Bayh-Dole Act Regulations
Reporting Obligations for Inventions based on Federally Funded Research
Under the Bayh-Dole Act, Cleveland Clinic is required to report government funded inventions to relevant funding agencies and provide a written description of the invention in technical detail. NOTE: Noncompliance with federal reporting requirements may result in the termination of grant funding.
Under the Bayh-Dole Act (1980), federal grant funded entities are permitted to elect title to federally funded inventions in exchange for commitments to commercialization and compliance. Cleveland Clinic Innovations (CCI) role is to promote the commercialization and public availability of inventions made at Cleveland Clinic.
Obligations of inventors
Obligations of institution (CCI):
- Report invention and grant number via an Invention Disclosure Form. As soon as a technology is invented, from which efforts were supported by a federally funded grant, inventors must provide CCI with a detailed written description of the invention(s), together with associated grant/contract number. (Note: this applies to subcontract under Federal contracts with industry partners.) The mechanism for fulfilling this obligation is completing Question 2 of the Invention Disclosure Form (IDF), and submitting the IDF to CCI.
- Report past inventions and grant numbers that were not originally reported via IDF. If an IDF had already been submitted prior to obtaining support from a federally funded grant, inventors must contact CCI to report the associated grant/contract number(s) related to the invention, regardless of the IDF’s status.
- Report periodic grant reports to OSRP or CCI. For federally funded inventions, inventors must disclose all periodic reports and grant close-out reports, in accordance with the relevant federal grant or contract to the Office of Sponsored Research & Programs (OSRP). OSRP and CCI will coordinate reporting to ensure that no inconsistent reports of inventions are made to the Federal Government.
- Assist with IP filings. Inventors must assist Cleveland Clinic with the patenting of federally funded inventions, and executing all documents necessary to uphold the Clinic’s Intellectual Property Policy.
- Report federally funded inventions within two months after receiving the IDF or receiving notification of awards for a previous IDF. CCI will manage the reporting obligation, in conjunction with OSRP. (Note: A confidential copy of the invention disclosure is provided to the Federal Government at this stage, in accordance with Federal statute.)
- Elect or waive title to federally funded inventions within two years of initial disclosure. CCI does not generally wait the entire two years to elect title (this is often done within several months of reporting the invention to the Government). If CCI decides to waive title, title to the inventions resides with the Federal Government.
- File an initial patent application on inventions to which it has elected to retain title. Such first filing must be made within one year of having elected title. Subsequent filings, including foreign filings and prosecution progress reports are reported periodically.
- Provide the Federal Government with annual reports describing utilization of federally funded inventions. Here, utilization is synonymous with commercialization – a report of royalties generated from commercialization of each federally funded invention is made to the Federal Government annually.
For more information on Bayh-Dole, please visit: https://era.nih.gov/iedison/bayh-dole.htm