Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations Approaches

By Kurt R. Karst –      

Efforts to include a 12-year period of exclusivity for biological products in the Trans-Pacific Partnership (“TPP”) agreement chapter on intellectual property rights are alive and well as folks ramp up for the 14th negotiating round of the TPP, which will take place in Leesburg, Virginia from September 6-15, 2012 (see here).  Such a move would align the TPP agreement with the 12-year period of reference product exclusivity provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).  As we previously reported (here and here), the TPP is a free trade agreement being hammered out among the United States – specifically, the United States Trade Representative (“USTR”), Ron Kirk – and several other partners, and is intended to further liberalize the economies of the Asia-Pacific region.  The TPP, which has been controversial and shrouded in secrecy, has also been touted as a model for all future U.S. trade and investment agreements. 

Although copies of the draft intellectual property chapter had previously been leaked and posted in the Internet, Representative Darrell Issa (R-CA), who is chairman of the House Oversight and Government Reform Committee, “officially leaked” the draft intellectual property chapter in May 2012.  Article 9 of the draft chapter (from February 2011), titled “Measures Related To Certain Regulated Products,” covers pharmaceutical products and includes placeholders for “provisions related to data protection for pharmaceutical products” and “provisions related to patent term/data protection relationship.”  Another leaked version of selected provisions of the chapter from September 2011 includes some additional details on Article 9, but still has a placeholder for specific provisions applying to biologics. 

In June 2012, Teresa Stanek Rea, Deputy Director of the U.S. Patent and Trademark Office, testified before the House Judiciary Subcommittee on Intellectual Property, Competition and the Internet and commented that the Obama Administration was seeking a period of 12-year exclusivitity for biologics in the TPP agreement.  This is contrary to the Obama Administration’s 2013 budget proposal, which seeks to reduce the 12-year exclusivity period under the BPCIA to 7 years.  According to Knowledge Ecology International, Ms. Rea subsequently retracted her comments and the USTR issued a statement that it has “not proposed a specific term for data exclusivity for biologics” and that “discussions on issues relating to biologics are continuing.”

Perhaps as a result of the flap in testimony, and in anticipation of the next round of TPP negotiations, a new round of letters have been sent to President Obama by several Members of Congress.  In a July 12th letter, Senators Patty Murray (D-WA) and Maria Cantwell (D-WA) say that “the TPP negotiations must ensure consistency with U.S. law, which provides 12 years of data protection for biologics,” and that 12-year exclusivity is “vitally important” and “an important foundation for a vibrant U.S. biopharmaceutical industry and workforce.”  Similarly, several members of the Massachusetts delegation – Representatives Edward Markey (D), Richard Neal (D), John Olver (D), James McGovern (D), John Tierney (D), Stephen Lynch (D), Niki Tsongas (D), and William Keating (D) – state in a July 13th letter that “[a]n agreement that reflects U.S. law on biologics exclusivity standards will help Massachusetts companies continue to expand and compete in the global economy.”  In the most recent letter from earlier this month, Senator Claire McCaskill (D-MO) says that TPP negotiations “should sustain the high standards on intellectual property rights that are the hallmark of U.S. law,” and that it is “especially important that the negotiations protect the 12 years of exclusivity that U.S. law now provides” for biologics.