Patently Innovative

Patently Innovative

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

1st Edition - January 2, 2012

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  • Author: R A Bouchard
  • Hardcover ISBN: 9781907568121
  • eBook ISBN: 9781908818089

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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

Table of Contents

  • Dedication


    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


Product details

  • No. of pages: 296
  • Language: English
  • Copyright: © Woodhead Publishing 2012
  • Published: January 2, 2012
  • Imprint: Woodhead Publishing
  • Hardcover ISBN: 9781907568121
  • eBook ISBN: 9781908818089

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

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