The US Supreme Court granted certiorari to consider the question of whether, under the America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention. Helsinn Healthcare v. Teva Pharmaceuticals, Case No. 17-1229 (Supr. Ct. June 25, 2018). The question presented is:

Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.

Helsinn is the owner of the four patents-in-suit directed to intravenous formulations of palonosetron for reducing or reducing the likelihood of chemotherapy-induced nausea and vomiting. Helsinn filed suit against Teva alleging that the filing of Teva’s Abbreviated New Drug Application constituted an infringement of various claims of those patents. Teva defended against the suit, arguing the asserted claims were invalid under the on-sale bar provision of 35 U.S.C. § 102 based the sale of patent products under a confidentiality agreement. The district court found that the patents-in-suit were not invalid. With respect to three of the patents, which are governed by the pre-America Invents Act version of § 102, the district court concluded that there was a commercial offer for sale before the critical date, but that the invention was not ready for patenting before the critical date. With respect to the fourth patent, which is governed by the AIA version of § 102, the district court concluded that there was no commercial offer for sale because the AIA changed the relevant standard and that, in any event, the invention was not ready for patenting before the critical date.

The Federal Circuit reversed the district court, finding asserted claims of the patents-in-suit were subject to an invalidating contract for sale prior to the critical date of January 30, 2002, and the AIA did not change the statutory meaning of “on sale” in the circumstances involved. The Court also found that the asserted claims were also ready for patenting prior to the critical date. Helsinn appealed to the Supreme Court.