The Biden administration has released a draft framework reviewing federal agencies’ authority under the 1980 Bayh-Dole Act to “march-in” and take back or redirect licenses to inventions arising from federally sponsored research at medical schools and universities. Controversially, the draft framework includes for the first time a high price for a pharmaceutical or other invention to be a justification for march-in. In the more than 40 years since Bayh-Dole was enacted, no march-in petition has been granted on pharmaceuticals, and the National Institutes of Health (NIH) has several times concluded that the act does not provide authority to march in over the price of a commercially available drug. The AAMC and other higher education associations have supported NIH’s prior interpretation of the law and argued that an exercise of march-in over commercial pricing would create disincentives for industry to work with universities developing new drugs in the future [refer to Washington Highlights, July 29, 2022]. The associations have urged the government to address drug affordability and access through other, more direct means.
The draft framework published by the Department of Commerce provides 60 days for public comment before implementation. The AAMC expects to comment. The department is also hosting a public informational webinar on the framework on Dec. 13.