KEI Comment to NIST on “Available to the Public on Reasonable Terms”

On February 6, 2024, KEI submitted comments to the National Institute of Standards and Technology (NIST) regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 FR 85593). This set of comments outlined that the draft guidance needs to explain what “available to the public on reasonable terms” means, in practice.

As noted in the comments,

“The draft guidance gives several examples of factors that may be considered when evaluating the merits of a march-in case. Some of the examples are unhelpful, important topics are missing, and there is a lack of attention given to solutions to known challenges, such as complex patent landscapes.

While KEI is pleased to see that the draft guidance clarifies that pricing is a factor in march-in cases, on the issue of standards for unreasonable pricing, the draft guidance gets a failing grade.”

A PDF of the full comments is available here: KEI-Comments-NIST-Available-on-Reasonable-Terms-6Feb2024

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.