The U.S. Department of Health and Human Services and the Department of Commerce are working to develop a framework for the implementation of the march-in provision in the Bayh-Dole Act, which allows the federal government to grant a license for a company to produce a patented drug, if the owner of the patent declines to grant permission.
The Bayh-Dole Act allows recipients of public funds to retain ownership and seek patents on inventions developed with those funds, according to a March 21 news release. The act also gives the government residual rights to these inventions, including the power to grant licenses to third parties when the benefits of the invention are not available to the public on reasonable terms.
“The Biden-Harris administration is committed to increasing access to health care and lowering costs," HHS Secretary Xavier Becerra said in the release. "We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public and better define how HHS could effectively utilize our authority moving forward.”
The new framework being developed will enable the government to better use its march-in authority to ensure federally-funded technologies serve the broader interests of the American public, the news release said.
"HHS, the National Institutes of Health and other agencies have been petitioned on several occasions to initiate march-in proceedings, but to date have not invoked this authority," the news release said. "Most recently, the NIH declined a petition to initiate a march-in proceeding for the prostate cancer drug Xtandi."
HHS will hold a workshop this year "to further refine the cases for which HHS could consider exercising march-in authority," the news release said. "HHS will seek input from a diverse array of stakeholders – including patient groups, industry, universities, small business firms and nonprofit organizations, as well as experts in technology transfer and innovation policy. The goal of the workshop will be to assess when the use of march-in is consistent with the policy and objectives of the Bayh-Dole Act."
