Patently Innovative: How Pharmaceutical Firms Use Emerging Patent Law to Extend Monopolies on Blockbuster Drugs

by R A Bouchard

Overview

Patently innovative 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.

• Includes empirical research to relate innovation to drug law
• A multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovation
• Discusses the impact of government regulation on firm innovation

Product Details

ISBN-13:	9781908818089
Publisher:	Elsevier Science
Publication date:	01/02/2012
Series:	Woodhead Publishing Series in Biomedicine
Sold by:	Barnes & Noble
Format:	eBook
Pages:	296
File size:	4 MB

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 appeared before the Federal Court of Canada and the Supreme Court of Canada. He has consulted with firms, universities, governments, and international organizations on legal, regulatory, and policy issues. He worked with the Government of Canada on its platforms for drug regulation and public private partnerships in technology commercialization. His research has been funded by federal and provincial funding agencies and private endowments. His scholarly expertise is focused on the intellectual property and regulatory aspects of therapeutic product development, including global aspects of technology commercialization, patenting, licensing, and regulatory approval, and empirical assessment of the impact of government stimulus packages and regulation on technology innovation. Dr Bouchard currently is 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

Dedication

Acknowledgements

List of figures and tables

List of abbreviations

About the author

Chapter 1: Introduction

Abstract:

1.1 The emergence of global pharmaceutical linkage

1.2 Canadian pharmaceutical linkage regulations

1.3 Organization

Chapter 2: Background: drug approval, drug patenting, pharmaceutical linkage, and public health policy

Abstract:

2.1 Drug approval

2.2 Patents

2.3 Linkage regulations

2.4 IPR rights and innovation policy

Chapter 3: Empirical analysis of drug approval

Abstract:

3.1 Introduction

3.2 Analysis

3.3 Results

3.4 Discussion

3.5 Interpretation of data

3.6 Study limitations

3.7 Assessing the lifecycle approach: the long view

3.8 Government as representative public agent

3.9 Summary and conclusions

Chapter 4: Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage

Abstract:

4.1 Introduction

4.2 Methods

4.3 Results

4.4 Discussion

Chapter 5: Empirical analysis of drug patenting in multiple high-value cohorts

Abstract:

5.1 Introduction

5.2 Methods

5.3 Results

5.4 Discussion

5.5 Summary and conclusions

Chapter 6: Implications of empirical data: are pharmaceutical linkage regulations a success?

Abstract:

6.1 Introduction

6.2 Debate preceding Bill C-91

6.3 ‘Original policy intent’

6.4 ‘Patent-specific’ analysis

6.5 Statutory interpretation

6.6 Revisiting the empirical data

6.7 Summary and conclusions

Chapter 7: Future directions: testable hypotheses and evolution toward global pharmaceutical linkage

Abstract:

7.1 Hypotheses regarding cluster-based drug development

7.2 Globalization of pharmaceutical linkage

Index

Editorial Reviews

Reviewer: Albert I Wertheimer, BS, MBA, PhD (Temple University School of Pharmacy)
Description: This is an in-depth, detailed look into the use of intellectual property protections by pharmaceutical manufacturers, and a review of global patent linkage regulations and how they are being used by the industry.
Purpose: The goal is to probe in detail the specific legal nexus between the innovative character of new and follow-on drugs, the scope of intellectual property protection afforded to these drugs under linkage regulations, and generic entry timing and the impact on public health. The book addresses an important topic, albeit an arcane one, which is underexplored.
Audience: As a result, it has a limited audience and would be of interest to patent attorneys, intellectual property personnel at pharmaceutical and biotechnology companies, and perhaps some other readers. The book is written at a level where in-depth knowledge of the subject is desirable for full understanding. The author is one of a small number of expects in this area, and he has done a good job in making the major points understandable to nonexperts.
Features: The book is divided into seven chapters and contains a good list of abbreviations, a thorough index and many illustrative tables and figures that help with comprehension. It starts with the regulatory drug approval process and moves into the linkage realm where we learn that these have come about often through trade treaties such as NAFTA or the TRIPS agreements. Perhaps one of its best features is the detailed compilation of references and citations from the world literature. The book considers the future of linkages and speculates on the impact of new drug and generic approvals.
Assessment: The book is unique in gathering all of this material in one place for people specializing in this area. It is well organized and written, with up-to-date citations and some thoughtful and thought-provoking commentary from a writer experienced in this very specialized area.

Doody's Review Service