Intellectual Property Policy

Regulations

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 recipient 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)

Invention Reporting System

• NIST iEdison - A system used by recipients to report inventions and patents resulting from federal research funding per the Bayh-Dole Act (35 U.S.C. 206). iEdison is used by more than 30 federal agencies for invention and patent reporting. For more information, contact the NIST iEdison administrator.

Notices

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) - 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 Recipients 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 Recipient/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 Recipients 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.