U.S. Still Demanding 12 Years Biologic Patent Protection Under TPP
As negotiators continue to shape the Trans-Pacific Partnership trade deal, the length of patent protection for biologics remains a sticking point with the U.S. continuing to push for 12 years of protection before a biologic drug can be copied.
U.S. Trade Representative Michael Froman confirmed the U.S. has not backed off its position on the issue, and that it has received considerable pushback from the other 11 countries involved in the negotiations. Five of the countries have no data exclusivity protections for biologics while the rest have between five and eight years, he said.
Froman made the remarks on Capitol Hill last week where he was testifying before the Senate Finance Committee and House Ways and Means Committee, pushing for passage of an update to the executive branch’s negotiating powers on trade with foreign countries.
Froman told the committees that TPP negotiators may have a final agreement within months. But it’s unclear if biologics will be part of the final trade deal given the reluctance of the other countries to adjust their patent laws to match the 12 years of patent protection biologics receive in the U.S.
Senate Finance Chairman Orrin Hatch (R-Utah) and fellow Republican Sen. John Cornyn of Texas voiced their continued support for 12 years of protection from biosimilar competition.
GPhA and patient advocacy groups, meanwhile, have kept up their opposition to the 12 year period, arguing it will limit access to medicines by prolonging brand monopolies. They also lashed out at patent linkage provisions and ones on granting of secondary patents.
GPhA President and CEO Ralph Neas spoke out against the TPP’s patent protections once again Wednesday in an Op-Ed to The Hill newspaper.
The countries joining the U.S. in the TPP talks are Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.
Read Froman’s prepared testimony here: www.fdanews.com/01-29-15-TPP-Testimony.pdf. — Bryan Koenig