Download or read book Patent Law Its Application to the Pharmaceutical Industry written by Swapnil Khadke and published by LAP Lambert Academic Publishing. This book was released on 2013 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of drugs is costly for pharmaceutical companies, and without intellectual property law protection, the formula for the drugs can be easily duplicated and the drugs can be synthesized at a cheaper cost. Thus, intellectual properties laws often allow companies to monopolize the synthesis and sales of drugs. Unfortunately, this exclusive right to manufacture and sell drugs provides the necessary monetary incentive for drug discovery. The patent law is based upon the Patent Act of 1952, codified in Title 35 of the United States Code. This statute allows inventors to obtain patents on processes, machines, manufactures, and compositions of matter that are useful, new, and nonobvious. Granted patents confer the right to exclude others from making, using, selling, offering to sell, or importing into the United States the patented invention. This book covers issues through the year 2002, Modifications of the Hatch-Waxman Act were implemented in P.L. 108-173, the Medicare Prescription Drug and Modernization Act of 2003.
Download or read book Competition and Patent Law in the Pharmaceutical Sector written by Giovanni Pitruzzella and published by Kluwer Law International. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Download or read book Patent Law and Its Application to the Pharmaceutical Industry written by and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Congressional interest in the availability of prescription drugs has focused attention on the role of patents in the pharmaceutical industry. The industry has been described as patent-intensive. Enterprises within this sector frequently obtain patent protection and enforce patent rights, and reportedly place a higher comparative value on patents than do competitors in many other markets. The patent law is based upon the Patent Act of 1952, codified in Title 35 of the United States Code. This statute allows inventors to obtain patents on processes, machines, manufactures, and compositions of matter that are useful, new, and nonobvious. Granted patents confer the right to exclude others from making, using, selling, offering to sell, or importing into the United States the patented invention. The Drug Price Competition and Patent Term Restoration Act of 1984 (the 1984 Act) â€" commonly known as the “Hatch-Waxman Actâ€ŗ â€" made several significant changes to the patent laws designed to encourage innovation in the pharmaceutical industry while facilitating the speedy introduction of lower-cost generic drugs. These changes include provisions for extending the term of a patent to reflect regulatory delays encountered in obtaining marketing approval by the Food and Drug Administration (FDA); a statutory exemption from patent infringement for activities associated with regulatory marketing approval; establishment of mechanisms to challenge the validity of a pharmaceutical patent; and a reward for disputing the validity, enforceability, or infringement of a patented and approved drug. The 1984 Act also provides the FDA with certain authorities to offer periods of marketing exclusivity for a pharmaceutical independent of the rights conferred by patents. Many experts agree the 1984 Act has had a significant effect on the availability of generic substitutes for brand name drugs. Lower cost generics tend to be rapidly marketed after patent expiration. Increasing investment in R&D and gains in the research intensity of the pharmaceutical industry appear to indicate that the act has not deterred the development of new drugs. However, some questioned whether the law is needed to achieve the stated goals. Critics maintained the necessity of patent-related incentives for innovation is mitigated by other federal activities. Supporters of the existing approach argued that these incentives are precisely what foster a robust pharmaceutical industry. Of fundamental interest was whether alterations of the act were in order to reflect any perceived changes in the research environment since the legislation was enacted in the 1980s. This background report covers issues through the year 2002. Modifications of the Hatch-Waxman Act were implemented in P.L. 108-173, the Medicare Prescription Drug and Modernization Act of 2003. For the latest information on these recent initiatives see CRS Report RL32377, The Hatch-Waxman Act: Legislative Changes Affecting Pharmaceutical Patents, April 30, 2004.
Download or read book TRIPS and Access to Medicines written by Renata Curzel and published by Kluwer Law International B.V.. This book was released on 2020-12-10 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although ideally a patent system for pharmaceuticals should serve to incentivize research into the development of new medicines, the COVID-19 pandemic has exposed the equal importance of drug access and affordability. This book, by focusing on the Brazilian rule which makes the grant of pharmaceutical patents dependent on the prior consent of the National Health Surveillance Agency (ANVISA), shows how the Brazilian model affords an example for other countries to follow in dealing with tensions between patent protection and the right to healthcare. Based on an empirical study in which the author examined 147 reports issued by ANVISA as a basis for its decisions, the book deals with such central questions concerning the interface of regulation and innovation in the patent system as the following: compatibility between ANVISA’s prior consent mechanism and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; how “evergreening” and “trivial patents” undermine public health and access to medicines; ways of correcting abuses of patent rights and controlling quality of patents; and the discourse on health as a human right. Along with her examination of ANVISA reports, the author analyzes how Article 229-C LPI, which introduced the need of ANVISA’s prior consent to the patent grant of pharmaceuticals in Brazil, has been interpreted in Brazilian case law. Interviews with Brazilian experts are also included. In its commitment to harmonizing patent rights and the right to access of affordable medicines, Brazil’s patent system for pharmaceuticals stands out as a workable response to the basic problem of access to medicines in the developing world. By describing the successes and failures in the Brazilian policy of promoting drug access, this book helps policymakers in developing and emerging countries to better explore TRIPS flexibilities when dealing with similar problems, and provides practitioners in the law of the World Trade Organization, patent law, competition law, and health law with a guide to how a more equitable pharmaceutical patenting system could work in practice.
Download or read book Innovation Economic Development and Intellectual Property in India and China written by Kung-Chung Liu and published by Springer Nature. This book was released on 2019-09-06 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.
Download or read book Patent Rights in Pharmaceuticals in Developing Countries written by Jakkrit Kuanpoth and published by Edward Elgar Publishing. This book was released on 2010-01-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policy-making in this area.
Download or read book Patent Law and Intellectual Property in the Medical Field written by Aggarwal, Rashmi and published by IGI Global. This book was released on 2017-06-30 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growing presence of technology has created significant changes within the healthcare industry. With the ubiquity of these technologies, there is now an increasing need for more advanced legal procedures. Patent Law and Intellectual Property in the Medical Field is a pivotal reference source for the latest research in support of developing convergent and interoperable systems to increase awareness and applicability of legal aspects in the medical field. Featuring extensive coverage on relevant areas such as compulsory licensing, parallel importing, and protection law, this publication is an ideal resource for researchers, medical and law professionals, academics, graduate students, and practitioners engaged in medical practice.
Download or read book Patent Law and Its Application to the Pharmaceutical Industry written by Wendy H. Schacht and published by . This book was released on 2000 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Patents in Europe written by Bengt Domeij and published by BRILL. This book was released on 2021-10-25 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry and patent legislation are inextricably linked. Pharmaceutical companies could not exist without some guarantee that they can recoup the cost of developing a new product. European patent law offers this opportunity, as it allows companies to exclude competition for a specific product for a fixed time scale. In Pharmaceutical Patents in Europe the current legal patent situation is examined by a detailed analysis of case law from the European Patent Office (EPO), the international body created with the signing of the European Patent Convention (EPC). Aspects of European patent law not primarily regulated in the EPC, for example Supplementary Protection Certificates and infringement matters, are examined in the setting provided by EC law and domestic laws of European states. This book is written for the reader who understands the main characteristics of patent law and is looking for a practitioner's text on the European pharmaceutical patent law scene. Moreover, the author's remarks can help all readers to look at the field with fresh eyes.
Download or read book The Chemist s Companion Guide to Patent Law written by Chris P. Miller and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an individual with experience as both a chemist and a patent attorney, The Chemist's Companion Guide to Patent Law covers everything the student or working chemist needs to know about patentability, explaining important concepts of patent law (such as novelty, non-obviousness, and freedom-to-operate) in easy-to-understand terms. Through abundant examples from case law as well as real-world situations with which a researcher might be faced, this book provides readers with a better understanding of how to put that knowledge into practice.
Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by Routledge. This book was released on 2017-02-17 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges
Download or read book Intellectual Property Rights and the Life Science Industries written by Graham Dutfield and published by World Scientific. This book was released on 2009 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.
Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Download or read book Patent Protection for Second Medical Uses written by Jochen Bühling and published by Kluwer Law International B.V.. This book was released on 2020-10-13 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: AIPPI Series, Volume Number 2. The second edition of Patent Protection for Second Medical Uses is a practical guide on the ever-relevant and controversial topic ‘Second Medical Use’ (SMU) patents, which play a significant role in the potential second-line patent protection and have become increasingly important. This edition’s analysis sheds light on the availability of protection for second medical use claims and its legal basis, followed by a detailed look at the specifics of various jurisdictions. Following the abandoning of ‘Swiss-type claims’ at the European Patent Office (EPO), applicants had to develop new filing strategies while such claims are still allowable in a number of national jurisdictions worldwide; the consequences of this have not yet fully been explored in practice. Jurisdictions around the world show significant differences in the treatment of such claims, although they share common approaches in patent law overall. This second edition furnishes a detailed and elaborate analysis, providing clarity, insight and guidance on legal issues and practical implications of SMU claims in twenty-four jurisdictions (the EPO and twenty-three individual countries). What’s in this book: This book, published under the aegis of the esteemed International Association for the Protection of Intellectual Property (AIPPI), contains a chapter-wise analysis by carefully chosen authors known for their expertise and experience in this field. Each chapter highlights such issues and topics as the following: availability and scope of protection; validity of claims; enforcement; infringement and investigations; and procedural aspects and tactical recommendations. The AIPPI studied certain aspects of second medical use claims on the occasion of its Congress in Toronto in 2014. This led to its Resolution Q 238 – ‘Second medical use and other second indication claims’, which triggered this comparative law analysis and a copy of which is found at the end of this book. How this will help you: This book is an enlightening compendium of contributions from across the globe. It not only renders guidance to interested legal practitioners when filing a patent application and assessing risks of conflict with existing patents or patent applications but also explains the key issues and contains practical advice when enforcing such claims or defending against an action. Also, this book will prove to be of immense practical interest for patent lawyers and patent attorneys and for the industries involved, applicants for pharmaceutical patents and third parties.
Download or read book Pharmaceutical Patent Issues written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 1997 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical and Biotech Patent Law written by Arnold & Porter Kaye Scholer Llp and published by . This book was released on 2019-06-07 with total page 1204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.
Download or read book The Commercialization of Pharmaceutical Patents in China written by James Hou and published by Edward Elgar Publishing. This book was released on 2021-03-26 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting detailed analysis of the industrialization of pharmaceutical patents in China, this timely book explores a range of related topics including a comparison of the ideal and existing state of the pharmaceutical market and patent industrialization. It argues that the core purpose of the industrialization of pharmaceutical patents is to promote the development of the local pharmaceutical industry whilst also protecting society’s right to safe and effective medication.
