Regeneron must face patent lawsuit over COVID-19 treatment

2 minute read

The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid

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  • Regeneron loses early bid to dismiss protein-patent claims
  • Judge says not yet clear if Regeneron has "safe harbor" from lawsuit

(Reuters) - Regeneron Pharmaceuticals Inc on Wednesday failed to persuade a federal judge in New York to throw out a lawsuit over its alleged misuse of a patented protein to test its breakthrough COVID-19 treatment.

U.S. District Judge Philip Halpern said during an oral argument that he could not grant Regeneron's request at an early stage of the case to find it immune from Allele Biotechnology and Pharmaceuticals Inc's infringement claims.

San Diego-based Allele sued Regeneron in October, accusing the rival biotech company of using Allele's fluorescent protein mNeonGreen to test its coronavirus antibody cocktail, REGEN-COV, without a license.

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Regeneron argued that it was protected from Allele's claims by a federal law that allows the use of patented inventions to test drugs during the U.S. Food and Drug Administration application process.

Tarrytown, New York-based Regeneron said last month that it sold more than $6 billion worth of REGEN-COV in 2021, making up over a third of its revenues.

Allele settled a lawsuit against Pfizer Inc and BioNTech SE in January over their use of the same protein in developing their widely distributed COVID-19 vaccine.

Halpern said Wednesday that more information was needed to determine whether Regeneron used Allele's protein solely to test REGEN-COV for the FDA approval process, which could undermine Regeneron's defense.

The judge noted Allele's argument that Regeneron may have also used the protein in testing for other purposes like quality control, but said he could not come to a conclusion based on the current, limited record.

Halpern also refused to grant Regeneron's bid to dismiss Allele's claims that it infringed willfully.

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 of Perkins Coie

For Regeneron: David Frazier 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

COVID-19 patent challenges mount as Moderna faces new vaccine lawsuit

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Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at