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Patently Innovative: How Pharmaceutical Firms Use Emerging Patent Law to Extend Monopolies on Blockbuster Drugs (Biohealthcare Publishing Series on Pharma, Biotech and Biosc)

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Patently Innovative: How Pharmaceutical Firms Use Emerging Patent Law to Extend Monopolies on Blockbuster Drugs (Biohealthcare Publishing Series on Pharma, Biotech and Biosc) Cover

 

Synopses & Reviews

Publisher Comments:

The availability of generic and brand-name drugs worldwide is a function of a combination of traditional patent law incentives and emerging 'linkage regulations', which legally tie brand and generic drug approval to drug patents through mandatory litigation for generic firms. Together, these systems of intellectual property law operate to shape the marketplace for brand and generic pharmaceuticals and thus determine the costs of public and private drug expenditures and access to essential medications in developed and developing nations.

The patent monopoly system has been in operation for about 500 years, with early patent laws in Italy and the United Kingdom. By contrast however, the linkage regime has only been in existence for 27 years following passage of the Hatch Waxman Act in the United States in 1984. By 2010 there was a global spread of the linkage regime stimulated in part by multilateral Free Trade Agreements with the United States and the European Union, which typically oblige participating nations to incorporate linkage provisions in exchange for preferential trade terms. Moreover, there appears to be movement afoot to broaden the concept of linkage outside the drug approval process to include that between patent rights and international trade regulation. Therefore, linkage regulations in respect of pharmaceuticals are emerging as a key driver of public health costs on the global stage.

This book provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.

The work focuses on an assessment of empirical data pertaining to how linkage regulations, which legally tie drug patenting to drug approval for both brand-name and generic pharmaceutical firms, can be used by sophisticated drug companies to substantially extend monopoly protection on blockbuster drugs.  It also shows how incentives provided by governments to stimulate pharmaceutical innovation can antecedently shape the rate and direction of innovation by firms in a manner opposite to that intended as a result of unintentional consequences. Particular attention is given to data relating to trends in the development of 'new' and 'follow-on' drugs and the relation of these trends to the institution of reforms in drug law and patent law intended to stimulate innovation.

- Emphasizes the importance of empirical research in probing the connection between innovation policy, IP law, food and drug law and therapeutic products

- Reviews the timeline for spread of pharmaceutical linkage worldwide

- Offers evidence for cluster-based drug development strategy

Book News Annotation:

Bouchard is a Canada-based intellectual property lawyer specializing in the regulation and litigation of biomedical products, and their innovation. The subtitle of this book is somewhat misleading in that the scope is much broader than it would indicate, and this is a scholarly study rather than a polemic. Discussion begins with introductory and background material regarding drug approval, drug patenting, pharmaceutical linkage, and public health policy. Following is empirical analysis of each of these topics in separate chapters. Completing the presentation are a summary regarding the implications of the data and whether or not linkage regulations are a success, and discussion of future directions. Annotation ©2012 Book News, Inc., Portland, OR (booknews.com)

Synopsis:

The availability of generic and brand name drugs worldwide is a function of a combination of traditional patent law incentives and emerging “linkage regulations”, which legally tie brand and generic drug approval to drug patents through mandatory litigation for generic firms. Together, these systems of intellectual property law operate to shape the marketplace for brand and generic pharmaceuticals and thus determine the costs of public and private drug expenditures and access to essential medications in developed and developing nations.

This book provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.

About the Author

Dr. Ron A. Bouchard is an intellectual property lawyer and scholar, specializing in the innovation, regulation, and litigation of biomedical products. His career has focused on the science, law, policy, regulation, and commercialization of medical technologies. He began his career as a medical scientist, completing a PhD and Postdoctoral Fellowship in the field of ion channel biophysics and Ca2+ imaging. He shifted focus to obtain a law degree specializing in pharmaceutical and biotechnology law and has been involved in the prosecution, acquisition, financing, distribution, and litigation of intellectual property rights. Dr. Bouchard has worked with the Government of Canada on its platforms for drug regulation and public private partnerships in technology commercialization.  He is currently involved with a new global consortium of scholars, physicians and economists studying the impact of emerging forms of patent law on the availability and costs of essential medications in developed and developing nations: the Consortium Study of Global Pharmaceutical Linkage.

Table of Contents

Introduction; Background: drug approval, drug patenting, pharmaceutical linkage, and public health policy; Empirical analysis of drug approval;  Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage; Empirical analysis of drug patenting in multiple high-value cohorts;  Implications of empirical data: are pharmaceutical linkage regulations a success?; Future directions: testable hypotheses and evolution toward global pharmaceutical linkage

 

Product Details

ISBN:
9781907568121
Author:
Bouchard, Ron A.
Publisher:
Woodhead Publishing
Author:
Bouchard, Ron
Subject:
Law : Intellectual Property - General
Subject:
Health and Medicine-Pharmacology
Edition Description:
Hardcover
Series:
Woodhead Publishing Series in Biomedicine
Publication Date:
20120131
Binding:
HARDCOVER
Grade Level:
SG
Language:
English
Pages:
296
Dimensions:
9 x 6 in

Related Subjects

Health and Self-Help » Health and Medicine » Pharmacology
History and Social Science » Law » General
History and Social Science » Law » Intellectual Property » General
History and Social Science » Law » Intellectual Property » Patent
History and Social Science » Law » Legal Guides and Reference

Patently Innovative: How Pharmaceutical Firms Use Emerging Patent Law to Extend Monopolies on Blockbuster Drugs (Biohealthcare Publishing Series on Pharma, Biotech and Biosc) New Hardcover
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Product details 296 pages Woodhead Publishing - English 9781907568121 Reviews:
"Synopsis" by ,
The availability of generic and brand name drugs worldwide is a function of a combination of traditional patent law incentives and emerging “linkage regulations”, which legally tie brand and generic drug approval to drug patents through mandatory litigation for generic firms. Together, these systems of intellectual property law operate to shape the marketplace for brand and generic pharmaceuticals and thus determine the costs of public and private drug expenditures and access to essential medications in developed and developing nations.

This book provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.

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