Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc. ( REGN )‘s effort to prevent the sale of Amgen Inc ( AMGN )‘s Eylea biosimilar.
Regeneron filed a notice of its appeal to the U.S. Court of Appeals for the Federal Circuit.
The appeal is from the Order issued on September 23, 2024, which denied Regeneron’s request for a preliminary injunction, along with any related orders, decisions, rulings, findings, or conclusions connected to that Order.
Reuters highlighted that an Amgen ( AMGN ) spokesperson expressed the company’s satisfaction with the decision. Amgen ( AMGN ) will reveal the timeline for launching its biosimilar Pavblu “in due course.”
Regeneron sued Amgen ( AMGN ) in January, alleging that it was developing a biosimilar that violated key patent protections for Eylea. The lawsuit claims the infringement of over 30 patents, which the pharma claims will “irreparably” harm its business if Amgen ( AMGN ) is not “enjoined” from violating these protections.
The lawsuit also notes, “Amgen’s commercial manufacture, use, offer for sale, and/or sale within the United States, or importation into the United States, of ABP 938 before the expiration of the '106 patent will cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief.”
In October 2023, Amgen ( AMGN ) said the FDA accepted its abbreviated Biologics Drug Application for ABP 938, a biosimilar copy of Eylea.
Stat News noted that the judge’s decision came as a surprise, given that this same judge had previously approved Regeneron’s requests for injunctions against other pharmaceutical companies attempting to release Eylea biosimilars.
In December, a court ruling found that Viatris Inc’s replica of Regeneron’s Eylea violated patent rights.
Price Action: REGN stock is down 6% at $1,025.44 at last check Tuesday.
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