Document Type

Response or Comment

Publication Date



Bayh-Dole, Patents, Regulations, March-In, Pricing


This letter is written in response to the notice of proposed rulemaking published in the Federal Register on January 4, 2021, seeking public comments on the revised regulations proposed by NIST to the University and Small Business Patent Procedure Act of 1980 (the “Bayh-Dole Act”). We submit this letter as academics who engage in research on patent law and biomedical innovation. The arguments also reflect practical knowledge that one of us has acquired from a decade of working with U.S. universities and biotech companies in the process of technology transfer as a lawyer practicing in two highly regarded Boston law firms, and experience that others of us have gained from working in the U.S. government and engaging in intellectual property policy work on Bayh-Dole related issues. We submit that the proposed rule-making includes changes that are contrary to the intent and the stated purpose of the Bayh-Dole Act and that unduly limit the interpretive authority of the Federal Government in administering the Act. We suggest alternative ways in which regulations implementing the Bayh-Dole Act could be changed to further the Act’s intent and purpose.