Skinny label: Supreme Court to weigh inducement claims against generics

The Supreme Court granted certiorari to review whether a generic drugmaker that fully carves out a patented use from its label can nonetheless be held liable for induced infringement based solely on marketing its product as a generic version of a branded drug and referencing public information about the branded product, without promoting the patented use.

In Amarin Pharma v. Hikma Pharmaceutical USA, Case No. 23-1169 (Fed. Cir. June 25, 2024), the US Court of Appeals for the Federal Circuit concluded that Amarin adequately pleaded induced infringement based on allegations that Hikma marketed its product as a “generic” version of Vascepa and cited publicly available information about Vascepa, even though Hikma’s label carved out the patented indication pursuant to Section viii of the Hatch-Waxman Act.

In its petition to the Supreme Court, Hikma argued that the Federal Circuit’s ruling threatened the statutory balance struck by Hatch-Waxman by exposing skinny-label generic manufacturers to inducement liability based on conduct unrelated to the carved-out use. According to Hikma, permitting inducement claims under these circumstances would effectively nullify Hatch-Waxman Section viii by allowing plaintiffs to rely on generic marketing statements that do not instruct or encourage use of the patented method.

The questions presented are:

  • When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?
  • Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?



Hot out of the oven: Trademark limits on pizza-inspired names

The US Court of Appeals for the Seventh Circuit affirmed-in-part and reversed-in-part a preliminary injunction barring the use of PIZZA PUFF, concluding that the trademark owner failed to demonstrate a likelihood of success on the merits because the term was likely generic and, in any event, was descriptively and fairly used. Illinois Tamale Company, Inc. v. LC Trademarks, Inc., Case Nos. 24-3317; 25-1072; -1076; -1112 (7th Cir. Jan. 16, 2026) (Scudder, St. Eve, Jackson-Akiwumi, JJ.)

Illinois Tamale Company (Iltaco), a Chicago-based food company, has sold its signature “Pizza Puff” since 1976, distributing the product nationwide alongside other “Puff”-branded products. Iltaco owns federal trademark registrations for PIZZA PUFF (registered in 2009) and PUFF (registered in 2022).

In March 2024, Little Caesars introduced “Crazy Puffs,” small baked dough cups filled with pizza ingredients. The product launched as part of Little Caesars’ long-running “Crazy” line and was marketed prominently under the Little Caesars name, logo, and orange trade dress. Little Caesars secured its own federal registration for CRAZY PUFFS, and the United States Patent and Trademark Office identified no conflicting marks during examination.

Following the product launch, Iltaco sent a cease-and-desist letter claiming that CRAZY PUFFS and the phrase “4 Hand-Held Pizza Puffs” infringed its trademarks. When Little Caesars declined to change its marketing, Iltaco sued for trademark infringement and unfair competition and sought a preliminary injunction. The district court issued a split ruling, enjoining Little Caesars from using PIZZA PUFF but permitting continued use of CRAZY PUFFS and PUFF. Both parties appealed.

The Seventh Circuit found that the district court applied the wrong legal standard in assessing the protectability of PIZZA PUFF. The Court explained that rather than asking whether competitors could offer similar products without using the term, trademark protectability turns on the “primary significance” test, which is whether consumers primarily understand the term as a brand name or as the common name of a product. Because generic terms can never function as trademarks, the Court focused on evidence of consumer perception.

Applying that framework, the Seventh Circuit found substantial evidence that PIZZA PUFF was generic:

  • More than 80% of surveyed consumers viewed the term as referring to a product category rather than a brand.
  • Dictionary definitions treated the term generically.
  • Third-party filings and industry usage consistently employed the phrase as a common name.

This evidence rebutted the presumption of validity afforded by Iltaco’s federal registration, and Iltaco failed to demonstrate a likelihood of proving distinctiveness at trial. The Court therefore concluded that Iltaco did not show a likelihood of success on the merits and reversed the preliminary injunction barring Little Caesars’ use of PIZZA PUFF.

The Seventh Circuit further found that even if PIZZA PUFF were distinctive, Iltaco still could not obtain injunctive relief because Little Caesars was likely to prevail on a fair-use defense. The Court emphasized that fair use requires only descriptive, good-faith use, and not a perfect fit between the challenged term and the product. Here, PIZZA PUFF plausibly described Little Caesars’ light, pizza-filled food [...]

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Baseball was very good to Roberto: Lanham Act permits claims against government officials in personal capacity

In a decision addressing the intersection of trademark law, sovereign immunity, and constitutional takings, the US Court of Appeals for the First Circuit partially revived Lanham Act claims brought by the heirs of baseball legend Roberto Clemente against senior officials of the Commonwealth of Puerto Rico. While affirming dismissal of claims against the Commonwealth itself and related public entities, the Court concluded that certain Lanham Act claims against individual government officials in their personal capacities were plausibly alleged and not barred by qualified immunity at the pleading stage. Clemente Props., Inc. v. Pierluisi-Urrutia, Case No. 23-1922, 2026 WL 125574 (1st Cir. Jan. 16, 2026) (Barron, Lipez, Thompson, JJ.)

The plaintiffs, Clemente’s sons and affiliated entities, alleged that Commonwealth officials improperly used Clemente’s name and likeness on commemorative license plates and registration tags without authorization. Proceeds from the program were directed toward a public initiative intended to replace an earlier Clemente-founded project. Plaintiffs claimed trademark infringement, false endorsement, false advertising, and dilution under the Lanham Act, as well as a taking in violation of the Fifth and Fourteenth Amendments. Defendants moved to dismiss on immunity grounds and for failure to state a claim. The district court granted the motions in full. Plaintiffs appealed.

The First Circuit reversed in part. The Court rejected the district court’s conclusion that the use of Clemente’s name and image was not “in connection with” goods or services under the Lanham Act. The Court explained that commemorative license plates and tags qualify as goods, and the fact that they were issued by a government entity did not remove them from the statute’s commercial scope. The Court also pointed to the United States Patent and Trademark Office’s Trademark ID Manual, which expressly recognizes license plates as registrable goods, and found no persuasive basis for excluding fundraising activities supporting the Roberto Clemente Sports District Fund from trademark scrutiny.

The First Circuit further concluded that plaintiffs adequately alleged commercial injury within the Lanham Act’s zone of interests and plausibly pleaded likelihood of confusion, including the mistaken impression that the Clemente family endorsed or financially benefited from the initiative. Accordingly, dismissal of Lanham Act claims under Section 32 (trademark infringement), Section 43(a) (false endorsement), and Section 43(c) (dilution) was improper with regard to officials sued in their personal capacities.

Sovereign immunity remained a shield for the Commonwealth, the Convention Center District Authority, and officials sued in their official capacities. However, the First Circuit concluded that qualified immunity did not bar the personal-capacity Lanham Act claims at the pleading stage and thus vacated dismissal and remanded for further proceedings.

The First Circuit affirmed dismissal of the false advertising claim, determining that plaintiffs failed to allege that defendants’ statements constituted commercial advertising or promotion as required under Section 43(a)(1)(B). The Court also affirmed dismissal of the Takings Clause claim, concluding that alleged infringements of intangible intellectual property do not support a categorical physical-taking theory and cannot be analyzed using frameworks applicable to physical occupation or appropriation.

Finally, the First Circuit deemed waived any [...]

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DMCA safe harbor is deep: Plaintiffs need to get specific

The US Court of Appeals for the Eleventh Circuit affirmed summary judgment for YouTube, finding that the company was protected by Section 512(c) of the Digital Millennium Copyright Act (DMCA). In doing so, the Court joined the Second and Ninth Circuits in requiring knowledge of specific infringing material, not generalized awareness of infringement on a platform, to defeat safe-harbor protection. Athos Overseas Ltd. Corp. v. YouTube, Inc., et al., Case No. 23-13156 (11th Cir. Jan. 7, 2026) (Pryor, Jordan, Marcus, JJ.)

Athos owns copyrights in classic Mexican and Latin American films and sued YouTube for hosting unauthorized uploads of its works. YouTube invoked the DMCA Section 512(c) safe harbor, which shields service providers from liability for infringing material stored at the direction of users if certain statutory conditions are met. Athos did not dispute that YouTube expeditiously removed content identified in valid takedown notices. Instead, Athos argued that YouTube’s internal technologies provided it with actual or “red flag” knowledge of additional infringing copies beyond those specifically identified, and that YouTube’s content moderation and curation tools gave it the “right and ability to control” infringing activity.”

The Eleventh Circuit rejected both arguments. Echoing Viacom Int’l v. YouTube and UMG Recordings v. Shelter Cap. Partners, the Court explained that Section 512(c) requires knowledge of specific instances of infringement. A service provider’s duty to act arises only when it knows which particular material is infringing, because expeditious removal is possible only with such specificity. Since YouTube’s tools do not automatically identify legally infringing content, and because Athos provided no evidence that YouTube knew which specific videos were infringing, there was no triable issue on knowledge.

The Court rejected Athos’ argument that YouTube’s ability to recommend videos, remove content, or set platform policies constituted the type of control that strips safe-harbor protection. The DMCA requires “something more” than ordinary content moderation, such as substantial influence over or inducement of specific infringing activity. Because Athos failed to establish such control, the Eleventh Circuit did not reach the question of whether YouTube derived a direct financial benefit from infringement.

The Eleventh Circuit affirmed summary judgment for YouTube, concluding that it remained entitled to Section 512(c) safe-harbor protection.




Federal question? You can’t hypothetically fair use your way into federal court

Addressing the limits of federal jurisdiction, the US Court of Appeals for the Sixth Circuit affirmed the dismissal of an action seeking a declaratory judgment that the fair use exception in federal copyright law required disclosure of a student survey under Kentucky’s open records statute. The Court determined that neither the hypothetical presence of a federal fair use defense nor the possibility of future copyright litigation was sufficient to confer federal jurisdiction. Stovall v. Jefferson County Board of Education, Case No. 25-5357 (6th Cir. Jan. 14, 2026) (Sutton, Boggs, Bloomekatz, JJ.)

Miranda Stovall, a Kentucky resident, learned that Jefferson County Public Schools planned to administer a mental health survey to students. She requested a copy of the survey under the Kentucky Open Records Act. The school district denied the request, citing an exemption for records prohibited from disclosure by federal law and asserting that the survey was copyrighted intellectual property of its publisher, NCS Pearson.

Stovall sued in federal court seeking a declaratory judgment that that disclosure of the survey would be permitted under the Copyright Act’s fair use doctrine. NCS Pearson moved to dismiss for lack of subject matter jurisdiction, and the district court granted that motion. Stovall appealed.

The Sixth Circuit affirmed, applying the established “arising under” framework used to assess federal-question jurisdiction under 28 U.S.C. Sections 1331 and 1338. Under that framework, a claim may arise under federal copyright law only if:

  • It is created by the Copyright Act.
  • It is a state law claim that necessarily raises a disputed and substantial copyright issue.
  • It asserts rights equivalent to those protected by copyright and is therefore preempted.

The Court concluded that none of these categories applied.

First, the Copyright Act did not create Stovall’s cause of action; her asserted entitlement to inspect or copy the survey arose solely under the Kentucky Open Records Act.

Second, although copyright law was implicated, it entered the case only as a potential defense to the school district’s disclosure obligation. The Sixth Circuit emphasized that federal jurisdiction cannot be manufactured by anticipating a federal defense, even where the defense involves copyright fair use. Because federal copyright law was not an essential element of Stovall’s state law claim, the case did not “arise under” federal law.

Third, the Sixth Circuit rejected Stovall’s argument that her claim was effectively a copyright dispute because it might provoke an infringement action by NCS Pearson. The Kentucky Open Records Act claim did not resemble an infringement action and did not seek to vindicate rights equivalent to those protected by the Copyright Act. Accordingly, it was not preempted and did not fall within exclusive federal jurisdiction.

The Sixth Circuit concluded that Stovall also lacked Article III standing under the Declaratory Judgment Act. The Court explained that a speculative fear of future litigation does not create the “substantial controversy” required to establish a justiciable case or controversy. Stovall had not alleged any prior infringement claim, threat of suit, or concrete indication that NCS Pearson intended to sue [...]

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