Sneak Preview: Awardee Patents Should Give Proper Credit to NIH
(The following was excerpted from a recent Thompson Grants Compliance Expert article.) Recipients receiving funding from the National Institutes of Health (NIH) for biomedical research and development (R&D) will be subject to additional disclosure requirements for patents arising from research funded by the agency, in follow up to recommendations included in a recent report from the General Accountability Office (GAO).
Congress asked GAO to review how NIH funding contributes to biomedical R&D, and particularly to drug development. In its analysis, GAO examined, among other things: (1) NIH funding for basic research, clinical trials and biomedical workforce training; (2) information about NIH-funded clinical trials reported to ClinicalTrials.gov; (3) the extent to which NIH support is disclosed in patents arising from research funded by the agency; and (4) the extent to which microdata for NIH grants are accessible to researchers for tracing the connection between NIH contributions and drug development.
This performance audit was conducted from January 2022 to April 2023. OIG reviewed select academic studies that used NIH and federal R&D microdata to evaluate outcomes of federally funded R&D.
NIH Funding Not Cited
Discoveries made by NIH scientists contributed directly to the development of drugs, including cancer treatments and vaccines, GAO noted. More broadly, NIH-funded biomedical R&D contributes to basic research investigating biological mechanisms of different diseases, clinical trials that study the safety and effectiveness of drug candidates and other biomedical or behavioral interventions, and training biomedical scientists who go on to work in federal laboratories, universities, hospitals and the pharmaceutical industry.
GAO found that NIH awardees did not consistently disclose NIH support in patents arising from research funded by the agency. For example, GAO identified 2,700 of 19,055 patents with application dates in calendar years 2012 through 2021 that did not fully or correctly disclose NIH support, as required to do so.
“NIH does not provide clear guidance that its awardees should name NIH as the funding agency and correctly identify the award number when disclosing NIH support in patents,” GAO said. “When awardees do not disclose the agency's support correctly, or do not name NIH as the funding agency, these parties cannot link patents to NIH funding and determine the extent of the agency’s involvement in developing the patented technologies.”
In its recent report based on its analysis, “National Institutes of Health: Better Data Will Improve Understanding of Federal Contributions to Drug Development,” GAO recommended that the Department of Health and Human Services (HHS), NIH’s parent agency, ensure that NIH update its Grants Policy Statement and related training materials to provide guidance that the government interest statement in a patent arising from NIH-funded research should clearly name NIH as the federal agency and identify NIH awards using, at a minimum, the institute code and serial number. NIH should also develop a procedure describing how researchers can access NIH microdata for the purposes of studying and evaluating the agency’s contributions to developing new drugs and treatments. HHS concurred with the recommendations.
(The full version of this story has now been made available to all for a limited time here.)
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