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Patently Innovative - 1st Edition - ISBN: 9781907568121, 9781908818089

Patently Innovative

1st Edition

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

Author: R A Bouchard
Hardcover ISBN: 9781907568121
eBook ISBN: 9781908818089
Imprint: Woodhead Publishing
Published Date: 2nd January 2012
Page Count: 296
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Table of Contents



List of figures and tables

List of abbreviations

About the author

Chapter 1: Introduction


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


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


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


4.1 Introduction

4.2 Methods

4.3 Results

4.4 Discussion

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


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?


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


7.1 Hypotheses regarding cluster-based drug development

7.2 Globalization of pharmaceutical linkage



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.

Key Features

  • 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


Patent attorneys and intellectual property personnel at pharmaceutical and biotechnology companies


No. of pages:
© Woodhead Publishing 2012
2nd January 2012
Woodhead Publishing
Hardcover ISBN:
eBook ISBN:

Ratings and Reviews

About the Author

R A Bouchard

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.

Affiliations and Expertise

Intellectual Property Lawyer and Scholar, Canada