Sens. Elizabeth Warren (D-MA) and Angus King (I-ME), and Rep. Lloyd Doggett (D-TX) are once again urging the federal government to “immediately strengthen and finalize” the Biden administration’s guidance around march-in rights.
Under the Bayh-Dole Act of 1980, the government can — in limited circumstances — “march in” and issue new licenses for certain patents that were based on federally-funded research. Warren, King and Doggett have long been proponents of using march-in rights to lower drug prices, and encouraged the government in February to firm up draft framework which specifies for the first time that a drug’s price may be considered in deciding whether to exercise march-in authority.
The lawmakers doubled down on that message in a letter to HHS Secretary Xavier Becerra and Commerce Secretary Gina Raimondo last week.
Warren, King and Doggett urged the HHS leaders “not to be deterred by congressional Republicans who are seeking to hamstring your authority to lower drug costs for Americans.” They cited a recent letter from Sen. Bill Cassidy (R-LA) which questioned HHS’ statutory authority to use price as a justification for march-in rights in the wake of the Supreme Court’s Chevron decision.
“In recent weeks, Republican members of Congress have sought to radically and incorrectly broaden the scope of the Supreme Court’s recent decision,” Warren, King and Doggett wrote on Friday, adding that the court’s decision doesn’t alter the “plain terms” of the Bayh-Dole Act, “which clearly empower agencies with ‘march-in’ rights.”
“Congress has explicitly and unambiguously delegated authority to your agencies to ensure that federal inventions, including pharmaceuticals and other medical products, developed using federal funds are ‘available to the public on reasonable terms,’” they wrote.
Critics have argued that the draft guidance misinterprets the law and could hinder innovation. A bipartisan group of lawmakers wrote in a February letter to the White House that “Congress would have to amend the law to allow ‘reasonable price’ to be a factor in triggering march-in rights.”
The US government has never used its march-in authorities around drug prices and NIH declined such an attempt in March 2023.