This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges
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
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.
Reviews for Contemporary Issues in Pharmaceutical Patent Law: Setting the Framework and Exploring Policy Options
'The editors have mustered a wide range of authors, including legal practitioners, academics and a Constitutional Court Justice, to opine on a broad range of topical issues confronting rule-makers concerning pharmaceutical patent law. This diversity makes for a varied discussion.' John A. Tessensohn, European Intellectual Property Review 'A solid reference book for scholars and those interested in governments' struggle between incentivising innovation and access to affordable medicine.' John A. Tessensohn, European Intellectual Property Review
