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Law360 (September 4, 2020, 6:42 PM EDT ) A U.S. Department of Health and Human Services subagency said Friday that it is investigating whether Moderna Therapeutics was upfront about government funding in patent applications related to its work on the Zika vaccine and its closely watched COVID-19 vaccine candidate.
Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority, or BARDA, said the agency is probing the Massachusetts-based company's compliance with a federal law that requires companies to disclose any government funding to the U.S. Patent and Trademark Office.
"The contracting officers responsible for the BARDA contracts with Moderna are reviewing the requirements to report the role of government-funding of inventions and identifying any Moderna patents or patent applications that may be associated with BARDA support," Disbrow wrote in a letter to Knowledge Ecology International, a nonprofit that urged the agency earlier this week to investigate the company.
KEI, which focuses on medical technology access, said in its letter to the agency Wednesday that while BARDA was among the first funders to support Moderna's messenger RNA research, a review of U.S. Securities and Exchange Commission filings and over 100 patent applications shows that not one of the company's patents or patent applications disclosed federal funding.
The biotechnology company should admit its funding sources or hand over the patents to the government under the Bayh-Dole Act, KEI said. The 1980 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.
BARDA is the second federal agency in a week to agree to investigate Moderna's funding sources for its vaccine patents. On Monday, the Pentagon's research arm, the Defense Advanced Research Projects Agency, said it was probing whether Moderna properly disclosed its funding sources for various patent applications. That announcement followed KEI's request last week that the defense research agency investigate whether Moderna reported funds it received to develop messenger RNA vaccines for viral infections, including its potential COVID-19 vaccine.
"Moderna has not been disclosing federal funding on its USPTO published patent application, despite tens of millions at first, and now billions of dollars in federal funding," KEI Director James Love said in an email on Friday. "Moderna has used the narrative that its proprietary platform somehow gives them legitimacy in charging high prices for the vaccines, compared to other companies."
"The DARPA and BARDA investigations, both launched in less than a week apart, could change that narrative, and give the government ... more freedom to share key inventions with other vaccine manufacturers, for COVID-19 now, and possibly vaccines for other diseases also," he said.
Representatives for Moderna and the U.S. Department of Defense did not immediately respond to requests for comment.
--Editing by Jill Coffey.
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