Jay Mitra Quoted in Law360, BioWorld, and IPWatchdog on U.S. Supreme Court’s Hikma Decision

Jay Mitra was quoted in Law360, BioWorld, and IPWatchdog regarding the U.S. Supreme Court’s unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. The court ruled in favor of generic drug manufacturers on the issue of “skinny labeling,” significantly raising the bar for pursuing induced patent infringement claims against them.

“Hikma has implications outside the world of Hatch-Waxman litigation. The Court rejected both Amarin’s argument that pleading the sheer possibility of induced infringement was sufficient at the motion to dismiss stage, as well as Hikma’s contention that active inducement had to be ‘express.’ Rather, the Court focused on the absence of ‘affirmative’ statements or actions by the alleged infringer, not ‘mere omissions, inactions, or non-feasance.’ Hikma does not fully close the door to induced infringement, including in the context of skinny labels, but it narrows the pathway for patentees to meet the pleading standards,” Mitra said.

 Read the articles: Law360, BioWorld, IPWatchdog. Subscription may be required.

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