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  • Washington Highlights

    NIH Declines to ‘March-In’ on Cancer Drug, NIST Releases New Bayh-Dole Regulations


    Stephen Heinig, Director, Science Policy
    For Media Inquiries

    On March 21, the National Institutes of Health (NIH) officially declined a petition to exercise “march-in rights” to take possession of patents on the drug Xtandi, a treatment for prostate cancer. The petitioners argued that Xtandi’s high price is a violation of provisions under the 1980 Bayh-Dole Act (P.L. 96-517) to make federally funded inventions available on “reasonable terms.”  

    The NIH’s decision letter from Lawrence Tabak, DDS, PhD, performing the duties of the NIH director, stated that the agency’s review determined that Xtandi is widely available on market and has treated 200,000 patients over a decade. Therefore, the University of California, which conducted the original research with NIH grants leading to the drug’s development, has met an inventor’s Bayh-Dole obligation to ensure an invention is reasonably available. The decision is consistent with prior march-in petitions arising over pharmaceutical prices and in all cases, the government has so far declined the requests.  

    In its response, the NIH expressed concern over the effect of high drug prices on access to health care. On the same day, the Department of Health and Human Services (HHS) announced a joint review of the government’s march-in authority, including the question of pricing. The HHS and the Department of Commerce confirmed they would involve concerned parties, including universities, in the review.  

    In July 2022, the AAMC joined several other higher education associations in a letter to HHS Secretary Xavier Becerra that urged the department and the NIH not to exercise march-in rights solely on the basis of price, as such action would not be a comprehensive solution to the problem of high drug prices and would undermine the ability of medical schools and universities to license inventions and advance drug discovery in the future [refer to Washington Highlights, July 29, 2022].  

    Also this week, the National Institute of Standards and Technology (NIST), a Department of Commerce agency, posted its long-awaited revised final rule on Bayh-Dole implementation, and opted not to clarify march-in provisions. The AAMC previously commented on NIST’s proposed regulations, including support for a clarification that “consumer price may not be used as a basis for exercising march-in rights.” [refer to Washington Highlights, April 9, 2021].  

    The agency announcements were preceded by a related March 22 Senate Health, Education, Labor, and Pensions Committee hearing, in which Senators questioned chief executive officer and director of Moderna, Stéphane Bancel, MBA, MEng, MSc, about pricing of the company’s bivalent COVID-19 vaccine and its connection to taxpayer-funded research.