Sanofi et al. v. Watson Labs. Inc., Sandoz Inc.

Sanofi et al. v. Watson Labs. Inc., Sandoz Inc.

(Fed. Cir. 2017)

Fitzpatrick Successfully Obtains Federal Circuit Affirmance for Client Sanofi in Multaq® Patent Dispute

On November 9, 2017, the Court of Appeals for the Federal Circuit affirmed a victory on behalf of Fitzpatrick’s client Sanofi against Watson and Sandoz in a Hatch-Waxman patent lawsuit concerning Sanofi’s Multaq® product.

The Federal Circuit panel, composed of Chief Judge Prost and Judges Taranto and Wallach, agreed with Sanofi that U.S. District Court Judge Richard G. Andrews did not clearly err in upholding the validity of U.S. Patent No. 8,410,167.  The panel unanimously rejected Watson and Sandoz’s argument that Judge Andrews applied an improper standard when assessing the validity of the ’167 patent claims, which are directed to the use of Sanofi’s Multaq® product to reduce the risk that certain patients with atrial fibrillation will need to be hospitalized.

The Federal Circuit also affirmed Judge Andrew’s holding that Watson and Sandoz intended to encourage infringement of the ’167 patent claims through the product labels that would be included with their generic products if those products were marketed.  The panel concluded that “[t]he evidence in this case supports the finding of intentional encouragement of infringing use and, therefore, of inducement.”

In addition, the Federal Circuit affirmed Judge Andrew’s claim construction of U.S. Patent No. 8,318,800 in Sanofi’s favor.  Watson and Sandoz stipulated to the validity of the claims of the ’800 patent the week before trial and the parties agreed that Sanofi’s proposed construction was dispositive on the issue of infringement.

The Fitzpatrick team was led by partners William Solander and Daniel Minion, with associates James Tyminski, Zachary Garrett and Anna Dwyer.