The National Institutes of Health recently rejected a request by private petitioners to exercise “march-in rights” under the 1980 Bayh-Dole Act to control the price of an expensive prostate-cancer drug, Xtandi. This marks the second time the agency has rejected march-in rights for this drug and the eighth time in the statute’s 43-year history that NIH has rejected march-in petitions in which the government is asked to vitiate private companies’ patent rights by granting licenses to other companies to produce a drug that resulted, in part, from government-funded research.
At the same time though, NIH’s parent agency, the Department of Health and Human Services, along with the Department of Commerce, announced the formation of an Interagency Working Group to develop “criteria and processes for making determinations where different factors, including price,” can justify application of Bayh-Dole’s march-in provisions. This effort to include consideration of drug prices in march-in determinations violates the explicit intent of the statute, exposes the Biden administration’s ignorance of how drug development occurs, and will destroy medical innovation — all while doing nothing to bring down drug costs.
