(More on Moderna here: https://www.keionline.org/moderna)
Luis Gil Abinader has taken a deep dive into Moderna’s surprising practice of never declaring government funding in its 126 patents and 154 patent applications, despite having had funding from multiple federal agencies.
One outcome of his research is a 25 page report (RN-2020-3) on Moderna’s failure to report funding from DARPA, and a request by KEI to DOD and DARPA to remedy this, including by taking title to patents where disclosures should have been made. (Text of letter below, and PDF version here).
KEI will also send a letter to BARDA. The letter below was addressed to DOD and DARPA, and focuses on their funding.
The obligation to disclose federal funding in patent applications has been subject to presidential executive orders, statutes, regulations and contracts, including those cited and quoted in Abinader’s report. The disclosure clarifies the public’s rights in the inventions and the obligations on the entity getting the money, on everything from the government’s worldwide royalty free license to the public’s march-in rights, obligations to make inventions available to the public on reasonable terms, and additional safeguards that can be exercised by a government inclined to do so.
Secondly, the disclosure changes the narrative about who has financed the inventive activity, often the most risky part of development.
One of the earlier norms on this was Franklin Roosevelt’s Executive Order 9424, on the Establishment of a Register of Government interests in patents.
In 2018, the regulations on disclosure were modified by NIST (see 83 FR 15954), where, among other things, the government gave itself unlimited time to remedy a failure to disclose federal funding, to eliminate one loophole that created an incentive ignore the disclosure requirement.
In the past, the US Department of Defense has taken title to patents where federal funding was not disclosed. See: Campbell Plastics v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004).
There is more on the broader issue of disclosure of government funding in patents here: https://www.keionline.org/bayh-dole/failure-to-disclose
The research on the Moderna/DARPA funding is outlined in a 25 page August 27, 2020 report by Luis Gil Abinader, titled: “Moderna failures to disclose DARPA funding in patented inventions.” RN-2020-3
Below is the text of the KEI letter to Dr. Mark T. Esper, Secretary of Defense, and Dr. Amy Jenkins, of the Pandemic Prevention Platform for the Defense Advanced Research Projects Agency (DARPA), regarding the apparent failure by Moderna to disclose DARPA funding in patent applications. (PDF copy here).
- August 27, 2020
Dr. Mark T. Esper
Secretary of Defense
Department of Defense
1000 Defense Pentagon
Washington D.C. 20301
Dr. Amy Jenkins
Pandemic Prevention Platform
Defense Advanced Research Projects Agency
675 North Randolph Street
Arlington, VA 22203-2114
Dear Dr. Esper and Dr. Amy Jenkins:
Attached is a request by Knowledge Ecology International (KEI) that the Department of Defense (DoD) investigate an apparent failure by Moderna Therapeutics (“Moderna”) to disclose awards from the Defense Advanced Research Projects Agency (DARPA) in applications for patents on inventions.
The request is outlined in the attached report by Luis Gil Abinader, dated August 27, 2020, titled: “2020:3 KEI Research Note: Moderna failures to disclose DARPA funding in patented inventions.”
The obligation to disclose U.S. federal government support in patent applications is a requirement of the Bayh-Dole Act and regulations issued by the U.S. Patent and Trademark Office.
Moderna was one of the awardees under the Autonomous Diagnostics to Enable Prevention and Therapeutics (ADEPT) program and performed research related to mRNA vaccines with funds granted by DARPA. Moderna used the ADEPT funding in their Chikungunya and Zika vaccines programs. It is likely that the DARPA awards more generally supported the establishment of their mRNA platform, which can be used against other viral infections, including COVID-19. This support is acknowledged by DARPA itself; for instance on the DARPA website there is currently a statement that states “[t]he first coronavirus vaccine to start human testing is from DARPA investment in the Moderna company.”
Several of the patents filed by Moderna since March 22, 2013 (when their first grant from DARPA was awarded) claim inventions related to methods and compositions for inducing an immune response by administering an mRNA vaccine. Some of these patents are specifically related to their Chikungunya and Zika vaccines programs, some are directed to vaccines against other viral infections, and others are generally relevant to the mRNA platform Moderna has developed.
KEI examined the 126 patents assigned to “Moderna” or “ModernaTx” as well as 154 patent applications. Despite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, not a single one of the patents or applications assigned to Moderna disclose U.S. federal government funding.
To protect taxpayer investments, the funding agency should remedy the failure to disclose by at a minimum requiring a correction to the patent and more appropriately by taking title to the patents themselves, as the sanction for the failure to disclose.
We also request the opportunity to discuss this issue with the appropriate persons at the DoD.
Knowledge Ecology International
1621 Connecticut Avenue NW
Washington, DC 20009