ABSTRACT

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

chapter 1|6 pages

Introduction

A Holistic Approach to Pharmaceutical Patent Law and Policy
ByBryan Mercurio, Daria Kim

part I|116 pages

Pharmaceutical Patents and Related Types of Protection

chapter 2|38 pages

Patentability of Pharmaceutical Inventions under TRIPS

Domestic Court Practice Testing International Policy Space
ByHenning Grosse Ruse-Khan, Roberto Romandini*

chapter 3|21 pages

Biologics, Biosimilars and Other Idiosyncrasies

ByYaniv Heled*

chapter 4|29 pages

Index of Data Exclusivity and Access (IDEAS)

An Analysis of Test Data Exclusivity Provisions in Free Trade Agreements and National Laws
ByOwais Hassan Shaikh

chapter 5|26 pages

Patent Linkage Regulations

The Importance of Context and of Balancing Competing Interests
ByBryan Mercurio

part II|63 pages

Balancing Patent Protection with Available Flexibilities

chapter 6|19 pages

The Bolar Exception

Legislative Models and Drafting Options
ByCarlos Correa

chapter 7|17 pages

Compulsory Licensing

Threats, Use and Recent Trends
ByChang-fa Lo

chapter 8|25 pages

A Manufacturing for Export Exception

ByXavier Seuba, Luis Mariano Genovesi, Pedro Roffe

part III|55 pages

A Broader View on Incentives for Pharmaceutical Innovation

chapter 9|14 pages

The Price of Exclusivity

The Economics of Patent Extensions and Data Protection
ByAidan Hollis*, Paul Grootendorst

chapter 10|22 pages

Rationalizing Innovation Incentives under Drug Approval Regulation

National Policy Perspective
ByDaria Kim