US govt sets scene for appropriating drug patents developed with federal funding

In the USA, the Biden administration announced a framework yesterday that proposes including prices as a factor when deciding if the public can easily obtain a taxpayer-funded drug and allowing government agencies to license the patent behind the product to another party if the cost is determined to be too high.

The US Department of Commerce’s National Institute of Standards and Technology (NIST) released for public comment its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, a tool to help agencies evaluate when it might be appropriate to require licensing of a patent developed with federal funding. The draft guidance will help agencies work through a range of policy considerations relevant to a potential march-in decision, including price. The proposed guidance is  now available in the Federal Register.

Under the University and Small Business Patent Procedures Act of 1980, commonly known as the Bayh-Dole Act, the government allows recipients of federal research funding to retain rights to inventions conceived or developed with that funding. The act gives federal agencies the right to “march in” under specific circumstances related to accessibility of the invention, as well as national health and safety (35 USC 203). There have been calls for greater clarity on when it is appropriate or warranted for a federal agency to exercise such rights.