Supreme Court to Review CAFC's Induced Infringement Ruling in Hikma v. Amarin

"On Friday, the U.S. Supreme Court granted certiorari to a petition filed by patent owner Hikma Pharmaceuticals, taking up Hikma's appeal of the U.S. Court of Appeals for the Federal Circuit's ruling from June 2024 finding that Amarin Pharma plausibly alleged patent infringement against Hikma's generic omega-3 fatty acid product. The decision indicates that the nation's highest court may be willing to overturn the Federal Circuit's finding that Hikma's U.S. Food & Drug Administration (FDA) -approved skinny label induced infringement in light of Hikma's public statements about its generic product."

"Hikma Pharmaceuticals filed a petition for writ last February presenting two questions: whether a drugmaker calling its product a "generic version" while citing public sales information about the branded drug induces infringement of a patented use fully carved out by the generic's label; and whether a complaint states an induced infringement claim if it doesn't allege any instruction or statement by the defendant mentioning the patented use. Last June, the Supreme Court invited the U.S. Solicitor General to file a brief reflecting the views of the U.S. government in the case."

Supreme Court granted certiorari in a dispute over whether public statements and marketing describing a product as a "generic version" can induce infringement of a patented, carved-out use despite an FDA-approved skinny label permitting noninfringing prescriptions. The Federal Circuit previously found Amarin plausibly alleged induced infringement based on Hikma's public statements about its generic omega-3 product. Hikma framed two questions about whether citing branded sales data and calling a product generic can constitute inducement and whether a complaint must allege explicit defendant instructions referencing the patented use. Hikma argues active inducement under 35 U.S.C. §271(b) requires intent to induce all claim steps and that passive statements cannot satisfy that standard.

Read at IPWatchdog.com | Patents & Intellectual Property Law