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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
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.
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
This collection of essays examines central issues of property theory from a variety of perspectives.
In a sophisticated defense of intellectual property, Merges draws on Kant, Locke, and Rawls to explain how IP rights are based on a solid ethical foundation and make sense for a just society. He also calls for appropriate boundaries: IP rights are real, but they come with real limits.
India and the Patent Wars contributes to an international debate over the costs of medicine and restrictions on access under stringent patent laws showing how activists and drug companies in low-income countries seize agency and exert influence over these processes. Murphy Halliburton contributes to analyses of globalization within the fields of anthropology, sociology, law, and public health by drawing on interviews and ethnographic work with pharmaceutical producers in India and the United States. India has been at the center of emerging controversies around patent rights related to pharmaceutical production and local medical knowledge. Halliburton shows that Big Pharma is not all-powerful, and that local activists and practitioners of ayurveda, India’s largest indigenous medical system, have been able to undermine the aspirations of multinational companies and the WTO. Halliburton traces how key drug prices have gone down, not up, in low-income countries under the new patent regime through partnerships between US- and India-based companies, but warns us to be aware of access to essential medicines in low- and middle-income countries going forward.
This book examines one of the most controversial aspects of the world trading system: patents and access to medication, and offers approaches to tackle the issue of how to better accommodate human rights in the trading system.