AIA reviews: An alternative to litigation, not a second chance

Addressing the scope of discretionary institution under the America Invents Act (AIA), the United States Patent and Trademark Office (USPTO) denied institution of inter partes review (IPR), concluding that the petitioner was attempting to use the Patent Trial & Appeal Board as a “second bite at the apple” after unsuccessfully litigating substantially similar invalidity issues in district court, contrary to the AIA’s purpose of providing a streamlined alternative to litigation. Magnolia Medical Technologies, Inc. v. Kurin, Inc., IPR2026-00097, Paper 17 (Director May 14, 2026).

Magnolia challenged the validity of Kurin’s patent directed to a blood-testing device in district court. After the district court excluded Magnolia’s invalidity expert based on disclosure deficiencies related to claim construction and a jury subsequently found the patent not invalid, Magnolia filed an IPR petition asserting substantially similar anticipation and obviousness grounds. The Director denied institution, concluding that Magnolia had already had a full and fair opportunity to litigate those issues in district court and was improperly attempting to relitigate them before the Board.

The Director explained that Congress created IPRs and post-grant reviews (PGRs) under the AIA to provide streamlined and cost-effective alternatives to district court litigation, not to facilitate repetitive validity challenges or expand parallel litigation. The decision noted that, in practice, many petitioners pursue AIA review alongside district court litigation, sometimes asserting overlapping invalidity theories or taking inconsistent positions across forums, thereby increasing costs and burdening both patent owners and the USPTO.

The Director further emphasized that AIA proceedings serve broader public-interest objectives beyond resolving private disputes, including promoting efficiency, fairness, predictability, and the integrity of the patent system. In exercising discretionary institution authority, the USPTO considers factors such as examiner error, inconsistent positions across forums, settled expectations, and whether institution would represent an appropriate use of USPTO resources.

Applying those principles, the Director concluded that Magnolia’s petition fell outside the intended purpose of AIA review because Magnolia was not using the Board as an alternative forum for resolving validity disputes, but instead to relitigate substantially similar invalidity theories after an unfavorable outcome in district court. The Director emphasized that Magnolia had already contested validity in district court using anticipation and obviousness grounds similar to those asserted in the petition and that the parties had expended substantial resources litigating those issues.

The Director rejected Magnolia’s argument that institution was warranted because no tribunal had adjudicated the merits of its anticipation and obviousness theories after the district court excluded its expert testimony. According to the Director, Magnolia had a full and fair opportunity to litigate those issues, and the exclusion of its expert resulted from deficiencies within Magnolia’s control. Permitting institution under those circumstances, the Director explained, would improperly allow Magnolia to obtain a “second bite at the apple” before the USPTO.

In discussing the public-interest considerations that inform discretionary institution decisions, the Director highlighted several precedential and informative decisions addressing issues such as substantial examiner error, inconsistent positions across forums, foreign sovereign petitioners, and settled expectations. The Director explained that these decisions reflect [...]

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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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Invalidity alone does not render a case exceptional

Addressing fee shifting under 35 U.S.C. § 285 and sanctions under 28 U.S.C. § 1927, the US Court of Appeals for the Federal Circuit affirmed in part and reversed in part a judgment dismissing a patent infringement complaint and awarding attorneys’ fees and costs, finding that the weakness of the plaintiff’s position, without more, did not justify a finding of exceptionality, and that counsel’s lack of diligence did not rise to the bad-faith conduct required for sanctions. mCom IP, LLC v. City National Bank of Florida, Case No. 24-2089 (Fed. Cir. May 15, 2026) (Dyk, Mayer, Taranto, JJ.)

mCom IP sued City National Bank of Florida in September 2023, asserting a patent directed to systems and methods for integrating financial institutions’ “e-banking touch points,” such as ATMs and online banking portals. Earlier that year, an inter partes review (IPR) initiated by Unified Patents resulted in all but four claims being found unpatentable as obvious under 35 U.S.C. § 103. mCom’s district court complaint asserted those four surviving claims.

The district court struck mCom’s initial complaint as a “shotgun pleading” and dismissed the amended complaint with prejudice for failure to state a claim. It also concluded that the asserted claims were invalid on the same obviousness grounds addressed in the IPR and awarded attorneys’ fees under § 285, finding the case exceptional, and imposed sanctions under § 1927 based on counsel’s litigation conduct. mCom appealed.

The Federal Circuit affirmed the dismissal but reversed the fee award and sanctions. The Court addressed two issues: whether the case was “exceptional” under § 285 and whether counsel had unreasonably and vexatiously multiplied the proceedings under § 1927.

Under § 285, a case is exceptional if it “stands out” based on the substantive strength of a party’s position or the unreasonable manner of litigation. The Federal Circuit rejected each basis relied on by the district court.

First, although the asserted claims were ultimately found invalid, the Federal Circuit emphasized that invalidity alone does not render a case exceptional. Rather, awarding fees requires a showing that the claims were “unusually or extraordinarily weak.” That standard was not met here where the asserted claims survived IPR and carried a presumption of validity, and where the burden of proof for invalidity in district court remains higher than in IPR.

Second, the Federal Circuit found that pleading deficiencies did not support exceptionality. The initial complaint’s defects were “purely formal,” and the amended complaint’s failure to state a claim, without more, did not render the overall litigation conduct unreasonable.

Third, the Federal Circuit rejected reliance on City National’s purported license defense, noting that no license had been established on the record.

Finally, the Federal Circuit found insufficient support for the contention that mCom pursued nuisance-value settlements, explaining that City National failed to provide evidence regarding settlement amounts or to tie prior litigation to the patent at issue.

The Federal Circuit also reversed the sanctions imposed under § 1927. Applying Eleventh Circuit law, the Federal Circuit explained that sanctions require conduct [...]

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Chill out: Numerical claim terms properly limited by industry standards

The US Court of Appeals for the Federal Circuit affirmed a noninfringement finding, concluding that a claim limitation reciting a pH range having only a lower limit referred to pH measured at standard temperature in the art. The Court also found that prosecution history estoppel and the disclosure-dedication rule foreclosed reliance on the doctrine of equivalents to capture a pH below the express lower limit. Actelion Pharms. Ltd. v. Mylan Pharms. Inc., Case No. 24-1641 (Fed. Cir. May 13, 2026) (Reyna, Taranto, Stoll, JJ.)

Actelion owns patents covering lyophilized epoprostenol formulations used to treat cardiovascular disease. Epoprostenol is unstable in water because acidic conditions catalyze its degradation. The patents sought to improve stability by manufacturing highly basic bulk solutions, thereby producing freeze-dried formulations that remained stable after reconstitution in typical intravenous fluid. The asserted claims recite bulk solutions having a pH “of 13 or higher” or “greater than 13.”

Mylan sought approval to market a generic version of Actelion’s Veletri® product and was sued under 35 U.S.C. § 271(e)(2). The district court construed “a pH of 13 or higher” to mean “a pH of 12.98 or higher.”

It was undisputed that Mylan’s bulk solution measured below a pH of 12.98 at standard temperature (25±2°C). Actelion nevertheless contended that infringement existed because the solution exceeded pH 13 at lower temperatures during refrigerated manufacturing.

The district court disagreed, finding that the claim term “a pH of 13 or higher” referred to a pH measured at a temperature standard in the field, and that therefore Mylan did not literally infringe. The district court further ruled that Actelion was barred from asserting and had not proved infringement under the doctrine of equivalents. Actelion appealed.

The Federal Circuit agreed with the district court that a person of ordinary skill would interpret the claimed pH values as measurements taken at standard temperature, absent an express indication otherwise. Although the claims did not specify measurement conditions, the specification consistently treated pH values as standard-temperature measurements. The Court emphasized that the specification compared results across pH levels without suggesting temperature-dependent variation and described an “alkaline environment” as “pH > 7,” a statement accurate only at standard temperature.

The Federal Circuit found that extrinsic evidence reinforced that understanding. The United States Pharmacopeia and expert testimony established that, in pharmaceutical formulations, pH is ordinarily measured at 25±2°C unless otherwise specified. The Court found no clear error in the district court’s factual findings on industry practice.

Because Mylan’s product failed to meet the pH limitation under that standard, the Federal Circuit affirmed the finding of no literal infringement.

The Federal Circuit also rejected Actelion’s doctrine of equivalents theory. During prosecution, Actelion amended the claims from “greater than 12” to “a pH of 13 or higher” after the examiner recognized unexpected results at pH 13 but not at pH 12. The Court found that this narrowing amendment gave rise to prosecution history estoppel, barring Actelion from recapturing lower pH values through equivalence.

Separately, the Federal Circuit applied the disclosure-dedication rule. The patents [...]

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Appellate deference: Reinforcing limits on reweighing evidence

Clarifying the proper scope of appellate review, the US Court of Appeals for the Federal Circuit affirmed an International Trade Commission final determination in full. The Court upheld the scope of the exclusion of only certain accused products and permitted importation of redesigned versions, concluding that the Commission correctly viewed the evidence and claim terms. Bissell, Inc. v. ITC, Case No. 24-1509 (Fed. Cir. May 11, 2026) (Moore, Taranto, Stoll, JJ.)

Bissell initiated a Section 337 investigation alleging that Tineco Intelligent imported wet/dry surface-cleaning devices that infringed Bissell’s patents. Following an evidentiary hearing, the administrative law judge (ALJ) found infringement of Tineco’s original products and recommended exclusion but concluded that Tineco’s redesigned products did not infringe and therefore fell outside the scope of relief.

The Commission affirmed the ALJ’s determination, which resulted in a limited exclusion order directed to the infringing products only. Both parties appealed.

Bissell challenged the finding that Tineco’s redesigned products did not literally infringe a limitation requiring that “the battery charging circuit is disabled” during the “self-cleaning mode . . . and remains disabled during the . . . cleanout cycle.” Tineco modified its products so that some battery charging did occur during a “self-cleaning mode,” but battery charging was disabled for most of the cleaning cycle. Before the ALJ, Bissell’s expert opined that infringement of this claim essentially only required a period in which self-cleaning occurred and while the battery charger was disabled. The ALJ rejected Bissell’s theory, determining that the claim required the battery charger to “remain[] disabled during the . . . cleanout cycle.”

According to Bissell, the ALJ’s conclusion amounted to improper claim construction. The Federal Circuit disagreed, finding that the ALJ had merely applied the plain and ordinary meaning of the claim term. As Bissell had not disputed that the ALJ’s findings were supported by substantial evidence, the Federal Circuit affirmed these findings.

Tineco cross-appealed the ALJ’s determination that Bissell’s domestic industry products satisfied the disabled battery limitation. According to Tineco, the evidence was inadequate to support the ALJ’s determination because the source code that Bissell’s expert relied on was never produced during the Commission trial.

The Federal Circuit found that Bissell’s expert testimony was sufficient under Federal Rule of Evidence 703, which permits experts to rely on facts or data they have been made aware of or personally observed, even if those materials are not themselves admissible, as long as they are of a type reasonably relied upon in the field. The Court emphasized that neither party disputed that experts in this context routinely rely on source code to assess infringement. The Court further concluded that substantial evidence supported the ALJ’s determination, highlighting that:

  • The source code had been produced during discovery.
  • The expert’s opinions were not conclusory.
  • Tineco did not meaningfully test the testimony through cross-examination or offer competing expert analysis.
  • The ALJ’s findings were independently corroborated by a Bissell internal document admitted at trial.

Practice note: Where the Commission uses the “face of the claim to [...]

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