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

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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Preliminary injunction? Not when substantial questions remain

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

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

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

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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Compound errors: Written description, not typographical error analysis, controls priority claim

The US Court of Appeals for the Federal Circuit affirmed summary judgment that the asserted patent was invalid as anticipated because the provisional application to which it claimed priority did not provide adequate written description support for the claimed compound. The Court explained that the proper inquiry was whether the provisional demonstrated possession of the later-claimed subject matter, not whether a discrepancy in the provisional could be characterized as an obvious typographical error. Enanta Pharmaceuticals, Inc. v. Pfizer Inc., Case No. 25-1427 (Fed. Cir. June 23, 2026) (Lourie, Bryson, Chen, JJ.)

Enanta owns a patent direct to coronavirus inhibitors. The patent claimed priority to a July 20, 2020, provisional application. In April 2021, before Enanta filed a nonprovisional application correcting what it later characterized as a typographical error, Pfizer publicly disclosed the compound that ultimately became part of its COVID-19 treatment, Paxlovid®.

The dispute centered on a structural limitation defining an alkyl substituent. The provisional disclosed NHC(O)-C2-C12-alkyl while the asserted patent claimed NHC(O)-C1-C12-alkyl. According to Enanta, the “C2” designation in the provisional was an obvious drafting error that a person of ordinary skill in the art would recognize and mentally correct.

The district court granted summary judgment that the patent was anticipated because the asserted claims were not entitled to the provisional application’s filing date. Enanta appealed.
While the Federal Circuit affirmed, it clarified that the district court framed the issue incorrectly. Rather than asking whether a court could correct an alleged error in the provisional, the proper question was whether the provisional itself provided sufficient written description support for the later-claimed invention.

In clarifying the appropriate inquiry, the Federal Circuit rejected Enanta’s reliance on cases addressing correction of errors in issued patents and decisions concerning genus-species written description issues, explaining that those authorities did not govern the priority analysis presented here. Nor could the Court simply construe the provisional to correct the alleged mistake because the disclosure was subject to reasonable debate.

Applying the written description standard, the Federal Circuit concluded that “C2 is simply different from C1.” Because the provisional disclosed only the C2 structure, it did not demonstrate that the inventors possessed the later-claimed C1 embodiment as of the provisional filing date. The Court also found Enanta’s expert testimony insufficient to create a genuine issue of material fact, explaining that generalized opinions regarding carbon chain nomenclature and drafting errors elsewhere in the specification did not establish written description support for the specific claimed limitation.

Because the asserted claims were not entitled to the provisional application’s priority date, Pfizer’s intervening public disclosure constituted anticipatory prior art, rendering the patent invalid.




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Tick tock: Related trade secrets have single accrual date under DTSA statute of limitations

The US Court of Appeals for the Federal Circuit reversed a judgment awarding damages and a permanent injunction, finding that the plaintiff’s trade secret misappropriation claims were barred by the statute of limitations under the Defend Trade Secrets Act (DTSA). Insulet Corp. v. EOFlow, Co. Ltd., Case No. 25-1807 (Fed. Cir. May 28, 2026) (Dyk, Reyna, JJ.) (Prost, J., dissenting).

Insulet manufactures the Omnipod, an adhesive wearable insulin patch pump currently sold in 25 countries. EOFlow developed a competing product, the EOPatch 2, marketed in Europe and South Korea. On August 3, 2023, Insulet filed suit against EOFlow alleging trade secret misappropriation under the DTSA and patent infringement.

The misappropriation allegedly occurred when EOFlow hired several former Insulet employees to develop the EOPatch 2. The employees included Steve DiIanni, former director of mechanical engineering at Insulet, who possessed “detailed technical information” about the Omnipod. Between March and May 2018, DiIanni provided EOFlow with computer-aided design (CAD) files and information regarding the Omnipod’s soft cannula and occlusion-detection algorithm.

The district court bifurcated the DTSA and patent claims. At trial on the DTSA claims, the jury found misappropriation of four trade secrets, including the Omnipod CAD files, and concluded that none of Insulet’s claims were barred by the statute of limitations. The jury initially awarded $170 million in compensatory damages and more than $280 million in exemplary damages. These amounts were reduced to $26 million and $34 million, respectively, with the district court’s grant of a permanent injunction. Insulet’s patent claims were dismissed without prejudice.

On appeal, Insulet moved to transfer to the Court of Appeals for the First Circuit. The Federal Circuit denied the motion, concluding that it retained jurisdiction because the dismissal of the patent claims functioned, at least in part, as a dismissal with prejudice, since the statute of limitations expired with respect to certain alleged acts of patent infringement. The Court then addressed two issues under the DTSA statute of limitations: when the statute of limitations begins to run and whether related trade secrets are subject to a single accrual date.

On the first issue, the parties disputed the applicable standard. EOFlow argued that the statute of limitations began to run under an inquiry-notice standard while Insulet contended that the Supreme Court’s 2010 decision in Merck & Co. v. Reynolds required application of a discovery standard under which the limitations period begins when the plaintiff discovers or reasonably should have discovered the facts underlying its claim. The Federal Circuit declined to decide which standard governed, concluding that Insulet’s claims were time-barred even under the more demanding Merck standard. Applying an access-plus-similarity framework, the Court found that, before the critical date, Insulet knew or should have known that EOFlow had access to its trade secrets through a former Insulet employee, and possessed sufficient information regarding similarities between the EOPatch 2 and Insulet’s trade secret technology to plead a misappropriation claim.

On the second issue, for which there was no controlling First Circuit authority, the Federal Circuit determined that the [...]

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E-I-E-I-No patents for data harvesting

Addressing patent eligibility and attorneys’ fees, the US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that five farming data patents were directed to patent-ineligible subject matter, but vacated and remanded the district court’s unexplained determination that the case was not exceptional. AGI SureTrack LLC v. Farmers Edge Inc., Case Nos. 24-1730; -1830 (Fed. Cir. Jun. 2, 2026) (Moore, Mayer, Lourie, JJ.)

AGI SureTrack owns five patents directed to capturing farming operation data in real time using passive data collection devices attached to farming equipment while the equipment performs farming operations. The claimed systems process and share the collected data through an online farming data exchange system or server. AGI sued Farmers Edge and Farmers Edge (US) for patent infringement.

At summary judgment, the district court found the asserted patents invalid under 35 U.S.C. § 101, concluding that the claims were directed to patent-ineligible subject matter. The district court also ruled that the case was not exceptional under 35 U.S.C. § 285 for purposes of awarding attorneys’ fees. AGI appealed the invalidity ruling, and Farmers Edge cross-appealed the no-exceptionality ruling.

The Federal Circuit affirmed the § 101 ruling under the two-step Alice framework. At Alice step one, the Federal Circuit found that AGI’s claims were directed to the abstract idea of collecting, analyzing, and transmitting farming data. The Court explained that claims using conventional computer components to collect, analyze, and present data (activities that can be characterized as mental processes) are directed to an abstract idea. The Court rejected AGI’s argument that the patents claimed an unconventional hardware and software system that solved interoperability problems among distinct brands of farming equipment. The claim language did not recite such a technological solution, and the specification described the invention as a way to track, store, and profit from farming operation data.

The Federal Circuit also rejected AGI’s reliance on claims involving detection of communication protocols and the use of stored “implement profiles” to decode farming equipment information. In the Court’s view, those limitations merely combined abstract concepts and did not change the character of the claims as being directed to data collection, processing, and transmission.

At Alice step two, the Federal Circuit found no inventive concept sufficient to transform the abstract idea into patent-eligible subject matter. The claims relied on generic computer components performing conventional functions. The Court explained that although the claimed automation may have increased the speed and efficiency of collecting and analyzing farming data, improved speed from automation alone does not supply an inventive concept. Considering the claim elements individually and as an ordered combination, the Court concluded that the patents did not claim a patent-eligible application for tracking and collecting farming data.

The Federal Circuit reached a different result on attorneys’ fees. The district court had ruled that the case was not exceptional under § 285 but provided no explanation for that determination. The Federal Circuit vacated and remanded, explaining that while district courts need not always provide extensive reasoning, they must provide enough [...]

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Trade secret owner may pursue unjust enrichment damages despite licensing history

The US Court of Appeals for the Federal Circuit affirmed in part, reversed in part, and vacated in part a district court’s post-trial rulings in a trade secret and contract dispute, finding that a trade secret plaintiff may pursue unjust enrichment damages under both the Defend Trade Secrets Act (DTSA) and the Michigan Uniform Trade Secrets Act (MUTSA) even where the parties have a prior licensing relationship. The Court also reinstated the jury’s breach-of-contract damages award and rejected the defendant’s attempt to impose a heightened knowledge requirement for combination trade secrets. Versata Software, LLC v. Ford Motor Co., Case No. 24-1140 (Fed. Cir. May 22, 2026) (Moore, Taranto, Hughes, JJ.)

Ford licensed Versata’s automotive configuration software under a Master Subscription and Services Agreement. When the agreement was about to expire, the parties failed to agree on renewal terms, and Ford released its own software, which it had developed while still licensing Versata’s software. Versata alleged that Ford misappropriated several combination trade secrets embodied in Versata’s software and breached the parties’ agreement. A jury found Ford liable for misappropriating three trade secrets and for breach of contract, awarding more than $22 million in trade secret damages and $82.26 million in contract damages.

Before trial, the district court had limited Versata to a reasonable royalty theory based on the parties’ licensing history and had excluded damages models that measured the value Ford allegedly derived from using the trade secrets. After trial, the district court reduced the trade secret damages award to $0 and the contract award to $3. Versata appealed.

The Federal Circuit found that the district court had legally erred by categorically precluding unjust enrichment damages. The Court explained that the plain language of both the DTSA and the MUTSA permits recovery of unjust enrichment caused by misappropriation that is not accounted for in actual loss. While prior licensing history may be relevant to damages, it does not foreclose unjust enrichment as a matter of law. The Court therefore vacated the zeroed-out trade secret damages judgment and remanded for a new damages trial, instructing the district court to reconsider the reasonable royalty models it had previously excluded because they were not based solely on licensing history.

On the contract award, the Federal Circuit reversed the district court’s decision and reinstated the jury’s $82 million award. Applying Michigan law, the Court concluded that Versata had given the jury a reasonably certain damages path in the form of three annual license figures ($17 million, $14.95 million, and $10.95 million) multiplied by seven and a half years. The jury’s $82.26 million award equated to about $10.97 million per year, which fell within the range supported by the evidence and did not shock the conscience.

The Federal Circuit also affirmed liability for trade secret misappropriation. Ford argued that Versata had to show that Ford knew the specific elements of each combination trade secret at the time of use or disclosure. The Court rejected that proposed heightened requirement, concluding that neither the DTSA nor the MUTSA [...]

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Patentee that retains exclusionary rights has constitutional standing notwithstanding broad license grant

The US Court of Appeals for the Federal Circuit reversed a district court decision dismissing a patent infringement suit for lack of constitutional standing, concluding that patentees that retain exclusionary rights, even after granting a broad license, maintain Article III standing. A.L.M Holding Company v. Zydex Industries Private Ltd., Case No. 25-1317 (Fed. Cir. May 19, 2026) (Chen, Cunningham, Stark, JJ.)

A.L.M. and Ergon co-own six patents directed to warm-mix asphalt technology. Prior to filing suit, the patentees entered into a licensing agreement with Ingevity Corporation, granting Ingevity an exclusive, worldwide, royalty-bearing license to manufacture, import, use, and sell products covered by the patents. The agreement also provided for shared control of infringement actions and an equal split of any resulting recoveries and costs. Despite the breadth of the license, the patentees retained certain rights, including the ability to make, import, and use the licensed products.

A.L.M. filed suit against Zydex. The district court dismissed the action, concluding that the patentees lacked constitutional standing because the license transferred away sufficient exclusionary rights, leaving A.L.M. without a cognizable injury under Article III.

Reviewing the issue de novo, the Federal Circuit reversed. The Court framed the proper inquiry for constitutional standing as whether the plaintiff retains an exclusionary interest in the asserted patents. The Court explained that, absent a transfer of all exclusionary rights, a patentee generally maintains the concrete injury necessary to satisfy Article III.

The Federal Circuit emphasized that the constitutional standing inquiry is distinct from the question of statutory standing under 35 U.S.C. § 281. While statutory standing concerns whether a party is entitled to bring suit under the Patent Act and may be cured by joinder of necessary parties, constitutional standing requires a threshold showing of injury in fact and cannot be remedied after the fact.

Applying that framework, the Federal Circuit found that the plaintiffs retained sufficient exclusionary interests. In particular, the patentees preserved rights to royalties and maintained a degree of control over sublicensing, including a veto right. These retained interests demonstrated that the patentees had not transferred all substantial rights in the patents and therefore continued to suffer a legally cognizable injury from alleged infringement.

Accordingly, the Federal Circuit concluded that the plaintiffs satisfied Article III standing requirements and reversed the district court’s dismissal.

Practice note: On the same day that the Federal Circuit issued its decision in A.L.M. Holdings, the same panel also issued a nonprecedential decision in Recor Medical, Inc. v. Medtronic Ireland Manufacturing Unlimited Co., in which it stated, “[i]n a precedential opinion we issued today in a different appeal addressing constitutional standing, A.L.M. Holding Co. v. Zydex Industries Private Ltd., No. 25-1317 (Fed. Cir. May 18, 2026), we held that the patent owner in that case had constitutional standing because it retained a right to sue for patent infringement that was not rendered illusory by the rights it granted to its licensee. Because Medtronic Ireland’s retained rights are materially the same as the patent owner’s in A.L.M., we hold that Medtronic [...]

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