US Department Of Defense Is Investigating Moderna’s Patents For Allegedly Failing To Disclose Federal Support
Colorized electron microscope photograph of SARS-CoV-2 (yellow) heavily infecting a dying cell (blue)

The United States Defense Advanced Research Projects Agency (DARPA) is investigating Moderna, a company developing a much hyped COVID-19 vaccine candidate, for allegedly failing to disclose federal funding on its US patent applications.

A Moderna spokesperson on Monday told Health Policy Watch that “the Company believes it has complied with applicable patent reporting requirements regarding patent filings.”

The spokesperson additionally referred to a patent application Moderna submitted to the World Intellectual Property Organization (WIPO), which did reference DARPA funding.

The comment was made in response to a letter and 25-page report from pharma watchdog Knowledge Ecology International urging the federal government to investigate the company for allegedly failing to disclose federal funding from US DARPA, a branch of the Department of Defense, in patent applications for investigational vaccines and treatments built on its messenger RNA platform.

DARPA spokesperson Jared Adams told the Financial Times that the department was “actively researching agency rewards to Moderna to identify which patents and pending patents, if any at all, may be associated with DARPA support,” following the publication of KEI’s letter.

“We are pleased that DARPA is now taking this seriously,” James Love, director of KEI told Health Policy Watch.

“Despite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, not a single one of the patents or applications assigned to Moderna disclose U.S. federal government funding,” KEI analyst Luis Gil Abinader writes in the research note, referring to patents granted by the US Patents and Trademark Office (US PTO).

It is likely that two DARPA grants, totaling around US $25 million, supported early development of Moderna’s mRNA platform, according to KEI’s letter to DARPA and the Secretary of Defense. Under the Bayh-Dole Act, the company should be required to disclose DARPA funding in patents for new vaccine or treatment candidates using the company’s proprietary messenger RNA (mRNA) platform, such as their investigational COVID-19 vaccine.

But none of 126 patents granted by the US PTO to Moderna have referenced the initial funding provided by DARPA, according to the KEI report. Published academic papers and disclosures filed to the US Securities and Exchange Commission (SEC) refer to the DARPA grants, but patents granted to Moderna for the same technologies do not mention DARPA funding. KEI highlighted 11 patents that they say should have referenced the DARPA funding, including patents for chikungunya and Zika vaccine candidates and patents related to the mRNA platform.

Moderna Disclosed DARPA Funding in a WIPO Patent Application, But Did Not List DARPA Funding Elsewhere

Moderna does disclose federal funding in one patent application filed with WIPO. The company references a DARPA grant in an application jointly filed with Vanderbilt University for an antibody treatment producing platform for the viral disease chikungunya.

Moderna spokesperson Ray Jordan noted that since 2013, Moderna had also publicly acknowledged the DARPA funding in contexts such as its October 2013 announcement that stated:

“This $24.6 million grant could support research for up to 5 years to advance promising antibody- producing drug candidates into preclinical testing and human clinical trials. The company also received a $0.7 million “seedling” grant from DARPA in March to begin work on the project.”

However, in contrast to the $25+M DARPA funding, private investors have supported the development of Moderna’s mRNA platform with approximately $5.1 billion in funding, Jordan said.

Still, regardless of the amount of DARPA funding that the company received, Moderna should still be required to disclose federal funding in it’s US patent applications, in line with requirements by the US PTO and the Bayh-Dole Act, according to KEI.

“The requirement to disclose DARPA funding on DARPA funded inventions has nothing to do with the investor funding or other grants, such as the US$2.45 billion in BARDA contracts,” said Love.

Furthermore, two inventors who are listed in US PTO patents that did not disclose DARPA funding are also listed in the WIPO patent application that did disclose federal funding, and these two inventors have acknowledged being funded by DARPA in academic papers, according to Love.

If the company is found to have failed to disclose DARPA funding, KEI recommended that the funding agency, DARPA, should at least request a correction to the patent. At most, it could be grounds for the agency to claim the patents themselves, as a sanction for the failure to disclose public funding, according to the KEI letter.

Image Credits: NIAID.

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