US Appeals Court orders new trial in patent infringement issue relating to Praluent (alirocumab)- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc.announced that the U.S. Court of Appeals for the Federal Circuit has ordered a new trial and vacated the permanent injunction in the dispute concerning Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). This ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent (alirocumab) injection in the U.S.

In the decision, the Federal Circuit ruled that the trial court erred by (1) excluding evidence regarding written description; (2) excluding evidence on enablement; (3) improperly instructing the jury on written description, holding that the law requires “a written description of the invention”, meaning the claimed antibody itself and not the antigen; and (4) improperly granting a permanent injunction. The Federal Circuit affirmed the trial court’s ruling that Amgen’s patents were non-obvious, which was one of Sanofi and Regeneron’s several challenges to validity of Amgen’s patents. Because of the improper exclusion of evidence, the court considered the record to be incomplete and concluded at this time that Sanofi and Regeneron are not entitled to judgment as a matter of law (JMOL) on the issues of written description and enablement. The schedule for the new trial has not yet been determined. The companies do not anticipate any new trial proceedings to start in 2017.