February 6, 2024
In December 2023, the U.S. 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. This policy is intended to be a tool to help agencies evaluate when it might be appropriate to require licensing of a patent developed with federal funding. The proposed guidance is now available in the Federal Register.
Why is this significant?
In 1980, the Bayh-Dole Act became law (formal title: The University and Small Business Patent Procedures Act of 1980). With that law, federally-funded research products could be patented by universities and small business contractors in order to license those products for further development.
This law is the basis of university drug discovery, patenting and licensing in the United States, in particular when those drugs are discovered with taxpayer dollars.
The Bayh-Dole Act is what has empowered universities to set the terms for how technologies developed on their campus are monopolized, monetized, and turned into real world products. It's the reason for the patenting of HIV/AIDs medicines that led to the formation of UAEM after the battle for access to stavudine in 2001.
Since the 1980s, there have been protections in the law for the health and safety of the public, and since the 1980s, the U.S. government has shied away from using those protections to protect the public from exorbitant prices of prescription medicines.
With this draft guidance, the U.S. government is considering a shift in this policy.
What did UAEM do?
UAEM North America's access team prepared a comment letter in response to the framework, which is available here.
In our comment, we support the development of the framework, caution against vague definitions used to describe making sure products are available on "reasonable terms" and argue that pricing thresholds should be clearly articulated, among other suggestions.
Download our full comment here.
In addition, UAEM joined joint comments with allies, which will be posted here once available.
