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HHS Launches Investigation into Moderna’s Patented Vaccines’ Funding Sources

by | Dec 4, 2020 | Legal Update |

REPOST OF BLOG FROM SEPTEMBER 2020 (lost in website changeover)

The Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services is investigating Moderna, Inc., a publicly traded biotechnology company.

Moderna is known for its drug development and vaccine technologies based exclusively on messenger RNA.

BARDA launches this probe to determine whether Moderna disclosed government funding in patent applications regarding the Zika vaccine and most recently, its candidacy for a COVID-19 vaccine.

The agency’s action follows Knowledge Ecology International’s (KEI), strong push for the agency to investigate Moderna. In a letter to the agency, KEI suggested that while BARDA originally supported Moderna’s Messenger RNA research, a review of the U.S. Securities and Exchange Commission filings and over 100 patent application demonstrates that Moderna did not disclose federal funding on any of their patents or applications.

BARDA’s acting director, Gary Disbrow, said in response to KEI’s letter, that “[t]he 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.”

Compliance with the federal law requires that companies disclose any government funding to the U.S. Patent and Trademark Office (USPTO). According to KEI, the Bayh-Dole Act requires companies to disclose when government-funded research assisted in patented invention. If violated, the government could ascertain the patent’s rights.

BARDA is not the only agency looking into Moderna’s funding sources. On August 31, the Pentagon’s Defense Advanced Research Projects Agency said it was investigating whether Moderna accurately disclosed funding on its patent applications. This investigation followed KEI’s request that the defense agency investigate whether Moderna properly disclosed funds it received to develop messenger RNA vaccines for viral infections, including its potential COVID-19 vaccine.

Why does USPTO disclosures matter? According to KEI Director James Love, Moderna’s use of its branded platform “somehow gives them legitimacy in charging higher prices for vaccines, compared to other companies.” These investigations could change Moderna’s story, giving the government “more freedom to share key inventions with other vaccine manufacturers” especially as the world races towards a vaccine for COVID-19.