Intellectual property rights in pharmaceutical test data : origins, globalisation, and impact / / Adam Buick

• Autore: Buick Adam <1944->
• Pubblicazione: Cham, Switzerland : , : Springer, , [2023]; ©2023
• Edizione: First edition.
• Descrizione fisica: 1 online resource (xvi, 227 pages)
• Disciplina: 346.048
• Soggetto topico: Clinical pharmacology; Drug development; Drugs - Testing - Law and legislation; Industrial property (International law)
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: Intro -- 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.
• Titolo autorizzato: Intellectual property rights in pharmaceutical test data
• ISBN: 9783031294365; 9783031294358
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910725085903321
• Lo trovi qui: Univ. Federico II