The Biden administration is considering the use of march-in rights, a controversial policy, to seize patents of certain expensive medications from drugmakers. The move aims to reduce high drug prices and enhance pharmaceutical competition. The new framework allows federal agencies to consider a medication’s price when deciding to break a patent, marking a departure from previous considerations. March-in rights, established under the Bayh-Dole Act of 1980, allow the government to take patents for drugs developed with taxpayer funds and share them with other pharmaceutical companies if the public cannot reasonably access the medications. This could lead to the development of lower-priced generic alternatives.
The Biden administration’s push is part of its broader efforts to lower drug prices in the U.S., aligning with President Joe Biden‘s health-care agenda. The pharmaceutical industry has traditionally opposed march-in rights, arguing that it discourages research and development of new drugs. While no agency has exercised march-in rights to date, the new framework introduces considerations of medication prices and allows public input for 60 days.
Senator Elizabeth Warren praised the administration’s approach, emphasizing the need to use every tool to bring down drug prices. However, the Pharmaceutical Research and Manufacturers of America, representing major drugmakers like Pfizer, Eli Lilly, and Johnson & Johnson, criticized the move, claiming it would be a loss for American patients and hamper public-private sector collaboration. The Biden administration has made efforts to lower drug prices, including allowing Medicare to negotiate drug prices and unveiling measures to counter anti-competitive practices by large health-care companies.
Despite this, march-in rights have not been used until now, and the framework provides a new dimension in addressing the challenges associated with high drug prices in the U.S.
