KEI Briefing Note 2018:1. Bayh-Dole Obligations to Disclose Federal Funding
Government oversight of under-reporting U.S. federal rights in patents.
- 1994. June 15, 1994, Inspector General Report to HHS on the under-reporting of federal funding of inventions at the Scripps Research Institute
- 1994. Underreporting federal involvement in new technologies developed at Scripps Research Institute : hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, second session, Washington, DC, July 11, 1994. Serial no. 103-93 Washington : U.S. G.P.O. : 1994.
- 1999. United States General Accounting Office. Technology Transfer Reporting Requirements for Federally Sponsored Inventions Need Revision. Report to the Chairman, Committee on the Judiciary, U.S. Senate. GAO/RCED-99-242. August 1999.
The Requirement for Disclosure Under the Bayh-Dole Act.
- The Bayh-Dole Act, 35 U.S.C. § 202(c)(1).
(c) Each funding agreement with a small business firm or nonprofit organization shall contain appropriate provisions to effectuate the following:
(1) That the contractor disclose each subject invention to the Federal agency within a reasonable time after it becomes known to contractor personnel responsible for the administration of patent matters, and that the Federal Government may receive title to any subject invention not disclosed to it within such time.
“Subject Invention” is a defined term under 35 U.S.C. §201(e):
(e) The term “subject invention” means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement…
- Federal Regulations. 37 CFR Part 401 – RIGHTS TO INVENTIONS MADE BY NONPROFIT ORGANIZATIONS AND SMALL BUSINESS FIRMS UNDER GOVERNMENT GRANTS, CONTRACTS, AND COOPERATIVE AGREEMENTS.
37 C.F.R. § 401.14
(a)The following is the standard patent rights clause to be used as specified
Patent Rights (Small Business Firms and Nonprofit Organizations)
(c) Invention Disclosure, Election of Title and Filing of Patent Application by Contractor
(1) The contractor will disclose each subject invention to the Federal Agency within two
months after the inventor discloses it in writing to contractor personnel responsible
for patent matters…
(d) Conditions When the Government May Obtain Title
The contractor will convey to the Federal agency, upon written request, title to any subject invention—
(1) If the contractor fails to disclose or elect title to the subject invention within the times specified in (c), above, or elects not to retain title; provided that the agency may only request title within 60 days after learning of the failure of the contractor to disclose or elect within the specified times.
HHS and NIH policies, guidelines, explainers:
- Reminder: All Subject Inventions Must Be Reported on the HHS 568 – Final Invention Statement and Certification (For Grant or Award) and in iEdison, February 17, 2016, NIH Notice No. NOT-OD-16-066.
This Notice is issued to remind ALL awardee institutions (including but not limited to Universities, Non-Profit entities, and For-Profit entities) that the HHS 568 must be filed by a grantee or contractor at the conclusion of a grant or contract, See, 37 C.F.R. 401.14(f)(5) https://grants.nih.gov/grants/bayh-dole.htm#401.14, the NIH Grants Policy Statement at 8.2.4 and 184.108.40.206 https://grants.nih.gov/grants/policy/nihgps/index.htm, and the terms and conditions of your funding agreement. It requires the reporting of all subject inventions that were made under an applicable NIH funding agreement.
Additionally, all subject inventions that were made under an applicable funding agreement and reported on the HHS 568 must be reported in iEdison. Failure to report (on the HHS 568 AND in iEdison) all inventions funded in whole or in part by NIH as required by your funding agreement’s terms and conditions, the NIH Grants Policy Statement, and the Bayh-Dole Act may result in your organization’s loss of rights in the invention or other actions as appropriate.
- Department of Health and Human Services, “Procedure for Submission of Final Invention Statement and Certification (For Grant or Award)Form HHS 568”, OMB No. 0925-0002.
- iEdison.gov & Intellectual Property FAQs and Resources.
- NIH eRA Communications Office, “Invention Reporting Timeline: At a Glance”, April 28, 2014.
- J.P. Kim, “Inventions, Data Sharing, and other Intellectual Property Considerations (Making the most from your research),” 2014 NIH Regional Seminar on Program Funding and Grants Administration, Baltimore, Maryland.
KEI Requests/Blogs Regarding Failures to Disclose
- 2019. KEI Requests the NIH to Investigate Failure to Disclose Federal Funding in Opdivo and Keytruda Patents. December 20, 2019.
- 2019. University of Pennsylvania Failure to Disclose Federal Funding for Bennett et al Patents on AAV Gene Therapy to Treat Blindness. September 9, 2019.
- 2019. University of Pennsylvania Failure to Disclose Federal Funding for Wilson et al Patents on AAV Gene Therapy. September 3, 2019.
- 2018. University of Pittsburgh Failure to Disclose Federal Funding for Patents on Vizamyl (INN flutemetamol F 18). May 18, 2018.
- 2018. Six organizations ask HHS Secretary Azar to take title of 5 patents on Exondys 51, as remedy to failure by inventors to disclose NIH funding. April 5, 2018.
- 2018. James Griffin, Dana-Farber Cancer Institute and Novartis failure to disclose NIH funding for patents on leukemia drug midostaurin (Trade name Rydapt), March 21, 2018.
- 2018. Six University of Pennsylvania and Daniel J. Rader patents on Juxtapid (lomitapide) failed to discuss multiple NIH grants, March 19, 2018.
- 2018. KEI request that HHS take ownership of US Patent 7,964,580 on sofosbuvir, now held by Gilead, for non-disclosure of NIH grants, March 14, 2018.
- 2018. Following KEI request for investigation, Cold Spring Harbor Labs says 7 patents require correction to disclose federal funding, October 20, 2017.
- 2017. Fred Hutchinson Cancer Center often fails to disclose federal funding of inventions on initial patent, October 20, 2017.
- 2017. Penn “Certificates of Correction” on Federal Funding for 5 CAR T Patents, October 18, 2017.
- 2017. KEI finds University of Pennsylvania failed to disclose government rights in five CAR T patents, October 17, 2017. Updated on October 18, 2017 to address Certificates of Corrections on the five patents.
- 2017. HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals’ Spinraza, March 16, 2017.
- 2017. Spinraza: KEI asks DHHS Office of the Inspector General (OIG) to investigate a failure to disclose federal funding in patents, January 19, 2017.
Media Coverage, Related Articles, & Blogs
- 2018. April 12. Raymond A. Miller, Hilary S. Cairnie, Aparna Nemlekar, and Megan E. Bowers. Gilead May Have Forfeited Ownership of Its Blockbuster Hepatitis Drug Patents. Bloomberg Law
- 2018. April 6. Brittany Meiling, Should Sarepta’s patents be seized by the government? Patient advocates pitch controversial drug pricing proposal. End Points
- 2018. April 6. Bill Meagher, Sarepta Hit With Call to Drop Duchenne Drug Costs: The biopharmaceutical company, which won controversial FDA approval for a Duchenne Muscular Dystrophy drug, now confronts patient groups asking HHS to take its patents and drop the price of that drug. The Street.
- 2018. April 5. Dani Kass. Nonprofits Urge HHS To Take Over Sarepta’s Exondys Patents. Law360.
- 2018. April 5. Ed Silverman. Trump administration is urged to override patents on pricey muscular dystrophy drug. STAT News.
- 2018. March 23. Dani Kass. Bayh-Dole Could Be A Drug Pricing Fix, If The Feds Want It. Law360.
- 2018. March 23. Raymond A. Miller, Hilary S. Cairnie, Aparna Nemlekar, Megan E. Bowers. NIH May Own Gilead’s Blockbuster Hepatitis Drug Due to Misstep. Pepperlaw.
- 2018. March 20. “Non-profit asks US government to take Gilead hepatitis C patent.” Life Sciences Intellectual Property Review.
- 2018. March 20. 2018. Silverman, Ed. “NIH is urged to probe Aegerion patents for failing to disclose federal funding.” STAT News.
- 2018. March 19. Saltzman, Jonathan. “Watchdog group says researcher who worked on Aegerion drug didn’t disclose taxpayer funding.” Boston Globe.
- 2018. March 16. Dani Kass. Feds Should Own Gilead Hep C Patent, Nonprofit Says. Law360.
- 2018. March 15. Silverman, Ed. “HHS is urged to investigate a Gilead hepatitis C patent for failing to disclose federal funding.” STAT News.
- 2017. October 21. James Love. Errors in Patent Grants: More Common in Medical Patents. Bill of Health.
- 2018. January 24. Jesse Schwartz. Cold Spring case illustrates Bayh-Dole risk in midst of drug price controversy. Tech Transfer Central
- 2017. October 6. Rebecca Trager. US government urged to exercise drug patent rights. Chemistry World
- 2017. April 10. Michael H. Brodowski. Changes to Bayh-Dole Act Regulations Impacting Ownership of Patent Rights. Goodwin Law.
- 2017. January 24. Ed Silverman. Should the US seize patents on a Biogen drug that starts at $750,000 a year? Boston Globe.
- 2017. January 18. Dennis Crouch. Bayh-Dole Act: Failing to Disclose Government Funding. Patently-O.
- 2016. November 18. Kaye Scholer, Kristen Riemenschneider, Ronald Lee and Amanda Johnson, Proposed Amendments to Bayh-Dole Act Regulations Tweak Rights to Inventions Made Using Federal Assistance. Arnold & Porter.
- 2005. February 14. Non-Compliance with Bayh-Dole Leads to Army Getting Patent Title. New York Law Journal.