Jul 26 2010
United States Trade Representative’s Special 301 Report
The United States Trade Representative’s (USTR) Special 301 Report is an annual review of the protection and enforcement of intellectual property rights in countries around the world, conducted under the authority granted in the Trade Act of 1974. Under Special 301 provisions, the USTR is charged with identifying which countries deny adequate and effective protection for intellectual property or deny fair market access for innovators who rely on that protection. A country that is identified as a Priority Foreign Country is deemed to have the most egregious policies with the greatest impact on U.S. products. These countries are subject to investigation that may potentially lead to dispute resolution in front of the appropriate body set out in the relevant trade agreement. Furthermore, USTR has created watch lists that identify problems in countries that do not yet rise to such a level to be identified as a Priority Foreign Country. Countries placed on the Priority Watch List are subject to increased bilateral attention and USTR may apply sanctions to countries that fail to implement provisions of a bilateral intellectual property agreement.
USTR must interpret intellectual property standards in light of the Doha Declaration on Public Health, discussed in my last post, which affirmed the right of WTO Members to utilize the TRIPS flexibilities to the fullest extent in order to promote access to medicines for all. USTR has previously favored TRIPS-Plus provisions—pushing for patent linkage, restrictions on compulsory licenses, and data exclusivity—in the face of the TRIPS flexibilities to promote access to medicines for all. In the 2010 Special Report, USTR formally pledged to respect “a country’s right to protect public health and, in particular, to promote access to medicines for all.” Furthermore, USTR formally acknowledged a country’s right to grant compulsory licenses, but encouraged countries to do so in a way that maintains IP protection and enforcement.
The intellectual property issues surrounding biologics and advocated for by the U.S. in recent legislation, including viability of patents and extended periods of data exclusivity, will surely be addressed in future Special 301 Reports. Biologic medicine will play an increasingly large role in global access to medicine initiatives, and with increased access comes debates over intellectual property and future innovation.