Please click on the gray boxes below to see a chart outlining the responsibilities of the recipient organizations for complying with extramural invention reporting (Also see an Invention Reporting Timeline: At a Glance (PDF - 308 KB)).
Grantee / Contractor Organization
- Employee Agreement to Disclose All Inventions
- Invention Report
- NIH grant number
- date of any public disclosure
- Election of Title to Invention
- Confirmatory license
- Nonelection of Title to Invention:
- Patent Application
- Issued Patent
- Extension of Time to Elect Title or File Patent
- Invention Utilization Reports:
- Change in Patent Application Status
- Annual Invention Statement
- Final Invention Statement and Certification
Grantee employees working under the funding award (e.g. PD/PI) must sign an agreement with the employee to abide by the terms of the Bayh-Dole Act as it relates to intellectual property rights.
When At the time of employment -- term of employment Discussion Grantee/contractor organizations and consortium participants must have policies in place regarding ownership of intellectual property, including conflict of interest issues. 37 CFR Reference 401.14(f)(2)
The grantee/contractor must submit a report of any "subject" invention. This includes a written description (the so called invention disclosure) of the invention that is complete in technical detail.
When Within 2 months of inventor's initial report to the grantee / contractor organization. Discussion
No single format for disclosing the invention to the federal government. The report must identify:
37 CFR Reference 401.14(a)(2)
Grantee/contractor organization must notify the federal agency sponsor of its decision to retain or waive title to invention and patent rights.
When Within 2 years of the initial reporting of the invention to the lead federal agency sponsor. (Earlier, if disclosed publicly) 37 CFR Reference 401.14(b)
For each invention, the grantee/contractor organization must provide a user license to the lead federal agency sponsor for each invention.
When When the initial non-provisional patent application is filed. 37 CFR Reference 401.14(f)(1)
Grantee/contractor organization must notify the federal sponsor that it will not retain ownership of an invention.
When Within 2 years of reporting to federal agency sponsor. (Earlier, if disclosed publicly.) 37 CFR Reference 401.14(c)(2)
Handled electronically through iEdison, otherwise a signed hard-copy request is required.
The grantee/contractor must inform the government of the the filing of any non-provisional patent application. The patent application must include a government support clause.
When Within 1 year after election of title, unless there is an extension. Discussion
Initial patent application must be defined as a non-provisional application. The patent application number and filing date must be provided. The following language is to be used on a patent application: "This invention was made with government support (identify the funding award) awarded by (identify the institute and federal agency). The government has certain rights to the invention."
37 CFR Reference 401.14(c)(3)
The grantee/contractor must notify the federal agency sponsor that a patent has been issued.
When When the patent is issued. Discussion The patent issue date, number, and evidence of the federal government support clause must be provided 37 CFR Reference 401.5(f)(2)
An extension of up to two years may be requested for election of title, or up to one year for filing a patent application.
When As needed. Discussion Request for extension of time must be made. Such requests are preapproved 37 CFR Reference 401.14(c)(4) Notes
If required by agencies; Information requirements defined in iEdison.
When Annually, when required by agencies. Discussion The grantee must submit information about the status of commercialization of any invention for which title has been elected. 37 CFR Reference 401.14(h) Notes
This report gives an indication of whether the objectives of the law are being met. Specific reporting requirements can be found in iEdison (http://iEdison.gov)
Grantee/contractor must notify federal agency sponsor of changes in patent status.
When Grantee/contractor must notify federal agency sponsor of changes in patent status, at least 30 days before any pending patent office deadline Discussion This notification allows the lead federal agency sponsor to consider continuing the patent action 37 CFR Reference 401.14(f)(3) Notes
When The grantee must indicate annually any inventions made during the previous budget period on all grant awards Discussion Part of all competitive applications and non-competing continuation progress reports 37 CFR Reference Notes The information is requested as a checklist item on the PHS 398 application and on the non-competing continuation progress report.
The grantee/contractor must submit a summary of all inventions made during the entire term of each grant/contract award. The report is to be submitted to the awarding unit for grants or the contracts management office.
When Due within 90 days after the project period (competitive segment) ends. Discussion Required information is specified on the HHS 568 form. If no inventions occurred during the award period, a negative report must be submitted. 37 CFR Reference §401.5(f)(1) Notes For grants, submitted via eRA Commons
- Rights to Inventions on Subcontracts
Subcontractors retain rights to their subject inventions
When Same reporting responsibilities, obligations and time frames as prime grantee/contractor organization Discussion Prime grantee/contractor organization cannot receive rights to subcontractor's subject invention(s) as a condition of awarding a grant or contract to subcontractor 37 CFR Reference 401.14(g)(1)
Notes Invention disclosure, confirmatory license, and proof of government support clause may be submitted electronically through iEdison.
- Assignment of Rights to Third Party
If the grantee/contractor is a non-profit organization, it must ask for approval from the federal agency sponsor to assign invention or U.S. patent rights to any third party, including the inventor (s).
When As needed Discussion Specific procedures to request third party assignment may vary between agencies. Consult lead agency prior to initiating request. For NIH, all communications for such requests must be sent to the Office of Extramural Research. The NIH Office of Technology Transfer serves in an advisory capacity to OER for the processing of such assignment requests. 37 CFR Reference 401.14(k) for non-profits. Notes Grantees that are for-profit entities (including small businesses) do not need to ask approval, but ongoing reporting remains a requirement for each invention.
Employee / Inventor
- Assignment of Invention Rights to the Inventor
The inventor may request assignment of invention rights. Agencies support requests of this type. In all cases, documentation is required when a grantee/contractor organization waives rights to the invention and the inventor(s) wishes to retain the invention rights.
When At the time the grantee/contractor organization elects not to pursue title and the inventor requests rights in the invention. Discussion
First, the grantee/contractor organization must elect not to retain rights in the invention. Second, the inventor must request the assignment of rights, agree to all terms associated with invention reporting as detailed in 37 CFR 401, and must pursue commercialization of the invention through patent filing or licensing as a research tool. Specific procedures for any agency should be determined prior to initiating the request.
37 CFR Reference 401.14(k)(1) non-profits Notes