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.
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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