[Ip-health] Regeneron failed to disclose BARDA funding in their REGN-COV2 patent

Luis Gil Abinader luis.gil.abinader at keionline.org
Tue Oct 20 06:41:05 PDT 2020


Link: https://www.keionline.org/34258

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

Posted on October 20, 2020 by KEI Staff

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:
https://www.keionline.org/wp-content/uploads/rn-2020-4.pdf

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:
https://www.keionline.org/bayh-dole/failure-to-disclose


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