Analysis of Special 301 Listings, 2009-2020

Abstract

Since its inception, the Special 301 Report has been an instrument used by the U.S. Trade Representative (USTR) to pressure foreign nations to change their laws at the behest of American business interests. Policies that allow countries to access lower-priced generic medicines feature prominently in USTR’s allegations of inadequate, ineffective protection of intellectual property.

This working paper reviews trends in Special 301 listings over the past 12 years. USTR has reduced the number of countries listed in the Report, but it has been consistent in its responsiveness to country listing requests by the Pharmaceutical Research and Manufacturers of America (PhRMA). This is especially true for the countries prioritized by PhRMA (those which PhRMA asked to have designated a Priority Foreign Country or placed on the Priority Watch List). USTR included between 75% and 100% of these PhRMA-prioritized countries in each year’s Special 301 Report over the period studied. USTR also consistently focused its attention on middle-income countries and populous countries.

USTR has regularly used the report to criticize countries for using TRIPS flexibilities. There has been an increased number of complaints about countries issuing compulsory licenses or adopting pro-compulsory licensing policies. Data exclusivity, patent linkage and the scope of patentability continue to be criticized in the Special 301 Reports. There have been increased complaints against countries for inadequate enforcement of intellectual property that affects pharmaceutical firms, and complaints over allegedly discriminatory market access policies.

This working paper was written in the author's capacity as the Shamnad Basheer IP/Trade Fellow at Texas A&M University School of Law.

Keywords: Trade Policy, Law, Intellectual Property, Patent, Data, TRIPS, USTR, Special 301, Access to Medicine

JEL Classification: K11, K33