Sterne Kessler Secures Patent Litigation Victory for Teva in Sleep Disorder Drug Dispute

Washington, D.C. (September 29, 2026) – Sterne, Kessler, Goldstein & Fox secured a favorable ruling on behalf of Teva Pharmaceuticals in a patent infringement case brought by Vanda Pharmaceuticals involving Teva’s sleep-disorder drug tasimelteon, a generic version of Vanda’s Hetlioz.

Judge Jennifer Hall of the U.S. District Court for the District of Delaware granted Teva’s motion for summary judgment of non-infringement, finding that no reasonable juror could conclude that Teva infringes Vanda’s asserted patents, which relate to specific methods of administering tasimelteon. The court rejected Vanda’s claims against Teva of direct infringement, actively inducing infringement, and contributory infringement, all of which were based on the sale of Teva’s tasimelteon product and its accompanying drug label.

Judge Hall’s ruling marks an early indicator of how the U.S. Supreme Court’s decision in Hikma v. Amarin last term could make certain induced infringement claims predicated on a drug product’s label more susceptible to judgment as a matter of law. As the court put it, “After Hikma, no reasonable juror could find that Defendants’ labels ‘encourage, recommend, or promote’ an infringing use.”

Teva Pharmaceuticals USA, Inc., is a leading manufacturer of generic and proprietary drug products. Teva secured FDA approval to market its tasimelteon product in 2022. 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.

The Sterne Kessler team was led by director J.C. Rozendaal, chair of the firm’s Trial & Appellate Practice Group. He was joined by directors Deirdre Wells, Donald Banowit, William H. Milliken, and Brady Gleason, and counsel Sasha Rao.

To view the decision, click here.

This is the second win for Teva Pharmaceuticals against Vanda relating to its tasimelteon product. In December 2022, in a prior lawsuit filed by Vanda against Teva Pharmaceuticals, Chief Judge Colm Connolly of the U.S. District Court for the District of Delaware found all four of Vanda’s patents asserted in that case invalid as obvious. The U.S. Court of Appeals for the Federal Circuit affirmed Judge Connolly’s decision in 2023, and the Supreme Court later denied Vanda’s petition for review of that decision. For more information on that case, click here.

About Sterne, Kessler, Goldstein & Fox

Based in Washington, D.C., Sterne Kessler is a leading intellectual property law firm providing strategic IP services to clients worldwide. With more than 170 attorneys, the firm offers integrated capabilities across patent and trademark prosecution, strategic counseling, post grant proceedings, and litigation before federal district and appellate courts and the International Trade Commission. Since 1978, Sterne Kessler has served as a trusted partner to innovative companies, startups, inventors, universities, and investors, helping them protect, enforce, and maximize the value of intellectual property. The firm is committed to delivering practical, business driven solutions that support innovation and long term strategic objectives.