Generic Pharmaceutical Patent and FDA Law

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Publisher :
ISBN 13 : 9780314991447
Total Pages : 643 pages
Book Rating : 4.9/5 (914 download)

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Book Synopsis Generic Pharmaceutical Patent and FDA Law by : Shashank Upadhye

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:

Medical Monopoly

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Publisher : University of Chicago Press
ISBN 13 : 022610821X
Total Pages : 345 pages
Book Rating : 4.2/5 (261 download)

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Book Synopsis Medical Monopoly by : Joseph M. Gabriel

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.

Drug Wars

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Publisher : Cambridge University Press
ISBN 13 : 131673949X
Total Pages : 165 pages
Book Rating : 4.3/5 (167 download)

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Book Synopsis Drug Wars by : Robin Feldman

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.

Generic drug entry prior to patent expiration an FTC study

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Publisher : DIANE Publishing
ISBN 13 : 1428951938
Total Pages : 129 pages
Book Rating : 4.4/5 (289 download)

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Book Synopsis Generic drug entry prior to patent expiration an FTC study by :

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:

The Global Politics of Pharmaceutical Monopoly Power

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Publisher :
ISBN 13 : 9789079700066
Total Pages : 136 pages
Book Rating : 4.7/5 ( download)

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Book Synopsis The Global Politics of Pharmaceutical Monopoly Power by : Ellen F. M. 't Hoen

Download or read book The Global Politics of Pharmaceutical Monopoly Power written by Ellen F. M. 't Hoen and published by . This book was released on 2009 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Transnational Legal Orders

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Publisher : Cambridge University Press
ISBN 13 : 1107069920
Total Pages : 559 pages
Book Rating : 4.1/5 (7 download)

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Book Synopsis Transnational Legal Orders by : Terence C. Halliday

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.

Patent Strategy in Pharmaceutical Industry

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Publisher : Nomos Verlagsgesellschaft
ISBN 13 : 9783848709915
Total Pages : 0 pages
Book Rating : 4.7/5 (99 download)

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Book Synopsis Patent Strategy in Pharmaceutical Industry by : Monica Donghi

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.

Pharmaceutical and Biotech Patent Law

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Publisher :
ISBN 13 : 9781402431388
Total Pages : 1204 pages
Book Rating : 4.4/5 (313 download)

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Book Synopsis Pharmaceutical and Biotech Patent Law by : Arnold & Porter Kaye Scholer Llp

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.

Significant Pharmaceuticals Reported in US Patents

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Publisher : Elsevier
ISBN 13 : 0080480918
Total Pages : 701 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Significant Pharmaceuticals Reported in US Patents by : Thomas F. DeRosa

Download or read book Significant Pharmaceuticals Reported in US Patents written by Thomas F. DeRosa and published by Elsevier. This book was released on 2010-07-07 with total page 701 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant Pharmaceuticals Reported in US Patents identifies the next generation of pharmaceuticals reported in US Patents. This "hands-on" title provides explicit laboratory methods for preparing the most recent and effective medications. Each entry documents the biological testing protocols used to evaluate a drug and the significance of the current treatment agent over previous methods. Pharmaceuticals are included in this review only if at least two of the following criteria were met: Effectiveness in treating an illness, Innovative, ease of preparation, synergy with existing Medications. Pharmaceuticals are reported for 27 separate classes of illness, including: AIDS, Alzheimer's Disease, Cardiovascular Disorders, Diabetes, Epilepsy, Hepatitis C, Osteoporosis, Obesity and Sleep Disorders. Significant Pharmaceuticals Reported in US Patents has been designed to be used as both a reference and synthetic guide for pharmaceutical, medicinal and organic chemists and graduate students. Researchers working in other areas will also find the information valuable as in many instances intermediates or the next generation pharmaceutical are readily convertible into other industrial products including: anti-oxidants, chemical additives, herbicides, polymer precursors, water purification agents. Clear structural depictions of reagents and chemical transformations have been supplied to permit the identification of other future applications. Identifies next generation pharmaceuticals Provides practical preparation methods for each active agent and derivatives Documents the analytical characterization and biological testing results of active agents

The Generic Challenge

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Publisher : BrownWalker Press
ISBN 13 : 1627347461
Total Pages : 240 pages
Book Rating : 4.6/5 (273 download)

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Book Synopsis The Generic Challenge by : Martin A. Voet

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.

Generic Animal Drugs

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Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Generic Animal Drugs by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment

Download or read book Generic Animal Drugs written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1987 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:

New Essays in the Legal and Political Theory of Property

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Publisher : Cambridge University Press
ISBN 13 : 9780521640015
Total Pages : 232 pages
Book Rating : 4.6/5 (4 download)

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Book Synopsis New Essays in the Legal and Political Theory of Property by : Stephen R. Munzer

Download or read book New Essays in the Legal and Political Theory of Property written by Stephen R. Munzer and published by Cambridge University Press. This book was released on 2001-06-18 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of essays examines central issues of property theory from a variety of perspectives.

India and the Patent Wars

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Publisher : Cornell University Press
ISBN 13 : 1501713981
Total Pages : 241 pages
Book Rating : 4.5/5 (17 download)

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Book Synopsis India and the Patent Wars by : Murphy Halliburton

Download or read book India and the Patent Wars written by Murphy Halliburton and published by Cornell University Press. This book was released on 2017-11-15 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Patents, Human Rights, and Access to Medicines

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Publisher : Cambridge University Press
ISBN 13 : 1108654037
Total Pages : 185 pages
Book Rating : 4.1/5 (86 download)

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Book Synopsis Patents, Human Rights, and Access to Medicines by : Emmanuel Kolawole Oke

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.

Second Generation Patents in Pharmaceutical Innovation

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Publisher : Nomos Verlagsgesellschaft
ISBN 13 : 9783848708741
Total Pages : 0 pages
Book Rating : 4.7/5 (87 download)

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Book Synopsis Second Generation Patents in Pharmaceutical Innovation by : Hyewon Ahn

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.

Intellectual Property and Public Health in the Developing World

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Publisher : Open Book Publishers
ISBN 13 : 1783742313
Total Pages : 193 pages
Book Rating : 4.7/5 (837 download)

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Book Synopsis Intellectual Property and Public Health in the Developing World by : Monirul Azam

Download or read book Intellectual Property and Public Health in the Developing World written by Monirul Azam and published by Open Book Publishers. This book was released on 2016-05-30 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Across the world, developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book, Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil, China, India, and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azam's legal expertise, concern for public welfare, and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organization's TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents, the consequences for developing countries, and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh, offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must-read for public policy-makers, academics and students, non-governmental organizations, and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people.

ANDA Litigation

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Publisher : American Bar Association
ISBN 13 : 9781614384786
Total Pages : 0 pages
Book Rating : 4.3/5 (847 download)

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Book Synopsis ANDA Litigation by : Kenneth L. Dorsney

Download or read book ANDA Litigation written by Kenneth L. Dorsney and published by American Bar Association. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.