USTR Embraces “TEAM” Approach in TPP Talks; Senators Back 12-Year Exclusivity for Biologics

By Kurt R. Karst –      

September 12th marked the beginning of the eighth round of Trans-Pacific Partnership (“TPP”) negotiations, which are taking place in Chicago, Illinois.  The TPP is an Asia-Pacific regional trade agreement being hammered out among the United States and eight other partners.  The TPP would cover trade in goods and services and also includes a proposed chapter on intellectual property.  As we previously reported, 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 U.S. Senators urge U.S. Trade Representative (“USTR”) Ron Kirk to support a 12-year period of exclusivity for biological products.  Colorado Senators Mark Udall (D) and Michael Bennett (D) state in their letter that “[b]eginning the biologics negotiations on an intellectual property standard consistent with U.S. 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 bipartisal group of 37 U.S. Senators says that they are united in urging the USTR to “propose a strong minimum term of regulatory data protection for biologics consistent with U.S. law.”

On the same day the letters were sent to USTR Kirk, the USTR issued a white paper outlining a new strategic initiative, titled “Trade Enhancing Access to Medicines” (or “TEAM”).  The TEAM strategy, which is supported by the U.S. Agency for International Development, is “designed to deploy the tools of trade policy to promote trade in, and reduce obstacles to, access to both innovative and generic medicines, while supporting the innovation and intellectual property protection that is vital to developing new medicines and achieving other medical breakthroughs,” according to the white paper.  “The TEAM initiative reflects fresh thinking about trade and access to medicines.  It is about more than allowing access to medicines.  It is about working with trading partners to develop strong and common standards to help drive access – propelling the TPP countries to the front of the line for important innovative medicines and for generic competition, while promoting U.S. jobs and exports.”

The USTR’s white paper identifies several goals, including:

Expedite access to innovative and generic medicines through a “TPP access window”: Promote the availability of life-saving and life-enhancing medicines in TPP markets and simultaneously establish a pathway for generics to enter those markets as quickly as possible by conditioning obligations to apply certain pharmaceutical-specific intellectual property protections on the requirement that innovators bring medicines to TPP markets within an agreed window of time.

The white paper is silent on the term of any biologics exclusivity period; however, we note that President Obama’s Budget for Fiscal Year 2012 proposed that “beginning in 2012, innovator brand biologic manufacturers would have 7 years of exclusivity. . . .”  A letter sent to President Obama this past summer concerning TPP negotiations stated that “[w]ere the TPP ultimately to contain a 12 year biologics exclusivity provision, it would impede the ability of Congress to achieve the Administration’s proposed 7 year change without running afoul of U.S. trade obligations.”