The field of technology transfer is vibrant and fast-moving, and the Bayh-Dole Act regulations shaping federal tech transfer respond and adapt to changing circumstances, new needs, and evolving developments and necessities.
Changes to the Bayh-Dole Act regulations are coordinated by the National Institute of Standards and Technology (NIST), and the latest round of regulation revisions was summarized and highlighted during a webinar hosted by the Federal Laboratory Consortium for Technology Transfer (FLC) on July 25, 2023.
The intense level of technology transfer stakeholder interest was reflected in the webinar’s viewership. Three hundred thirty-four tech inventors and representatives from businesses, government agencies, and research institutes attended the 17-minute presentation, and another one hundred fifty of their colleagues registered to view the webinar at later times.
Dr. Amy Thomsen, the FLC’s Professional Development Director, hosted the webinar, and NIST’s Associate Director for Innovation and Industry Services, Mojdeh Bahar, moderated the presentation. An overview of the regulatory changes was given by Bethany H. Loftin, the Interagency and iEdison Specialist in NIST’s Technology Partnerships Office (TPO), who led the award-winning modernization of iEdison, which is the central platform for reporting inventions and patents resulting from federal research.
Associate Director Bahar placed the revisions in context when she said, “The United States government spends more than $175 billion on research and development annually. New knowledge is essential to innovation, and in turn, innovation is essential to our economic competitiveness and national security. We have world-class universities and federal labs continuously generating cutting-edge research advancements from this investment. In order to encourage the adoption of these research outcomes, it is important that we periodically review our regulations and processes to ensure that they are up-to-date and don’t cause unnecessary confusion or barriers to the development and application of federally-funded inventions.”
Updating the Bayh-Dole Act regulations was a major undertaking. The previous round of Bayh-Dole revisions had been issued in 2018, and developments in technology transfer during the intervening years highlighted the imperative need to issue revisions.
NIST kicked off the project when it requested comments and suggestions from interested parties on January 4, 2021. More than 81,000 responses were received, reviewed, discussed, and evaluated by a panel of experts. NIST issued the revisions resulting from this process in the Federal Register on March 24, 2023.
In addition to providing an overview of the changes, Bethany Loftin also detailed some of the finer points in the revisions regarding reporting on intellectual property resulting from federally-funded research. These changes are of special interest to users of the iEdison system.
Ms. Loftin furnished a summary of outdated and duplicative provisions that were removed during the updating process, as well as instances of minor word changes and a list of streamlined requirements and redesignated Bayh-Dole sections.
Changes to part 401 of the regulations, covering the rights to inventions made by non-profit organizations and small businesses under government grants, contracts, and cooperative agreements, were detailed, with emphasis given to changes to the initial stages of the march-in process and increased consultation. Specifics of the doubling of agency decision-making time on potential march-ins from 60 days to 120 days were also provided.
The provisions allowing agencies to request annual reports on all inventions and close-out reports were repositioned in the regulations. Clarifications regarding the filing of initial patent applications and provisional and nonprovisional applications were highlighted during the webinar.
Refinements to the provisions specifying when the federal government may obtain title to an invention were elaborated, and clarifications to provisions on royalties were underscored in the presentation.
Users of iEdison were pleased to learn that the task of meeting new Bayh-Dole reporting requirements is being made more user-friendly by introducing easy-to-run iEdison reports.
Stakeholders were encouraged to review the full text of the revisions, which is found at https://www.federalregister.gov/documents/2023/03/24/2023-06033/rights-to-federally-funded-inventions-and-licensing-of-government-owned-inventions.
NIST continues and expands its mission to promote technology transfer, to further public understanding of technology transfer, and to foster the development of this vital topic. An updated FAQs page on the latest Bayh-Dole regulatory revisions will be announced soon. NIST welcomes questions and comments to TPO [at] NIST.GOV () about technology transfer and changes to the Bayh-Dole rules.