Federal Circuit Clarifies the On-Sale Bar Under the AIA: No Public Disclosure of the Invention Is Required if the Existence of the Sale Is Public

May 8, 2017

Reading Time : 2 min

More than one year before the filing date of the patents, Helsinn entered into a purchase agreement with a third party to distribute a chemotherapy-related drug. Certain aspects of the agreement were made public in Securities and Exchange Commission filings, but the details of the invention were redacted. Helsinn was eventually granted four patents on the chemotherapy-related drug, including one post-AIA patent (the “’219 patent”). The district court, however, held that, although there was a sale, it did not trigger the on-sale bar on the ’219 patent because § 102 under the AIA now “requires a public sale or offer for sale of the claimed invention.”1  The district court stated that, to be “public” under the AIA, the sale must publicly disclose the details of the patented invention.

The Federal Circuit disagreed and reversed the decision. First, the court recognized that there were no statements by Congress that, under the AIA, “the sale or offer documents must themselves publicly disclose the details of the claimed invention before the critical date.” Notably, even if Congress intended to overrule “secret or confidential” sales, it discussed only cases that were “concerned entirely with whether the existence of the sale or offer was public,” not whether the invention itself was publicly disclosed. The Federal Circuit held that by including “otherwise available to the public” in the AIA, Congress intended that “the public sale itself would put the patented product in the hands of the public.” Here, it was undisputed that the existence of Helsinn’s purchase agreement (i.e., the sale) was public, which the Federal Circuit found met any “public” requirement under the AIA.

Second, the Federal Circuit emphasized that “[r]equiring such a disclosure as a condition of the on-sale bar would work as a foundational change in the theory of the statutory on-sale bar.” The court cited a litany of its cases that explicitly rejected any “requirement that the details of the invention be disclosed in the terms of sale.” The court then relied on the primary purpose of the on-sale bar: “publically offering a product for sale that embodies the claimed invention that places it in the public domain, regardless of when or whether actual delivery occurs.”

Ultimately, the Federal Circuit declined to “decide this case more broadly than necessary.” Notably, the court concluded that, “after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of the sale.” The court refused to “find that distribution agreements will always be invalidating under § 102(b),” but instead found that the particular supply agreement at issue was invalidating.                    

Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., No. 2016-1284, 2016-1787 (Fed. Cir. May 1, 2017)


1 On the three pre-AIA patents, the district court held that there was a sale, but that the sale did not trigger the on-sale bar because the invention was not “ready for patenting” at the time of the sale.

Share This Insight

Previous Entries

IP Newsflash

August 29, 2025

In a recent order addressing four IPR proceedings, the PTAB exercised its inherent authority under 37 C.F.R. § 42.5(a) to sua sponte authorize post-hearing discovery on a potentially dispositive privity issue. The order followed a Director review decision that vacated and remanded earlier IPRs involving the same parties, patent family, and privity issue. 

...

Read More

IP Newsflash

August 29, 2025

The Patent Trial and Appeal Board denied institution of an inter partes review petition in part because it determined that a patent reference was not prior art under the common ownership exception of pre-AIA 35 U.S.C. § 103(c)(1).

...

Read More

IP Newsflash

August 11, 2025

In considering a motion to dismiss infringement claims for two related patents, the District of Massachusetts recently held that pre-suit knowledge of a “parent” patent, without more, is insufficient to establish pre-suit knowledge of the “child” patent for purposes of indirect and willful infringement.

...

Read More

IP Newsflash

August 8, 2025

Following a jury verdict finding trade secret misappropriation, the District Court for the District of Massachusetts granted-in-part a plaintiff’s motion for a permanent injunction to prohibit defendants from using plaintiff’s trade secrets. The district court further required defendants to reassign to plaintiff patents and patent applications that disclosed or were derived from plaintiff’s trade secrets as part of its equitable relief.

...

Read More

IP Newsflash

August 6, 2025

In ruling on a recent motion to strike, a judge in the Eastern District of Texas permitted a damages expert to rely on a damages theory based on defendant’s “avoided costs,” holding that this theory did not run afoul of the “entire market value rule.”

...

Read More

IP Newsflash

August 5, 2025

The Federal Circuit recently vacated a decision by the Patent Trial and Appeal Board after concluding that the board’s analysis of licensing evidence offered as a secondary consideration of nonobviousness constituted legal error and was not supported by substantial evidence. According to the court, the board applied a more exacting and improperly heightened nexus standard than is required by law for license evidence.

...

Read More

IP Newsflash

August 5, 2025

A Northern District of California judge recently granted a motion to reconsider his summary judgment ruling that defendant was barred from raising certain “device art” due to IPR estoppel under 35 U.S.C. § 315(e)(2). In the original ruling, the judge adopted the broader rule that IPR estoppel applies to device art that is “materially identical” to patents or printed publications that petitioners raised, or could have raised, in an IPR. Following that ruling, however, the Federal Circuit issued its Ingenico decision adopting the narrower view that IPR estoppel applies only to “grounds” based on patents and printed publications and not to device-based grounds. Citing Ingenico as a “change of law,” defendant moved for reconsideration of the court’s ruling, and the court granted the motion.

...

Read More

IP Newsflash

August 5, 2025

In a recent decision designated as Informative, the USPTO Director determined that the Patent Trial and Appeal Board abused its discretion by instituting two inter partes review proceedings challenging the same patent, based on petitions advancing different constructions of the same claim term. The Director expressed concerns that permitting multiple petitions based on alternative claim constructions effectively circumvents word count limitations, strains board resources, and undermines procedural efficiency.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.