to the Brazilian Patent Office and filed away, without any further examination, for an unknown period of time. Therefore, the examination of pharmaceutical product and process applications under this new workflow is problematic for local and global pharmaceutical manufacturers for multiple reasons. PMID:24206261

  14. Prevention of mother-to-child HIV-1 transmission in Burkina Faso: evaluation of vertical transmission by PCR, molecular characterization of subtypes and determination of antiretroviral drugs resistance

    PubMed Central

    Sagna, Tani; Bisseye, Cyrille; Compaore, Tegewende R.; Kagone, Therese S.; Djigma, Florencia W.; Ouermi, Djeneba; Pirkle, Catherine M.; Zeba, Moctar T. A.; Bazie, Valerie J. T.; Douamba, Zoenabo; Moret, Remy; Pietra, Virginio; Koama, Adjirita; Gnoula, Charlemagne; Sia, Joseph D.; Nikiema, Jean-Baptiste; Simpore, Jacques

    2015-01-01

    Background Vertical human immunodeficiency virus (HIV) transmission is a public health problem in Burkina Faso. The main objective of this study on the prevention of mother-to-child HIV-1 transmission was to determine the residual risk of HIV transmission in infants born to mothers receiving highly active antiretroviral therapy (HAART). Moreover, we detect HIV antiretroviral (ARV) drug resistance among mother–infant pairs and identify subtypes and circulating recombinant forms (CRF) in Burkina Faso. Design In this study, 3,215 samples of pregnant women were analyzed for HIV using rapid tests. Vertical transmission was estimated by polymerase chain reaction in 6-month-old infants born to women who tested HIV positive. HIV-1 resistance to ARV, subtypes, and CRFs was determined through ViroSeq kit using the ABI PRISM 3,130 sequencer. Results In this study, 12.26% (394/3,215) of the pregnant women were diagnosed HIV positive. There was 0.52% (2/388) overall vertical transmission of HIV, with rates of 1.75% (2/114) among mothers under prophylaxis and 0.00% (0/274) for those under HAART. Genetic mutations were also isolated that induce resistance to ARV such as M184V, Y115F, K103N, Y181C, V179E, and G190A. There were subtypes and CRF of HIV-1 present, the most common being: CRF06_CPX (58.8%), CRF02_AG (35.3%), and subtype G (5.9%). Conclusions ARV drugs reduce the residual rate of HIV vertical transmission. However, the virus has developed resistance to ARV, which could limit future therapeutic options when treatment is needed. Resistance to ARV therefore requires a permanent interaction between researchers, physicians, and pharmacists, to strengthen the network of monitoring and surveillance of drug resistance in Burkina Faso. PMID:25630709

  15. 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. PMID:25927945

  16. 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

  17. Patents and the supply of therapeutic products.

    PubMed

    Hayhurst, W L

    1992-01-01

    In some countries protests against the grant of exclusive rights in developments that benefit humanity have caused limits to be placed on the scope of patent rights. A characteristic of all modern patent systems is that the invention that one seeks to patent must have some practical utility and be new. The US is making patent protection available even for methods of medical treatment and for non human living things. A patent will expire in most developed countries 20 years from the filing of the application except in the US which grants patents from 17 years. India, China, and Brazil grant patents for shorter terms. In Australia and New Zealand, the term of a patent may be extended. In France and the US; extensions of term are possible only for medically related inventions. A patent grants to the owner of the patent the right, during its term, to exclude others from making, using, or selling the patented inventions. A patent grants to the owner of the patent the rights, during its term, to exclude others from making, using, or selling the patented invention. A patent owner who attempts to enforce a patent may be faced with a challenge that the patentee has misbehaved. In the US an alleged infringer may argue that the patentee misled the Patent Office when applying for the patent. The Patent laws of many countries enable the government to use patented inventions but compensate patent owners. Under sections 37 and 38 of the French patent legislation the government may decree that licenses are available in the interests of public health. In connection with Roussel-Uclaf's mifepristone, RU-486 it has been reported that such a decree cannot be made for a medicine that has not been approved by the government for distribution. The Canadian government has announced its intention to cancel the provisions in the Canadian Patent Act relating to compulsory licensing of medicines. Negotiations are continuing under the General Agreement on Tariffs and Trade that may lead to an

  18. Rituximab: how approval history is reflected by a corresponding patent filing strategy.

    PubMed

    Storz, Ulrich

    2014-01-01

    Because drug development is not a static process, a drug's market authorisation may change over time. In many cases, the number of indications for which a drug is approved increases. Because this facet of drug development also comes at significant costs, a corresponding patent filing strategy is required to protect these investments. The strategy as applied to rituximab, which is approved for a variety of indications, is discussed in this review. PMID:24866199

  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. PMID:26036354

  20. A comprehensive review of patented antileishmanial agents.

    PubMed

    Rama, Murugappan; Kumar, Nanjangud Venkatesh Anil; Balaji, Seetharaman

    2015-01-01

    On 14 October 2010, the WHO reported that more than 1 billion people worldwide who live in remote rural areas are affected by neglected tropical diseases. Leishmaniasis is caused by protozoa of more than 20 different species in humans. The three major forms of disease are cutaneous, mucocutaneous and visceral leishmaniasis (VL). Cutaneous leishmaniasis causes an ulcer on exposed parts of the body and it was estimated that 0.7-1.3 million cases occur worldwide annually. Mucocutaneous leishmaniasis leads to destruction of mucous membranes in various parts of the body and it was reported that it occurs widely in South America. VL is a deadly disease and it is characterized by various symptoms, such as anemia, fever, fatigue and weight loss. The WHO estimated that 200,000-400,000 cases per annum of VL occur worldwide. Although different drugs and drug combinations are used for leishmaniasis, US FDA-approved drugs are limited. Miltefosine is the only drug approved for all forms of leishmaniasis and AmBisome(®) is approved for VL. Moreover, the drugs used for leishmaniasis have severe side effects. The article summarizes the patents filed between January 2010 and June 2013 for antileishmanial activity. The article covers only the chemical agents and excludes the vaccines and the peptides. A large number of compounds are filed for antileishmanial activity annually, but only a few are more potent than reference drugs such as miltefosine, pentamidine and metronidazole. In addition, most of the compounds are not as efficient as amphotericin B. Therefore, there is a need for novel compounds that are not only potent than the FDA-approved AmBisome and miltefosine, but are also less toxic and more cost effective in humans. This article provides an eclectic compilation of different classes of compounds that are active against amastigotes (the protozoa form found in humans) for the treatment of leishmaniasis. PMID:25565159

  1. 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. PMID:26961667

  2. 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...

  3. 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...

  4. 48 CFR 27.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Administration of patent... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights under Government Contracts 27.305 Administration of patent rights clauses....

  5. 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....

  6. 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....

  7. 48 CFR 1327.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Administration of patent... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1327.305 Administration of patent rights clauses....

  8. 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...

  9. 48 CFR 1227.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Administration of patent... TRANSPORTATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1227.305 Administration of patent rights clauses....

  10. 48 CFR 2427.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Administration of patent... AND URBAN DEVELOPMENT SOCIOECONOMIC PROGRAMS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 2427.305 Administration of patent rights clauses....

  11. 48 CFR 1227.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Administration of patent... TRANSPORTATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1227.305 Administration of patent rights clauses....

  12. 48 CFR 2427.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Administration of patent... AND URBAN DEVELOPMENT SOCIOECONOMIC PROGRAMS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 2427.305 Administration of patent rights clauses....

  13. 48 CFR 1327.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Administration of patent... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1327.305 Administration of patent rights clauses....

  14. 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...

  15. 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....

  16. 48 CFR 1227.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Administration of patent... TRANSPORTATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1227.305 Administration of patent rights clauses....

  17. 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....

  18. 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...

  19. 48 CFR 1327.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Administration of patent... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1327.305 Administration of patent rights clauses....

  20. 48 CFR 2427.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Administration of patent... AND URBAN DEVELOPMENT SOCIOECONOMIC PROGRAMS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 2427.305 Administration of patent rights clauses....

  1. 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....

  2. 48 CFR 1227.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Administration of patent... TRANSPORTATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1227.305 Administration of patent rights clauses....

  3. 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....

  4. 48 CFR 27.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Administration of patent... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights under Government Contracts 27.305 Administration of patent rights clauses....

  5. 48 CFR 1327.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Administration of patent... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1327.305 Administration of patent rights clauses....

  6. 48 CFR 2427.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Administration of patent... AND URBAN DEVELOPMENT SOCIOECONOMIC PROGRAMS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 2427.305 Administration of patent rights clauses....

  7. 48 CFR 27.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Administration of patent... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights under Government Contracts 27.305 Administration of patent rights clauses....

  8. 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....

  9. 48 CFR 27.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Administration of patent... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights under Government Contracts 27.305 Administration of patent rights clauses....

  10. 48 CFR 1327.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Administration of patent... GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1327.305 Administration of patent rights clauses....

  11. 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....

  12. 48 CFR 1227.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Administration of patent... TRANSPORTATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 1227.305 Administration of patent rights clauses....

  13. 48 CFR 27.305 - Administration of patent rights clauses.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Administration of patent... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patent Rights under Government Contracts 27.305 Administration of patent rights clauses....

  14. 48 CFR 2427.305 - Administration of 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 Administration of patent... AND URBAN DEVELOPMENT SOCIOECONOMIC PROGRAMS PATENTS, DATA, AND COPYRIGHTS Patent Rights Under Government Contracts 2427.305 Administration of patent rights clauses....

  15. 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....

  16. 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....

  17. The phage display technique: advantages and recent patents.

    PubMed

    de Almeida, Sintia Silva; Magalhães, Aryane Aparecida C; de Castro Soares, Siomar; Zurita-Turk, Meritxell; Goulart, Luiz Ricardo; Miyoshi, Anderson; Azevedo, Vasco

    2011-08-01

    Phage display technology has advanced considerably since its creation, and the number of research projects using this technique is constantly increasing, generating numerous antibody and antigen libraries. These libraries, besides expediting library screening, improving selection methods and allowing evaluation of novel applications, have great potential for the development of new vaccines, drugs and diagnosis tests. Consequently, patent registries for the protection of these sequences are essential. PMID:21663585

  18. 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. PMID:20166289

  19. Formulation Patents and Dermatology and Obviousness

    PubMed Central

    Mei, Dan-Feng; Liu, Josephine; Davitz, Michael A.

    2011-01-01

    Most patents covering dermatologic products contain patent claims directed to the pharmaceutical formulation of the product. Such patents, known as formulation patents, are vulnerable to attacks based on the legal argument that the formulations covered are obvious over formulations already known prior to the filing of the patent application. Because obviousness is an important concept in patent law, recent court cases concerning obviousness and formulation patents were examined and discussed below. Courts have ruled that patent claims are obvious when features of the claimed formulation are found in the prior art, even if the features or characteristics of the formulation are not explicitly disclosed in the prior art. However, patentees have successfully overcome obviousness challenges where there were unexpected results or properties and/or the prior art taught away from the claimed invention. PMID:24309313

  20. 75 FR 18213 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOZOBIL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... product, animal drug product, medical device, food additive, or color additive) was subject to regulatory... marketing the human drug product MOZOBIL (plerixafor). MOZOBIL is indicated in combination with granulocyte... commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that...

  1. 75 FR 32951 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... product, animal drug product, medical device, food additive, or color additive) was subject to regulatory... marketing the human drug product PROMACTA (eltrombopag olamine). PROMACTA is indicated the treatment of... marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA...

  2. 22 CFR 92.72 - Services in connection with patents and patent applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Services in connection with patents and patent... RELATED SERVICES Miscellaneous Notarial Services § 92.72 Services in connection with patents and patent applications. (a) Affidavit of applicant. The form of the affidavit of an applicant for a United States...

  3. 22 CFR 92.72 - Services in connection with patents and patent applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Services in connection with patents and patent... RELATED SERVICES Miscellaneous Notarial Services § 92.72 Services in connection with patents and patent applications. (a) Affidavit of applicant. The form of the affidavit of an applicant for a United States...

  4. 22 CFR 92.72 - Services in connection with patents and patent applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Services in connection with patents and patent... RELATED SERVICES Miscellaneous Notarial Services § 92.72 Services in connection with patents and patent applications. (a) Affidavit of applicant. The form of the affidavit of an applicant for a United States...

  5. 22 CFR 92.72 - Services in connection with patents and patent applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Services in connection with patents and patent... RELATED SERVICES Miscellaneous Notarial Services § 92.72 Services in connection with patents and patent applications. (a) Affidavit of applicant. The form of the affidavit of an applicant for a United States...

  6. 22 CFR 92.72 - Services in connection with patents and patent applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Services in connection with patents and patent... RELATED SERVICES Miscellaneous Notarial Services § 92.72 Services in connection with patents and patent applications. (a) Affidavit of applicant. The form of the affidavit of an applicant for a United States...

  7. Past, present and future of pharmaceutical patents under Korea-US Trade Agreement.

    PubMed

    Shin, Yoon Suk

    2016-07-01

    The introduction of substance patents in 1987 was viewed with apprehension as it was believed that the system would only reinforce the domination of the technology of advanced countries based on the trade agreement between Korea and the USA. However, substance patents provided the Korean pharmaceutical industry with the driving force required to develop new substances, and the Korean pharmaceutical industry has been constantly improving its research and development capability. The patent-approval linkage system was implemented according to the Korea-US Free Trade Agreement in 2015. The system comprises the following: registering the drugs in the Green List, notifying the listed patent and marketing approval holders about the application for generic marketing approval, patent holder's request for staying generic sales and first generic exclusivity. Korean generic companies are expected to have opportunities that enable them to challenge the global market by accumulating experience of designing of generic products, making patent challenges and strategically developing of new drugs or incrementally modified drugs through the linkage system. PMID:27338849

  8. 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. PMID:26091710

  9. Patent owner options for correcting errors in US patents after grant.

    PubMed

    Armstrong, MaryAnne

    2014-09-01

    With the implementation of the America Invents Act, there has been considerable focus on options for third parties to attack the validity of US patents. However, there have also been a number of important court cases in the USA that have considered the question of what may be patented in the USA. These decisions have radically changed what may be patented in the USA, particularly in the field of biopharmaceuticals. Equally important to understanding what options are available to a third party to attack a patent, are the options and procedures available to patent owners to correct errors in patents and strengthen the validity of a patent prior to enforcement. PMID:25374319

  10. 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....

  11. 43 CFR 2532.2 - Trust patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Trust patent. 2532.2 Section 2532.2 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) INDIAN ALLOTMENTS Allotments § 2532.2 Trust patent... patent will be suspended for a period of 2 years from date of settlement; but in those cases where...

  12. 43 CFR 2542.4 - Patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patent. 2542.4 Section 2542.4 Public Lands..., Contiguous to Spanish or Mexican Grants § 2542.4 Patent. (a) Upon submission of satisfactory proof of... there be no protest, contest or other objection against the application, patent will then be issued...

  13. 43 CFR 2562.7 - Patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patent. 2562.7 Section 2562.7 Public Lands... Patent. The application and proofs filed therewith will be carefully examined and, if all be found regular, the application will be allowed and patent issued upon payment for the land at the rate of...

  14. 43 CFR 2562.7 - Patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patent. 2562.7 Section 2562.7 Public Lands... Patent. The application and proofs filed therewith will be carefully examined and, if all be found regular, the application will be allowed and patent issued upon payment for the land at the rate of...

  15. 43 CFR 2541.3 - Patents.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patents. 2541.3 Section 2541.3 Public... § 2541.3 Patents. (a) Any applicant who satisfied all requirements for a claim of class 1 or class 2... will receive a patent conveying title to all other minerals except: (1) Any minerals which, at the...

  16. 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... LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied fully... and patent and shall state the statutory authority for such liens. The receipt shall be submitted...

  17. 43 CFR 2543.5 - Patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patent. 2543.5 Section 2543.5 Public Lands...: Arkansas § 2543.5 Patent. Upon submission of satisfactory proof, if no protest or contest is pending, patent will be issued....

  18. 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....

  19. 43 CFR 2562.7 - Patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patent. 2562.7 Section 2562.7 Public Lands... Patent. The application and proofs filed therewith will be carefully examined and, if all be found regular, the application will be allowed and patent issued upon payment for the land at the rate of...

  20. 43 CFR 402.10 - Patent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Patent. 402.10 Section 402.10 Public Lands... LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied fully... and patent and shall state the statutory authority for such liens. The receipt shall be submitted...

  1. 43 CFR 2562.7 - Patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patent. 2562.7 Section 2562.7 Public Lands... Patent. The application and proofs filed therewith will be carefully examined and, if all be found regular, the application will be allowed and patent issued upon payment for the land at the rate of...

  2. 43 CFR 2631.4 - Patents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patents. 2631.4 Section 2631.4 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) RAILROAD GRANTS Patents for Lands Sold by Railroad Carriers (Transportation Act of 1940) § 2631.4 Patents. If all be found regular and in conformity with...

  3. 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... LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied fully... and patent and shall state the statutory authority for such liens. The receipt shall be submitted...

  4. 43 CFR 2543.5 - Patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patent. 2543.5 Section 2543.5 Public Lands...: Arkansas § 2543.5 Patent. Upon submission of satisfactory proof, if no protest or contest is pending, patent will be issued....

  5. 43 CFR 2542.4 - Patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patent. 2542.4 Section 2542.4 Public Lands..., Contiguous to Spanish or Mexican Grants § 2542.4 Patent. (a) Upon submission of satisfactory proof of... there be no protest, contest or other objection against the application, patent will then be issued...

  6. 43 CFR 2541.3 - Patents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patents. 2541.3 Section 2541.3 Public... § 2541.3 Patents. (a) Any applicant who satisfied all requirements for a claim of class 1 or class 2... will receive a patent conveying title to all other minerals except: (1) Any minerals which, at the...

  7. 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....

  8. 43 CFR 2631.4 - Patents.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patents. 2631.4 Section 2631.4 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) RAILROAD GRANTS Patents for Lands Sold by Railroad Carriers (Transportation Act of 1940) § 2631.4 Patents. If all be found regular and in conformity with...

  9. 43 CFR 2541.3 - Patents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patents. 2541.3 Section 2541.3 Public... § 2541.3 Patents. (a) Any applicant who satisfied all requirements for a claim of class 1 or class 2... will receive a patent conveying title to all other minerals except: (1) Any minerals which, at the...

  10. 43 CFR 402.10 - Patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Patent. 402.10 Section 402.10 Public Lands... LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied fully... and patent and shall state the statutory authority for such liens. The receipt shall be submitted...

  11. 43 CFR 2631.4 - Patents.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patents. 2631.4 Section 2631.4 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) RAILROAD GRANTS Patents for Lands Sold by Railroad Carriers (Transportation Act of 1940) § 2631.4 Patents. If all be found regular and in conformity with...

  12. 43 CFR 2542.4 - Patent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patent. 2542.4 Section 2542.4 Public Lands..., Contiguous to Spanish or Mexican Grants § 2542.4 Patent. (a) Upon submission of satisfactory proof of... there be no protest, contest or other objection against the application, patent will then be issued...

  13. 43 CFR 2631.4 - Patents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Patents. 2631.4 Section 2631.4 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) RAILROAD GRANTS Patents for Lands Sold by Railroad Carriers (Transportation Act of 1940) § 2631.4 Patents. If all be found regular and in conformity with...

  14. 43 CFR 2541.3 - Patents.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patents. 2541.3 Section 2541.3 Public... § 2541.3 Patents. (a) Any applicant who satisfied all requirements for a claim of class 1 or class 2... will receive a patent conveying title to all other minerals except: (1) Any minerals which, at the...

  15. Understanding Patenting Decisions: A Classroom Exercise

    ERIC Educational Resources Information Center

    Bernard, John C.; Yiannaka, Amalia

    2010-01-01

    Although many students have some knowledge of patents, it can be difficult for them to understand the components of an innovator's decision-making process. Key issues, such as whether to patent or to use trade secrecy, how broad a scope to claim, and what to do in the event of patent infringement, can be difficult to grasp from a standard lecture.…

  16. 43 CFR 2543.5 - Patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Patent. 2543.5 Section 2543.5 Public Lands...: Arkansas § 2543.5 Patent. Upon submission of satisfactory proof, if no protest or contest is pending, patent will be issued....

  17. 43 CFR 2542.4 - Patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Patent. 2542.4 Section 2542.4 Public Lands..., Contiguous to Spanish or Mexican Grants § 2542.4 Patent. (a) Upon submission of satisfactory proof of... there be no protest, contest or other objection against the application, patent will then be issued...

  18. 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....

  19. 48 CFR 35.012 - Patent rights.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 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,...

  20. 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,...

  1. 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... LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied fully... and patent and shall state the statutory authority for such liens. The receipt shall be submitted...

  2. 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....

  3. 48 CFR 35.012 - Patent rights.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 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,...

  4. 48 CFR 35.012 - Patent rights.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 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,...

  5. 43 CFR 2532.2 - Trust patent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Trust patent. 2532.2 Section 2532.2 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) INDIAN ALLOTMENTS Allotments § 2532.2 Trust patent... patent will be suspended for a period of 2 years from date of settlement; but in those cases where...

  6. 43 CFR 2543.5 - Patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Patent. 2543.5 Section 2543.5 Public Lands...: Arkansas § 2543.5 Patent. Upon submission of satisfactory proof, if no protest or contest is pending, patent will be issued....

  7. 43 CFR 2532.2 - Trust patent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Trust patent. 2532.2 Section 2532.2 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) INDIAN ALLOTMENTS Allotments § 2532.2 Trust patent... patent will be suspended for a period of 2 years from date of settlement; but in those cases where...

  8. 43 CFR 2532.2 - Trust patent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Trust patent. 2532.2 Section 2532.2 Public... OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) INDIAN ALLOTMENTS Allotments § 2532.2 Trust patent... patent will be suspended for a period of 2 years from date of settlement; but in those cases where...

  9. 48 CFR 35.012 - Patent rights.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 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. Educators Guide to U.S. Patents.

    ERIC Educational Resources Information Center

    Prostano, Emanuel T.; Prostano, Joyce S.

    There are more than 4.8 million patents in the U.S. Patents File. It is the most comprehensive collection of technological information in the world. By their nature, patents are "teaching" documents, and are used as a source of basic information, as a vehicle for teaching critical and creative thinking, and in many school "invention programs."…

  11. 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…

  12. Patenting for the research scientist: an update.

    PubMed

    Crespi, R Stephen

    2004-12-01

    Academic institutional research constantly produces results worthy of patent protection, but coping with the demands of patent law presents considerable challenges to bioscientists working in these institutions. Inventors need, however, to be aware of recent patent office guidelines and court decisions if they are to seek useful intellectual property as a basis for technology transfer to industry. PMID:15542154

  13. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Patent term adjustment determination. 1.705 Section 1.705 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent...

  14. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Patent term adjustment determination. 1.705 Section 1.705 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent...

  15. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Patent term adjustment determination. 1.705 Section 1.705 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent...

  16. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Patent term adjustment determination. 1.705 Section 1.705 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent...

  17. 37 CFR 1.705 - Patent term adjustment determination.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patent term adjustment determination. 1.705 Section 1.705 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent...

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

    PubMed Central

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

    2016-01-01

    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. PMID

  19. 37 CFR 1.378 - Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent. 1.378 Section 1.378 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National...

  20. 37 CFR 1.378 - Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent. 1.378 Section 1.378 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National...

  1. 37 CFR 1.378 - Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent. 1.378 Section 1.378 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National...

  2. 37 CFR 1.378 - Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Acceptance of delayed payment of maintenance fee in expired patent to reinstate patent. 1.378 Section 1.378 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National...

  3. A Functional, Genome-wide Evaluation of Liposensitive Yeast Identifies the “ARE2 Required for Viability” (ARV1) Gene Product as a Major Component of Eukaryotic Fatty Acid Resistance*

    PubMed Central

    Ruggles, Kelly V.; Garbarino, Jeanne; Liu, Ying; Moon, James; Schneider, Kerry; Henneberry, Annette; Billheimer, Jeff; Millar, John S.; Marchadier, Dawn; Valasek, Mark A.; Joblin-Mills, Aidan; Gulati, Sonia; Munkacsi, Andrew B.; Repa, Joyce J.; Rader, Dan; Sturley, Stephen L.

    2014-01-01

    The toxic subcellular accumulation of lipids predisposes several human metabolic syndromes, including obesity, type 2 diabetes, and some forms of neurodegeneration. To identify pathways that prevent lipid-induced cell death, we performed a genome-wide fatty acid sensitivity screen in Saccharomyces cerevisiae. We identified 167 yeast mutants as sensitive to 0.5 mm palmitoleate, 45% of which define pathways that were conserved in humans. 63 lesions also impacted the status of the lipid droplet; however, this was not correlated to the degree of fatty acid sensitivity. The most liposensitive yeast strain arose due to deletion of the “ARE2 required for viability” (ARV1) gene, encoding an evolutionarily conserved, potential lipid transporter that localizes to the endoplasmic reticulum membrane. Down-regulation of mammalian ARV1 in MIN6 pancreatic β-cells or HEK293 cells resulted in decreased neutral lipid synthesis, increased fatty acid sensitivity, and lipoapoptosis. Conversely, elevated expression of human ARV1 in HEK293 cells or mouse liver significantly increased triglyceride mass and lipid droplet number. The ARV1-induced hepatic triglyceride accumulation was accompanied by up-regulation of DGAT1, a triglyceride synthesis gene, and the fatty acid transporter, CD36. Furthermore, ARV1 was identified as a transcriptional of the protein peroxisome proliferator-activated receptor α (PPARα), a key regulator of lipid homeostasis whose transcriptional targets include DGAT1 and CD36. These results implicate ARV1 as a protective factor in lipotoxic diseases due to modulation of fatty acid metabolism. In conclusion, a lipotoxicity-based genetic screen in a model microorganism has identified 75 human genes that may play key roles in neutral lipid metabolism and disease. PMID:24273168

  4. Pharmaceutical patent law: the Canadian perspective.

    PubMed

    Aumand, Livia; Norman, John

    2016-07-01

    This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry. PMID:27346187

  5. Entrepreneurial patent management in pharmaceutical startups.

    PubMed

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

    Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. PMID:26948802

  6. 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.

  7. The Patentability of Stem Cells in Australia.

    PubMed

    Petering, Jenny; Cowin, Prue

    2015-10-01

    The potential therapeutic applications of stem cells are unlimited. However, the ongoing political and social debate surrounding the intellectual property and patenting considerations of stem cell research has led to the implementation of strict legislative regulations. In Australia the patent landscape surrounding stem cells has evolved considerably over the past 20 years. The Australian Patents Act 1990 includes a specific exclusion to the patentability of human beings and of biological processes for their generation. However, this exclusion has received no judicial consideration to date, and so its scope and potential impact on stem cell patents is unclear. PMID:26134481

  8. 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

    ... Patent Extension; VIMPAT --NDA 22-253 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... new drug application (NDA) 22-253 for VIMPAT TABLETS and is publishing this notice of that... the new drug application (NDA 22-253) for VIMPAT tablets was submitted on September 28, 2007. 3....

  9. US photovoltaic patents: 1991-1993

    NASA Astrophysics Data System (ADS)

    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.

  10. Molecular farming, patents and access to medicines.

    PubMed

    Drake, Pascal M W; Thangaraj, Harry

    2010-08-01

    Transgenic plants have several advantages over other expression systems for the production of recombinant medicines, including low costs, large-scale production and the ability to produce complex multimeric proteins with appropriate post-translational modifications. Several plant-made pharmaceuticals, including the enzyme glucocerebrosidase, insulin and IFN-alpha(2b), are approaching commercialization and these developments have been accompanied by considerable patenting activity. In the present article, we investigated plant-made pharmaceutical patents between the years 2002 and 2008. There was a clear downward trend in the number of patents filed between these years and a greater number of patents were filed by public sector institutions or inventors than by the private sector. The USA dominated patenting activity providing nearly 30% of inventors. The majority of patents were for vaccine candidates (55%), followed by therapeutics (38%) and antibodies (7%). The relationship of patenting to innovation and access to medicines, particularly in the developing world, will be discussed. PMID:20673006

  11. 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

  12. 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.

  13. Patented nanomedicines for the treatment of brain tumors.

    PubMed

    Caruso, Gerardo; Raudino, Giuseppe; Caffo, Maria

    2013-11-01

    Patients affected by malignant brain tumors present an extremely poor prognosis, notwithstanding improvements in surgery techniques and therapeutic protocols. Brain tumor treatment has been principally hampered by limited drug delivery across the blood-brain barrier (BBB). An efficacious chemotherapeutic treatment requires a pharmacological agent that can penetrate the BBB and target neoplastic cells. Nanotechnology involves the design, synthesis and characterization of materials that have a functional organization in at least one dimension on the nanometer scale. Nanoparticle systems can represent optimal devices for delivery of various drugs into the brain across the BBB. Nanoparticle drug-delivery systems can also be used to provide targeted delivery of drugs, improve bioavailability and sustain release of drugs for systemic delivery. In this patent review, the recent studies of certain nanoparticle systems in treatment of brain tumors are summarized. Common nanoparticles systems include polymeric nanoparticles, lipid nanoparticles and inorganic nanoparticles. Various patents of nanoparticle systems able to across the BBB to target brain tumors are also reported and discussed. PMID:24237240

  14. Chinese patent medicine liu wei di huang wan combined with antihypertensive drugs, a new integrative medicine therapy, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

    PubMed

    Wang, Jie; Yao, Kuiwu; Yang, Xiaochen; Liu, Wei; Feng, Bo; Ma, Jizheng; Du, Xinliang; Wang, Pengqian; Xiong, Xingjiang

    2012-01-01

    Objectives. To assess the beneficial and adverse effects of Liu Wei Di Huang Wan (LWDHW), combined with antihypertensive drugs, for essential hypertension. Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of LWDHW combined with antihypertensive drugs for essential hypertension reported in any language, with main outcome measures as blood pressure. The quality of the included studies was assessed with the Jadad scale and a customized standard quality assessment scale. Results. 6 randomized trials were included. The methodological quality of the trials was evaluated as generally low. The pooled results showed that LWDHW combined with antihypertensive drugs was more effective in blood pressure and the scale for TCM syndrome and symptom differentiation scores compared with antihypertensive drugs alone. Most of the trials did not report adverse events, and the safety is still uncertain. Conclusions. LWDHW combined with antihypertensive drugs appears to be effective in improving blood pressure and symptoms in patients with essential hypertension. However, the evidence remains weak due to the poor methodological quality of the included studies. PMID:23258998

  15. Chinese Patent Medicine Liu Wei Di Huang Wan Combined with Antihypertensive Drugs, a New Integrative Medicine Therapy, for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Wang, Jie; Yao, Kuiwu; Yang, Xiaochen; Liu, Wei; Feng, Bo; Ma, Jizheng; Du, Xinliang; Wang, Pengqian; Xiong, Xingjiang

    2012-01-01

    Objectives. To assess the beneficial and adverse effects of Liu Wei Di Huang Wan (LWDHW), combined with antihypertensive drugs, for essential hypertension. Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of LWDHW combined with antihypertensive drugs for essential hypertension reported in any language, with main outcome measures as blood pressure. The quality of the included studies was assessed with the Jadad scale and a customized standard quality assessment scale. Results. 6 randomized trials were included. The methodological quality of the trials was evaluated as generally low. The pooled results showed that LWDHW combined with antihypertensive drugs was more effective in blood pressure and the scale for TCM syndrome and symptom differentiation scores compared with antihypertensive drugs alone. Most of the trials did not report adverse events, and the safety is still uncertain. Conclusions. LWDHW combined with antihypertensive drugs appears to be effective in improving blood pressure and symptoms in patients with essential hypertension. However, the evidence remains weak due to the poor methodological quality of the included studies. PMID:23258998

  16. Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease

    PubMed Central

    Mackey, Tim K.; Liang, Bryan A.

    2012-01-01

    Objective The threat of non-communicable diseases (“NCDs”) is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights (“IPRs”) that may impede generic production and availability and affordability to essential NCD medicines. Methods Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study. Materials We examined the patent and exclusivity status of medicines listed in the World Health Organization’s (“WHO”) Model List of Essential Drugs (Medicines) (“MLEM”) and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA. Results Of the 359 MLEM medicines identified, 22% (79/359) address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria. Conclusions We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global

  17. 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

  18. Neurologic Outcomes in HIV-Exposed/Uninfected Infants Exposed to Antiretroviral Drugs During Pregnancy in Latin America and the Caribbean.

    PubMed

    Spaulding, Alicen B; Yu, Qilu; Civitello, Lucy; Mussi-Pinhata, Marisa M; Pinto, Jorge; Gomes, Ivete M; Alarcón, Jorge O; Siberry, George K; Harris, D Robert; Hazra, Rohan

    2016-04-01

    To evaluate antiretroviral (ARV) drug exposure and other factors during pregnancy that may increase the risk of neurologic conditions (NCs) in HIV-exposed/uninfected (HEU) infants. A prospective cohort study was conducted at 24 clinical sites in Latin America and the Caribbean. Data on maternal demographics, health, HIV disease status, and ARV use during pregnancy were collected. Infant data included measurement of head circumference after birth and reported medical diagnoses at birth, 6-12 weeks, and 6 months. Only infants with maternal exposure to combination ARV therapy (cART) (≥3 drugs from ≥2 drug classes) during pregnancy were included. Microcephaly, defined as head circumference for age z-score less than -2, and NC were evaluated for their association with covariates, including individual ARVs, using bivariable and logistic regression analyses. From 2002 to 2009, 1,400 HEU infants met study inclusion criteria. At least one NC was reported in 134 (9.6%; 95% confidence interval [CI]: 8.1-11.2), microcephaly in 105 (7.5%; 95% CI: 6.2-9.0), and specific neurologic diagnoses in 33 (2.4%; 95% CI: 1.6-3.3) HEU infants. Microcephaly and NC were not significantly associated with any specific ARV analyzed (p > 0.05). Covariates associated with increased odds of NC included male sex (odds ratio [OR] = 1.9; 95% CI: 1.3-2.8), birth weight <2.5 kg (OR = 3.1; 95% CI: 2.1-4.8), 1-min Apgar score <7 (OR = 2.5; 95% CI: 1.4-4.4), and infant infections (OR = 2.5; 95% CI: 1.5-4.1). No ARV investigated was associated with adverse neurologic outcomes. Continued investigation of such associations may be warranted as new ARVs are used during pregnancy and cART exposure during the first trimester becomes increasingly common. PMID:26879281

  19. 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

  20. US photovoltaic patents, 1951--1987

    NASA Astrophysics Data System (ADS)

    1988-09-01

    This document contains 2195 U.S. 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 1951 through 1987; no patents were found in 1950. The entries were located by searching USPA, the data base of the U.S. 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 terrwstrial PV power technologies.

  1. US photovoltaic patents, 1951--1987

    SciTech Connect

    Not Available

    1988-09-01

    This document contains 2195 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 1951 through 1987; no patents were found in 1950. 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.

  2. The academic advantage: gender disparities in patenting.

    PubMed

    Sugimoto, Cassidy R; Ni, Chaoqun; West, Jevin D; Larivière, Vincent

    2015-01-01

    We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women's rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women's patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women--and in particular academic women--contributed are associated with a higher number of International Patent Classification (IPC) codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed. PMID:26017626

  3. The Academic Advantage: Gender Disparities in Patenting

    PubMed Central

    Sugimoto, Cassidy R.; Ni, Chaoqun; West, Jevin D.; Larivière, Vincent

    2015-01-01

    We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women’s rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women’s patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women—and in particular academic women—contributed are associated with a higher number of International Patent Classification (IPC) codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed. PMID:26017626

  4. Inhibitors of influenza viruses replication: a patent evaluation (WO2013019828).

    PubMed

    Xie, Yuanchao; Song, Weiguo; Xiao, Weidong; Gu, Changjuan; Xu, Wenfang

    2013-11-01

    A series of compounds incorporating two aromatic heterocycles were prepared as inhibitors of influenza virus replication in the patent. Some of them presented potent activity against influenza virus in Madin-Darby canine kidney (MDCK) cells and in influenza therapeutic mouse model. These compounds in the patent were also defined to be pharmaceutically acceptable salts and pharmaceutical compositions that were claimed to be useful for treating influenza. In view of the threat of influenza pandemic, it is necessary to discover new anti-influenza drugs. Although there is a lack of essential biological data and the molecular mechanisms are not clear, these compounds with potent antiviral activity stand for a new type of anti-influenza agents and deserve further studies. PMID:23967861

  5. Oral solid self-emulsifying formulations: a patent review.

    PubMed

    Tarate, Bapurao; Chavan, Rahul; Bansal, Arvind K

    2014-01-01

    Self-emulsifying compositions are lipidic drug delivery systems that provide a number of delivery advantages. A variety of excipients are available for designing of these drug delivery systems. These systems can be classified as Type I, II, III, and IV, and alternatively as solid, semi-solid, and liquid. Till date many patents have been published on self-emulsifying compositions, and a few commercial products have also been launched. The purpose of this review is to have insights into the patent literature capturing the developments in the area of oral solid self-emulsifying formulations. Though the main emphasis is on developments in solid self-emulsifying formulations, an overview of different manufacturing techniques has also been provided. These formulations can be grouped as conventional, granules, pellets, tablets, supersaturable, controlled release, eutectic-based, and positively charged. The components of self-emulsifying formulations described in this review are not limited only to oils, surfactants, and cosurfactants but also include binders, polymers, diluents, alkalinizing agents, stabilizing agents, preservatives, and viscosity adjusting agents. The inventions highlighted in this article provide useful guidelines for enhancement of oral bioavailability of drugs through this drug delivery platform. PMID:24628371

  6. Patentability of self-replicating technologies.

    PubMed

    Shear, Richard H

    2015-01-01

    Patents provide an incentive to inventors, investors, and entrepreneurs to conduct research and development, especially in risky (i.e., unpredictable) fields of technology. This review discusses whether self-replicating technologies are patentable within the United States and the issues surrounding them. Self-replicating technologies discussed include plants, bacteria, and genetic technology and the historical legal precedents that have led to the current status of the patent law. To clearly understand these issues, the review also discusses various U.S. Supreme Court cases that, although not related to self-replicating technologies, have an impact on these patentability issues. Finally, some thoughts regarding patent strategy are presented so as to maximize patent protection for these technologies. PMID:25256175

  7. 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

  8. Patentability of Parthenogenic Stem Cells: International Stem Cell Corporation v. Comptroller General of Patents.

    PubMed

    Mansnérus, Juli

    2015-06-01

    The European Court of Justice (ECJ) has recently issued a ruling in Case C-364/13 International Stem Cell Corporation v. Comptroller General of Patents Designs and Tademarks (Case) that aims at harmonising the patenting practices regarding interpretation of Article 6.2.c of Directive 98/44/EC (Biotech Patent Directive) in respect of patentability of human parthenogenic stem cells (hpSCs). The Case alters the patenting regime for human embryonic stem cell (hESC) applications, by stating that moral restrictions against hESC-patents are only applicable to such cells derived from embryos that had the potential to develop into a human being. Consequently, hpSC-based inventions may be patentable in Europe. This Case represents a leap forward to striking a balance between protecting human dignity and integrity whilst granting patent incentives for biomedical research. PMID:26399046

  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. 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... MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) MINERAL PATENT APPLICATIONS Lode Mining Claim Patent Applications § 3862.8-1 Land descriptions in patents. The land description in a patent...

  11. 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 patents. 1.46 Section 1.46 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Who May...

  12. 37 CFR 3.81 - Issue of patent to assignee.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Issue of patent to assignee. 3.81 Section 3.81 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE... of patent to assignee. (a) With payment of the issue fee: An application may issue in the name of...

  13. 37 CFR 42.221 - Amendment of the patent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Amendment of the patent. 42.221 Section 42.221 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Post-Grant Review...

  14. 37 CFR 42.121 - Amendment of the patent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Amendment of the patent. 42.121 Section 42.121 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Inter Partes Review...

  15. 37 CFR 1.14 - Patent applications preserved in confidence.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Patent applications preserved in confidence. 1.14 Section 1.14 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES General...

  16. 37 CFR 1.81 - Drawings required in patent application.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Drawings required in patent application. 1.81 Section 1.81 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions The...

  17. 37 CFR 1.46 - Assigned inventions and patents.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Assigned inventions and patents. 1.46 Section 1.46 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Who May...

  18. 37 CFR 1.215 - Patent application publication.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Patent application 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...

  19. 37 CFR 42.221 - Amendment of the patent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Amendment of the patent. 42.221 Section 42.221 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Post-Grant Review...

  20. 37 CFR 1.42 - Applicant for patent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Applicant for patent. 1.42 Section 1.42 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Who May Apply for...