Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc., 139 S. Ct. 628

Helsinn developed palonosetron (Aloxi) and entered two agreements (license and supply) with MGI granting rights to distribute 0.25 mg and 0.75 mg doses in the U.S.; both agreements required MGI to keep proprietary information confidential.
Helsinn publicly announced the partnership and filed redacted agreements in an SEC Form 8-K, but the specific 0.25 mg dose was not disclosed publicly in those filings.
Nearly two years after the agreements, Helsinn filed a provisional patent application (Jan 30, 2003) and later (2013) obtained U.S. Patent No. 8,598,219 covering a 0.25 mg fixed dose; the ’219 patent is governed by the AIA.
Teva sought FDA approval for a generic 0.25 mg product and was sued by Helsinn for patent infringement; Teva countered that the claimed dose was invalid under the AIA’s “on sale” bar as having been sold more than one year before the provisional filing.
The district court held the AIA’s on-sale bar did not apply because the public disclosures did not reveal the claimed dose; the Federal Circuit reversed, holding that a publicly disclosed sale can trigger the on-sale bar even if sale terms do not disclose invention details.
The Supreme Court granted certiorari to resolve whether a sale to a third party obligated to maintain confidentiality can constitute an "on sale" event under 35 U.S.C. §102(a).

Issue	Helsinn's Argument	Teva's Argument	Held
Whether a sale to a third party who must keep the invention confidential can place the invention “on sale” under the AIA	The AIA’s phrase “or otherwise available to the public” means the enumerated terms (including “on sale”) should be read to require public availability; secret sales cannot trigger the on-sale bar	Pre-AIA precedent and the AIA’s reenactment of “on sale” mean a commercial sale or offer for sale can trigger the bar even if the sale was confidential	The Supreme Court held such a secret commercial sale can qualify as prior art under §102(a); affirmed the Federal Circuit
Whether Congress changed the meaning of “on sale” when it enacted the AIA by adding “or otherwise available to the public”	The added catchall limits the listed categories so that each requires public availability	The addition of the catchall was not a sufficient change to alter the established judicial meaning of “on sale”	The Court presumed Congress adopted the settled pre-AIA judicial interpretation; the catchall did not change the meaning

Pfaff v. Wells Elecs., 525 U.S. 55 (establishing two-part on-sale test: commercial offer for sale and invention ready for patenting)
Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed. Cir. 2001) (recognizing that secret sales can invalidate patents)
Woodland Trust v. Flowertree Nursery, Inc., 148 F.3d 1368 (Fed. Cir. 1998) (inventor’s secret commercial use may constitute public use or sale)
Paroline v. United States, 572 U.S. 434 (discussed by Helsinn in argument about statutory construction of associated words)
Federal Maritime Comm’n v. Seatrain Lines, Inc., 411 U.S. 726 (same as Paroline — cited on associated-words canon)
Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92 (19th-century precedent focusing on sale rather than public disclosure)