1 Analyses of this federal-register by attorneys

  1. Proposed Framework Would Expand US Government’s Discretion to ‘March-In’ on Patent Rights

    Morgan LewisNathan SmithJanuary 2, 2024

    rcising march-in rights on a more regular basis.[1] On December 7, 2023, the White House released a statement in connection with the Biden administration’s stated goal of increasing affordability of healthcare and prescription drugs, announcing the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (the Draft Framework). The White House stated that the Draft Framework seeks to “promote lowering prescription drug costs for American families” by providing guidance to “agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions, which specifies that price can be a factor in considering whether a drug is accessible to the public.” See Fact Sheet: Biden-⁠Harris Administration Announces New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition (last accessed Dec. 21, 2023).[2]SeeRequest for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, 88 Fed. Reg. 85,593 (December 8, 2023).[3]SeeMarch-In Rights and U.S. Global Competitiveness (last accessed Dec. 27, 2023).[4]See id. (noting that “petitioners asked the NIH to exercise march-in rights due to concerns over the high price of an HIV/AIDS treatment, Norvir/ritonavir, and a glaucoma treatment, Xalatan/Latanoprost, but the agency declined because it deemed each drug was available to the public on a sufficient basis”).[5]SeeWould march-in support the policy & objective of Bayh-Dole, considering the specific case and broader context? Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights(last accessed Dec. 21, 2023).[View source.]