In a letter sent last week, non-profit patient advocacy group, Knowledge Ecology International (KEI), requested that the US Biomedical Advanced Research and Development Authority (BARDA) carry out such a probe.
The obligation to disclose US federal government support in patent applications is a requirement of the Bayh-Dole Act and regulations issued by the US Patent and Trademark Office (USPTO).
James Love, director of KEI, told BioPharma-Reporter that given the amount of money flowing to Moderna, he decided to look at the patent disclosures in May.
The pharma watchdog alleges that it examined 127 USPTO granted patents and 154 USPTO patent applications assigned to Moderna or Moderna TX and that it reportedly found no disclosures of federal funding for the inventions from any agency of the federal government, including BARDA.
KEI said it was aware of one WIPO PCT application filed with Vanderbilt University that does disclose National Institutes of Health (NIH) and funding from the US Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense.
It is possible that Moderna has patent applications filed but not yet published that will disclose federal funding, wrote the advocacy group in a note on its website.
Gary Disbrow, acting director, BARDA, said the agency is investigating KEI's claims.
“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. Following this review, BARDA contracting officers will be in touch with the company and will ensure Moderna’s compliance with its contractual requirements," he commented in a letter, published on the KEI website.
A spokesperson for BARDA confirmed that probe in an email sent to BioPharma-Reporter this week.
As well as supporting Moderna's clinical program for its Covid-19 vaccine, that agency had given financial backing to the early development of the company’s investigational Zika vaccine.
If Moderna has failed to disclose BARDA funding, KEI said it expected the biotech 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,” said Love.
KEI had also made a request to DARPA, an agency that has funded Moderna’s vaccine efforts since 2013, for a similarly focused enquiry.
DARPA has initiated an investigation into the patents awarded to Moderna as well, said KEI.
A spokesman for that agency, Jared Adams, in an emailed response, told this publication: “It appears that all past and present DARPA awards to Moderna include the requirement to report the role of government-funding for related inventions. Further, DARPA is actively researching agency awards to Moderna to identify which patents and pending patents, if any at all, may be associated with DARPA support. This effort is ongoing."
"To their credit, DARPA and BARDA have been responsive to our complaints," said Love.
Vaccine candidate pricier than rivals
Having commenced the Phase 3 trial of its covid-19 vaccine candidate, mRNA-1273, in late July, Moderna indicated that its vaccine will be priced higher than those of its rivals.
In another development, US Senator for Illinois, Dick Drubin, has written letters to Moderna and other vaccine manufacturers, AstraZeneca, Sanofi, GlaxoSmithKline, Merck, Pfizer, Novavax, and Janssen/Johnson & Johnson, asking about, among other issues, federal funding of the vaccine, government rights in patents, and the Bayh-Dole obligation.
Moderna has not responded to our request for comment on the patent funding disclosure allegations.