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Access to Medicine in the Global EconomyInternational Agreements on Patents and Related Rights$
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Cynthia Ho

Print publication date: 2011

Print ISBN-13: 9780195390124

Published to Oxford Scholarship Online: May 2011

DOI: 10.1093/acprof:oso/9780195390124.001.0001

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Complicated Compulsory Licenses: The Waiver/Article 31bis “Solution”

Complicated Compulsory Licenses: The Waiver/Article 31bis “Solution”

Chapter:
(p.195) 7 Complicated Compulsory Licenses: The Waiver/Article 31bis “Solution”
Source:
Access to Medicine in the Global Economy
Author(s):

Cynthia M. Ho (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195390124.003.0008

This chapter explains an important, yet often misunderstood exception to the TRIPS requirement that a compulsory license must be issued predominantly for domestic use (except where issued to address anticompetitive conduct). It assumes an understanding of the usual compulsory licensing requirements addressed in Chapter 5 and builds upon it. The WTO Council has created an official waiver (“the Waiver”) of the usual domestic use requirement to help countries export low-cost generic drugs made under a compulsory license to predominantly poor countries. The chapter explains when the Waiver is relevant, as well as the additional requirements necessary to use it beyond those that apply to all compulsory licenses. It ends with an evaluation of the effectiveness of the Waiver in achieving its intended purpose.

Keywords:   TRIPS, compulsory licensing, WTO, waiver, licensing law, patent law

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