Download the letter from Pamela Norris submitted to the Federal Register (pdf)
A strong supporter of achieving societal impact from university research, Dr. Pamela Norris, vice provost for research at the George Washington University (GW), submitted a letter on February 6, 2024 in response to a Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (Federal Register/Vol. 88, No. 235/Dec. 8, 2023) (“Draft Guidance”) from the National Institute of Standards and Technology (NIST).
The Draft Guidance proposed new rules for all inventions made by universities, research institutes, and companies using federal funding. In brief, all federal funding agencies would be newly required to consider requests by any party for them to march-in and take rights to the invention away from the owners based on the price of the resultant products. The Draft Guidance did not specify how agencies should evaluate prices.
U.S. taxpayers and the U.S. economy have greatly benefited from the public-private partnerships enabled by the Bayh-Dole Act, which allows grantees and contractors to own inventions arising from federally funded research. Before the Bayh-Dole Act, 33,000 patents that were developed at least in part based on federal funding sat on the shelf without any investors, startups, or companies taking an interest in developing them into products and services that could benefit Americans. The Bayh-Dole Act encouraged academic research institutions to work with industry to explore if and how federally funded innovations could reach and benefit the public. The Draft Guidance makes it less likely that industry will license and devote time, effort, and resources to developing federally funded innovation.
GW researchers have used federal funding in the process of inventing two treatments for cancer patients that are currently undergoing clinical trials. If march-in rights can be used for pricing purposes, it will be more difficult for the companies developing these therapies to raise enough funds from investors to complete the clinical trials, obtain Food and Drug Administration approval, and make the drugs available to the public.
Dr. Norris’s letter adds to comments from many prestigious organizations in calling for NIST to reconsider the Draft Guidance, including: Association of American Universities (AAU), Council on Government Relations (COGR), Association of Public and Land-grant Universities (APLU), Association of American Medical Colleges (AAMC), American Council on Education (ACE), AUTM, and more.