On December 8, 2023, the National Institute of Standards and Technology (NIST) issued a Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593).

Today KEI submitted comments to NIST regarding the transparency of march-in proceedings. The Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights published by NIST includes a footnote that states, “All portions of the march-in proceeding are closed to the public and are held confidential.” As our comments note, this statement “is at odds with the statute, the regulation implementing the statute, a World Health Organization (WHO) resolution on transparency, and widely accepted notions of good governance.”

KEI’s comments outline how this overly broad statement in the guidance runs counter to:

• 35 U.S.C. 202(c)(5)
• 37 CFR § 401.6 (4)
• WHA72.8 – Improving the transparency of markets for medicines, vaccines, and other health products, and
• The NIH’s practices in previous march-in cases.

A PDF of our full comments is available here: KEI-Comments-NIST-March-in-Guidance-Transparency-5Feb2024

Note: NIST’s RFI 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. KEI submitted a series of comments on several different important topics for NIST to consider as they finalize the guidance.

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