The Catholic University of America

Summary of Federal Laws

Research

The Bayh-Dole Act of 1980 (Patent Rights in Inventions Made with Federal Assistance)

35 U.S.C. § 200-212; 37 C.F.R. Part 401

Purpose: Establishes a uniform policy for the disposition and licensing of rights to patentable inventions discovered in the course of federally-funded research. The definition of a subject invention is intellectual property that is either conceived or first actually reduced to practice in performance of a government-funded project. This Act gives grantee/contractor organizations first rights to title of a subject invention stemming from federally-funded research, provided the federal funding agency is notified of the invention within 60 days, receives a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention, the federal agency support is acknowledged in any related patent application, and commercialization is actively pursued. In certain instances, the university may retain title to inventions made with the assistance of federal funding.

Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, Final Rule, 83 Fed. Reg. 15954, April 13, 2018, effective May 14, 2018.

Changes made include the following:

The 60-day limit within which the government may seek ownership of an invention where the contractor fails to provide appropriate disclosure or election has been eliminated. This gives the federal government  an unlimited time period within which to assert ownership to an invention following the discovery of the contractor’s non-compliance with the Bayh-Dole Act’s disclosure and election requirements.

The contractor is obligated to require its employees to assign rights in a subject invention to the contractor.

Decisions to discontinue patent prosecution must be communicated to the government within 60 days prior to the statutory deadline (an increase from the prior 30-day notice period).


The deadline to provide notice to convert a provisional patent application to a non-provisional patent application is 10 months from priority in order to give the government 60 days’ notice prior to expiration of the application.

See the Bayh Dole Research Institutions Alert dated 9/6/18 for *Practical Advice Regarding Changes to Bayh Dole Act Obligations.*

See the Stanford v. Roche case below for how to draft agreements with researchers.

 

GAO Review: Review by the General Accounting Office on Bayh-Dole compliance is likely to focus on the following:

  • whether there is sufficient training to secure full compliance and implementation of the Act;

  • how universities determine when research should become a reportable invention;

  • how universities decide whether to patent inventions;

  • how universities comply with the requirements for small business preferences;

  • how universities monitor their licensees' progress to reach milestones set forth in the license agreements; and

  • whether the Bayh-Dole Act has had the affect of turning faculty away from basic research to more commercial ventures.

 

Selected Case Law

Stanford University v. Roche Molecular Systems, U.S. Supreme Court, June 6, 2011. Case No. 09-1159
In a case that highlights the importance of drafting, the U.S. Supreme Court, in a decision (7-2) authored by the Chief Justice, held that an inventor who was a research fellow at Stanford but who also conducted at research at Cetus (with Roche Molecular later acquiring certain Cetus assets relevant to this case) had not signed away his rights to an invention that is used to quantify blood borne levels of the HIV virus. The Court held the Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions, and that patent law is unique and the basic idea that inventors have the right to patent their inventions has not changed "in the 220 years since the first Patent Act." 

The agreement the inventor signed with Stanford stated the inventor "agreed to assign" to Stanford his right title and interest resulting from his employment at the University. In contrast, the agreement he signed at the Company Cetus stated he “will assign and do[es] hereby assign” to Cetus his “right, title and interest in each of the ideas, inventions and improve-ments” made “as a consequence of [his] access” to Cetus."

 

Resources

 Bayh Dole Regulations FAQ on NIST (on 2018 regulations)

U.S. Patent and Trademark Office

 

updated 4-22-19