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The Scope of ‘Patent Linkage’ in the US–South Korea Free Trade Agreement and the Potential Effects on International Trade Agreements

Published online by Cambridge University Press:  20 January 2017

Eugenia Costanza Laurenza
Eugenia Costanza Laurenza*
Affiliation:
FratiniVergano – European Lawyers
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Extract

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

Type
Reports
Information
European Journal of Risk Regulation , Volume 6 , Issue 3 , September 2015 , pp. 439 - 442
Copyright
Copyright © Cambridge University Press 2015

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References

1 Free Trade Agreement Between the United States of America and the Republic of Korea, originally signed on 30 June 2007, final amendments and review agreed upon on 21 February 2012 and entry into force on 15 March 2012 (available online at https://ustr.gov/trade-agreements/free-trade-agreements/korus-fta/final-text).

2 C. Garrison, “Exceptions to patent rights in developing countries”, UNCTAD - ICTSD Project on IPRs and Sustainable Development, August 2006, p. 60.

3 Agreement on Trade–Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C.

4 Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), 21 United States Code § 301 et seq., signed on 24 September 1984.

5 Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148), 42 United States Code § 262, signed 23 March 2010.

6 Chapter 5 of the KORUS FTA, titled “Pharmaceutical Products and Medical Devices”, establishes a set of obligations concerning the pharmaceutical sector and medical devices aimed at facilitating trade in these products and reducing regulatory barriers.

7 As clarified by Article 5.8 of the KORUS FTA.

8 A scanned copy of the letter was leaked on “Heesob's IP Blog” in a posting titled “US Ambassador confirmed patent linkage under FTA includes biologics”, 11 March 2015 (available online at http://hurips.blogspot.be/2015/03/us-ambassador-confirmed-patent-linkage.html).

9 Ibid.

10 See proposals for Article QQ.E.17 of the ‘leaked’ “Intellectual Property [Rights] Chapter: Consolidated Text (Rebooted): Clean version: 11 May 2015” of the TPP (available online at http://keionline.org/tpp/11may2015-ip-text), which is the most recent consolidated draft text publicly available at the time of writing of this article.