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The Biden Administration’s Push to Lower Drug Prices Through March-In Rights

18 Jul 2024 1:48 PM | Deborah Hodges (Administrator)

Patients and health care professionals concerned about the high prices of US pharmaceuticals have urged the federal government to exercise its march-in rights on some pharmaceutical patents. [JAMA]

Built into the Bayh-Dole Act of 1980, march-in stands on the principle that if the government funds an invention, then the public should enjoy the benefits of using the invention. March-in rights allow the government to demand an invention developed with government dollars be licensed to a third party, including when the invention has not been put to practical use or when necessary to meet societal health needs. These rights are written into federal law and companies therefore know they exist when engaging with federally funded research. The federal government has never exercised its march-in rights.

On December 8, 2023, the Biden administration proposed a framework for US agencies to utilize march-in, laying the groundwork for the federal government to assist in the generation of pharmaceutical and other goods that the public cannot sufficiently access. This Viewpoint explores the proposal and clarifies for physicians and the biomedical industry the likely impact on US drug prices.

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