By Donald Zuhn —

On August 4, Rep. Henry Waxman (D-CA) led a group of seven House Democrats in asking President Obama to exclude the 12-year data exclusivity period provided by the biosimilar approval pathway of the Patient Protection and Affordable Care Act (PPACA) from the intellectual property provisions of the Trans-Pacific Partnership (TPP) agreement (see "House Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade Agreement").  One week earlier, however, a bipartisan group of forty Representatives sent their own letter to the President, indicating their support for the President's "continued efforts to ensure that intellectual property standards in the Trans-Pacific Partnership ("TPP") trade agreement are consistent with U.S. law, protect U.S. interests and sustain and help grow U.S. jobs."

The TTP, or Trans-Pacific Strategic Economic Partnership Agreement, is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam (Canada, Japan, the Philippines, South Korea, and Taiwan have also expressed interest in participating in the agreement).  The seventh round of TTP negotiations was held in Ho Chi Minh City, Vietnam, in June, and two more rounds of negotiations are scheduled to take place in September (in the United States) and in October (in Peru).  The nine TPP members have set a goal of reaching the outlines of an agreement by November of this year.

In their July 27 letter, the forty-member House coalition states that "[c]ritical to increasing U.S. companies' ability to export and contribute to U.S. GDP growth is ensuring that our government does all it can to help provide a level playing field for U.S. companies globally and advocate for intellectual property rights that provide certainty for America's innovative companies in the biosciences and other sectors."  The letter adds that "[s]etting strong standards allows our companies to secure the capital investments needed to generate tomorrow's new treatments and potential cures and make them available to patients around the world."

In contrast with Rep. Waxman's letter, the letter from the forty legislators specifically seeks to have the 12-year data exclusivity period provided by the PPACA included in the TTP.  In fact, the legislators state that:

In the course of the TPP negotiations on intellectual property rights issues, we urge you to support current U.S. law on biologics, which provides for 12 years of protection.  The U.S.-led biopharmaceutical industry would be disadvantaged if the U.S. does not ensure consistency with U.S. law as part of the TPP, because foreign countries do not provide the same type of protection rules.  The current protections for biologic drugs were debated extensively and received strong bipartisan support in both the House and the Senate.  This provision is critical to keeping and expanding high-value U.S. jobs offered by America's biotech sector and spurring the R&D investment needed to seize extraordinary opportunities for medical advances to combat our most costly and challenging diseases.  Continued R&D investment is needed to ensure that the cures and treatments the biotechnology sector delivers today will continue and allow more patients to access to these revolutionary therapies.

The July 27 letter was signed by Representatives Ron Kind (D-WI), Erik Paulsen (R-MN), Joseph Crowley (D-NY), Vern Buchanan (R-FL), Richard Neal (D-MA), Aaron Schock (R-IL), Mike Thompson (D-MS), Wally Herger (R-CA), John Larson (D-CT), Devin Nunes (R-CA), Bill Pascrell, Jr. (D-NJ), Dave Reichert (R-WA), John Carney (D-DE), Charles Boustany, Jr. (R-LA), Gerald Connolly (D-VA), Adrian Smith (R-NE), Susan Davis (D-CA), Lynn Jenkins (R-KA), Anna Eshoo (C-DA), Rick Berg (R-ND), Martin Heinrich (D-NM), Diane Black (R-TN), James Himes (D-CT), Marsha Blackburn (R-TN), Rush Holt (D-NJ), Michael Burgess (R-TX), Michael Honda (D-CA), David Dreier (R-CA), Rick Larsen (D-WA), Brett Guthrie (R-KY), Gregory Meeks (D-NY), Tom Latham (R-IA), Loretta Sanchez (D-CA), Cathy McMorris Rodgers (R-WA), Allyson Schwartz (D-PA), Joseph Pitts (R-PA), Adam Smith (D-WA), John Sullivan (R-OK), Edolphus Towns (D-NY), and Lee Terry (R-NE).  One of the letter's signatories, Rep. Anna Eshoo, was primarily responsible for the inclusion of the biosimilar approval pathway and the 12-year data exclusivity period in the PPACA, having introduced an amendment to the House health care reform bill in June 2009 along with Rep. Jay Inslee (D-WA) and Rep. Joe Barton (R-TX) (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period").

TTP members – original four members in orange and additional five members in green.