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Law360 (September 3, 2020, 5:32 PM EDT ) The Biomedical Advanced Research and Development Authority must investigate whether Moderna Therapeutics was upfront about government funding in its patent applications related to its work on the Zika vaccine and its closely watched COVID-19 vaccine candidate, a nonprofit has urged the agency.
Knowledge Ecology International asked BARDA's acting director Gary L. Disbrow in a letter Wednesday to probe the Massachusetts-based company's failure to tell the U.S. Patent and Trademark Office that the U.S. Department of Health and Human Services agency was bankrolling its inventions.
The biotechnology company should admit its funding sources or hand over the patents to the government under the Bayh-Dole Act, the nonprofit said.
"If Moderna has failed to disclose BARDA funding, we expect Moderna to at a minimum publish corrections to the patents with the USPTO," KEI director James Love wrote in the letter. "However, KEI believes that BARDA needs to send a signal to the companies it funds that failures to disclose have consequences, by exercising its legal remedies and taking title to the patents."
Wednesday's letter comes just days after the Defense Advanced Research Projects Agency said it's investigating whether Moderna properly disclosed its funding sources for various patent applications. That announcement followed KEI's request last week that the Defense Advanced Research Projects Agency investigate whether Moderna reported funds it received to develop mRNA vaccines for viral infections, including its potential COVID-19 vaccine.
In that letter, KEI asked the U.S. Department of Defense to demand ownership of the patents under the Bayh-Dole Act because most of the DARPA funds resulted in patented inventions for which the government funding was never disclosed, as required under the 1980 law. The law requires companies to disclose when government-funded research played a role in a patented invention, and any violation could lead to the government taking over the patent's rights.
Love said KEI was just getting started with the DARPA investigation and that a probe by BARDA would involve bigger sums of money that are more relevant to the work on Zika and the potential COVID-19 vaccine.
"BARDA has given Moderna about 100 times as much money as DARPA," Love said in an email. "I'm sure that Moderna will file new patents based upon its work this year on BARDA grants. BARDA should be making sure the nondisclosure practices are ended, and they should also be looking at the other companies they are funding."
Through an analysis of Moderna's U.S. Securities and Exchange Commission filings and over a hundred patent applications, KEI said there's evidence that the company proceeded with its Zika vaccine without disclosing its primary funding source. Not one of the patents assigned to Moderna or the patent applications it has filed disclose federal funding even though BARDA was among the first funders to support Moderna's mRNA research, Wednesday's letter said.
"It seems unlikely that none of these patent applications benefited from BARDA funding, and there are undoubtedly more relevant USPTO patent applications that have yet to be published, as well as USPTO provisional applications that are not published," Love said.
Representatives for Moderna, DOD and BARDA did not immediately respond to requests for comment.
--Editing by Haylee Pearl.
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