Pfizer and BioNTech recently emerged from a lawsuit unscathed after Allele Biotechnology and Pharmaceuticals cried patent infringement against a trio of pandemic juggernauts. For Regeneron, however, the legal battle is set to roll on.
Earlier this week, U.S. District Judge Philip Halpern shot down Regeneron’s bid to dismiss Allele’s lawsuit. The San Diego-based company claims Regeneron developed its COVID-19 antibody cocktail REGEN-COV using Allele’s fluorescent protein, mNeonGreen, without its permission.
In the world of medical research, fluorescent proteins are injected into living cells to help scientists visualize molecular changes and determine the cells’ response to treatments. Allele's mNeonGreen is one of the brightest and most stable monomeric fluorescent proteins to date, the company has said.
Regeneron, for its part, argues its use of the protein was protected under a federal law that lets companies use patented inventions “solely for uses reasonably related” to the development and regulatory submission of pharmaceuticals.
“Regeneron believes Allele’s litigation is without merit, and that the safe harbor patent statute and legal precedent supports our position that Regeneron’s use of laboratory markers to generate data for the FDA review process of our REGEN-COV investigational medicine is exempt from infringement,” a company spokesperson said over email. “We look forward to presenting our full case to the U.S. District Court for the Southern District of New York in due course.”
Regeneron will need to file its response to the court’s latest decision by March 16, Halpern said in an order filed Wednesday in the U.S. District Court for the Southern District of New York.
Until more information comes out, it’s unclear whether Regeneron exclusively used Allele’s protein to test REGEN-COV for the FDA approval process, which could jeopardize its defense, Halpern said Wednesday, as cited by Reuters.
The judge pointed to Allele’s argument that Regeneron might have used mNeonGreen for other testing purposes, such as quality control, Reuters noted.
As for Pfizer-BionNTech, the mRNA partners recently resolved their lawsuit with Allele in a “mutually satisfactory manner,” Allele said in January.
Allele and Pfizer-BioNTech agreed to dismiss all claims with prejudice, meaning they can’t be refiled.
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When Allele filed its pair of lawsuits against Pfizer-BioNTech and Regeneron in October, the company said it was seeking damages that amount to no less than a reasonable royalty. It’s not immediately clear how much money Allele is seeking.
REGEN-COV turned in impressive sales in 2021, but Regeneron isn’t expecting an encore in 2022. That’s because an FDA ruling in January vetoed the therapy for use in patients infected with the virus’s omicron variant. The antibody cocktail ginned up $6.19 billion in sales in 2021. Thanks to the FDA’s decision, however, Regeneron has said it doesn’t expect to record any U.S. REGEN-COV sales in the first half of the year.