Download or read book Generic Pharmaceutical Patent and FDA Law written by Shashank Upadhye and published by . This book was released on 2008 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patents and Pharmaceutical Drugs written by Julio J. Nogués and published by World Bank Publications. This book was released on 1990 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lengthen effective patent protection in industrial countries and press developing countries to introduce patent protection. These two tactics have become important parts of the R&D-intensive pharmaceutical industry's strategy to regain losses in market share associated with more stringent drug safety regulations and increased competition from generic drug companies.
Download or read book Second Generation Patents in Pharmaceutical Innovation written by Hyewon Ahn and published by Nomos Verlagsgesellschaft. This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society.
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Download or read book Intellectual Property Pharmaceuticals and Public Health written by Kenneth C. Shadlen and published by Edward Elgar Publishing. This book was released on 2011-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume's editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars and decision-makers interested in the global politics of intellectual property rights and public health.' – Duncan Matthews, Queen Mary, University of London, UK This up-to-date book examines pharmaceutical development, access to medicines, and the protection of public health in the context of two fundamental changes that the global political economy has undergone since the 1970s, the globalization of trade and production and the increased harmonization of national regulations on intellectual property rights. With authors from eleven different countries presenting case studies of national experiences in Africa, Asia and the Americas, the book analyzes national strategies to promote pharmaceutical innovation, while at the same time assuring widespread access to medicines through generic pharmaceutical production and generic pharmaceutical importation. The expert chapters focus on patents as well as an array of regulatory instruments, including pricing and drug registration policies. Presenting in-depth analysis and original empirical research, this book will strongly appeal to academics and students of intellectual property, international health, international political economy, international development and law.
Download or read book The Generic Challenge written by Martin A. Voet and published by BrownWalker Press. This book was released on 2020-05-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
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.
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patents for Chemicals Pharmaceuticals and Biotechnology written by Philip W. Grubb and published by Oxford University Press, USA. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The nature and origins of patent rights -- Historical developments -- Harmonization of patent law -- What can be patented -- Filing a patent application -- Obtaining a granted patent : patent cooperation treaty procedure -- Obtaining a granted patent : European patent office procedure -- Obtaining a granted patent : national procedures -- Maintaining a patent in force and extending the patent term -- Enforcing patent rights -- Invalidity and amendment of granted patents -- Chemical inventions -- Pharmaceutical inventions -- Biotechnological inventions -- Patenting of genes, plants, and animals -- The patent practitioner and his function -- Drafting the patent specification -- Drafting the claims -- Prosecution of the patent application to grant -- Inventorship, ownership, and compensation -- Commercial exploitation of patents -- How to catch the infringer and how not to be caught -- Patent aspects of licensing -- Patents and competition law : United Kingdom and European Union -- Patents and competition law : United States
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 Patent term extension and the pharmaceutical industry written by and published by DIANE Publishing. This book was released on 1981 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 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 Medical Monopoly written by Joseph M. Gabriel and published by University of Chicago Press. This book was released on 2014-10-24 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: During most of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.
Download or read book Patent Strategy in Pharmaceutical Industry written by Monica Donghi and published by Nomos Verlagsgesellschaft. This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book investigates lifecycle management strategies used by pharmaceutical companies attempting to maximize the value of their product portfolio. Such strategies are sometimes referred to by generic drug companies as "evergreening". The analysis focuses on two of these strategies, namely product improvements and product line extensions. In particular, an evaluation of the patents that follow the basic one and that accompany the development of a drug from research to market is attempted. Two "blockbuster" drugs, Taxotere and Xalatan, were randomly chosen to carry out such analysis. The patent portfolio of the originator companies is outlined and some important patents for each area of research (e.g. formulations, combinations, delivery devices) are shortly described. Patent filing trends for the two drugs, both in regards of the originator and in regards of other competing companies (amongst these also the generics) are schematically shown.
Download or read book Patents Human Rights and Access to Medicines written by Emmanuel Kolawole Oke and published by Cambridge University Press. This book was released on 2022-03-03 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patent rights on pharmaceutical products are one of the factors responsible for the lack of access to affordable medicines in developing countries. In this work, Emmanuel Kolawole Oke provides a systematic analysis of the tension between patent rights and human rights law, contending that, in order to preserve their patent policy space and secure access to affordable medicines for their citizens, developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws. Through a comprehensive analysis of court decisions from three key developing countries (India, Kenya, and South Africa), Oke assesses the effectiveness of national courts in resolving conflicts between patent rights and the right to health, and demonstrates how a model of human rights can be incorporated into the adjudication of patent rights.
Download or read book Transnational Legal Orders written by Terence C. Halliday and published by Cambridge University Press. This book was released on 2015-01-19 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transnational Legal Orders offers an empirically grounded approach to the emergence of legal orders beyond nation-states that reframes the study of law and society.
