As the Biden administration rolls out new draft guidance around the use of march-in rights on high-priced drugs, some critics argue that the step is unlikely to have a near-term impact on drug pricing and could harm innovation.
Under the Bayh-Dole Act of 1980, the government can, in limited circumstances, “march in” and issue new licenses for certain patents that were based on federally-funded research. The government has never exercised that authority, and the framework released Thursday is the first time that price has been considered an explicit factor in determining whether march-in authority is appropriate.
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