federal-circuit
Supreme Court Issues Decision in Helsinn v. Teva
Michelle NyeinMichael J. PomianekMichael J. Pomianek
Introduction
On January 22, 2019, the Supreme Court issued a decision in Helsinn Healthcare S.A. et al. v. Teva Pharmaceuticals USA, Inc., No. 17-1229. The Supreme Court unanimously held that the America Invents Act (AIA) on-sale bar, like the pre-AIA on-sale bar, extends to “secret sales.”
Background
Under pre-AIA law, a sale or offer for sale of an invention—including an inventor’s “secret” sales to a third party that is required to keep the invention confidential—could act as a bar to patentability. The AIA retained the pre-AIA “on sale” terminology but added the catch-all phrase “or otherwise available to the public.” The US Patent and Trademark Office (USPTO) subsequently issued guidelines explaining that the AIA on-sale bar does not cover “secret sales” and explained that activities are “secret” if they are among individuals having an obligation of confidentiality to the inventor. The district court that decided the Helsinn case initially applied the USPTO interpretation, holding that Helsinn’s pre-critical-date sale, which was under an agreement of confidentiality, did not trigger the AIA on-sale bar. In May 2017, however, the Federal Circuit reversed the district court decision, holding that “secret sales”—at least those sales in which the existence of the sale is public but the details of the invention are kept confidential—can trigger the AIA on-sale bar.
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