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The Development AgendaGlobal Intellectual Property and Developing Countries$
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Neil Weinstock Netanel

Print publication date: 2008

Print ISBN-13: 9780195342109

Published to Oxford Scholarship Online: January 2009

DOI: 10.1093/acprof:oso/9780195342109.001.0001

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Expanding Patent Rights in Pharmaceuticals

Expanding Patent Rights in Pharmaceuticals

The Linkage between Patents and Drug Registration

(p.247) 11 Expanding Patent Rights in Pharmaceuticals
The Development Agenda

Carlos M. Correa

Oxford University Press

In some developed countries, the patent owners' exclusive rights have been stretched by allowing them to block the marketing approval of competing pharmaceutical generic products. This creates a “linkage” between patent protection and drug approval, two separate areas of regulation with distinct objectives. This form of “linkage” has been systematically introduced in the free trade agreements signed by the US with a number of countries, often under conditions that are more stringent than those applicable in the USA itself. This chapter examines the judicially-based “linkage” implemented in the USA and Canada, and the administrative regimes generated by the referred to agreements. The implications for public health in developing countries may be significant, particularly as patents on variants of existing pharmaceuticals may be unduly used to exclude competition of low priced generic medicines.

Keywords:   drug marketing approval, free trade agreements, Orange Book, evergreening patents, TRIPS Agreement, DR-CAFTA, generic medicines, patent

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