On 16 December 2014 and 18 December 2014, the World Trade Organization (WTO) undertook a trade policy review of the United States of America. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). At the December 2014 Trade Policy Review (TPR) of the United States, the Government of India asked USTR specific questions on US state practice on compulsory licensing including uses under 28 USC §1498, under the Clean Air Act (42 USC §7608) and as a remedy to anticompetitive practices under the Sherman Act; the United States deflected India’s questions with an anodyne references to the Doha Declaration on TRIPS and Public Health and Article 31 of the TRIPS Agreement.
The Government of India questioned the United States of the consistency of its Special 301 Report with the WTO panel ruling on US — Section 301 Trade Act, “[c]ould the US, then, confirm that without recourse to the multilateral trading system it shall not identify any WTO member country as priority foreign country pursuant to Sections 181 and 182 of the Trade Act of 1974 as a Priority Foreign Country classification would be a unilateral determination inconsistent with the provisions of Article 23 of the DSU?”
India also submitted an additional written question on the Special 301 process.
Question 41: Has the Special 301 process been utilized in any manner that conflicts with WTO norms and procedures?RESPONSE: The Special 301 process is consistent with WTO norms and procedures.
The Government of India’s questions on compulsory licensing and the Special 301 Report, and USTR’s responses can be found below. The document reference number of the 444 page compilation of questions and responses for the December 2014 TPR of the United States is WT/TPR/M/307/Add.1.
Secretariat Report 3.200, Page 94:
Question 45: Could the U.S. state the number of compulsory licenses issued till date under 28 USC §1498, under the Clean Air Act (42 USC §7608) and as a remedy to anticompetitive practices under the Sherman Act, separately? Could the U.S. further specify the products for which the compulsory licenses have been issued? Could the U.S. also clarify the grounds on which such compulsory licenses have been issued?
RESPONSE: The United States recognizes that Article 31 of the TRIPS Agreement permits other use of the subject matter of a patent without the authorization of the rightholder under certain conditions. As affirmed in the Doha Declaration on TRIPS and Public Health, the United States respects a trading partner’s right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the patent system in promoting the development and creation of new and innovative lifesaving medicines. Consistent with these views, the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions
of Article 31 of the TRIPS Agreement, and encourages its trading partners to consider ways to address their public health challenges while maintaining IPR systems that promote investment, research, and innovation.Question 46: Could the U.S. state the number of compulsory licenses issued for government use out of the total compulsory licenses issued?
RESPONSE: The United States recognizes that Article 31 of the TRIPS Agreement permits other use of the subject matter of a patent without the authorization of the right holder under certain conditions. As affirmed in the Doha Declaration on TRIPS and Public Health, the United States respects a trading partner’s right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the patent system in promoting the development and creation of new and innovative lifesaving medicines. Consistent with these views, the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of Article 31 of the TRIPS Agreement, and encourages its trading partners to consider ways to address their public health challenges while maintaining IPR systems that promote investment, research, and innovation.
Question 47: Could the U.S. elucidate whether any assessment has been undertaken to ascertain the impact of compulsory licenses being issued on the research and development expenditure of patent holders?
RESPONSE: The United States recognizes that Article 31 of the TRIPS Agreement permits other use of the subject matter of a patent without the authorization of the right holder under certain conditions. As affirmed in the Doha Declaration on TRIPS and Public Health, the United States respects a trading partner’s right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the patent system in promoting the development and creation of new and innovative lifesaving medicines. Consistent with these views, the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of Article 31 of the TRIPS Agreement, and encourages its trading partners to consider ways to address their public health challenges while maintaining IPR systems that promote investment, research, and innovation.
Secretariat Report 3.222, Page 100:Question 48: The Panel in U.S. Section 301 was clear in its reasoning when it stated that Members faced with even a threat of unilateral action, especially when it emanates from an economically powerful Member, may in effect be forced to give in to the demands imposed by the Member exerting the threat, even before DSU procedures have been activated. Could the US, then, confirm that without recourse to the multilateral trading system it shall not identify any WTO member country as priority foreign country pursuant to Sections 181 and 182 of the Trade Act of 1974 as a Priority Foreign Country classification would be a unilateral determination inconsistent with the provisions of Article 23 of the DSU?
RESPONSE: In its report, the panel in U.S. – Sections 301–310 of the Trade Act of 1974 (DS152) determined that Sections 304, 305, and 306 of the Trade Act of 1974 were not inconsistent with the obligations of the United States, including the obligations under Article 23 of the DSU.
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