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

Following up on Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., from our firm Fall 2018 Newsletter article, on June 22, 2019, the U.S. Supreme Court unanimously affirmed the judgment of the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”). In doing so, the Supreme Court held that a commercial sale to a third party who is required to keep the invention confidential, may bar an invention from being patentable under 35 U.S.C. § 102 (“§ 102”).

            With Justice Clarence Thomas writing the majority opinion for this case, the Supreme Court first determined the scope of the on-sale bar prior to the 2011 America Invents Act (“AIA”). Relying on its decision in Pfaff v. Wells Electronics, Inc.(“Pfaff”), the Supreme Court noted that pre-AIA, a commercial sale of an invention that was ready for patenting made more than one year prior to the filing date of the U.S. patent application, was subject to the on-sale bar of § 102.  After taking notice of the scope of the pre-AIA”™s on-sale bar, the Supreme Court next determined whether the changes to § 102 under AIA altered the meaning of the on-sale bar.

            In regard to the statutory language, the Supreme Court noted the majority of the AIA”™s on-sale bar language was identical to that of its predecessor”™s. In light of Congress”™ recycled use of the pre-AIA language, the Supreme Court reasoned that Congress had adopted the judicial construction set forth in Pfaff. Subsequently, the Supreme Court analyzed whether the addition of the catchall clause, “or otherwise available to the public,” was sufficient evidence that Congress intended to alter the meaning of the term “on sale.”

            Specifically, the Supreme Court discussed whether the catchall phrase limited the on-sale bar to the type of disclosures that reveal the claimed invention to the public. The Supreme Court concluded that the catchall phrase was added to § 102 to “capture material that does not fit into the statute”™s enumerated categories but is nevertheless meant to be covered.” Furthermore, the Supreme Court declined to adopt a broad interpretation of the catchall phrase because the phrase “on sale” had acquired a well-settled meaning when the AIA was enacted and the adoption of such interpretation would upset that precedent.

            Ultimately, the Supreme Court”™s decision upheld roughly two decades of precedent that any commercial sale of an invention, prior to issuance of a patent, may place an invention “on sale,” within the meaning of § 102. Accordingly, the Supreme Court demonstrated its reluctance to change a well-settled judicial interpretation of a statute without clear evidence that Congress intended to change the meaning of that statute.