Reminder Notice Regarding Requirements of the Bayh-Dole Act and the NIH’s Implementing Regulations

Notice Number:

NOT-OD-15-004

Key Dates

Release Date: October 2, 2014

Related Announcements

NOT-OD-22-158 - Update: iEdison to Transition from NIH eRA to NIST; Downtime and Action Items Required in Preparation for August 9 Launch of New iEdison
NOT-OD-17-065
NOT-OD-16-066
NOT-OD-15-119

Issued by

National Institutes of Health (NIH)

Purpose

The purpose of this Guide Notice is to provide background information and to remind funding recipients of the requirements of the Bayh-Dole Act of 1980 and its implementing regulations.

Background

It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PDs/PIs and funding recipients are expected to make the results and accomplishments of their activities available to the research community and to the public at large. If the outcomes of the research result in inventions, the provisions of the Bayh-Dole Act of 1980, as implemented in 37 CFR 401, apply.

As long as funding recipients abide by the provisions of the Bayh-Dole Act, as amended by the Technology Transfer Commercialization Act of 2000 (P.L. 106-404), 37 CFR 401 and any other applicable regulations, they have the right to retain title to any invention conceived or first actually reduced to practice under their NIH federal funding agreements. The principal objectives of these laws and the implementing regulation are to promote commercialization of federally funded inventions, while ensuring that inventions are used in a manner that promotes free competition and enterprise without unduly encumbering future research and discovery.

The regulation requires the federal funding recipient to use patent and licensing processes to transfer federally-supported technology to industry for development. Alternatively, unpatented research products or resources research tools may be made available through licensing to vendors or other investigators. Sharing of copyrightable outcomes of research may be in the form of journal articles or other publications.

The Bayh-Dole Act of 1980

Application to Federal Funding Recipients

The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212) and the related Executive Order 12591 (April 10, 1987) provide incentives for the practical application of research supported through Federal funding agreements. To be able to retain rights and title to inventions made with Federal funds ( subject inventions ), the funding recipient must comply with a series of regulations that ensure the timely transfer of the technology to the private sector, while protecting limited rights of the Federal government.

The regulations apply to any subject invention defined as any invention either conceived or first actually reduced to practice in the performance of work under the Federal award and to all types of recipients of Federal funding. This includes non-profit entities and small businesses or large businesses receiving funding through grants, cooperative agreements, or contracts as direct recipients of funds, or as consortium participants or subcontractors under those awards.

Funding Recipient Responsibilities for Invention Reporting for NIH

The following is a list of Recipient Responsibilities for Invention Reporting. A complete list of the reporting requirements under the Bayh-Dole Act can be found at 37 CFR 401.14. For additional information including statutory and regulatory citations, please see the NIH Grants Policy Statement.

• Employee Agreement to Disclose All Inventions to the Funding Recipient
• Invention Report and Disclosure
• Rights to Consortium Participant Inventions
• Election of Title to Invention
• Confirmatory License
• Patent Application (Unless following the NIH Biological Materials Policy)
• Assignment of Rights to a Third Party
• Issued Patent
• Extension of Time to Elect Title or File Patent
• Change in Patent Application Status
• Invention Utilization Report
• Annual Invention Statement
• Final Invention Statement and Certification

Failure of the funding recipient to comply with any of these or other regulations cited in 37 CFR 401 and/or associated NIH policies on intellectual property and resource sharing may result in the loss of patent rights or a withholding of additional grant funds.

Electronic Reporting

Bayh-Dole regulations allow funding recipients to report inventions electronically (37 CFR 401.16). NIH strongly supports electronic reporting through an Internet-based system, Interagency Edison (http://iEdison.gov). To meet the objectives of the Federal Financial Assistance Management Improvement Act of 1999 (P.L. 106-107), funding recipients should make all reasonable efforts to submit invention reports using iEdison. The system supports confidential transmission of required information and provides a utility for generating reports and reminders of pending reporting deadlines.

An updated electronic Research Administration (eRA) website is now available for external users of the iEdison module for invention reporting. The new website offers a centralized and current source of information about the iEdison system which is managed by NIH and used by more than 30 federal agency offices. You can access the new pages by going to the eRA website and clicking on the Invention Reporting tab, or you can use the following URL: http://era.nih.gov/iedison/iedison.cfm. Both options will take you to the new pages.

Inquiries

Please direct all inquiries to:

Scott Cooper
Division of Extramural Inventions & Technology Resources (DEITR)
Office of Policy for Extramural Research Administration
Telephone: 301-435-0785
Email: [email protected]