Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government “march-in” authority under the Bayh-Dole Act. The framework would allow federal agencies to consider price as a factor in determining whether a drug or other taxpayer-funded invention is sufficiently accessible to the public. If the proposed construct is adopted, federal agencies could force federal funding recipients to license their inventions to third parties for commercialization. Use of price in connection with “march-in” rights in this manner previously has been requested by consumer groups and suggested by certain political figures, but no federal government agency has adopted this approach with respect to pharmaceuticals or any other type of government-funded invention in the more than 40 years since the Bayh-Dole Act’s passage. This would be the first time march-in rights could be used as a mechanism to regulate drug pricing.
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