Bial - Portela & CA S.A., et al. v. Torrent Pharmaceuticals Ltd., et al.

A judge in the US District Court for the District of Delaware ruled in favor of Analysis Group client Bial-Portela and its parent company on two key aspects of Bial’s patent infringement action against Torrent Pharmaceuticals and other manufacturers of generic eslicarbazepine acetate tablets. The defendants filed abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA), seeking to market generic versions of Aptiom®, Bial’s anticonvulsive drug therapy, which is used in the treatment of partial-onset seizures.

On behalf of the plaintiff, the law firm Finnegan, Henderson, Farabow, Garrett & Dunner retained Analysis Group to evaluate the commercial success of Bial’s patents, including whether there is a causal relationship (or “nexus”) between the invention claimed in the patents and the marketplace success of Aptiom. An Analysis Group team led by Vice President Yao Lu worked with Managing Principal John C. Jarosz, who testified at deposition and trial on the success of Bial’s product by comparing its market share to that of Bial’s competitors. Mr. Jarosz further opined that patent inventions, including once-daily dosing, were a driver of the marketplace success of Aptiom, in part by citing physicians who identified convenient dosing as a leading reason they chose to prescribe the drug to patients over competing products.

Citing Mr. Jarosz's testimony, the Honorable Colm F. Connolly concluded that Bial had demonstrated the commercial success of several of the Bial patents. The Court also found that the defendants had failed to prove, by clear and convincing evidence, that the asserted claims of Bial’s patents were invalid as obvious and that Bial’s marketing spend was not solely responsible for Aptiom's success.