Unpublished Paper
Comment on Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
(2024)
Abstract
Under 37 CFR 401.6 of the Bayh-Dole Act, the National Institutes of Health (NIH) has been granted the power to exercise march-in rights in situations where federally funded projects are not being made reasonably available to the public. The right to march-in is authorized in cases where federal funding results in patent nonuse, unreasonable pricing, and insufficient product availability.
In the aftermath of the pandemic, public interest organizations have underscored the need for exercising such rights in situations where public health, safety, or security is at stake. To examine and streamline the implementation of the march-in process, the National Institute of Standards and Technology (NIST) was tasked with promulgating regulations concerning the management and licensing of federally funded inventions. In turn, the NIST requested public comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (hereinafter, guidelines)
The note below responds to the call for comments on the guidelines. The note focuses on a handful of general themes: (1) the need for differentiating the use of march-in rights in the context pharmaceutical and products when public health is involved, (2) acknowledging the issues of localism versus global trade that are involved in the context of either funding or supporting technologies implicating local or global public health, (3) promoting procedural stability by instituting reasonable timelines for marching-in, implementing a uniform appeals process, and increasing transparency in information regarding a contractor’s government funding, and (4) accelerating the pace of intervention where delay in the implementation of march-in can cause potentially irreparable harm and the loss of lives.
Keywords
- Federal transfer of technology,
- march-in rights,
- Bayh-Dole Act,
- federal funding,
- innovation,
- policy paper
Disciplines
Publication Date
February 6, 2024
Citation Information
Srividhya Ragavan. "Comment on Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights" (2024) Available at: http://works.bepress.com/srividhya_ragavan/362/