[17-1229] Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. Justia (with opinion) · Docket · oyez.org Argued on Dec 4, 2018. Decided on Jan 22, 2019. Petitioner: Helsinn Healthcare S.A.. Respondent: Teva Pharmaceuticals USA, Inc., et al.. Advocates: Kannon K. Shanmugam (for the petitioner) Malcolm L. Stewart (Deputy Solicitor General, Department of Justice, for the United States as amicus curiae, supporting the petitioner) William M. Jay (for the respondents) Facts of the case (from oyez.org) Helsinn owns four patents describing intravenous formulations of palonosetron for reducing the likelihood of chemotherapy-induced nausea and vomiting (“CINV”). All four claim priority to a provisional patent application filed on January 30, 2003. The critical date for the on-sale bar is one year earlier, January 30, 2002, which means the sale of the invention before that date can invalidate the patent. In its defense, Teva argued that the asserted claims were invalid under the on-sale bar provision of 35 U.S.C. § 102. The sale referenced by Teva in its defense was an exclusive supply and purchase agreement between Helsinn and MGI Pharma. Everything about the agreement except the terms and price was publicly disclosed. The district court upheld as valid Helsinn’s patents and rejected Teva’s “on sale” defense. The Federal Circuit reversed, finding that the patents were subject to an invalidating contract for sale prior to the critical date of January 30, 2002, The court also noted that the evidence that the formulation was ready for patenting before the critical date was “overwhelming.” Question Does an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential qualify as prior art for purposes of determining the patentability of the invention? Conclusion An inventor’s sale to a third party who is obligated to keep the invention confidential constitutes invalidating prior art. Justice Clarence Thomas authored the opinion for a unanimous (9–0) Court. The patent statute in force immediately before the America Invents Act (AIA) contained an “on-sale bar” which invalidated patents that had been on sale. Applying the presumption that when Congress reenacts the same language, it adopts the earlier judicial construction of the phrase, the Court found that the AIA consequently prohibits patents that had previously been on sale. Therefore, the commercial sale to a third party who is required to keep the invention confidential falls within the on-sale bar of the AIA and invalidates the patent.