Moderna’s COVID-19 and Zika patent applications to be investigated
A US Department of Health and Human Services agency will investigate whether biopharmaceutical company, Moderna Therapeutics, fully disclosed information on government funding in patent applications relating to its COVID-19 vaccine candidate and its work on a Zika vaccine.
Acting director of the Biomedical Advanced Research and Development Authority, (BARDA), Gary Disbrow, confirmed in a letter, issued on September 4, that the agency is probing the pharmaceutical company in response to a complaint from Knowledge Ecology International (KEI), a nonprofit that focuses on access to medical technology.
Disbrow wrote: “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.”
BARDA’s move follows an announcement by the Pentagon's research arm, the Defense Advanced Research Projects Agency (DARPA), which confirmed last week that it was also examining whether Moderna properly disclosed its funding sources for various patent applications.
According to a report published by KEI on August 28, Moderna failed to disclose that it had received about $25 million in grants from DARPA to develop its vaccine technology in its vaccine patents to the US Patent and Trademark Office (USPTO).
In public letters to both BARDA and DARPA, KEI director James Love claimed that during its research, KEI examined the 126 patents assigned to Moderna as well as 154 patent applications, which showed that not a single one of the patents or applications assigned to Moderna disclosed US federal government funding.
According to the Bayh-Dole Act of 1980, companies are required to disclose when government-funded research played a role in a patented invention.
The letters requested information concerning the measures the agencies are taking to ensure that Moderna properly discloses funding of inventions for which Moderna holds patents.
“If Moderna has failed to disclose BARDA funding, we expect Moderna to at a minimum publish corrections to the patents with the USPTO. 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," Love wrote in the letter to BARDA.
WIPR has approached Moderna for comment.
