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

855 F.3d 1356 (2017)

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

United States Court of Appeals for the Federal Circuit

855 F.3d 1356 (2017)

Facts

Almost two years before applying for a patent covering .25 mg doses of palonosetron for intravenous treatment of chemotherapy symptoms, Helsinn Healthcare S.A. (Helsinn) (plaintiff) entered agreements to license and supply a product embodying the invention in exchange for exclusivity, an $11 million dollar initial payment, and future royalties. The agreements were contingent on successful clinical trials and FDA approval but were binding the date they were entered. The agreements were announced in a joint press release and publicly filed with the price and dosage redacted, before either condition was met. Helsinn completed clinical trials in 2002 but did not file a provisional patent application covering it until January 2003. After receiving FDA approval, Helsinn filed applications that issued as the patents, three before enactment of the America Invents Act (AIA) and one after. In 2011, Teva Pharmaceuticals USA, Inc. (Teva) (defendant) filed a new-drug application for a generic version of Helsinn’s drug, and Helsinn sued alleging patent infringement. The district court found one of Helsinn’s agreements constituted a commercial sale or offer under the pre-AIA on-sale bar provision but not one under the AIA version because details of the invention were redacted when the agreement was disclosed. The court ultimately concluded neither version barred patentability because the product Helsinn offered for sale was not ready for patenting. Therefore, the patents were not invalid and infringed. Helsinn appealed.

Rule of Law

Issue

Holding and Reasoning (Dyk, J.)

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