Contemporary Issues in Pharmaceutical Patent Law

Developed and developing country governments around the world often struggle to provide prompt and affordable access to medicines for the populace and so maintain proper levels of health care at affordable prices.

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.

Throughout, the volume emphasises the need for governments to think and act in a systemic manner and break away from the ‘silo’ method of dividing responsibilities between various government departments.

The book sets out ways in which law and policy in the area of pharmaceutical patents, health and policy can be integrated in order to ensure coherence and regulatory predictability.

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 Seuba6. 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