IP UPDATE

In vitro data, broad dosage ranges fail to enable patient-treatment claims

by Lisette Donewald | Jul 23, 2026 | Life Sciences, Patents

Clarifying the enablement standard for pharmaceutical method-of-treatment claims, the US Court of Appeals for the Federal Circuit affirmed a post-verdict grant of judgment as a matter of law (JMOL), finding patents directed to daily administration of a “unit dosage” to cancer patients invalid for lack of enablement. The Court concluded that the specification’s in vitro data and broad dosage ranges – some exceeding the maximum tolerated dose in humans – did not provide sufficient guidance for translating the disclosed results into a workable patient-dosing regimen. Wyeth LLC v. AstraZeneca Pharmaceuticals LP, Case No. 24-2325 (Fed. Cir. July 9, 2026) (Lourie, Linn, Hughes, JJ.)

Pharmaceutical and healthcare company Wyeth owns patents directed to methods of treating gefitinib- and/or erlotinib-resistant non-small cell lung cancer (NSCLC) by administering a daily “unit dosage” of an irreversible epidermal growth factor receptor (EGFR) inhibitor. A jury found that competitor AstraZeneca, which markets the irreversible EGFR inhibitor Tagrisso® (osimertinib), induced infringement and awarded Wyeth $107.5 million in damages. After trial, however, the district court granted AstraZeneca’s renewed JMOL motion, finding the asserted claims invalid for lack of enablement.

Wyeth appealed, arguing that the district court improperly changed its construction of “unit dosage” after trial, applied that revised construction in its enablement analysis, and improperly granted JMOL on enablement grounds.

The dispute centered on the construction of “unit dosage,” which the district court defined as “physically discrete units suitable as unitary dosage for the subject, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect.” Wyeth argued that the claims required only the identification of compounds capable of inhibiting EGFR activity. AstraZeneca countered that, because the claims expressly required daily administration to a patient, they necessarily required a dosage regimen suitable for human treatment.

The Federal Circuit agreed with AstraZeneca, finding that the claims “plainly require the daily administration of a unit dosage to a patient to achieve a therapeutic effect in treating g/e-resistant NSCLC, not merely the identification of compounds capable of inhibiting EGFR activity in vitro.”

The Federal Circuit rejected Wyeth’s contention that the district court had effectively imported US Food and Drug Administration (FDA) approval requirements into the enablement inquiry. The Court emphasized that enablement did not require proof of regulatory-grade safety or efficacy. Because the claims required daily administration to patients, however, the specification had to teach a skilled artisan how to arrive at a workable human-dosing regimen without undue experimentation.

The Federal Circuit determined that the specification failed to do so, as it disclosed only three exemplary compounds (EKB-569, HKI-357, and HKI-272), described their in vitro activity, and provided only broad projected dosage ranges (1-1,000 mg and 2-500 mg) without explaining how to translate those ranges into effective human dosing.

The trial record reinforced the lack of enablement. AstraZeneca presented unrebutted testimony, including from Wyeth’s own experts and co-inventors, that at least two disclosed compounds could not be administered within the claimed dosage ranges without exceeding the maximum tolerated dose in humans. One co-inventor testified that the [...]

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Specificity matters: Eighth Circuit rejects broad trade secret claims

by Jodi Benassi | Jul 23, 2026 | Trade Secrets

The US Court of Appeals for the Eighth Circuit affirmed a district court’s summary judgment against a trade secret plaintiff, finding that the plaintiff’s broad descriptions of confidential business information failed to identify its alleged trade secrets with sufficient specificity. Wilbur-Ellis Company v. Gompert, et al., Case Nos. 25-1577; -1682 (8th Cir. July 7, 2026) (Shepard, Erickson, Grasz, JJ.)

Wilbur-Ellis, an international marketer and distributor of agricultural products, specialty chemicals, and ingredients, sued four former employees after they left to join competitor J.R. Simplot Company, alleging breach of the duty of loyalty, trade secret misappropriation under the Defend Trade Secrets Act (DTSA) and the Nebraska Trade Secrets Act (NTSA), and tortious interference with business relationships. During discovery, the district court denied Wilbur-Ellis’s requests to compel discovery from both Simplot and the former employees, concluding that Wilbur-Ellis had not identified its alleged trade secrets with sufficient specificity to justify the requested discovery. After denying Wilbur-Ellis’s request to delay summary judgment pending additional discovery, the district court granted summary judgment to the former employees on the trade secret and tortious interference claims and on most of the duty-of-loyalty claims. Wilbur-Ellis appealed.

Discovery orders affirmed

Wilbur-Ellis argued that the district court improperly prevented it from obtaining discovery from Simplot by requiring it to identify its alleged trade secrets with greater specificity before permitting third-party discovery.

The Eighth Circuit disagreed, finding that the district court did not abuse its discretion in denying Wilbur-Ellis’s motion to compel. The Eighth Circuit noted that the district court had identified several concerns, including that Wilbur-Ellis’s trade secret disclosure was extremely broad, appeared to treat nearly everything the former employees encountered as a trade secret, and raised concerns that the requested third-party discovery would amount to a fishing expedition. The Court emphasized that Wilbur-Ellis did not dispute those findings on appeal or that it had sought third-party discovery before exhausting discovery from the former employees.

Trade secret claims fail for lack of specificity and evidence

Wilbur-Ellis also argued that the district court improperly granted summary judgment on its DTSA and NTSA claims. The Eighth Circuit disagreed, concluding that Wilbur-Ellis failed to present sufficient evidence that it possessed protectable trade secrets or that the defendants misappropriated them. The Court explained that Wilbur-Ellis relied on broad descriptions of categories of information – such as customer information, financial information, and business strategy – without identifying the specific trade secrets allegedly taken, who misappropriated them, or how they were misappropriated. The Court further found that, although Wilbur-Ellis identified its password-protected SeedWare database as confidential, it failed to produce evidence that the defendants improperly acquired, disclosed, or used any information contained in the database. Because Wilbur-Ellis failed to connect its allegations to specific trade secrets or admissible evidence of misappropriation, the Court found summary judgment was appropriate.

Duty of loyalty claims

Wilbur-Ellis next argued that the district court improperly granted summary judgment on its breach of the duty of loyalty claims. The Eighth Circuit disagreed, finding that Wilbur-Ellis failed to present admissible evidence that [...]

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Preliminary injunction? Not when substantial questions remain

by Tyler Jackson | Jul 23, 2026 | Patents

The US Court of Appeals for the Federal Circuit reversed a preliminary injunction in a patent infringement action, finding that the district court’s claim construction raised, at a minimum, substantial questions regarding infringement and that the patentee failed to establish irreparable harm. Ridge Corp. et al. v. Kirk NationaLease Co. et al., Case No. 25-1254 (Fed. Cir. July 13, 2026) (Dyk, Mayer, Taranto, JJ.)

Ridge Corporation, the exclusive licensee of manufacturer Cold Chain’s patent directed to an insulated overhead door, sued truck leasing and maintenance company Kirk NationaLease Co. (KNL) for patent infringement, tortious interference with business relationships, and false patent marking. After the Federal Circuit vacated an initial preliminary injunction because Ridge lacked standing to sue without the patent owner, Cold Chain joined the present action as a plaintiff. The district court again granted a preliminary injunction, concluding that the plaintiffs had demonstrated a likelihood of success on the merits. KNL appealed.

KNL argued that the district court improperly construed several disputed claim limitations and, therefore, erred in concluding that the plaintiffs were likely to succeed on the merits. The Federal Circuit agreed, explaining that a preliminary injunction should not issue where an accused infringer raises one or more substantial questions concerning infringement – questions that the patentee cannot show lack substantial merit.

The Federal Circuit identified three claim limitations that raised substantial questions of noninfringement:

The district court improperly construed the limitation requiring a panel that is “flexible along the entire length of the panel,” explaining that both the claim language and prosecution history supported a narrower construction.
The accused product raised a substantial question regarding the limitation requiring that “foam insulating material” form the second outermost surface of the door because the prosecution history distinguished prior art sandwich constructions on that basis.
The district court construed the term “insulated overhead door” too broadly, explaining that the specification and industry evidence supported construing the term as referring to a door suitable for cold-storage applications.

The Federal Circuit also determined that the district court erred in finding irreparable harm. Ridge asserted that it had reduced prices because of the defendants’ allegedly infringing products, but the Court found no evidence establishing the required causal nexus between the accused sales and Ridge’s pricing decisions. The Court likewise rejected Ridge’s reliance on its false-marking and tortious-interference claims because there was no credible evidence that the challenged conduct was likely to recur, making prospective injunctive relief inappropriate.

Practice note: This decision illustrates that a patentee seeking preliminary injunctive relief must establish more than a plausible infringement theory. Where the accused infringer raises substantial questions regarding claim construction or infringement, a preliminary injunction is inappropriate.

Heirs’ lights flicker out: Sixth Circuit affirms MillerKnoll’s Bubble Lamp rights

by Lauren Hong | Jul 23, 2026 | Trademarks

The US Court of Appeals for the Sixth Circuit affirmed summary judgment for the manufacturer of an iconic lamp design, finding that the designer’s heirs could not pursue trademark infringement and related tort claims based on the contractual transference of ownership and use of the intellectual property associated with the lamp. The Court concluded that the governing agreements authorized the manufacturer’s conduct and that the designer’s family later ratified the manufacturer’s ownership by accepting royalties with knowledge of its ownership claim. Nelson v. MillerKnoll, Inc., Case No. 25-1940 (6th Cir. July 7, 2026) (Boggs, Clay, Gilman, JJ.)

George Nelson, a prominent mid-century furniture designer, created the cloth-covered hanging fixtures known as the Bubble Lamp while serving as design director of Herman Miller, now MillerKnoll. George and Herman Miller did not enter into a formal written agreement addressing ownership of the Bubble Lamp’s intellectual property during the designer’s employment.

After George’s death, his widow, Jacqueline Nelson, entered into a 2006 agreement under which Herman Miller agreed to pay royalties on certain products designed by George. In 2015, while a related foundation was litigating against another company that had registered and sold Bubble Lamp trademarks, George’s son, Mico Nelson, executed an addendum on Jacqueline’s behalf. The addendum expanded the royalty arrangement to include “Nelson branded Lamp Products” and granted Herman Miller exclusive worldwide rights to manufacture, use, sell, and license those products.

Herman Miller later acquired the Bubble Lamp business and related trademark registrations, including two product-configuration marks and the BUBBLE LAMP word mark.

The Nelson family sued MillerKnoll, alleging that it had improperly obtained the Bubble Lamp’s intellectual property as part of a broader scheme to deprive the family of George’s rights. The complaint asserted federal and state trademark infringement, fraud, conspiracy, unjust enrichment, and cancellation of the trademark registrations. The district court granted summary judgment to MillerKnoll on all claims. The Nelson family appealed.

The principal issue on appeal was whether the 2006 agreement and 2015 addendum merely licensed MillerKnoll to use the Bubble Lamp’s intellectual property or also authorized MillerKnoll ownership of that intellectual property.

Applying Michigan contract law, the Sixth Circuit concluded that the agreements unambiguously granted MillerKnoll both ownership and use rights. Although the agreements referred to “Licensed Products,” that term was contractually defined to include products whose rights MillerKnoll owned. Other provisions granted MillerKnoll “exclusive right, title, and interest” in the covered designs and the sole right to enforce the associated proprietary rights.

That contractual authorization defeated the Nelson family’s Lanham Act claim. The Sixth Circuit explained that authorized use of a mark cannot support an infringement claim under § 43(a) because authorized conduct does not create the type of source confusion the statute is intended to prevent.

The same reasoning foreclosed the state-law trademark and tort claims. Because the agreements authorized MillerKnoll’s ownership and use of the Bubble Lamp’s intellectual property, the Nelson family could not recover for conduct to which it had consented.

The Sixth Circuit also concluded that Mico independently ratified MillerKnoll’s ownership. [...]

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Lanham Act vs. First Amendment: Clarifying the proper scope of commercial speech

by Ian J. Howard | Jul 23, 2026 | Trademarks

The US Court of Appeals for the Tenth Circuit affirmed in part and reversed in part the dismissal of a false advertising complaint, clarifying that courts must take a “holistic” approach when determining whether challenged statements constitute commercial speech under the Lanham Act. KetoNatural Pet Foods, Inc. v. Hill’s Pet Nutrition, Inc., Case No. 24-3185 (10th Cir. July 14, 2026) (Tymkovich, Phillips, McHugh, JJ.)

KetoNatural Pet Foods sells grain-free pet food while Hill’s Pet Nutrition sells more traditional pet food containing grains. KetoNatural alleged that Hill’s lost sales and market share after KetoNatural and other nontraditional pet food companies entered the market. According to KetoNatural, Hill’s responded by working with veterinarians and nonprofit organizations to publicize false claims that boutique, exotic, and grain-free (BEG) diets are associated with an increased risk of dilated cardiomyopathy in dogs.

KetoNatural sued Hill’s for false advertising under the Lanham Act. To state a false advertising claim, a plaintiff must plausibly allege, among other elements, that the defendant made a false or misleading representation of fact in commercial advertising or promotion.

Hill’s moved to dismiss KetoNatural’s complaint. The district court granted the motion, finding that KetoNatural had not adequately alleged either that Hill’s engaged in commercial speech or that the challenged statements were false. KetoNatural appealed.

The Tenth Circuit concluded that KetoNatural plausibly stated a claim for false advertising based on some of the statements made by Hill’s on its website, but Hill’s was not vicariously liable for the statements made by certain veterinarians and nonprofit organizations. In drawing these conclusions, the Tenth Circuit relied on the Supreme Court’s 1983 decision in Bolger v. Youngs Drug Products Corporation, which enunciated three factors for determining whether speech is commercial in character:

It is an advertisement,
It references a specific product, and
It is made with economic motivation.

The Hill’s website stated that BEG diets were linked to a higher risk of canine heart disease without promoting any particular product. Although such statements did not constitute “a classic advertising campaign” and did not reference a specific product, they functionally served to promote Hill’s products given the company’s position as one of three dominant market players in the traditional dog food industry. And critically, Hill’s was clearly economically motivated to make such statements to regain its waning market share.

Furthermore, the Tenth Circuit found that KetoNatural had adequately alleged that these statements were false because, under the establishment claim doctrine, which had been adopted by other federal appellate courts, KetoNatural sufficiently pleaded that “the scientific studies” that Hill’s relied on did “not establish the assertion for which they are cited.”

By contrast, the Tenth Circuit concluded that Hill’s was not vicariously liable for the statements made by veterinarians and nonprofit organizations. According to the Court, the veterinarians and other third parties were too attenuated from Hill’s such that a reasonable inference could not be drawn that their statements were promoting Hill’s products. Moreover, the veterinarians and other third parties lacked an adequate economic motive. Importantly, KetoNatural [...]

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