These march-in rights have existed for more than forty years, but have never been utilized—let alone leveraged to attempt to reduce the price of a marketed drug. A compulsory license to only a subset of patents would not facilitate more access and would weigh against march-in rights under the Framework. This policy was later incorporated into the Department of Commerce’s implementation of the Bayh-Dole Act (see 37 C.F.R. 12Peter S. Arno & Michael H. Davis, Why Don’t We Enforce Existing Drug Price Controls? 23Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, 88 Fed.

Source: Washington Post December 20, 2023 17:29 UTC