Lexology December 7, 2023
The Biden administration made a significant announcement today, December 7, 2023, marking a potential turning point in the way the U.S. government handles pharmaceutical patents. The administration asserted its authority, using so-called “march-in” rights, to license patents to third parties—in this case, patents of certain costly medications in a push to reduce high drug prices and promote competition.
What are March-In Rights?
March-in rights are a provision under the Bayh-Dole Act of 1980, allowing the federal government to license patents (a “nonexclusive, partially exclusive, or exclusive” license to a “responsible applicant”) to third parties under specific conditions related to products produced through a public-private partnership using federal funding. These conditions have historically included unmet public health needs, failure to make...
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