This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine.
This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO).
This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine.
Author(s): Adam Buick
Publisher: Springer
Year: 2023
Language: English
Pages: 235
City: Cham
Acknowledgements
Contents
Abbreviations
List of Figures
List of Tables
Chapter 1: Introduction
1.1 Introduction
1.2 Regulation and Globalisation
1.3 Scope and Aims of This Book
1.4 Methodology
1.5 Structure of This Book
References
Chapter 2: An Overview of the Protection of Submitted Test Data
2.1 Introduction
2.2 Pharmaceutical Test Data and the Drug Development Process
2.3 Test Data Exclusivity
2.3.1 Test Data Exclusivity and Other Intellectual Property Rights
2.3.1.1 The Relationship Between Test Data Exclusivity and the Patent System
2.3.1.2 The Relationship Between Test Data Exclusivity and Trade Secrets
2.3.1.3 The Relationship Between Test Data Exclusivity and Other Forms of Non-Patent Exclusivity
2.3.2 Test Data Exclusivity at the International Level
2.4 The Test Data Exclusivity Debate
2.4.1 Conflicts Between Test Data Exclusivity and the Logic of Patent Law
2.4.1.1 Incentivising Delayed Drug Launches
2.4.1.2 Undermining Measures Designed to Promote Public Health
2.4.1.3 Lack of Disclosure of Information
2.4.1.4 Absence of Appeal Mechanisms
2.5 Test Data Exclusivity and Biologic Drugs
2.5.1 The Origins and Development of Abbreviated Approval Pathways for Biosimilars
2.5.2 Approaches to Test Data Exclusivity for Data Submitted in Association with Biologics
2.6 Alternatives to Test Data Exclusivity
2.7 The Impact of Test Data Exclusivity on Access to Medicine
2.8 Conclusion
References
Chapter 3: The Origins of Test Data Exclusivity
3.1 Introduction
3.2 The History of Pharmaceutical Regulation in the US and the Origins of Test Data Exclusivity
3.2.1 Elixir Sulfanilamide, Thalidomide and Pre-marketing Approval
3.2.2 The Crisis of the Late 1970s and the Drug Price Competition and Patent Term Restoration Act
3.3 The Origins of Test Data Exclusivity in Europe and Japan
3.4 Conclusion
References
Chapter 4: The Protection of Submitted Test Data and the TRIPS Agreement
4.1 Introduction
4.2 Article 39.3
4.3 The History of the Protection of Submitted Test Data in TRIPS
4.3.1 Intellectual Property and the Uruguay Round
4.3.1.1 Parallel Negotiations
4.3.2 The Protection of Undisclosed Data
4.3.3 The Proposals on the Protection of Submitted Test Data
4.4 Interpreting Article 39.3
4.4.1 Unfair Commercial Use
4.4.2 Other Terms
4.4.2.1 New Chemical Entity
4.4.2.2 The Submission of Undisclosed Test or Other Data
4.4.2.3 Considerable Effort
4.4.2.4 Prohibition on Disclosure
4.4.3 What Must Members Do to Comply with Article 39.3?
4.4.3.1 Does Article 39.3 Prohibit the Use of Submitted Test Data in Relation to Compulsory Licensing or Other Measures Design...
4.5 The Significance of Article 39.3
4.6 Conclusion
References
Chapter 5: The Globalisation of Test Data Exclusivity
5.1 Introduction
5.2 The Protection of Submitted Test Data and Trade Post-TRIPS
5.3 Test Data Exclusivity in Trade Agreements
5.3.1 Discussion of US-Led Trade Agreements
5.3.1.1 Term and Scope of Protection
5.3.1.2 Biologics
5.3.1.3 Article 39.3 Criteria
5.3.1.4 Additional Requirements
5.3.1.5 Exceptions
5.3.1.6 Concluding Remarks on Test Data Exclusivity Provisions in US-Led Trade Agreements
5.3.2 Discussion of EFTA and Swiss-Led Agreements
5.3.2.1 Alternatives to Test Data Exclusivity
5.3.2.2 Term and Scope of Protection
5.3.2.3 Biologics
5.3.2.4 Article 39.3 Criteria
5.3.2.5 Additional Requirements
5.3.2.6 Exceptions
5.3.2.7 Concluding Remarks on Test Data Exclusivity Provisions in EFTA/Swiss-Led Agreements
5.3.3 Discussion of EU-Led Agreements
5.3.3.1 Term and Scope of Protection
5.3.3.2 Biologics
5.3.3.3 Article 39.3 Criteria
5.3.3.4 Additional Requirements
5.3.3.5 Exceptions
5.3.3.6 Concluding Remarks on Test Data Exclusivity Provisions in EU-Led Agreements
5.3.4 Concluding Remarks on Test Data Exclusivity and Trade Agreements
5.4 Test Data Exclusivity and Accession to the World Trade Organisation
5.5 The Globalisation of Test Data Exclusivity and the Role of Coercion
5.6 Explaining the Globalisation of Test Data Exclusivity
5.7 Conclusion
References
Untitled
Chapter 6: Approaches to the Implementation of the Protection of Submitted Test Data
6.1 Introduction
6.2 Non-exclusivity Based Approaches to the Protection of Submitted Test Data
6.2.1 Jurisdictions with No Regulatory Framework for the Protection of Submitted Test Data
6.2.2 Jurisdictions Which Protect Submitted Test Data Only Against Misappropriation
6.2.3 Jurisdictions with Ambiguous Provisions on the Protection of Submitted Test Data
6.2.4 Does It Matter if These Approaches Do Not Conform with Article 39.3?
6.3 Test Data Exclusivity at the National Level
6.4 National Approaches to Test Data Exclusivity
6.4.1 Methodology
6.4.2 General Observations
6.4.3 Basic Test Data Exclusivity Protection
6.4.3.1 Term
6.4.3.2 Data Exclusivity Per Se and Market Exclusivity
6.4.3.3 Qualification for Protection
6.4.4 Protection for Other Types of Submitted Test Data
6.4.4.1 Protection for Data Submitted Regarding Non-novel Uses of Small Molecule Drugs
6.4.4.2 Protection for Data Submitted Regarding Biologic Drugs
6.4.5 Disclosure of Submitted Test Data
6.4.6 Exceptions to Test Data Exclusivity
6.5 Conclusion
References
Chapter 7: The Impact of Test Data Exclusivity on Abbreviated New Drug Applications in the United States
7.1 Introduction
7.2 The Potential Impact of Test Data Exclusivity
7.3 The Impact of Test Data Exclusivity in the United States 1999-2009
7.3.1 The US Drug Approval System in Detail
7.3.1.1 Patent Law
7.3.1.2 Market Authorisation
7.3.1.3 Test Data Exclusivity
7.3.1.4 Other Forms of Exclusivity
7.3.2 Method
7.3.3 Findings
7.3.4 Discussion
7.4 Conclusion
References
Chapter 8: The Impact of Test Data Exclusivity on Measures for the Protection of Public Health
8.1 Introduction
8.2 Test Data Exclusivity and Measures for the Protection of Public Health
8.2.1 Compulsory Licensing of Pharmaceuticals and Test Data Exclusivity Post-TRIPS
8.2.2 Test Data Exclusivity and the Response to COVID-19
8.2.2.1 Test Data Exclusivity and the Proposed TRIPS Waiver
8.2.2.2 Compulsory Licensing During the COVID-19 Pandemic
8.2.3 The Impact of Test Data Exclusivity on Measures for the Protection of Public Health
8.3 Reconciling Test Data Exclusivity and Measures for the Protection of Public Health
8.4 Conclusion
References
Chapter 9: Conclusion
9.1 Findings of This Book
9.2 Implications for the Future
9.3 Concluding Remarks
References
Appendix A: The Following Tables A1, A2 and A3 Contain the Data Used at Sect. 6.4.3.1 for the Purposes of Calculating the Impa...
Appendix B: The Following Table A4 Contains the Data Used in Chap. 7 for the Purposes of Calculating the Impact of Test Data E...
