By Donald Zuhn --
With the eighth round of negotiations of the Trans-Pacific Partnership (TPP) agreement currently underway in Chicago, a number of Senators have written to the U.S. Trade Representative, Ambassador Ron Kirk, to push for the inclusion of intellectual property provisions that are consistent with U.S. biologics exclusivity standards (i.e., 12 years of data exclusivity). 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.
In a letter sent today by Senators Mark Udall (D-CO) and Michael Bennet (D-CO), the Colorado legislators "stress the importance of proposing a high standard of intellectual property rights for biologics, which is consistent with the 12 years of exclusivity under U.S. law." The letter states 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." The Senators conclude their letter by stating that "[a]s we continue to look towards the inclusion of clear and enforceable intellectual property rights in the TPP Agreement, we hope that the Office of the U.S. Trade Representative finalizes its negotiations in a manner that reflects U.S. law on biologics exclusivity standards."
In a second letter sent today, 37 Senators, led by Senators Orrin Hatch and John Kerry, state that "[w]hile the views of individual members of Congress may differ as to the desirability of [the TPP] negotiations, we are united in urging you to propose a strong minimum term of regulatory data protection for biologics consistent with U.S. law." Noting that "U.S. law provides for a 12-year term of regulatory data protection for biologics," the group declares that this 12-year period "should serve as the baseline for the administration's objectives for this aspect of the negotiation." The legislators point out that "[t]his 12-year term was the result of careful deliberations in which the U.S. Congress arrived at a bipartisan consensus taking into account and weighing many factors," and contends that "the agreed upon term of protection best supports the Congress' goals of maintaining the nation's competitiveness as the leading innovator of biologics products, increasing the number of high-value jobs, and improving access to safe and affordable medicines by creating a clear pathway for the regulatory approval of biosimilar drugs."
The letters sent to Ambassador Kirk today follow two letters sent to President Obama by several House members over the summer. In one letter, sent by Rep. Henry Waxman (D-CA), Jim McDermott (D-WA), Fortney Pete Stark (D-CA), Rosa DeLauro (D-CT), Janice Schakowsky (D-IL), Peter Welch (D-VT), and Raul Grijalva (D-AZ), the House legislators "strongly recommend[ed]" that President Obama seek 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"). In a letter sent one week earlier than the Waxman letter, 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" (i.e., in support of the 12-year exclusivity period) (see "Legislators Urge President to Include 12-Year Data Exclusivity Period in Free Trade Agreement").
After the round of negotiations in Chicago concludes, TPP members are scheduled to meet in Peru in October. The nine TPP members have set a goal of reaching the outlines of an agreement by November of this year.