USPTO “clarifies” June 27, 2012 testimony on biologics exclusivity and India compulsory license

Deputy USPTO Director Teresa Stanek Rea has issued a retraction of her statement regarding Administration support for 12 years of exclusive rights in test data for biologic drugs, and moderated somewhat her statement on the India compulsory license for Nexavar. USTR also issued a statement on the issue of biologic test data in response to Rea’s earlier comments.

On June 27, 2012, Rea appeared before the House Judiciary Subcommittee on Intellectual Property, Competition and the Internet and bashed India for granting a compulsory license on the patents for the cancer drug Nexavar, and told members of Congress the Obama Administration was seeking 12 years of test data protection for biologic drugs in the proposed Trans Pacific Partnership Agreement (TPPA).

A KEI blog on Rea’s June 27 comments on the India compulsory licensing issue (/node/1447) provides a link to a youtube video of one of the exchanges with the Subcommittee chair on the India compulsory license.

A clip of Rea’s exchange with Representative Ben Quayle (R-AZ) on the 12 year period of exclusivity for biologic drug test data is available here. The President’s budget calls for a 7 per period of exclusive rights, and USTR has claimed it has yet to decide what to table in the TPPA negotiations on this topic.

After Stanek’s testimony, KEI contacted USPTO, criticizing her statement on India, and pointing out the USPTO position on biologic test data was contrary to the President’s budget. We are pleased to see the correction on the 12 years of test data rights, and somewhat pleased that the blog seems to moderate her more aggressive comments before the Subcommittee on the India compulsory license, which included repeated assertions that India was acting outside the WTO rules.

This is the clarification from Rea’s blog.
Monday Jul 02, 2012
USPTO on the Hill: Supporting U.S. Innovators in Global Markets

Guest blog by Deputy Director Teresa Stanek Rea

Last week, I had the distinct honor to testify in front of the House Judiciary Subcommittee on Intellectual Property, Competition and the Internet at a hearing titled: “International IP Enforcement: Protecting Patents, Trade Secrets and Market Access.” This was my first opportunity, since joining the USPTO, to talk about the great successes we have had at this agency in front of Congress. I was pleased to be asked to share our experiences and successes with members of Congress and it was a positive experience.


I was also asked some questions during my testimony and want to take this opportunity to clarify my responses relative to data protection for biologics and compulsory licensing under TRIPS and wanted to take this opportunity to clarify my responses. Although compulsory licensing can be permissible under the TRIPS Agreement, we encourage our trading partners to consider ways to address their public health challenges while maintaining intellectual property rights systems that promote investment, research, and innovation. The broad interpretation of Indian law in a recent decision by the Controller General of Patents of India regarding compulsory licensing of patents, in my view, may undermine those goals.

I was also asked to comment on a twelve year period for data protection for biologics which is favored by the research-based pharmaceutical industry. The Trans-Pacific Partnership (TPP) negotiations are ongoing and the United States Government has not made a proposal for a longer term of data protection for biologic medicines. We will continue to work with our colleagues in the Office of the U.S. Trade Representative who are leading these negotiations as this process moves forward.

USTR also issued a statement, which was given to KEI and to the Huffington Post:

“US negotiators have not proposed a specific term for data exclusivity for biologics. We have been engaging with our TPP negotiating partners to learn more about how their systems address the issue of biologics and biosimilars before proposing any specific provisions regarding exclusivity for biologic medicines; discussions on issues relating to biologics are continuing because we want to get the substance right. “