BARDA Joins DARPA in Examining Moderna Contracts for Disclosure Problems

September 10, 2020

A second government agency, the Biomedical Advanced Research and Development Authority (BARDA), is now scrutinizing contracts awarded to Moderna, examining whether the vaccine maker failed to disclose millions of dollars it got in federally funded awards in several patents and patent applications the firm has filed for its vaccines.

BARDA has awarded the high-profile vaccine maker almost $955 million to develop a COVID-19 vaccine based on its mRNA technology, which Moderna developed in conjunction with the National Institutes of Health (NIH).

The BARDA scrutiny comes a week after a spokesman with the Defense Advanced Research Projects Agency (DARPA) said that agency was “actively researching agency awards to Moderna to identify which patents and pending patents, if any at all, may be associated with DARPA support.” He added that “all past and present DARPA awards to Moderna” seemed to include a requirement to report other government funding for related inventions (DID, Sept. 1).

The BARDA and DARPA probes were sparked by an advocacy group that analyzed 127 Moderna patents and 154 patent applications across its 10-year history. The group, Knowledge Ecology International (KEI), said that the obligation to disclose U.S. federal government support in patent applications is a requirement of the 1980 Bayh-Dole Act, which was designed to protect public investment, as well as regulations issued by the Patent and Trademark Office. KEI is a nonprofit group that advocates to protect taxpayer investments in patents.

Despite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, none of the patents or applications assigned to Moderna disclose U.S. federal government funding, said KEI in a statement. The group said Moderna’s financial support from these government agencies translates to the U.S. government owning certain rights over the patents, which could mean that U.S. taxpayers have an ownership stake in vaccines made and sold by the firm.

Moderna has garnered almost $1 billion from the Trump administration for research and development of its COVID-19 vaccine candidate, which was the first to enter human trials. The company also holds a $1.5 billion contract to sell 100 million doses of the vaccine to the U.S.

Thus far, though, the U.S. government has never pulled patent rights from a drugmaker under Bayh-Dole. Given how closely Moderna is working with Operation Warp Speed to develop a COVID-19 vaccine, it’s not likely that will happen now.

“If Moderna has failed to disclose BARDA funding, we expect Moderna to, at a minimum, publish corrections to the patents with the U.S. Patent & Trademark Office,” wrote KEI Director Jamie Love to BARDA last week. “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 patent.”

In response, BARDA’s Acting Director Gary Disbrow confirmed that 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.”

In a statement to FDAnews, Moderna said the company worked with various U.S. government agencies and is “aware of and consults with our agency collaborators regarding our contractual obligations under each of these agreements, including those with respect to IP, and believe we comply with those obligations.” — Suz Redfearn