The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency review of the march-in guidance, which was announced in tandem with the NIH’s rejection of the Xtandi march-in petition in March 2023.
When the comment period was announced, KEI published a brief FAQ to provide an overview of march-in rights.
KEI Comments to NIST
KEI submitted a series of comments on several different important topics for NIST to consider as they finalize the guidance:
- KEI Comment to NIST on Transparency of March-in Proceedings. February 5, 2024.
- KEI Comment to NIST on Bayh-Dole Rights and Cases of Mixed Patent Landscapes. February 6, 2024.
- KEI Comment to NIST on “Available to the Public on Reasonable Terms.” February 6, 2024.
- KEI Comment to NIST on the Bayh-Dole Letter to the Washington Post and the Legislative History of the Act. February 6, 2024.
- KEI also included a submission to NIST incorporating by reference previous comments relevant to the issues in the draft guidance:
- Love, James. “Lower Drug Costs Are Just a Federal License Away. But They Require Biden Administration Leadership.” Scientific American. January 23, 2024.
- KEI Briefing Note 2021:3 The number of standard and material CRADAs executed by the NIH from 1985 to 2020 and the relationship to NIH reasonable pricing clause.
- KEI Letter to U.S. Army Medical Research and Material Command regarding “Intent To Grant an Exclusive License of U.S. Government-Owned Patents” (81 FR 89087). March 10, 2017. Comments incorporating a detailed discussion of the Bayh-Dole Act requirements in 35 USC 209 regarding the “practical application” of the invention, which includes making the vaccine “available to the public on reasonable terms.”
- KEI Briefing Note 2021:1 Comments on the Proposal to Eliminate Unreasonable Prices as a Standalone Basis for March-in Rights (Modify 37 CFR § 401.6). Discussion of “available to the public on reasonable terms” including a history of the issue, legislative discussions, and legal definitions of reasonable terms.
All of the comments received are publicly available on Regulations.gov at docket NIST–2023–0008. Below are a selection of comments from notable organizations:
Select Comments Submitted to NIST
Civil Society:
- Robert Sachs, Xtandi march-in petitioner and prostate cancer patient
- Public Citizen
- Comments endorsed by over 30 civil society groups seeking greater access to medicines
- American Federation of Labor and Congress of Industrial Unions (AFL-CIO) Tech Institute
- Families USA
- Universities Allied for Essential Medicines (UAEM)
- US PIRG
- T1 International
Academics:
- Aaron S. Kesselheim, MD, JD, MPH, Professor of Medicine, Brigham and Women’s Hospital/Harvard Medical School, and Anushka Bhaskar, M. Phil., Harvard University PORTAL
- Nikhil Chaudhry, BA, Melissa Barber, PhD, Anthony So, MD, MPA, Ravi Gupta, MD, MS, Joseph S. Ross, MD, MHS, and Reshma Ramachandran, MD, MPP, MHS, Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRIIT)
University-related Associations:
- Association of University Technology Managers (AUTM)
- Association of Public and Land-grant Universities (APLU)
- Bayh-Dole Coalition
- Joint University Association Letter including AUTM
Government:
- Federal Trade Commission (FTC)
- Bicameral Congressional Letter led by Sens. King and Warren and Rep. Doggett
Industry:
- Pharmaceutical Research and Manufacturers Association (PhRMA)
- Biotechnology Innovation Organization (BIO)
- National Association of Manufacturers (NAM)
- National Pharmaceutical Council (NPC)
- Astellas Pharma US, Inc.
Under the Trump Administration, NIST had previously sought to alter regulations pertaining to march-in rights. After receiving over 80,000 submissions during that public comment period, the Biden Administration declined to enact those proposed changes. KEI’s page of comments submitted to that round of proposed NIST changes is available here.