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Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.
United States Supreme Court
139 S. Ct. 628 (2019)
Helsinn Healthcare S.A. (plaintiff) makes Aloxi, a drug for chemotherapy nausea made from palonosetron. During clinical trials of .25 and .75 mg dosages, Helsinn contracted with a U.S. company to license and market any FDA-approved palonosetron product in the U.S. The contracts included dosage information but required confidentiality. Helsinn filed a provisional patent for those two dosages, followed by four applications claiming priority. The fourth, filed in 2013, covered a dose of .25 mg. Meanwhile, in 2011, Teva Pharmaceuticals USA, Inc. (defendant), sought FDA approval to market a generic equivalent of the .25 mg dose. When Helsinn sued Teva for patent infringement, Teva countered that Helsinn’s patent was not valid because the .25 mg dose was on sale more than a year before Helsinn filed its provisional application. The trial court ruled that the on-sale bar of the Leahy-Smith America Invents Act (AIA) did not apply because Helsinn’s supply and marketing agreements did not make the .25 mg dose available to the public, instead keeping it confidential. The Federal Circuit reversed, reasoning that public disclosure of the sale sufficed to apply the on-sale bar, even though the details of the dosage were kept confidential. The United States Supreme Court granted review.
Rule of Law
Holding and Reasoning (Thomas, J.)
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