India and the Patent Wars
India and the Patent Wars

Author: Murphy Halliburton

Publisher: Cornell University Press

Published: 2017-11-15

Total Pages: 261

ISBN-13: 1501713981

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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.

The WTO and India's Pharmaceuticals Industry
The WTO and India's Pharmaceuticals Industry

Author: Sudip Chaudhuri

Publisher: Oxford University Press, USA

Published: 2005

Total Pages: 384

ISBN-13:

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The establishment of the World Trade Organization (WTO) in 1995 brought about significant changes in international economic relations between countries. To comply with the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the WTO, India introduced product patent protection in pharmaceuticals from January 2005. TRIPS has generated a huge controversy in India and abroad. India has emerged as a major source of low-cost, quality drugs for the entire world and thus plays an important role. While there are a large number of pharmaceutical manufacturers in the world, only a handful of multinationals dominate the industry. By using patent rights, multinational companies prevented developing countries like India from realizing their potential of industrial growth and drug prices were among the highest in the world.

Use Patents, Carve-Outs, and Incentives -- A New Battle in the Drug-Patent Wars
Use Patents, Carve-Outs, and Incentives -- A New Battle in the Drug-Patent Wars

Author: Arti K. Rai

Publisher:

Published: 2014

Total Pages: 0

ISBN-13:

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The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms. In contrast, this Perspective uses the lens of a recently decided Supreme Court case, Caraco Pharmaceutical Laboratories v. Novo Nordisk, to examine conflicts between incentives and access in an important new arena -- "carve out" efforts by generic firms to avoid use patents held by brand-name firms. With the number of approvals for drugs that are new chemical compounds dropping significantly in recent years, new uses for existing compounds, and the scope of patent protection for such uses, are increasingly contested territory. Caraco holds, quite correctly, that Congress intended generics to be able to challenge overly broad claims regarding use patents that brand name firms make to the FDA. However, the litigation-based approach for challenge that Congress has provided is highly inefficient. An administrative approach, in which the FDA might consult with the Patent and Trademark Office, would clearly be more efficient. Lurking behind these administrative policy issues is an issue of substantive innovation policy. The decision in Caraco, although doctrinally correct, arguably reduces patent-related incentives to test potential new uses rigorously. However, patents are not the only possible incentives. Public funding can play, and indeed already has played, a significant role in rigorous testing of new uses. Going forward, brand-name firms could view Caraco's partial restriction on their proprietary claims as a spur to leverage public-sector investment.

Drug Patents in India
Drug Patents in India

Author: Amitendu Palit

Publisher:

Published: 2013

Total Pages: 6

ISBN-13:

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Using the Supreme Court of India's rejection of Novartis0́9s appeal for patenting and exclusive marketing of the cancer drug Glivec as a backdrop, this paper discusses India's intellectual property rights law and its implications for pharmaceutical innovations and generic drug manufacturing. It argues that despite the common belief that patent regulations favor generic drugs production and thus enable access to cheaper drugs by the domestic poor, in practice domestic price ceilings on essential drugs have encouraged generic manufacturers to increasingly focus on export markets.

Patent Wars in the Valley of the Shadow of Death
Patent Wars in the Valley of the Shadow of Death

Author: Uche Ewelukwa

Publisher:

Published: 2014

Total Pages: 0

ISBN-13:

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Attempts to assist developing countries' access to much needed pharmaceuticals have been implemented but will not address all the problems associated with public health in the developing world. The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) sought to balance access to low priced, essential medical supplies with a legal environment that respects intellectual property rights. Under TRIPS and the subsequent Doha Declaration, developing countries without adequate manufacturing capacities can import pharmaceuticals produced in foreign countries under compulsory licenses. Though, this arrangement's true effectiveness at providing low cost pharmaceuticals to the developing world is not fully apparent. Careful analysis of the TRIPS negotiation history helps uncover the motivations of developing countries, developed countries, and pharmaceutical companies in addressing issues of public health and intellectual property rights. By examining specific cases in the United States of abuse by pharmaceutical companies to delay or suppress generic competition, parallels can be drawn as to how abuse may occur internationally despite TRIPS. Both the lack of a multilateral framework on competition policy and the costs associated with the potential implementation of TRIPS pose significant burdens for developing countries. Compulsory licensing creates conditions that impose unnecessary costs on developing countries, which limit the practical application of acquiring necessary pharmaceuticals, and will not address all the problems related to public health.

The Global Politics of Pharmaceutical Monopoly Power
The Global Politics of Pharmaceutical Monopoly Power

Author: Ellen F. M. 't Hoen

Publisher:

Published: 2009

Total Pages: 136

ISBN-13: 9789079700066

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In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.

Pharmaceutical Patent Wars, Reverse-Payment Settlements, and Their Anticompetitive Effects for Consumers
Pharmaceutical Patent Wars, Reverse-Payment Settlements, and Their Anticompetitive Effects for Consumers

Author: Steven Adamson

Publisher:

Published: 2017

Total Pages: 31

ISBN-13:

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Generic drugs have been provided considerable cost-savings to consumers. The Hatch-Waxman Act provides economic incentives to both generic and brand-name manufacturers, but it is a complicated piece of legislation scattered across numerous sections of the United States Code. This obfuscation has led to abuse by brand name and generic drug manufacturers, resulting in anticompetitive behaviors for the consumer. Despite attempts to ameliorate the problem, a review of case law makes plain that the judicial and legislative systems are currently inadequate to address this problem. Litigation typically arises in the context of patented drug filings after a generic drug manufacturer files an Abbreviated New Drug Application for a generic drug modeled after the patented drug, an act of constructive patent infringement. This then initiates paragraph IV patent litigation. In order to avoid a finding of patent invalidity, branded and generic manufacturers have entered into collusive “reverse-payment” agreements in which the branded manufacturer agrees to pay the generic company to stay out of the market. While direct cash payments seem to have been foreclosed in FTC v. Actavis, subsequent iterations of reverse payments have evaded this holding, allowing reverse payments to continue to the frustration of many consumers. Finally, the latest mode of manipulation does not involve monetary transfers, but rather manipulates the FDA system via product hopping, risk evaluation monitoring systems, and sham citizen petitions, to achieve anticompetitive aims. This articles examines the patenting system for generic drugs, the numerous modes of reverse-payment, particularly with the difficulty of prescribing a bright-line approach to often fluid definitions of “reverse payments.” This is the first article to review the array of reverse payment modes, explaining how legislative and judicial efforts to combat these practices have failed, and arguing for a systemic legislative approach to solving this problem.

Intellectual Property, Pharmaceuticals and Public Health
Intellectual Property, Pharmaceuticals and Public Health

Author: Kenneth C. Shadlen

Publisher: Edward Elgar Publishing

Published: 2011-01-01

Total Pages: 353

ISBN-13: 0857938614

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'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.

Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.