Regeneron loses key defense in 19 treatment patent lawsuit
By Blake Brittain
Oct 4 -Biotech company Regeneron Pharmaceuticals REGN.O lost a bid on Friday to be held immune from allegations that it misused a patented protein while testing a COVID-19 treatment.
U.S. District Judge Philip Halpern rejected Regeneron's pretrial argument that he should throw out Allele Biotechnology and Pharmaceuticals' patent lawsuit over the treatment based on a federal law allowing the use of patented inventions to test drugs during the U.S. Food and Drug Administration application process.
Attorneys and spokespeople for Regeneron did not immediately respond to a request for comment on the decision. An attorney for Allele declined to comment.
The companies stipulated last year that Regeneron was liable for patent infringement if its "safe harbor" defense failed, leaving the amount of damages Regeneron owes to be determined at a future trial.
San Diego-based Allele sued Regeneron in 2021, accusing the rival biotech company of using Allele's fluorescent protein mNeonGreen to test its coronavirus antibody cocktail REGEN-COV without a license. Tarrytown, N.Y.-based Regeneron earned nearly $6.2 billion from sales of REGEN-COV that year, according to a company report.
Allele settled a lawsuit against Pfizer and BioNTech in 2022 over their use of the same protein in developing their COVID-19 vaccine Comirnaty.
Halpern denied Regeneron's earlier bid to dismiss the case in 2022 and said he needed more information before ruling on the company's safe harbor defense. The judge said on Friday that Regeneron was not immune from Allele's allegations, finding that mNeonGreen was "a research tool that is not under the scope of the safe harbor provision."
The case is Allele Biotechnology and Pharmaceuticals Inc v. Regeneron Pharmaceuticals Inc, U.S. District Court for the Southern District of New York, No. 7:20-cv-08255.
For Allele: David Anstaett, Martin Gilmore, Christopher Hanewicz, Andrew Dufresne, Elise Edlin and Maria Stubbings of Perkins Coie
For Regeneron: Michael Morin, David Frazier, Arlene Chow and Michelle Ernst of Latham & Watkins
Read more:
Regeneron, Pfizer sued for patent infringement over COVID antibody cocktail, vaccine
Pfizer, biotech firm end patent fight over COVID-19 vaccine
Regeneron must face patent lawsuit over COVID-19 treatment
Reporting by Blake Brittain in Washington
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