The document is a joint letter from several major higher education and research associations—including the Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), the Council on Governmental Relations (COGR), the American Council on Education (ACE), and the Association of American Medical Colleges (AAMC)—submitted to the National Institute of Standards and Technology (NIST) regarding proposed changes to the Bayh-Dole Act implementing regulations (37 CFR Parts 401 and 404). The associations express their appreciation for NIST’s efforts to improve the effectiveness of technology transfer from universities and other entities to the private sector, while emphasizing the pivotal role that the Bayh-Dole Act has played in spurring innovation and commercialization of federally funded research discoveries. They focus primarily on concerns about the proposed scope and application of "march-in rights," particularly the clarification that such rights should not be used to control end-user prices of commercial products like drugs, warning this could deter private investment and hinder the development of new therapies without addressing broader drug pricing challenges.
The letter also addresses technical clarifications related to government use licenses, advocating for a more precise definition to avoid complicating licensing negotiations; calls for improvements to the U.S. manufacturing waiver process to make it more efficient and predictable; and supports standardized reporting systems like iEdison. Throughout, the associations largely endorse related suggestions from the Association of University Technology Managers (AUTM) and urge NIST to consider their comments to strengthen technology transfer and innovation. While supportive of most proposed changes—especially those simplifying licensing and clarifications on royalties—the associations remain committed to collaborating with NIST and other agencies on crafting comprehensive solutions to address drug costs, without undermining the successful public-private partnership model that Bayh-Dole has facilitated for over forty years.
This letter provides association comments regarding changes proposed to Part 401 Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants Contracts and Cooperative Agreements.
