Regeneron failed to disclose BARDA funding in their REGN-COV2 patent

Regeneron Pharmaceuticals failed to disclose U.S. government funding in a patent that claims antibodies against COVID-19. The obligation to acknowledge U.S. government funding in patents is required under an existing contract between Regeneron and the Biomedical Advanced Research and Development Authority (BARDA), as well as under the Bayh-Dole Act and regulations issued by the United States Patent and Trademark Office (USPTO). The patent in question is U.S. patent 10,787,501 (the “‘501 patent”), titled Anti-SARS-CoV-2-spike glycoprotein antibodies and antigen-binding fragments, which claims the priority benefits of U.S. provisional applications 63/004,312, filed April 2, 2020; 63/014,687, filed April 23, 2020; 63/025,949, filed May 15, 2020; and 63/034,865, filed June 4, 2020.

A research note by Luis Gil Abinader on this issue is available here: RN-2020-4

Comments by KEI staff:

Luis Gil Abinader, the author of the research note. “Regeneron has received massive funding for its work on COVID-19. Federal agencies are apparently not monitoring the required disclosures.”

James Love, Director of KEI. “The U.S. government has the right to take ownership of patents where inventors fail to disclose federal funding. The fact that this rarely happens leads to cases like this, where companies ignore the requirement. There are several reasons why the disclosures are important. The narrative about who funded the inventive work on a new drug, vaccine or diagnostic test can influence the public’s attitudes about the reasonableness of prices. When the government does have rights, there are several important obligations on patent holders, including the obligation to make products available to the public on reasonable terms, the ability to force licensing to enable more competition or follow-on innovations, and to terminate monopolies when inventions are not developed. The NIH, BARDA, DARPA and other federal agencies have been lax on enforcing the disclosure requirement, and no company has faced sanctions when they fail to disclose.”

More on the issue of non-disclosure of federal funding here: