Sanofi et al. v. Glenmark Pharmaceuticals, Inc. USA et al.

Sanofi et al. v. Glenmark Pharmaceuticals, Inc. USA et al.

(D. Del. 2016)

Fitzpatrick Successfully Defends Patents Related to Sanofi’s Multaq® Product

On August 31, 2016, Judge Richard G. Andrews of the District of Delaware ruled in favor of Fitzpatrick’s client Sanofi, upholding the validity of U.S. Patent No. 8,410,167.  The ‘167 patent is directed to the use of Sanofi’s Multaq® product to reduce the risk that certain patients with atrial fibrillation will need to be hospitalized.

Judge Andrews rejected the arguments advanced by several generic pharmaceutical company Defendants that the claims of the ‘167 patent were obvious.  Fitzpatrick successfully established that a person of ordinary skill in the art would not have had a reasonable expectation that dronedarone (the active ingredient in Sanofi’s Multaq® product) would reduce the risk of cardiovascular hospitalization in the types of patients included in Sanofi’s ATHENA clinical study.  Judge Andrews also rejected arguments that certain disclosures relating to the ATHENA clinical study constituted an invalidating public use.

Judge Andrews further found that the product labels that would be included with the Defendants’ proposed generic dronedarone products would encourage physicians to practice the methods of all but one of the asserted claims of the ‘167 patent and would thus inevitably lead to infringing uses.

Also, upon reconsideration, Judge Andrews construed the claims of U.S. Patent No. 8,318,800 covering solid pharmaceutical formulations of the active ingredient in Multaq® in Sanofi’s favor.  The Defendants 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 of the issue of infringement.       

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