On May 23, TrialSite looked at “windfall” trading profits for Moderna executives, along with other issues with the firm. Now, the US DHHS subagency, the Biomedical Advanced Research and Development Authority, or BARDA, announced Friday it is looking into whether Moderna was, “upfront about government funding in patent applications related to its work on the Zika vaccine and its closely watched COVID-19 vaccine candidate.” The story was outlined on September 4 by Law360. BARDA’s acting director Gary Disbrow says that they are probing Moderna’s compliance with federal law requiring firms to report any government funding to the US Patent 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 said in a letter to Knowledge Ecology International (KEI), a nonprofit that on September 2 asked BARDA to investigate the firm.
Federal Funding Disclosure Required by Bayh-Dole Act
The KEI request noted that “while BARDA was among the first funders to support Moderna’s messenger RNA, a review of US Securities and Exchange Commission filings over 100 patent applications shows that not one of the company’s patents or patent applications disclosed federal funding.” KEI says that under the 1980 Bayh-Dole Act, firms must disclose if publicly-funded research had a role in a patented invention. Violation of the Act could “lead to the government taking over the patent’s rights.” Independently, Monday, DARPA said it was looking into whether Moderna disclosed its funding for, “various patent applications.” “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’s Director James Love opined. He went on, “Moderna has used the narrative that its proprietary platform somehow gives them legitimacy in charging high prices for the vaccines, compared to other companies.” He says these investigations might change the narrative “and give government…more freedom to share key inventions with other vaccine manufacturers, for COVID-19 now, and possibly vaccines for other diseases also.”
Call to Action: Moderna is an incredibly important company positioned as one of the leading developers of COVID-19 vaccine candidates. TrialSite will continue to monitor this situation.