Contemporary Issues in Pharmaceutical Patent Law Setting the Framework and Exploring Policy Options

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 – The Integration of Pharmaceutical Law and Policy: Objectives, Agenda and Mandate, Bryan Mercurio Part 1: Patent Protection for Pharmaceutical Inventions 2. Patentability of Pharmaceuticals, Roberto Romandini and Henning Grosse Ruse-Khan 3. Extension of Patent Protection Term, Pei-Kan Yang 4. Biologics, Biosimilars and Patents, Yaniv Heled Part 2: Balancing Patent Protection with Available Flexibilities 5. Experimental Use, Xavier Seuba 6. Compulsory Licensing: Threats, Use and Recent Trends, Chang-fa Lo Part 3: Patent Protection by Another Name 7. Data Exclusivity, Owais Hassan Shaikh 8. Patent Linkage, Bryan Mercurio 9. The Price of Exclusivity: the economics of patent extensions and data protection, Aidan Hollis 10. Regulatory Integrity in Pharmaceutical Innovation Framework, Daria Kim

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.