Appeals court lifts injunction on Praluent

Regeneron is challenging both the injunction ruling and the validity of the appeal process.
Regeneron is challenging both the injunction ruling and the validity of the appeal process. | File photo
The U.S. Court of Appeals for the Federal Circuit suspended a permanent injunction on Praluent, a cholesterol management drug, pending Sanofi and Regeneron Pharmaceuticals’ appeal. This ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the U.S. during the appeal process.
“The decision is important for patients in the U.S. who will continue to have access to Praluent during the appeals process, giving them a choice (of) treatment that best meet their individual needs,” Karen Linehan, executive vice president of Regeneron’s partner Sanofi, said.
Regeneron’s rival, Amgen, claims to have patented the drug which resulted in a lawsuit. A judge ruled for a permanent injunction to which Regeneron and Sanofi appealed in court. The companies are challenging both the injunction ruling and the validity of the appeal process.
“It is our longstanding position that Amgen’s asserted patent claims are invalid and we look forward to the appeal process,” said Joseph LaRosa, senior vice president and general counsel at Regeneron, said. "We continue to believe the facts and controlling law support our position in the case “We will continue to vigorously defend our case through the appeal process.”
The suspension is only for the U.S. market, and no outside clinical trials are in the works.
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