Section 301 Report Shows Changes To Two Drug Patent Issues

May 07, 2010

Inside U.S. Trade

The 2010 Special 301 Report on Intellectual Property Rights (IPR) released late last week by the Office of the U.S. Trade Representative shows little change from last year’s citations of countries with weak IPR regimes, but differs in its treatment of drug patent policies in a way that non-governmental organizations say appears to reflect a new U.S. trade policy regarding access to medicines...

... The report issued on April 30 cites fewer countries for having no data exclusivity measures that protect test data generated by brand-name pharmaceutical companies for period of time before they can be used to gain marketing approval for generic versions of these drugs.

Furthermore, this year’s report limits criticism of countries that have no patent linkage system to nations that have already signed free trade agreements with the U.S. requiring such an arrangement. A patent linkage system requires that a country’s officials issuing marketing approvals for generic drugs cannot do so before determining that it does not violate a patent.

Sean Flynn, associate director of the Program on Information Justice and Intellectual Property at American University, noted that 29 countries were cited for not having data exclusivity measures in last year’s report while 15 countries were cited in the 2010 report.

Those changes likely came as a result of the administration meeting both publicly and privately with civil society groups including a closed door session with NGOs on Special 301, according to Flynn...

The complete story available to Inside U.S. Trade subscribers at