Intellectual Property Policy

Division of Extramural Inventions & Technology Resources (DEITR) in the NIH Office of Extramural Research

Inventions arising from federally funded research projects are required to be reported to the government agency that funded the project, per the Bayh-Dole Act (the Patent and Trademark Law Amendments Act). The Act permits businesses (large and small) and nonprofits (including universities) to retain ownership of the inventions made under federally funded research and contract programs, while also giving the government the license to practice the subject invention. In turn, the organizations are expected to file for patent protection and to ensure commercialization upon licensing for the benefit of public health. Read the regulations at Bayh-Dole Act (37 CFR 401).

Key Provisions

The contractor or grantee or cooperative agreement awardee (i.e. the funding recipient) is required to:

• Report each new invention to the federal funding agency within two months of the invention being reported to the funding recipient
• Decide whether to retain ownership of the technology and notify the agency of any decision to retain title within two years of the date of disclosure (i.e. elect to own the invention)
• File for patent (or plant variety protection, in the case of plants), within one year of electing to retain title.
• Provide a license to the government to also practice the subject invention
• Keep government informed of progress in patenting or commercializing the invention
• Report any commercialization, licensing efforts, or other efforts to bring the technology to practical applications (utilization)

• Interagency Edison (iEdison) - A system for the electronic reporting of inventions and patents to the federal funding agency. iEdison is used by more than 30 federal agencies for invention and patent reporting. For information, please see the Invention Reporting website for detailed information on navigating iEdison, FAQs, and more.
• Edison Report-Lite (ERL) - A tracking feature of iEdison for agency staff to view reported inventions and monitor compliance

• Timeline for Reporting - Chart detailing the responsibilities of the organizations for complying with extramural invention reporting.
• Utilization Reporting – Brief PowerPoint presentation about utilization reporting including how to create a utilization report, what is a utilization report, and the importance of utilization reporting.
• Extramural Inventions and Technology Resources – Webinars

Policy Resources

• Protecting Taxpayers' Interests (07/2001) - NIH Response to the Congressional Committee Report Request for a Plan to Ensure Taxpayers' Interests are Protected.
• Federal Register Notice - Sharing Biomedical Research Resources (12/23/1999) - (PDF) - Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice.
• Federal Register Notice - Developing Sponsored Research Agreements (11/08/1994) - Developing Sponsored Research Agreements - Considerations for Recipients of NIH Research Grants and Contracts.
• Overview of Selected NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources

NIH Guide Notices

• NIH Guide Notice NOT-OD-16-066 — Reminder: All Subject Inventions Must Be Reported on the HHS 568 - Final Invention Statement and Certification (For Grant or Award) and in iEdison (2/17/16)
• NIH Guide Notice – NOT-OD-080 Notice Regarding Requirement of Grantees and Contractors to Submit Invention Disclosures, Related Reports and Documents Via iEdison (3/17/2015)
• NIH Guide Notice - NOT-OD-15-004 - Reminder Notice Regarding Requirements of the Bayh-Dole Act and the NIH’s Implementing Regulations (10/02/2014)
• NIH Guide Notice - Invention Rights for Foreign Grantee/Contractors (NOT-OD-06-005) (10/13/2005) - Rights to Subject Inventions Made through Federal Funding to Foreign Entities.
• NIH Guide Notice - VA Intellectual Property Reporting (04/23/2001) - Guidance on Intellectual Property Reporting for NIH Grantees that also Have Involvement with the Veteran's Administration.
• NIH Guide Notice - Biological Materials Reporting (05/17/1996) - NIH Procedures for Handling Non-election of Title to Patentable Biological Materials.
• NIH Guide Notice - 20/20 View of Invention Reporting (09/22/1995) - A 20/20 View of Invention Reporting to the National Institutes of Health.