Table of Contents

Research Handbook on the Protection of Intellectual Property under WTO Rules

Research Handbook on the Protection of Intellectual Property under WTO Rules

Intellectual Property in the WTO Volume I

Research Handbooks on the WTO series

Edited by Carlos M. Correa

This comprehensive Handbook provides an in-depth analysis of the origin and main substantive provisions of the TRIPS Agreement, the most influential international treaty on intellectual property currently in force.

Chapter 19: Disease-based Limitations on Compulsory Licenses Under Articles 31 and 31bis

Kevin Outterson

Subjects: development studies, development studies, economics and finance, intellectual property, law - academic, intellectual property law, international economic law, trade law


Kevin Outterson* 1. Disease-based limitations on compulsory licenses in TRIPS Article 31 Article 31 of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) permits a World Trade Organization (WTO) Member country to issue a compulsory license of a patent under certain conditions.1 Compulsory licenses are not limited to any category of diseases. The text of Article 31 never mentions any specific diseases, a deliberate decision by the negotiating group to avoid any disease-based limitation.2 This provision has been misunderstood – perhaps deliberately so – in the pages of the Wall Street Journal and the Financial Times to imply that Article 31 only applies to national public health emergencies like HIV/AIDS or only to the least-developed countries. When Thailand (a middle-income country) attempted to use TRIPS flexibilities guaranteed and encouraged by the Doha Declaration on drugs for cancer and heart disease, a backlash ensued from the conservative media, pharmaceutical manufacturers, patent blogs, and the governments of the United States and the European Union.3 A Wall Street Journal editorial attacked the * This chapter is a modified and expanded version of Should Access to Medicines And TRIPS Flexibilities Be Limited To Specific Diseases? 34 AM. J. L. & MED. 279 (2008), used by permission. An earlier version of this project was submitted to the WHO IGWG in 2007: A Request for Clarification Concerning the Proper Scope of the IGWG’s Work to Improve Access to Patented Medicines, Submission to the WHO IGWG (September 30, 2007). 1 Section 31 of the TRIPS Agreement does not use...

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