The Federal Trade Commission (FTC) has responded to the National Institute of Standards and Technology’s (NIST) request for information (RFI) on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights under the Bayh-Dole Act. The FTC's comment was submitted on the final day of the comment period.
As per the Federal Register, this draft guidance framework examines factors that an agency might consider when deciding whether to exercise march-in rights. The RFI for this framework was published in the Federal Register on December 8, 2023. The comments submitted will be utilized by NIST and the Interagency Working Group for Bayh-Dole to develop a final framework.
The FTC press release explains that the Bayh-Dole Act grants federal government the power to "march in" on patents for inventions developed with federal funding, requiring that patent holders license their patents to other applicants. The draft framework indicates that a "high price" is a valid reason for the government to exercise its march-in rights.
In its commentary on this draft document, according to another FTC press release, it praised NIST and the Interagency Working Group for Bayh-Dole for their efforts to reactivate march-in rights and expressed support for using "high price" as a basis. The FTC perceives these rights as an "important check" on companies charging American taxpayers high prices for drugs developed with federally funded research.
The FTC said in its press release, "Lack of competition in pharmaceutical markets can lead to inflated pricing, rendering some lifesaving treatments out of reach for many Americans." It further added, "Contrary to industry claims that high drug prices are necessary to fund research and development (R&D), drug prices often depend more on whether the drug faces competition than the drug’s R&D costs. At the same time, pharmaceutical firms enjoy hundreds of billions of dollars of taxpayer investment in R&D. March-in rights are an essential check to ensure that taxpayer-funded inventions are affordable and accessible to the public."
