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Patently Innovative

Book Description

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

Table of Contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. Dedication
  6. Acknowledgements
  7. List of figures and tables
  8. List of abbreviations
  9. About the author
  10. Chapter 1: Introduction
    1. Abstract:
    2. 1.1 The emergence of global pharmaceutical linkage
    3. 1.2 Canadian pharmaceutical linkage regulations
    4. 1.3 Organization
  11. Chapter 2: Background: drug approval, drug patenting, pharmaceutical linkage, and public health policy
    1. Abstract:
    2. 2.1 Drug approval
    3. 2.2 Patents
    4. 2.3 Linkage regulations
    5. 2.4 IPR rights and innovation policy
  12. Chapter 3: Empirical analysis of drug approval
    1. Abstract:
    2. 3.1 Introduction
    3. 3.2 Analysis
    4. 3.3 Results
    5. 3.4 Discussion
    6. 3.5 Interpretation of data
    7. 3.6 Study limitations
    8. 3.7 Assessing the lifecycle approach: the long view
    9. 3.8 Government as representative public agent
    10. 3.9 Summary and conclusions
  13. Chapter 4: Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage
    1. Abstract:
    2. 4.1 Introduction
    3. 4.2 Methods
    4. 4.3 Results
    5. 4.4 Discussion
  14. Chapter 5: Empirical analysis of drug patenting in multiple high-value cohorts
    1. Abstract:
    2. 5.1 Introduction
    3. 5.2 Methods
    4. 5.3 Results
    5. 5.4 Discussion
    6. 5.5 Summary and conclusions
  15. Chapter 6: Implications of empirical data: are pharmaceutical linkage regulations a success?
    1. Abstract:
    2. 6.1 Introduction
    3. 6.2 Debate preceding Bill C-91
    4. 6.3 ‘Original policy intent’
    5. 6.4 ‘Patent-specific’ analysis
    6. 6.5 Statutory interpretation
    7. 6.6 Revisiting the empirical data
    8. 6.7 Summary and conclusions
  16. Chapter 7: Future directions: testable hypotheses and evolution toward global pharmaceutical linkage
    1. Abstract:
    2. 7.1 Hypotheses regarding cluster-based drug development
    3. 7.2 Globalization of pharmaceutical linkage
  17. Index