Regeneron Pharmaceuticals has reached a settlement in a patent dispute over the use of a patented protein in its testing of the COVID-19 treatment REGEN-COV, according to a filing in New York federal court. The settlement resolves allegations made by Allele Biotechnology and Pharmaceuticals, which claimed that Regeneron used its fluorescent protein, mNeonGreen, without a license for testing its coronavirus antibody cocktail.
The case, which had been ongoing since 2020, was dismissed by U.S. District Judge Philip Halpern on Monday after both companies disclosed their agreement in a joint court filing on Friday. In their statement, both parties described the settlement as a “mutually satisfactory resolution,” but declined to provide further details about the terms.
Allele, based in San Diego, originally sued Regeneron in 2020, accusing the company of infringing on its patent for the mNeonGreen protein. This fluorescent protein, according to Allele, was used by Regeneron in the development and testing of REGEN-COV, its highly profitable antibody treatment for COVID-19. The drug earned Regeneron nearly $6.2 billion in sales in 2021.
The settlement follows a similar case where Allele also settled with Pfizer and BioNTech in 2022 over the use of the same protein in the development of the COVID-19 vaccine Comirnaty.
The legal battle saw several key developments. In 2022, U.S. District Judge Halpern denied Regeneron’s request to dismiss Allele’s case and rejected Regeneron’s argument that it was immune from the patent claims under the “safe harbor” provision of federal law, which allows the use of patented inventions for drug testing during FDA application processes.
Despite this, the companies stipulated that Regeneron would be liable for patent infringement if the “safe harbor” defense failed, leaving the issue of damages to be determined at a future trial.
With the settlement now in place, the case has been resolved without a trial, and the terms of the settlement remain confidential.
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