Key U.S. Supreme Court Developments in 2022 and Outlook for 2023

“Even if denied Juno When biogen Admittedly disappointing, but practitioners and patent holders may be happy with the court’s permission Ruling For at least half of the disclosure requirements of Section 112(a), Amgen

supreme courtIt’s that time again. Now that 2022 is (almost) gone, it’s time to look back at the exciting grants and surprising rejections. Ruling U.S. Supreme Court petitions involving patent and trademark issues, and what to expect from the Supreme Court in 2023.

exciting grant

The 2022 Supreme Court minutes were relatively light on intellectual property issues. After repeatedly dismissing several long-awaited patent and trademark lawsuits, the court Ruling In a new case in November 2022.

The court Ruling petition in Amgen, Complainant, v. Sanofi November 4, 2022. Court review acknowledged the question “whether enablement is governed by the statutory requirement that the specification teaches one skilled in the art to ‘make and use’ the claimed invention, 35 USC §112. , or alternatively, should allow one skilled in the art to “reach the full scope of the claimed embodiments” without undue experimentation. In other words, it is possible to cumulatively identify and create all or nearly all embodiments of an invention without expending substantial “time and effort.” The technology in question includes two patents directed to isolated monoclonal antibodies owned by Amgen. The Federal Circuit found that the claim language lacked enablement (for exampleClaim 1 of the The Federal Circuit’s reasoning was that the practice of claims that recite functional limitations should take into account the amount of experimentation required to make and use the full scope of the claimed invention.

The Secretary-General explained the government’s position to the court and recommended that the court not allow it. Ruling in this case. To the surprise of many, the court chose to grant the petition despite the Attorney General’s recommendation. Ultimately, the courts decided to give patent owners flexibility in the wording of their claims to avoid minor modifications by potential infringers, and to allow patent owners more flexibility in terms of claims that could hinder future innovation. A balance must be struck between not giving broad claim coverage.

the court also acknowledged Ruling of Abitron Austria GmbH, claimant, v. Hetronic International, Inc. November 4, 2022. The issue before the court was that the Court of Appeals had applied the Lanham Act outside the territory of Abitron’s foreign sales, foreign sales, and foreign sales by foreign sellers to foreign customers. It is whether or not there was an error in the use in a foreign country that did not. US or Confused US Consumers. At the circuit court level, the Lanham Act ruled that a defendant’s foreign conduct overseas would affect U.S. commerce by reducing foreign sales and income. Notably, the Secretary General’s Opinion encouraged the Court to allow: Ruling of this petition.

Jack Daniel’s petition Ruling also granted to Jack Daniel’s Properties, Inc., Complainant, v. VIP Products LLC, 21 November 2022. VIP Products sells dog toys that resemble Jack Daniels Old No. 7 whiskey bottle squares. However, instead of “Jack Daniels,” the bottle-shaped dog toy says “Bad Spaniel.” A lower court ruled that VIP’s dog toys were likely to confuse consumers, infringe Jack Daniel’s trademark, and damage Jack Daniel’s reputation.This was overturned in the Circuit Court, and VIP has First Amendment benefits in using the Jack Daniel’s mark on dog toys, declaring dog toy products “non-commercial” and claiming dilution due to discoloration. The court ruled that Jack Daniel’s Ruling Petition to two questions: (1) Humorous use of another’s trademark as one’s own on a product is subject to the traditional likelihood of confusion analysis of the Lanham Act, or alternatively, Whether you get enhanced First Amendment protection from claims of infringement. (2) Whether the humorous use of another’s mark as one’s own in a commercial product is “noncommercial” under 15 USC § 1125(c)(3)(C). Trademark Dilution Reform Act.

surprising denial

This year has been filled with numerous requests for the Supreme Court to review difficult issues facing intellectual property, but as usual, the Court has responded to those requests and denied: . RulingPerhaps the biggest disappointment of the year was the American Axle & Manufacturing, Inc., Complainant v. Neapco Holdings LLC, etc.The lawsuit was the latest in a lengthy attempt to get the courts to restructure patent eligibility under 35 USC § 101. Even the Attorney General recommended granting the petition, at least on the question of whether it claims manufacturing processes. An automotive driveshaft that simultaneously reduces two types of driveshaft vibration is patent eligible under 35 USC § 101. Unfortunately for many who hoped the court would clarify the subject’s eligibility, the court opposed and dismissed the general secretary’s recommendation. Ruling.

Another surprising denial is that Juno Therapeutics, Inc., et al. vs. Juno Therapeutics, Inc., et al. November 7, 2022. Juno The written description requirement under 35 USC § 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. It was whether to request to do. The subject of this patent is variable fragments of single chain antibodies, an area of ​​technology fraught with issues of enablement and written description. Juno In particular, it highlights the problems of attempting to claim antibody-binding elements based on functional properties rather than structural features.

But Juno didn’t stop there. Juno filed a request for rehearing on November 23, 2022, requesting that the court allow a rehearing of the order dismissing the petition. Rulingvacate the order and suspend the action pending resolution Amgen Both cases arise from the same statutory limitation of Section 112(a).

Challenges to Section 112(a) were also a major issue. Biogen International GmbH, et al., v. Mylan Pharmaceuticals Inc.among them Ruling It was denied earlier this year. however, biogen The main issue focused on the written description: “If the specification describes the invention, is the written description requirement met, or does the specification determine whether the claimed invention is ‘valid’?” Must I emphasize it by disclosing data demonstrating something and emphasizing the claimed invention? I will explain it again and again. therefore, Biogen distinguished from Amgen When Juno It calls into question various aspects of Section 112(a).

despite the denial of Juno When Biogen Admittedly disappointing, but practitioners and patent holders may be happy with the court’s permission Ruling For at least half of the disclosure requirements of Section 112(a), Amgen.

Toward 2023

The Court has sought the general secretary’s comments on several pending petitions, including: Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, et al..; Interactive Wearables, LLC vs. Polar Electro Oy et al.;When Tropp v. Travel Sentry, Inc.

In particular, the general secretary briefs the court. Teva Regarding the government’s position on the use of Section VIII statements accompanying abbreviated new drug applications (known as “skinny labels”) as a way to avoid infringement of method patents. , has already had a ripple effect. Prior to this decision, it had been determined that medicines marketed under thin labels did not infringe patented treatments that were exempt from labeling. In this case, GSK, which owns Coreg (carvedilol), marketed a generic version of carvedilol under a “skinny label” listing hypertension and left ventricular dysfunction after myocardial infarction (LVD after myocardial infarction) as indications. sued Teva as Coreg’s orange book list included “reducing mortality from congestive heart failure”. Based on expert testimony on congestive heart failure and post-MI LVD, GSK believes that Teva’s inclusion of post-MI LVD treatment in its “skinny label” will “reduce mortality caused by congestive heart failure”. successfully claimed to provoke an infringement of their claim to the ‘Method’. “Intertwined”. The purpose of skinny labels is to provide a more timely means of bringing generic drugs to market. While the court awaits the Secretary General’s comments, the future of Skinny Label remains uncertain.

Finally, another interesting case that is likely to call for court review is: Novartis Pharmaceuticals Corporation v. HEC Pharm Co., LTDIn this case, the Federal Circuit reversed its previous judgment against Novartis and found that Novartis’ Gilenya patent lacked written explanation to support negative limitations in its claims. This was also a unique case procedurally, as the panel for the judgment in early January 2022 consisted of Justice O’Malley (writing for the majority), Justice Lynn and Chief Justice Moore (dissenting). . After Judge O’Malley resigned and Judge Hughes replaced the panel, HEC requested a new trial. Justice Hughes agreed with Chief Justice Moore to order a new trial, resulting in Chief Justice Moore writing the dissenting opinion as Justice Lynn in the majority opinion.

Novartis has filed a motion to stay the Federal Circuit’s decision. Ruling I was preparing a petition. The court granted a temporary stay, but ultimately the request for a stay he was denied on October 13, 2022. Ruling A petition to reconsider the Federal Circuit’s extraordinary ruling in early 2023.

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Author: Jo PanuwatD

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