FTC submits comment to NIST supporting use of march-in rights as a check on inflated pharma prices

The USA’s Federal Trade Commission yesterday issued a comment in response to the National Institute of Standards and Technology’s (NIST) request for information on its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights under the Bayh-Dole Act.

Under the Bayh-Dole Act, the federal government has the right to “march in” on patents on inventions created using taxpayer funds - to require the patent holder to license the federally funded patent to other applicants. The draft interagency framework provides guidance outlining when the government should exercise its march-in rights, which have never before been utilized. The draft framework makes clear that high price is an appropriate basis for exercising march-in rights.

In the comment, the FTC applauds the NIST, which is part of the US Department of Commerce, and the Interagency Working Group for Bayh-Dole, which includes the US Department of Health and Human Services, for their efforts to reactivate march-in rights as an important check on companies charging Americans inflated prices for drugs developed with taxpayer-funded research. In the comment, the FTC expressed support for an expansive and flexible approach to march-in rights, including providing that agencies can march in on the basis of high prices.