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

Justia Summary

Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U.S.C. 102(a)(1), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application.

The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions.