BioCentury
ARTICLE | Politics & Policy

Biologics exclusivity unresolved in trade deal

November 15, 2013 2:02 AM UTC

The U.S. government and other countries negotiating the Trans-Pacific Partnership (TPP) have not agreed on terms for protecting biologics from biosimilar competition, according to a leaked copy of an August 2013 draft of IP provisions of the free trade agreement. The Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) have lobbied intensively for the Obama administration to seek a 12-year exclusivity period, mirroring the exclusivity available in the U.S.; President Obama has publicly called for reducing U.S. exclusivity for biosimilars to seven years.

The draft TPP agreement also includes a proposal supported by the U.S. and Japan to bar countries from denying patents "on the basis that the product did not result in enhanced efficacy of the known product." This proposal -- which is opposed by a number of countries, including Australia and Canada -- is intended to prevent Pacific countries from enacting legislation like provisions of Indian patent law that prevented Novartis AG (NYSE:NVS; SIX:NOVN) from patenting Gleevec imatinib. India is not a participant in the TPP negotiations (see BioCentury Extra, April 1). ...