The US Biomedical Advanced Research and Development Agency (BARDA) is investigating Moderna’s patents for allegedly failing to disclose federal funding, making it the second US agency to review the company’s patents.

The BARDA probe comes just days after the US Defense Advanced Research Projects Agency (DARPA) began an investigation into Moderna’s patents, after pharma watchdog Knowledge Ecology International (KEI) sent DARPA a letter alleging that Moderna had failed to disclose DARPA funding in its US patent applications.

In a public letter to acting head of BARDA Gary Disbrow on Wednesday, KEI wrote that Moderna, the biotech company behind a promising COVID-19 vaccine candidate, has failed to disclose millions of dollars of federal funding on patents granted by the US Patents and Trademarks Office (PTO). Disclosure of federal funding in patent applications is required under the Bayh-Dole Act.

“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,” said Disbrow, in a letter responding to the KEI request. “Following this review, BARDA Contracting Officers will be in touch with the company and will ensure Moderna’s compliance with its contractual requirements.”

So far, BARDA has provided nearly US$ 1 billion to the biotech firm to fund development of it’s COVID-19 vaccine candidate. The agency had also supported early development of the company’s investigational Zika vaccine.

Moderna Discloses Funding In One WIPO Application, But Fails To Disclose Funding In US Patent Applications

“Moderna has not been disclosing federal funding on its inventions [for patents filed with the US PTO],” James Love, director of KEI, told Health Policy Watch. “It is important for BARDA and DARPA to enforce the obligation to disclose.”

A Moderna spokesperson told Health Policy Watch that the company believed it had complied with all patent disclosure laws, in regards to the DARPA probe. Moderna does disclose DARPA funding on one patent application submitted to the World Intellectual Property Organization (WIPO).

However, KEI claims that out of 127 US PTO-granted patents and 154 USPTO patent applications, not one has disclosed federal funding.

Moderna received a modest US $25 million in funding from DARPA in the early 2010s to kickstart development on their Zika and chikungunya vaccine candidates.

However, “The US Biomedical Advanced Research and Development Agency has given roughly 100 times the money to Moderna than Moderna has received from the Defense Advanced Research Projects Agency,”  said Love.

BARDA has granted the biotech firm nearly US $1 billion in funding to accelerate development of a COVID-19 vaccine candidate, built on the company’s proprietary messenger RNA platform.

However, the agency also supported development of Moderna’s Zika vaccine with a US $125 million grant, according to the company’s Securities and Exchange Commission (SEC) filings from 2018. But USPTO-granted patents related to Moderna’s Zika vaccine do not list the BARDA funding.

“The patents are not just for a specific disease, they are for inventions that have applications across different diseases. Moderna’s work on Zika and Chikungunya were both relevant to the COVID 19 vaccine work,” explained Love.

Image Credits: NIAID.