Lexology July 15, 2024
In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration believes that a pharmaceutical product is not available to the public at a reasonable price. As a quick recap, the Act grants the government authority to exercise “march-in rights,” allowing federal agencies to require patent licenses be given to third parties if a product was developed with the assistance of federal funding and one of four statutory criteria under the Act is satisfied. On December 8, 2023, the Biden administration released the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (the “Draft Guidance”), providing a...
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