USTR Embraces 'TEAM' approach in TPP talks; Senators back 12-year exclusivity for biologics

September 12 marked the beginning of the eighth round of Trans-Pacific Partnership (TPP) negotiations, which are taking place in Chicago, Illinois, USA. The TPP is an Asia-Pacific regional trade agreement being hammered out among the USA and eight other partners (Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam).

The TPP would cover trade in goods and services and also includes a proposed chapter on intellectual property, noted Kurt Karst of Hyman of Phelps & McNamara on the law firm’s FDA Law Blog, saying that the chapter on intellectual property is where the latest battle over biologics exclusivity is happening, and which was the subject of several letters from Members of Congress sent earlier this year.

In a new round of letters reported on by Patent Docs, several US Senators urge US Trade Representative (USTR) Ron Kirk to support a 12-year period of exclusivity for biological products. Colorado Senators Mark Udall (Democrat) and Michael Bennett (Democrat) state in their letter that “beginning the biologics negotiations on an intellectual property standard consistent with US law will make sure that Coloradans can continue to lead the world in the innovation of biologics while also assuring a reasonable pathway for biosimilar products.” Meanwhile, another letter signed by a bipartisan group of 37 US Senators says that they are united in urging the USTR to “propose a strong minimum term of regulatory data protection for biologics consistent with US law,” Mr Karst explained.