[Ip-health] USTR: Biologics DE faces strong opposition in TPP

Peter Maybarduk pmaybarduk at citizen.org
Fri Mar 29 17:36:36 PDT 2013

Inside U.S. Trade - 03/29/2013
Marantis: Data Protection For Biologics Faces Strong Opposition In TPP
Posted: March 28, 2013
Acting U.S. Trade Representative Demetrios Marantis last week conceded that there is "a lot" of opposition from other countries participating in the Trans-Pacific Partnership (TPP) negotiations to the idea of providing stronger data protections for so-called biologic drugs, for at least two reasons.
In a March 19 hearing before the Senate Finance Committee, Marantis said this is a new issue for TPP countries. Moreover, he noted that some TPP partners do not currently provide any data protection for biologic drugs, signaling that it may be difficult to convince these countries to sign up for tough protections for such drugs in TPP.
"It's a new area of innovation," and TPP partners "treat biologics in very different ways," he said. "Some don't provide protection; some do." Of current TPP partners, Chile, Mexico and Peru do not provide data protection for biologic drugs, according to the Biotechnology Industry Organization.
In light of these challenges, Marantis said the administration is seeking "the right balance between flexibility and specificity," adding that the administration looks forward to "working with [senators] to strike this balance." The administration has also been talking to TPP partners "very seriously" about this issue, he said.
But Marantis repeatedly emphasized that the administration has not yet decided whether to propose that all TPP partners adopt the 12 years of data exclusivity for biologics that is contained in the health care law passed during President Obama's first term. "We are still reflecting upon how to best proceed," he testified.
"I don't know yet what we're going to do with respect to the term of data protection," he added. In response to questions from several senators, Marantis would only say that the administration recognizes biologics as a "vital area" of innovation and that the issue of data exclusivity protections for these drugs has been a "tough" one in the talks.
Data exclusivity refers to the period of time during which the patent holder can restrict undisclosed data used to develop a brand-name drug, thereby delaying the introduction of a competitive generic version. U.S. law provides 12 years of data exclusivity for biologics, but only five years for conventional drugs.
Sen. Robert Menendez (D-NJ) emphasized that the treatment of biologics in TPP will be "one of the areas" that he will look at when deciding whether he can support a final TPP deal.
Ranking Member Orrin Hatch (R-UT) added that providing 12 years of data exclusivity for biologics would be consistent with the 2002 expired fast-track law. That law contains a negotiating objective stating that the administration should seek intellectual property rights provisions in international trade negotiations that are similar to those in U.S. law.
Hatch noted that the administration is taking the position that it is proceeding with new trade negotiations as if it had fast-track negotiating authority, meaning it should support 12 years of protections in the talks.
Despite Marantis' testimony on the challenges USTR faces in this area, Chairman Max Baucus (D-MT) and Hatch called on him in a March 22 letter to stay strong on data exclusivity.
"We urge you to seek commitments from our trading partners that reflect the level of protection under U.S. law, for example 12 years of regulatory data protection for biologic pharmaceuticals," said the letter, which generally stressed the need for a strong intellectual property chapter in TPP.
Inside U.S. Trade - 03/29/2013, Vol. 31, No. 13

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