On March 21, 2023, the Biden administration rejected a request to leverage march-in rights for the prostate cancer drug XTANDI (enzalutamide), finding the drug to be “widely available,” but announced a plan to “pursue a whole-of-government approach to review its march-in authority.”

Background

March-in rights, established under the Bayh-Dole Act, allow the government to take title to patents on inventions created with federal funding.
The federal government has yet to exercise march-in rights.
To date, march-in rights have been threatened against:
Gilead’s Veklury (remdesivir)
AbbVie’s Norvir (ritonavir)
Viatris/Pfizer’s Xalatan (latanoprost)
Sanofi Genzyme’s Fabrazyme (agalsidase beta)
Novartis’s Gleevec (imatinib mesylate)
Astellas/Pfizer’s Xtandi (enzalutamide)
Xtandi has been targeted several times between 2019-2022
Other recent developments
Feb. 2022: On Feb. 8, 12 House members signed a letter and on Feb. 17, Sens. Warren (D-MA) and King (D-ME) and Rep. Doggett (R-TX) signed a letter supporting march-in rights on Xtandi.
Mar. 8, 2022: 29 policy organizations wrote a letter to HHS opposing march-in rights.
Mar. 17, 2022: The Bayh-Dole coalition, along with multiple pharmaceutical industry groups, wrote a letter to HHS opposing march-in rights.
Mar. 24, 2022: Progressive groups sent a letter to HHS supporting march-in rights.
June 23, 2022: Letter to HHS from 100 lawmakers, led by Sen. Warren (D-MA) and Rep. Doggett (D-TX) supporting the use of march-in rights and/or Sec. 1498.

HHS and DOC Announce Plan to Review March-In Authority

On March 21, 2023, the Department of Health and Human Services (HHS) and Department of Commerce (DOC) announced a plan to pursue a “whole-of-government” approach to review its march-in authority.
The Interagency Working Group for Bayh-Dole will develop a framework to implement the march-in provision, which will include the criteria and factors (such as price) for making determinations.
HHS will convene a workshop in 2023 with the goal of assessing “when the use of march-in is consistent with the policy and objectives of the Bayh-Dole Act.” HHS states that it will seek input from various stakeholders, including patient groups, industry, universities, small business firms, nonprofit organizations, and experts in technology transfer and innovation policy.
On March 21, 2023, DOC’s National Institute of Standards and Technology also published the revised Bayh-Dole Act rule “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions”.
DOC stated that the revisions were made in response to more than 80,000 comments received to the proposed rule and are intended to streamline procedures, apply technical corrections, and remove or correct outdated references.
Pursuant to President Biden’s Executive Order on Promoting Competition in the American Economy, DOC did not finalize any provisions that would have prohibited the government’s use of march-in rights solely based on a drug’s price.
Next steps
HHS and DOC have not released further details on what the “whole of government” approach will entail.
In a statement, HHS Secretary Xavier Becerra noted that “we [HHS] look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward.”

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