Sterne Kessler Secures Victory on Behalf of Teva Pharmaceuticals

Sterne, Kessler, Goldstein & Fox has secured a victory on behalf of Teva Pharmaceuticals in a patent-infringement lawsuit filed by Vanda Pharmaceuticals, Inc. In December 2022, Chief Judge Colm Connolly of the U.S. District Court for the District of Delaware found all four of Vanda’s asserted patents invalid as obvious. The Federal Circuit affirmed that decision in May 2023. On April 22, 2024, the U.S. Supreme Court denied Vanda’s petition for review of that decision, cementing Teva’s win.

Teva Pharmaceuticals USA, Inc. is a leading manufacturer of generic and proprietary drug products. Teva applied for FDA approval to market a generic version of Hetlioz (tasimelteon). Tasimelteon is a melatonin-receptor agonist that is indicated for the treatment of non-24 hour sleep-wake disorder, a rare circadian rhythm disorder that typically afflicts totally blind individuals. Vanda, the holder of the Hetlioz NDA, filed suit against Teva in the District of Delaware for infringement of several Orange Book-listed patents that same year. Over the course of the litigation, Vanda asserted well over 100 claims from approximately a dozen patents against Teva. The case went to trial in March 2022. The district court opinion is available here, and the Federal Circuit opinion affirming the district court’s decision is available here.

The team was led by Director J.C. Rozendaal and includes fellow Directors Byron L. Pickard, Deirdre M. Wells, and William H. Milliken and Counsel Sasha S. Rao.