Lexology December 12, 2023
On December 7, 2023, the U.S. Department of Health and Human Services and Department of Commerce announced development of a framework for implementation of the government’s “march-in” authority under the Bayh-Dole Act.1 This framework would articulate guiding criteria for agencies deciding whether to exercise this authority to compel a patent owner to license a patent on a federally funded invention to another party on reasonable terms and, for the first time, would allow agencies to consider the price of the patented product in making that assessment. A White House fact sheet also issued on December 7 explained that this proposed framework is intended “to support lowering prescription drug costs and increase Americans’ access to life-saving medications,”2 signaling that the proposed...
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