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| NIDDK Home : Research Funding : Notification Requirements to Retain Patent Rights | |||||||||
Notification Requirements to Retain Patent RightsWhenever an Institution's research work is funded either in whole or in part through NIH research grants, contracts, and cooperative agreements, ("Recipient"), the funded work is subject to the requirements of the Bayh-Dole Act of 1980 (referred to as "Bayh-Dole" or "the Act"). Recipients have rights to elect title to inventions their employees create in performance of the grant, so long as they abide by the required notification and reporting procedures, as summarized in pertinent part below: RECIPIENT RESPONSIBILITIESIn keeping with the objectives and policies of Bayh-Dole, the Recipients are required to effectively and efficiently transfer technology to industry for commercial development. However, in doing so, Recipients must also comply with the specific terms of the Act, its implementing regulations, and the terms and conditions of each NIH award, and ensure that such compliance is reflected in their agreements with commercial entities. In carrying out Recipient's responsibilities, Recipients need to concern themselves with
Notification Requirements and Records (back to top) In Sponsored Research Agreements, as in other contexts, Recipients must also ensure that invention, patent and license notification requirements are made timely. Timeliness considerations include prompt (1) employee notification to Recipient administrators of an invention made under NIH funding, (2) written disclosure to NIH in sufficient technical detail to adequately describe the invention, (3) written election to the NIH of whether or not the Recipient will retain title to such invention, (4) adherence to time frames for initial filing of patent applications in the United States and the filing of foreign patent applications, (5) execution and delivery of all documents necessary to establish or confirm NIH rights throughout the world in the subject inventions to which the Recipient has elected to retain title, (6) notification to the NIH of any decision not to continue patent prosecution, pay fees, or defend the patent in a reexamination or opposition proceeding on a patent, in any country, and (7) conveyance of title to NIH when requested. Recipients must also specify in any United States patent applications and any patents that cover a subject invention that the invention was made with government support. Specifically, as conditions of NIH grants and cooperative agreements, Recipients must give NIH timely notice when an invention has been created. A final invention statement and certification listing all inventions that were conceived or first actually reduced to practice during the course of work under the funding agreement is required within ninety (90) days following the expiration or termination of support on the related project. Additionally, Recipients need to adhere to the specific requirements contained in the patent clauses of their contracts as well as to the general provisions of the Federal Acquisition Regulations. Recipients must also document their compliance with the requirements of the Act, regulations, and terms and conditions of NIH awards generally, and as related to Sponsored Research Agreements. Recipient records must be available for review by authorized Federal officials in accordance with the terms and conditions of the award. For example, concerning access and retention of records under NIH grants and cooperative agreements, regulations require grantees to retain financial and programmatic records, supporting documents, statistical records, and all other grantee records which may reasonably be considered pertinent to a grant or subgrant. Since October 1995, there have been two ways that invention utilizations can be reported to the NIH: by paper correspondence, or as a feature of the Interagency Edison Internet-based invention reporting system (http://iedison.gov). Using either approach, utilization reporting involves response to 8 questions relating to the status of commercialization, extent of licensing, and an indication as to whether or not any invention-related products have reached the market. The reporting procedure and a new list of utilization questions, adopted by NIH in 2002, are summarized below.
The content of all Bayh-Dole-related reports are maintained by the NIDDK, and the NIH, as confidential, releasable only through the Freedom of Information Act. More information on Bayh-Dole can be found at: www.niddk.nih.gov/patient/patent.pdf. |
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Director: Dr. Allen Spiegel || Contact NIDDK | |||||||||
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