Document Type
Response or Comment
Publication Date
2-6-2024
Abstract
This comment focuses on criterion #3 of the march-in provisions of the Bayh Dole Act, which pertains to “…action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the contractor, assignee, or licensees.” We recognize that the term “public use” in Bayh Dole refers not only to commercialization or availability of products representing practical applications of the inventions made with federal funding and licensed to industry under the terms of the Act, but also use of these inventions to achieve a series of socioeconomic goals (i.e., access to and affordability of medicines). As such, we suggest that assessment of the march-in provisions of the Act should address not only the contractor, assignee, or licensee actions to commercialize practical applications of the subject invention, but also their actions in relation to the articulated socioeconomic goals of the Bayh Dole Act.
Recommended Citation
Ledley, Fred D. and Zhou, Edward, 2024. Comments Re: Draft Guidance Considering Exercise of March-In Rights - Docket No.: 230831-0207, CISI Publication.