After Two Jury Verdicts, Court Finds Repatha Patents Invalid
Delaware district court rules patent claims for antibodies targeting PCSK9 are invalid for lack of enablement; saga to continue with Amgen appeal.
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Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.
A court in Dusseldorf ruled that Praluent infringes a patent for Amgen's better-selling PCSK9 inhibitor Repatha, saying that Sanofi and Regeneron must stop selling their biologic in Germany. It's unclear whether there will be any readthrough to ongoing patent disputes in other countries.
ODYSSEY Outcomes data added to US label for Praluent; update includes claim for reduced cardiovascular incident risk and trial data indicating an all-cause mortality benefit.