In Rejecting “March-In Rights” Petition for Xtandi, NIH Sends a Strong Message in Support of Intellectual Property Protections

Earlier this week, the National Institutes of Health rejected a petition to initiate “march-in” proceedings.


Earlier this week, the National Institutes of Health rejected a petition to initiate “march-in” proceedings for the prostate cancer drug Xtandi (enzalutamide). A group of drug pricing advocates had filed a petition urging the federal government to invoke a provision of the 1980 Bayh-Dole Act that would allow Xtandi’s patent to be licensed to other manufacturers in an attempt to lower prices for the drug.

John Stanford, Executive Director of Incubate, issued the following statement:

We support NIH’s decision to decline to invoke “march-in rights” on Xtandi’s patent which we believe would have been an inappropriate use of the agency’s authority under the Bayh-Dole Act and would have weakened the intellectual property (IP) protections that America’s biotechnology sector depends on.

This provision of the Bayh-Dole Act was never intended to be used a price-control mechanism, and such an interpretation would destabilize the IP protections that drive America’s global biopharmaceutical leadership. Since Bayh-Dole was enacted, the federal government has rejected calls for this interpretation of march-in rights. NIH’s recent decision is consistent with this view.

American innovators depend on a strong foundation of IP protection. Investors must have confidence that when they make an extraordinarily risky and costly bet on an innovation, they have an opportunity to recoup their investment.  Weakening IP protections would create uncertainty, reduce investors’ ability to confidently pursue new innovations, and, in turn, stifle the investment that fuels advances in medical technology. Alongside this announcement, the Biden Administration announced the creation of an interagency working group to review its “march-in authority.” Bayh-Dole was enacted more than 40 years ago to create a technology transfer process from universities and research institutions receiving federal funding to the private sector in response to the rampant wasting away of promising new technologies in the years leading up to it. Since its passage, Bayh-Dole has been a resounding success and has transformed numerous promising discoveries into lifesaving medicines. As the working group examines this issue, we urge it to maintain our nation’s legacy of strong IP protection that encourages public-private collaboration for the benefit of patients, as opposed to considering policies like march-in, which would cede our leadership in life sciences to competitors like China.