IP UPDATE
Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
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In vitro data, broad dosage ranges fail to enable patient-treatment claims

by | Jul 23, 2026 | ,

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 | Jul 23, 2026 |

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 | Jul 23, 2026 |

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.



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

by | Jul 23, 2026 |

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 | Jul 23, 2026 |

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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Federal Circuit: Mandate rule applies only to issues actually decided on appeal

by | Jul 23, 2026 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness determination, finding that the Board did not exceed the scope of the Court’s prior mandate by addressing a claim limitation that the Board had not reached in its original final written decision. Intellectual Pixels Ltd. v. Sony Interactive Entertainment LLC, Case No. 24-2174 (Fed. Cir. July 10, 2026) (Dyk, Stoll, Stark, JJ.)

Sony Interactive Entertainment petitioned for inter partes review (IPR) of an Intellectual Pixels Limited (IPL) patent directed to methods and systems for generating digital images using an external visual server. IPL is a UK-based intellectual property licensing company known for holding a US patent that covers methods for generating and displaying digital images using a remote visual server. A key feature of the claimed invention was that the external server assumed responsibility for generating the images, relieving the client device of that processing burden.

The primary prior art reference disclosed a system in which a game was hosted “exclusively on a server/host computer” while users played the game through separate client or terminal computers. The Board instituted review but, in its first final written decision, concluded that Sony had not shown the challenged claims to be unpatentable.

Sony appealed. The Federal Circuit vacated the Board’s decision, finding that substantial evidence did not support the Board’s determination regarding the claim limitation requiring “generating” a new image.

On remand, the Board addressed a separate “compressing” limitation, concluded that the prior art satisfied that limitation, and issued a second final written decision finding the challenged claims unpatentable as obvious.

IPL appealed, arguing that the Board violated the Federal Circuit’s mandate by revisiting findings that had not been expressly disturbed in the first appeal. Under the mandate rule, issues decided on appeal generally may not be reconsidered by a lower tribunal on remand.

The Federal Circuit rejected IPL’s argument. One of the two findings IPL identified had, in fact, been vacated by the Court’s prior decision as unsupported by substantial evidence. The other concerned the Board’s observation that the primary reference was “completely silent as to the content or origin of that ‘compressed video MPEG stream.’” The Court concluded that this second finding fell outside the scope of the prior mandate because it related to the “compressing” limitation, which the Board had not reached in its first final written decision. Because the Board’s original decision rested only on the “generating” limitation, the “compressing” issue was not before the Court in the first appeal and, therefore, was not resolved – expressly or implicitly – by the Court’s mandate.

The Federal Circuit also noted that its prior discussion of the “generating” limitation had implicitly undermined IPL’s reliance on the Board’s earlier observation. Both the “generating” and “compressing” limitations referred to “at least one updated image,” making the prior finding difficult to reconcile with the Court’s earlier analysis.

IPL relied on a 2025 Federal Circuit decision, Bitmanagement Software GmBH v. United States, suggesting that factual findings made during [...]

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A $40 million jury instruction error sends trade secret dispute back to trial

by | Jul 23, 2026 |

The US Court of Appeals for the Ninth Circuit reversed a jury damages award, a permanent injunction, and an attorneys’ fee award in a trade secret misappropriation case, finding that the district court improperly instructed the jury on which party bore the burden of proving whether the asserted trade secrets were “readily ascertainable through proper means.” Comet Technologies USA, Inc. et al. v. XP Power, LLC, Case Nos. 23-15601; 25-15709; 25-745 (9th Cir. July 14, 2026) (Hamilton, Nelson, Bumatay, JJ.) (Bumatay, dissenting)

Comet Technologies, a Swiss-based leader in x-ray and radio-frequency products, sued US-based competitor XP Power after three former Comet engineers left to join XP, allegedly bringing thousands of confidential documents relating to Comet’s radio-frequency power technologies, product designs, and research and development. Comet asserted claims under the federal Defend Trade Secrets Act (DTSA) and California’s Uniform Trade Secrets Act (CUTSA).

Before trial, Comet narrowed its case to five alleged trade secrets and voluntarily dismissed its CUTSA claims, leaving only its DTSA claims. The parties addressed the effect of that dismissal on the jury instructions, with XP requesting that the burden of proving lack of ready ascertainability be shifted to Comet to conform to the DTSA while Comet argued that the instruction should be removed entirely. The district court rejected both requests without an on-the-record explanation and left in Instruction 20, which told the jury that XP was not liable for misappropriation if XP proved by a preponderance of the evidence that the alleged trade secrets were readily ascertainable by proper means, meaning they could be lawfully “obtained, discovered, developed, reverse-engineered, or compiled without significant difficulty, effort, or expense.”

The jury found that XP misappropriated three of the five trade secrets and awarded Comet $20 million in compensatory damages and $20 million in exemplary damages. The district court also entered a permanent injunction and awarded more than $17 million in attorneys’ fees. XP appealed.

Erroneous jury instruction: “Readily ascertainable by proper means”

XP argued that the district court improperly instructed the jury that XP bore the burden of proving that Comet’s alleged trade secrets were “readily ascertainable by proper means.” Comet argued that XP invited the instructional error by requesting that the challenged instruction be given to the jury and, alternatively, that any error was harmless because the instructions were accurate as a whole, they correctly stated the law, and the evidence overwhelmingly established that Comet’s trade secrets were not readily ascertainable through proper means.

The Ninth Circuit agreed with XP, explaining that under the DTSA, lack of ready ascertainability is an element of Comet’s DTSA claim – not an affirmative defense – and, therefore, Comet bore the burden of proof. The Court rejected Comet’s invited-error argument, finding that XP timely objected after Comet dismissed its CUTSA claims and correctly argued that, under the DTSA, Comet – not XP – bore the burden of proving that the alleged trade secrets were not readily ascertainable through proper means.

The Ninth Circuit also rejected Comet’s harmless-error argument. The Court explained that [...]

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Who decides trademark strength: Judge or jury?

by | Jul 16, 2026 | ,

The Supreme Court granted certiorari to decide whether the strength of a trademark in a likelihood-of-confusion analysis under 15 U.S.C. § 1114 is a question of law for the court or a question of fact for the jury. RiseandShine Corp. v. PepsiCo, Inc., Case No. 24-1016 (Supr. Ct. June 29, 2026).

RiseandShine sued PepsiCo in the US District Court for the Southern District of New York, alleging that PepsiCo’s Mtn Dew Rise Energy drink infringed RiseandShine’s RISE marks for cold-brew coffee products. The district court granted RiseandShine a preliminary injunction, but the US Court of Appeals for the Second Circuit vacated and remanded.

The Second Circuit concluded that the district court erred in its analysis of the strength of the RISE marks and the similarity of the parties’ marks. Treating trademark strength as a question of law, the Second Circuit found that the RISE marks were weak because of the “strong logical associations between ‘Rise’ and coffee.” After reviewing images of the parties’ cans, the Second Circuit also concluded that the district court erred in finding PepsiCo’s mark confusingly similar to the RISE marks.

On remand, the district court entered summary judgment for PepsiCo, relying on the Second Circuit’s determination that the RISE marks were “inherently weak as a matter of law” and that the similarity factor “weigh[ed] strongly against” RiseandShine. The Second Circuit affirmed, reiterating that trademark strength is a question of law.

RiseandShine petitioned for certiorari, which the Supreme Court granted. The question presented is: Whether trademark strength is a question of fact in a likelihood-of-confusion analysis under 15 U.S.C. § 1114.



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Back on track: Contextual inquiry required before applying § 112(f) to software claim element

by | Jul 16, 2026 |

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s indefiniteness ruling based on an insufficient means-plus-function analysis under 35 U.S.C. § 112(f) while affirming the denial of judgment as a matter of law (JMOL) and a new trial following a jury verdict finding a related patent invalid as anticipated. TrackTime, LLC v. Amazon.com Services LLC, Audible, Inc., Case No. 24-1102 (Fed. Cir. July 2, 2026) (Prost, Taranto, JJ; Kovner, J., sitting by designation.)

TrackTime sued Amazon and Audible for patent infringement, asserting two related patents directed to time-synchronized transcript technology for audio and video files. One patent relates to methods for annotating and sharing time-synchronized transcripts on mobile devices. The other relates to “tap-to-jump” technology, which allows a user to tap a word in a transcript and jump to the corresponding point in the associated audio or video file.

The district court issued a claim construction order finding the annotation-and-sharing patent invalid for indefiniteness. The court concluded that the claim terms “executable program code configured to facilitate annotation” and “executable program code configured to synchronously play multimedia” were means-plus-function terms that recited functions without sufficient corresponding structure. Because the specification did not adequately disclose structure for performing those functions, the district court held the terms indefinite.

The tap-to-jump patent proceeded separately to a jury trial. The jury found the asserted claim invalid on multiple grounds, including anticipation by a prior art program called LiveNote, and found no infringement. The district court later denied TrackTime’s post-trial motions for JMOL and a new trial. TrackTime appealed both the indefiniteness ruling on the annotation-and-sharing patent and the denial of JMOL and a new trial on the tap-to-jump patent.

The Federal Circuit vacated and remanded the indefiniteness ruling on the annotation-and-sharing patent, finding the district court’s § 112(f) analysis insufficient considering the Federal Circuit’s intervening decision in Dyfan, LLC v. Target Corp. (2022). In Dyfan, the Court explained that determining whether a limitation should be construed under § 112(f) requires a full contextual analysis, including whether the claim language recites sufficient structure when viewed in light of the specification, the surrounding claim language, and how a person of ordinary skill in the art would understand the term.

The Federal Circuit found that the district court did not conduct the full inquiry required by Dyfan because it failed to consider extrinsic evidence regarding usage in the field and how a skilled artisan would understand the disputed “executable program code” limitations. The Court declined to decide the § 112(f) issue in the first instance, leaving it to the district court on remand to determine whether the disputed limitations, read in context, recited sufficient structure for performing the claimed annotation and synchronous-play functions on a mobile device.

The Federal Circuit reached a different result on the tap-to-jump patent. TrackTime argued that LiveNote failed to disclose three limitations, namely “performing a data lookup,” a “mobile computing device,” and a “touch-sensitive input interface.” The Court rejected each argument. It found that TrackTime [...]

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Construing claims to fit the brand

by | Jul 9, 2026 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s claim construction and grant of a preliminary injunction, concluding that an accused infringer’s proposed construction would have produced the “highly improbable” result of excluding the patentee’s Orange Book-listed drug from the scope of the asserted claims. Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, Case No. 25-2016 (Fed. Cir. July 1, 2026) (Bryson, Stoll, JJ.) (Dyk, J., dissenting in part)

Otsuka sued Hetero Labs, alleging that Hetero Labs’ generic drug product would infringe Otsuka’s patent rights. Otsuka moved for a preliminary injunction to prevent Hetero Labs from entering the market. The district court granted the motion, concluding that Otsuka was likely to succeed on its infringement claim. Hetero Labs appealed, arguing that the district court erred in construing the asserted claims.

The central dispute concerned how to calculate the patent’s claimed weight ratio. The representative claim requires administering dextromethorphan in combination with quinidine, with the proviso that the “weight to weight ratio of dextromethorphan to quinidine is 1:0.5 or less.” The district court construed “dextromethorphan” and “quinidine” to include their pharmaceutically acceptable salts. Under that construction, the claimed ratio is calculated using the full weight of the compounds as administered – for example, the full weight of dextromethorphan hydrobromide rather than only the dextromethorphan active moiety. Hetero Labs, by contrast, argued that when the compounds are administered as salts, the ratio must be calculated using only the weight of the active moieties.

The Federal Circuit affirmed the district court’s construction, concluding that the intrinsic evidence supported construing “dextromethorphan” and “quinidine” to include both the free base compounds and their pharmaceutically acceptable salts. The Court found that the patent claims, specification, and prosecution history consistently used those terms to encompass the compounds in the form in which they are administered. The Court also found that extrinsic evidence supported its construction. Relying in part on its 2007 decision in Osram GmbH v. ITC, the Court explained that Hetero Labs’ proposed construction would produce the “highly improbable” result of excluding Otsuka’s Orange Book-listed Nuedexta product – the very product the patent was intended to protect – from the scope of the claims. The Court also rejected Hetero Labs’ indefiniteness argument, concluding that the claims were not rendered indefinite simply because they encompassed formulations using either free bases or pharmaceutically acceptable salts.

Judge Dyk, dissenting in part, concluded that the district court’s construction was inconsistent with both the intrinsic evidence and the purpose of the claimed invention. According to Judge Dyk, the invention depended on maintaining a specific ratio of dextromethorphan to quinidine to ensure that:

  • Dextromethorphan achieved a therapeutic effect
  • Quinidine slowed the metabolism of dextromethorphan
  • Patients were not exposed to excessive amounts of quinidine

In his view, calculating the claimed ratio using the full weight of pharmaceutically acceptable salts rather than only the active moieties distorted that relationship by incorporating the weight of carrier ions that have no therapeutic significance. Judge Dyk also disagreed with the majority’s reliance [...]

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