Challenging the Use of the US Special 301 Procedures against Measures Promoting Access to Medicines - Options under the WTO Agreements
Journal of International Economic Law, Volume 19, Issue 1, March 2016, Pages 51-86, DOI: 10.1093/jiel/jgw004
33 Pages Posted: 19 Oct 2015 Last revised: 29 Apr 2018
Date Written: September 1, 2015
In April 2014, the United States Trade Representative (USTR) listed India on its Special 301 Priority Watch List, following India’s refusal to grant a patent over the leukemia drug Gleevec and its compulsory licensing of the cancer drug Nexavar. USTR also undertook an out-of-cycle review of India’s intellectual property laws, to determine whether or not to upgrade India to the more serious Priority Foreign Country status, which would potentially trigger retaliation through withdrawal of GSP benefits. In response, India threatened to take the United States to the World Trade Organization’s Dispute Settlement Body over Special 301. This article examines whether such a challenge to Special 301 in the WTO would succeed, both in the India context and more generally. It takes three lines of inquiry. The first is whether or not the Special 301 procedure violates the procedural obligations under article 23 of the Dispute Settlement Understanding (DSU). The second is whether or not any related withdrawal of GSP benefits would be in line with the Enabling Clause. Finally, the article examines whether there are substantive limitations on intellectual property protections under TRIPS which could be used to challenge the validity of Special 301. It concludes that some, but not all, aspects of Special 301 may be inconsistent with WTO obligations.
Keywords: Special 301, access to medicines, patents, World Trade Organization, TRIPS
JEL Classification: K33, K32
Suggested Citation: Suggested Citation