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This collection explores the complexities associated with the intersection of pharmaceutical law and policy and public health. Focusing on patent and relevant regulatory laws, the collection provides a comprehensive overview of the most important and pressing issues governments are currently facing in regards to ensuring access to medicines at an affordable cost. Each chapter focuses on a separate issue and offers clear, balanced and detailed analysis of the international framework, trends and available policy options.
This collection explores the complexities associated with the intersection of pharmaceutical law and policy and public health. Focusing on patent and relevant regulatory laws, the collection provides a comprehensive overview of the most important and pressing issues governments are currently facing in regards to ensuring access to medicines at an affordable cost. Each chapter focuses on a separate issue and offers clear, balanced and detailed analysis of the international framework, trends and available policy options.
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Autorenporträt
Bryan Mercurio is Professor and Vice Chancellor's Outstanding Fellow of the Faculty of Law at the Chinese University of Hong Kong. Daria Kim is Doktorandin at the Max Planck Institute for Innovation and Competition.
Inhaltsangabe
1. Introduction: A Holistic Approach to Pharmaceutical Patent Law and Policy, Bryan Mercurio and Daria Kim Part 1: Pharmaceutical Patents and Related Types of Protection 2. Patentability of Pharmaceutical Inventions under TRIPS: Domestic Court Practice Testing International Policy Space, Roberto Romandini and Henning Grosse Ruse-Khan 3. Biologics, Biosimilars and Other Idiosyncrasies, Yaniv Heled 4. Index of Data Exclusivity and Access (IDEAS): An Analysis of Test Data Exclusivity Provisions in Free Trade Agreements and National Laws, Owais Hassan Shaikh 5. Patent Linkage Regulations: The Importance of Context and of Balancing Competing Interests, Bryan Mercurio Part 2: Balancing Patent Protection with Available Flexibilities 6. The Bolar Exception: Legislative Models and Drafting Options, Carlos Correa 7. Compulsory Licensing: Threats, Use and Recent Trends, Chang-fa Lo 8. A Manufacturing for Export Exception, Xavier Seuba, Luis Mariano Genovesi and Pedro Roffe Part 3: A Broader View on Incentives for Pharmaceutical Innovation 9. The Price of Exclusivity: The Economics of Patent Extensions and Data Protection, Aidan Hollis and Paul Grootendorst 10. Rationalizing Innovation Incentives under Drug Approval Regulation: National Policy Perspective, Daria Kim 11. The Trans-Pacific Partnership Agreement and Its Implications for Access to Medicine, Jakkrit Kuanpoth
1. Introduction: A Holistic Approach to Pharmaceutical Patent Law and Policy, Bryan Mercurio and Daria Kim Part 1: Pharmaceutical Patents and Related Types of Protection 2. Patentability of Pharmaceutical Inventions under TRIPS: Domestic Court Practice Testing International Policy Space, Roberto Romandini and Henning Grosse Ruse-Khan 3. Biologics, Biosimilars and Other Idiosyncrasies, Yaniv Heled 4. Index of Data Exclusivity and Access (IDEAS): An Analysis of Test Data Exclusivity Provisions in Free Trade Agreements and National Laws, Owais Hassan Shaikh 5. Patent Linkage Regulations: The Importance of Context and of Balancing Competing Interests, Bryan Mercurio Part 2: Balancing Patent Protection with Available Flexibilities 6. The Bolar Exception: Legislative Models and Drafting Options, Carlos Correa 7. Compulsory Licensing: Threats, Use and Recent Trends, Chang-fa Lo 8. A Manufacturing for Export Exception, Xavier Seuba, Luis Mariano Genovesi and Pedro Roffe Part 3: A Broader View on Incentives for Pharmaceutical Innovation 9. The Price of Exclusivity: The Economics of Patent Extensions and Data Protection, Aidan Hollis and Paul Grootendorst 10. Rationalizing Innovation Incentives under Drug Approval Regulation: National Policy Perspective, Daria Kim 11. The Trans-Pacific Partnership Agreement and Its Implications for Access to Medicine, Jakkrit Kuanpoth
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