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Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Exploring the relationship between competition law and technology pools, this book provides general-purpose details of the biotechnology patent pool scheme while discussing historical developments, approaches of the US Department of Justice, Federal Trade Commission, and the European Union Competition Commission via EU regulations. In addition to these regulatory approaches and evolution in concept and theory of technology pools, this book illustrates relationship issues including tying arrangements and essential facility consideration vis-à-vis technology pools. It analyzes the modalities of forming such pools in the area of biotechnology, specifically illustrating that the formation of technology pools is possible and can be safely undertaken, and proposes a viable solution and structure. Patent pools in the biotechnology industry will pave the way towards open collaborative research, reducing patent thickets. Formation of such pools will increase access to various technology and patents otherwise out of bounds, resulting in a reduction of licensing costs and a spur in the development of new solutions. Most importantly, such pools will reduce the frequency of patent toll gates, making the entire spectrum of research interesting from the perspective of researchers as well as investors. This book will be an aid to researchers studying intellectual property, patents, and biotechnology, as well as to interest groups including funding agencies, venture funds, angel investors, and proponents of the open-source movement.
As technological developments multiply around the globeâ€"even as the patenting of human genes comes under serious discussionâ€"nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology. This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnologyâ€"areas characterized by high development cost and easy reproducibility. The volume covers these and other issues: Modern economic theory as a basis for approaching international IPRs. U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries. Trends in science and technology and how they affect IPRs. Pros and cons of a uniform international IPRs regime versus a system reflecting national differences.
A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.
This is an incredibly interesting book on an increasingly pertinent topic. . . the book is succinctly written and provides a comprehensive overview of EU law. . . providing a really useful analysis of the European cases concerned with the imposition of a duty to deal in relation to intellectual property. . . This book is a thoroughly enjoyable read, and perhaps because of its brevity the author retains her focus on the central issues being examined. I found it to be engaging and thought provoking. Jane Nielsen, Competition and Consumer Law Journal The book caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself. Journal of Intellectual Property Rights Using the example of research tools in biopharmaceutical research and innovation, this book examines the complexities of the relationship between two fundamental areas of law and policy intellectual property rights and competition law. It addresses a question that is certain to become paramount in other industries also: how to strike the balance between initial and follow-on innovation so as to ensure that access to essential research tools (or other fundamental elements to follow-on innovation) is not impeded. The book concludes by suggesting how competition law could be used to complement the patent balance. Competition Law and Patents caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself.
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.
Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
This authoritative book from one of the top experts in the field sets out a detailed and practical analysis of the complex and often fraught relationship between EU competition rules and intellectual property rights. It is an essential resource for competition lawyers litigating Tech and Pharma cases and advising companies in those sectors, for in-house counsel within those industries, and for IP lawyers needing to understand the competition aspects of licensing agreements. It is also an indispensable reference for courts, enforcement agencies and national competition authorities, as well as for scholars researching in the field.
. . . a lovely little book which is full of telling points. Read it and you won t be disappointed. Jeremy Phillips, IPkat.com Meir Pugatch has done an excellent job by assembling an international and diverse cast of contributing authors, who have offered new insights into a broad span of the most pressing IP-related issues. . . a collection of high quality articles by eminent authorities on IPR is very useful for scholars in the academic fields of law, practitioners, and government officials interested in the field of international trade and intellectual property policy; intellectual property law, technology transfer and valuation and international business. Madhu Sahni, Journal of Intellectual Property Rights Intellectual property (IP) has become one of the most influential and controversial issues in today s knowledge-based society. This challenging book exposes the reader to key issues at the heart of the public debate now taking place in the field of IP. It considers IP at the macro level where it affects many issues. These include: international trade policy, ownership of breakthrough technologies, foreign direct investment, innovation climates, public private partnerships, competition rules and public health where it is strongly embedded in contemporary business decision making. Meir Pugatch has assembled an international and diverse cast of contributing authors, who offer new insights into a broad span of the most pressing IP-related issues. They shed light on the increasing dominance of IP in the design and execution of basic and applied research, the evaluation of intangible assets, and the protection and management of knowledge assets, underscoring its importance in relation to national economic development strategies and business strategies of knowledge-based industries and companies. The Intellectual Property Debate will appeal to scholars, practitioners, and government officials interested in the fields of international trade and intellectual property policy, intellectual property law, technology transfer and valuation, and international business.