Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.

Helsinn Healthcare S.A. (the plaintiff) produces a drug for chemotherapy nausea under the name Aloxi. Aloxi is made from palonosetron. During clinical trials, the plaintiff contracted with a U.S. company to license and market any FDA-approved palonosetron product in the U.S. The contract included dosage information, but required confidentiality. Subsequently, the plaintiff filed a provisional patent for Aloxi, followed by four applications claiming priority.

Teva Pharmaceuticals USA, Inc. (the defendant), sought FDA approval to market a generic equivalent of Aloxi. The plaintiff sued for patent infringement. The defendant responded, arguing that the plaintiff’s patent was invalid because Aloxi was “on sale” for more than a year before the date of the plaintiff’s filing of its provisional patent application.

The trial court held that the on-sale bar of the America Invents Act (AIA) did not apply because the plaintiff’s supply and marketing agreements did not make Aloxi available to the public because the contract kept it confidential. The Federal Circuit reversed, reasoning that public disclosure of the sale was sufficient to trigger the on-sale bar, even though the details of the dosage of Aloxi were kept confidential. The United States Supreme Court granted review.