“Although the denials of Juno and Biogen were certainly disappointing, practitioners and patent holders may be glad to have the Court grant certiorari on at least one half of the disclosure requirements in Section 112(a) by way of Amgen.”
It’s that time again. As 2022 has come and (almost) gone, it’s time to look back at the exciting grants and surprising denials of certiorari petitions involving patent and trademark matters by the Supreme Court of the United States, and what to look forward to from the Court in 2023.
In 2022 the Supreme Court docket was relatively light on intellectual property matters. After numerous denials of some highly anticipated patent and trademark cases, the Court kept us in suspense by granting certiorari in new cases in November 2022.
The Court granted the certiorari petition in Amgen, Inc., Petitioner, v. Sanofi on November 4, 2022. The question granted for the Court’s review is “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort’.” The technology at issue involves a pair of patents directed to an isolated monoclonal antibody owned by Amgen. The Federal Circuit found the language in the claims lacked enablement (e.g., claim 1 recites: “An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: …, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.”). The Federal Circuit’s reasoning was that enablement for claims that recite functional limitations requires the consideration of the amount of experimentation required to make and use the full scope of the claimed invention.
The Solicitor General briefed the government’s position to the Court, recommending that the Court not grant certiorari in this case. Surprising many, the Court opted to grant the petition despite the Solicitor General’s recommendation. Ultimately, the Court will need to strike a balance between giving patent holders the flexibility in their claim language to avoid minor modifications by a potential infringer, while also not giving the patent holder broad claim scope that would impede future innovation.
The Court also granted certiorari in Abitron Austria GmbH, Petitioner, v. Hetronic International, Inc. on November 4, 2022. The question presented to the Court is whether the court of appeals erred in applying the Lanham Act extraterritorially to Abitron’s foreign sales, in foreign countries, by foreign sellers, to foreign customers, for use in foreign countries that never reached the U.S. or confused U.S. consumers. At the circuit court level, the Lanham Act was held to apply extraterritorially whenever a foreign defendants’ conduct abroad effectively diverts foreign sales from a U.S. plaintiff, based on the rationale that reducing foreign sales and revenue affects U.S. commerce. Notably, the Solicitor General’s brief encouraged the Court to grant certiorari of this petition.
Jack Daniel’s petition for certiorari was also granted in Jack Daniel’s Properties, Inc., Petitioner, v. VIP Products LLC, on November 21, 2022. VIP Products sells dog toys that resemble the square-shape of a Jack Daniels Old No. 7 whiskey bottle; however, instead of “Jack Daniels” the bottle-shaped dog toy reads “Bad Spaniels”. The lower court found that VIP’s dog toys would likely confuse consumers, infringed Jack Daniel’s marks, and tarnished Jack Daniel’s reputation. This was reversed at the circuit court, which held that VIP had a First Amendment interest in using the Jack Daniel’s marks on their dog toys, and rendered the dog toy products “noncommercial” and exempt from dilution-by-tarnishment claims. The Court granted Jack Daniel’s certiorari petition on two questions: (1) Whether humorous use of another’s trademark as one’s own on a commercial product is subject to the Lanham Act’s traditional likelihood-of-confusion analysis, or instead receives heightened First Amendment protection from trademark-infringement claims; and (2) Whether humorous use of another’s mark as one’s own on a commercial product is “noncommercial” under 15 U.S.C. § 1125(c)(3)(C), thus barring as a matter of law a claim of dilution by tarnishment under the Trademark Dilution Revision Act.
Although this year was filled with numerous requests for Supreme Court review of challenging issues facing intellectual property, as usual, the Court met those requests with denials of certiorari. Perhaps the biggest letdown of the year was the denial of review in American Axle & Manufacturing, Inc., Petitioner v. Neapco Holdings LLC, et al. on June 30, 2022. This case was the latest in a long line of attempts to have the Court reframe patent eligibility under 35 U.S.C. § 101. Even the Solicitor General recommended granting the petition at least regarding the question of whether claiming a process for manufacturing an automobile driveshaft that simultaneously reduces two types of driveshaft vibration is patent-eligible under 35 U.S.C. § 101. Unfortunately for many holding out hope that the Court would provide clarity on subject matter eligibility, the Court went against the Solicitor General’s recommendation and denied certiorari.
Another surprising denial was Juno Therapeutics, Inc., et al., v. Kite Pharma, Inc. on November 7, 2022. The central issue in Juno was whether the written description requirement under 35 U.S.C. § 112(a) requires an inventor to demonstrate possession of the full scope of the claimed invention, including all “known and unknown” variations of each component of the invention. The subject matter of the patent is single-chain antibody variable fragments, which is a technology area jammed with issues of enablement and written description. Juno particularly highlights the issues with attempts to claim antibody binding elements based on their functional properties, rather than by their structural features.
However, Juno did not stop there. Juno filed a request for rehearing on November 23, 2022, requesting that the Court grant rehearing of its order denying the petition for certiorari, vacate that order, and hold their case in abeyance pending the resolution of Amgen because the questions in both cases arise from the same statutory limitation in Section 112(a).
A challenge to Section 112(a) was also the main question in Biogen International GmbH, et al., v. Mylan Pharmaceuticals Inc., in which certiorari was denied earlier this year. However, in Biogen the main issue focused on written description, and whether the requirement for written description is satisfied when “specification describes the invention, or must the specification also disclose data that demonstrates the claimed invention is ‘effective’ and emphasize the claimed invention by singling it out and describing it more than once.” Thus, Biogen was distinguished from Amgen and Juno in questioning different aspects of Section 112(a).
Although the denials of Juno and Biogen were certainly disappointing, practitioners and patent holders may be glad to have the Court grant certiorari on at least one half of the disclosure requirements in Section 112(a) by way of Amgen.
Looking Forward to 2023
The Court has requested the comments of the Solicitor General in several pending petitions, including Teva Pharmaceuticals USA, Inc., v. GlaxoSmithKline LLC, et al.; Interactive Wearables, LLC, v. Polar Electro Oy, et al.;and Tropp v. Travel Sentry, Inc.
Notably, the Solicitor General will be briefing the Court in Teva on the government’s stance on the use of section VIII statements accompanying an Abbreviated New Drug Application (known as a “skinny label”) as a way to avoid infringement of a method patent. The decision for GSK by the Federal Circuit has already had rippling effects. Prior to this decision, drug product marketed under a skinny label would be found to not infringe a patented treatment method exempted from the label. In this case GSK, which owns Coreg (carvedilol), sued Teva for their marketing of a generic version of carvedilol under a “skinny label” listing hypertension and left ventricular dysfunction following myocardial infarction (post-MI LVD) as indications. The Orange Book listing for Coreg included “decreasing mortality caused by congestive heart failure”. GSK successfully argued that Teva’s inclusion of treating post-MI LVD on their “skinny label” would induce infringement their claims to, “a method of decreasing mortality caused by congestive heart failure” based on expert testimony that congestive heart failure and post-MI LVD are “intertwined”. The purpose of the skinny label is to provide an avenue for more timely entrance of generic drugs to the market. The future of the skinny label hangs in the balance while the Court awaits the Solicitor General’s comments.
Lastly, another interesting case that will likely seek review of the Court is Novartis Pharmaceuticals Corporation v. HEC Pharm Co., LTD. In this case, the Federal Circuit reversed its previous ruling for Novartis, now finding that Novartis’s Gilenya patents lacked written description support for a negative limitation in the claims. This was also a procedurally unique case because panel of the earlier January 2022 decision consisted of Judge O’Malley (writing for the majority), Judge Linn, and Chief Judge Moore (dissenting). Upon Judge O’Malley’s subsequent retirement and replacement on the panel by Judge Hughes, HEC requested a rehearing. Judge Hughes agreed with Chief Judge Moore to order a rehearing, which resulted in a reversal with Chief Judge Moore now writing the majority opinion with Judge Linn as the dissent.
Novartis filed a request for a stay of the Federal Circuit decision while their certiorari petition was being prepared. The Court granted a temporary stay, but ultimately the request for a stay was denied on October 13, 2022. It is likely that Novartis will file a certiorari petition requesting review of the unusual Federal Circuit decision in early 2023.
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