NIST Requests Comments on Proposed Changes to Bayh-Dole Regulations

Credit: N. Hanacek/NIST

GAITHERSBURG, Md. — The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) is seeking feedback on proposed changes to regulations that support the University and Small Business Patent Procedures Act of 1980, commonly known as the Bayh-Dole Act. This update to Bayh-Dole represents an important element of the Return on Investment Initiative for Unleashing American Innovation through inventions arising from the federal government’s more than $150 billion annual investment in research and development. The call for comments was published in the Federal Register. 

“The Bayh-Dole Act is a foundational pillar of U.S. innovation, technology transfer and entrepreneurship,” said Under Secretary of Commerce for Standards and Technology and NIST Director Walter G. Copan. “This proposed modernization of Bayh-Dole for the 21st century is the culmination of an extensive nationwide stakeholder engagement process and also represents a consensus of federal government interagency experts. We at NIST look forward to receiving feedback on these proposed updates, in support of America’s enduring role as the world’s innovation leader.” 

The act requires universities, other nonprofit organizations and businesses to disclose inventions that were developed with the use of federal funds. It allows those organizations to retain title to their inventions, incentivizing inventors, entrepreneurs and investors in the interests of economic vitality and for the public good.   

The proposed revisions remove outdated and unnecessary language and reorganize a number of sections for clarity. The revisions also:

• Clarify definitions and applicability of Bayh-Dole to large businesses;
• Provide additional clarification for processes for march-in, assigning rights to employee inventors, small business considerations, and filing provisional patent applications;
• Create a new requirement for agencies to annually report statistics about the implementation of Bayh-Dole;
• Provide additional information about the purpose and use of royalties collected by federal agencies for licensed inventions; and
• Align exclusive licensing processes with statutory requirements and update appeals processes for licensing activities.

The proposed updates are the result of a collaborative process that began with the launch of NIST’s Return on Investment Initiative in 2018. The initiative’s goal is to maximize opportunities for the transfer of federal investments in science and technology to benefit society and to create further value for the American economy. NIST collected input from a broad array of stakeholders through a Request for Information, public meetings and other engagements, and in 2019 published the Unleashing American Innovation green paper, which included 15 findings that would support improvements to technology transfer. Among the findings were changes to the Bayh-Dole Act regulations that could improve compliance, enhance a contractor’s ability to commercialize inventions and increase the return on the federal investment through new products and services. 

Although NIST is primarily a nonregulatory agency, the director of NIST has the delegated authority of the Secretary of Commerce to issue implementing regulations under the Bayh-Dole Act that apply to all federal agencies. In conjunction with the National Science and Technology Council and the Office of Science and Technology Policy, NIST further serves as convener of the Interagency Working Group for Bayh-Dole and the Interagency Working Group for Technology Transfer. NIST also is the host institution for the Federal Laboratory Consortium for Technology Transfer, serving the more than 300 U.S. federal laboratories.

NIST intends to hold a webinar regarding the proposed changes in the Federal Register notice. Comments are due no later than April 5, 2021, and should be submitted via the Federal e-Rulemaking Portal, with the docket identification number: 201207-0327.

NIST promotes U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology in ways that enhance economic security and improve our quality of life. To learn more about NIST, visit NIST.gov.