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

November 5, 2024

The Federal Circuit vacated a district court’s fee award because the district court considered certain information that was not relevant to the question of whether plaintiff’s case was exceptional. Specifically, the Federal Circuit held that only those “red flags” that related to the successful Section 101 defense, which served as the basis for the district court’s grant of summary judgment, could be used to show the case was fatally flawed.   

...

Read More

IP Newsflash

November 1, 2024

The Federal Circuit’s decision in Kyocera Senco Industrial Tools Inc. v. International Trade Commission articulated a bright-line test for patent expert admissibility: to testify from the perspective of a “person of ordinary skill in the art” (POSITA), the expert must at least meet the definition of a POSITA for the patents-in-suit. Absent that level of skill, Kyocera holds that the witness’s testimony is not sufficiently reliable or relevant enough to be relied on by a fact-finder.

...

Read More

IP Newsflash

October 29, 2024

The PTAB denied a petitioner’s motion to compel routine discovery that sought information from a parallel ITC investigation for alleged inconsistent positions taken by patent owner in the IPR. The board found that patent owner had not taken inconsistent positions but warned patent owner that it had an ongoing duty to produce any information inconsistent with arguments made during the present IPR, even if that information related to arguments patent owner had dropped at the ITC.

...

Read More

IP Newsflash

October 11, 2024

The Central District of California ruled that the heightened pleading standard of Federal Rule of Civil Procedure 9(b) applies to all three prongs of a false patent marking claim, including the third prong, competitive injury. In doing so, took a clear stand on an issue with a nationwide split among district courts.

...

Read More

IP Newsflash

October 10, 2024

In a patent case containing a variety of federal and state law claims, the District of Massachusetts retained supplemental jurisdiction over the state law claims even after all the federal law claims were dismissed.

...

Read More

IP Newsflash

October 3, 2024

The Federal Circuit recently upheld the USPTO’s authority under the estoppel provision 37 C.F.R. § 42.73(d)(3)(i) to prohibit a patent owner from obtaining patent claims that are not patentably distinct from claims previously declared unpatentable in inter partes review (IPR) proceedings. However, the court clarified that the regulation applies only to new claims or amended claims, not previously issued claims.

...

Read More

IP Newsflash

September 27, 2024

In Kyocera Senco Industrial Tools Inc. v. International Trade Commission, the Federal Circuit held that an expert must meet the definition of a “person of ordinary skill in the art” of the asserted patents in order to opine on infringement, among other issues. This new bright-line test and the underlying rationale, however, raised several new questions regarding expert admissibility. SeeFederal Circuit: Narrow Definition of Skill in the Art Dooms Expert’s Testimony” and “Grappling With A Bright-Line Patent Expert Admissibility Test.” The Federal Circuit recently addressed one of those questions, namely whether an expert must have acquired the requisite level of skill as of the time of the invention or whether it is sufficient for an expert to acquire that knowledge at a later date.

...

Read More

IP Newsflash

September 23, 2024

The Director of the USPTO initiated sua sponte review of a PTAB panel’s decision to impose sanctions based on patentee’s conduct during IPR proceedings. The PTAB cancelled all of patentee’s claims, including those not unpatentable on the merits, after finding that patentee deliberately withheld data relevant to the patentability of the claims at issue. In her review, the Director addressed which regulations are implicated upon a party’s misconduct during AIA proceedings and addressed whether entry of judgment in the trial was an appropriate sanction.

...

Read More

© 2024 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.