The U.S. House of Representatives will delay a vote on the Innovation Act (H.R. 9), a patent reform bill, until September at the earliest.
The Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America have convinced a number of lawmakers to support their demands for excluding drug patents from the IPR process.
BIO and PhRMA support changing H.R. 9 and the Senate’s Patent Act (S. 1137) “to preserve the integrity of the Drug Price Competition and Patent Term Restoration Act (commonly referred to as Hatch-Waxman) and the Biologics Price Competition and Innovation Act by exempting certain biopharmaceutical patents on approved medicines” from the IPR process.
The trade associations wrote that the “tremendous uncertainty caused by IPR challenges to patents on FDA-approved products threatens to undermine” Hatch-Waxman. They told Congress “there is no evidence that IPRs will allow generic and biosimilar companies to bring products to market more quickly,” because “it is highly unlikely that IPR can or will be used to invalidate all of the patents covering a particular FDA-approved drug or biologic.”
BIO and PhRMA added, however, that “the risks and uncertainties associated with having to defend patents in multiple venues is already impacting investment considerations by innovator biopharmaceutical companies and potential investors.”