This is the agenda for a discussion of proposals to change Bayh-Dole regulations and Stevenson-Wydler Act statutes. The proposals for the changes in regulations were noticed on January 4, 2021, and the proposed changes in the statutes were published on December 2020, both after the Presidential election. Final action will depend upon the Biden administration. Public comments on the regulations are due on April 5, 2021. The notice is available here.
A video of the event is available below.
Date: Wednesday January 27, 2021
Time: 2:00pm-4:00pm EST
To register for the event, on Zoom, send a note to: bayh-dole-proposals@keionline.org
Federal Register Notice – https://www.federalregister.gov/documents/2021/01/04/2020-27581/rights-to-federally-funded-inventions-and-licensing-of-government-owned-inventions
NIST webpage – https://www.nist.gov/tpo/bayh-dole
AGENDA
Introduction
Proposed modification of regulations for the Bayh-Dole Act:
- Restrict grounds for march-in rights, as regards the pricing of products. (Modify 37 CFR § 401.6)
- Exclude certain inventions that are conceived or first actually reduced to practice under a funding agreement from definition of “Subject Invention.” (Modify 37 CFR § 401.14. Standard patent rights clauses definition of Subject invention, and 37 CFR § 401.1)
- Restrict standing to appeal the granting of an exclusive license to a federally owned patented invention to entities seeking commercialize inventions, as opposed to persons damaged by the agency action. (Modify 37 CFR § 404.11)
- Weaken working requirements for inventions by considering licensing and license payments as a means of providing the benefits of the inventions to the public. (Changing 37 CFR § 404.2, Policy and Objective).
- Other topics
Proposed legislative changes to Stevenson-Wydler Act statutes:
- Extend secrecy of CRADA data from five to 12 years (15 U.S.C. 3710a(c)(7)(B))
- Extend Other Transactions Authority to all federal labs (15 U.S.C. 3715(f))
- Expansion of Agreements for Commercializing Technology (ACT) Authority (15 U.S.C. 3710e)
- Increase of cap for royalties to federal employees to $500,000 per year from $150,000 for inventions. (15 U.S.C. 3710c)
- Creation of agency non-profit foundations (15 U.S.C. 3725) that can, like the Foundation for the NIH or the Foundation for CDC, solicit corporation contributions and influence agency operations. (15 U.S.C. 3723c)
- Broader authority to DOC/NIST to issue regulations for all federal agencies as regards the Steven-Wydler Act (15 U.S.C. 3710(g)(1)).
- Authorize federal copyright of software (Primary authority reference in 17 USC 105; programmatic implementation in 15 U.S.C. 3710).
- Other topics