December 20, 2023
March-In Rights: A Hostile Regulatory Environment
As part of its initiative on march-in rights – the practice of relicensing patents that received federal funding – to make products more affordable to the public, the Biden Administration released an interagency draft framework under the Bayh-Dole Act to permit the government to march-in for medical products and prescription drugs. In a new insight, Director of Health Care Policy Laura Hobbs reviews two proposed march-in health care scenarios presented in the proposed framework to better understand the long-term negative impact march-in rights would have on innovation as well as patient access to the newest medicines.
The two scenarios proposed in the interagency framework to justify the use of march-in rights do not appear to demonstrate that relicensing drug patents would reduce costs for patients or improve access to new medicines. Moreover, the use of march-in rights is likely to reduce private investment in public research, the foundation for the majority of new discoveries and innovative products. If the government relicenses patents, private companies may return to their own research – which conflicts with the intent of the Bayh-Dole Act to incentivize public-private collaboration.
The United States is a leader in medical innovation and prescription drug development. Finalizing a march-in framework and respective federal agency authority will just be another obstacle to pharmaceutical innovation in an increasingly hostile regulatory environment.