Challenging the Use of Special 301 against Measures Promoting Access to Medicines: Options Under the WTO Agreements

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 leukaemia 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 Generalized System of Preferences (GSP) benefits. In response, India threatened to take the USA to the World Trade Organization’s (WTO’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.