Precedential and Key Federal Circuit Opinions
1. INTELLECTUAL PIXELS LIMITED v. SONY INTERACTIVE ENTERTAINMENT LLC [OPINION] (2024‑2174, 07/10/2026) (Dyk, Stoll, Stark)
Dyk, J. The Court affirmed the Patent Trial and Appeal Board’s decision on remand holding claims 1–12 of U.S. Patent No. 10,681,109 unpatentable as obvious. The patent relates to methods for generating digital images using an external visual server and systems implementing the disclosed method. In an earlier appeal, the Court vacated the Board’s initial decision finding the claims not unpatentable because there was not substantial evidence supporting the Board’s decision that the primary prior-art reference, Wiltshire, failed to disclose the claimed “generating” limitation. On remand, the Board concluded that Wiltshire disclosed both the generation and compression of updated images and held the challenged claims obvious. On appeal, Intellectual Pixels argued (1) that the Board violated the Federal Circuit’s mandate by revisiting issues relating to the claimed image-compression limitation after remand; and (2) that the Board’s decision was not supported by substantial evidence because “Wiltshire does not teach compression of newly generated images into an MPEG stream.”
Regarding the first argument of whether the Board exceeded the mandate on remand, the Court held that because the Board’s initial decision rested solely on the absence of the “generating” limitation, any findings regarding “compressing” were outside the scope of the prior appeal and remained open for consideration on remand. The Court emphasized that the mandate rule precludes reconsideration only of issues “actually decided” or necessarily decided in the prior appeal.
Regarding the second argument of whether Board’s obviousness finding was supported by substantial evidence, the Court held that there was sufficient evidence that the disputed limitation was met by a combination of Wiltshire and a secondary reference.
2. WYETH LLC v. ASTRAZENECA PHARMACEUTICALS LP [OPINION] (2024‑2325, 07/09/2026) (Lourie, Linn, Hughes)
Lourie, J. The Court affirmed the district court’s grant of judgment as a matter of law that asserted claims of U.S. Patent Nos. 10,603,314 and 10,596,162 are invalid for lack of enablement. The patents relate to methods of using irreversible inhibitors to treat “gefitinib and/or erlotinib resistant” non-small cell lung cancer (“NSCLC”). Following a jury verdict finding infringement and no invalidity, the district court granted JMOL of invalidity because “no reasonable jury could have found that the asserted patents enabled a skilled artisan to administer the claimed ‘unit dosage’ of the claimed irreversible EGFR inhibitor to a patient without undue experimentation.” Specifically, the district court relied on the fact that the patent specification disclosed “no working examples of unit dosages administered to patients,” and credited AstraZeneca’s “unrebutted evidence that some disclosed dosage levels would be toxic, including doses required to achieve a therapeutic effect in patients.”
On appeal, Wyeth argued that the district court improperly altered its claim construction post-verdict by reading clinical safety and efficacy requirements into the claims. The Court disagreed, explaining that the claims plainly require administering a “unit dosage” daily to a patient and that the district court merely clarified what was already inherent in its prior construction of “unit dosage.” The Court emphasized that this limitation requires producing a therapeutic effect in a patient, which “draws the claims beyond merely requiring ‘killing cancer cells,’ yet constrains them short of requiring full-blown FDA-type clinical safety standards.”
On the issue of enablement, the Court held that the specification failed to teach a skilled artisan how to determine therapeutically effective daily dosages across the full scope of the claimed irreversible EGFR inhibitors. The Court explained that “the specification must provide some basis for translating information about the disclosed compounds’ in vitro activity into the claimed daily dosing regimen,” but instead left “the determination of the claimed ‘unit dosage’ entirely to the knowledge of the skilled artisan.” The patents disclosed only three example compounds and provided no working examples of how to extrapolate in vivo dosing from in vitro results patient dosing, or otherwise calculate a “unit dosage.” The Court also found that AstraZeneca’s unrebutted trial evidence that at least two of the disclosed compounds would require dosages exceeding maximum tolerated levels in humans to achieve therapeutic effects reinforced the lack of guidance provided by the specification.
In arriving at its decision, the Court recognized that while “it is accepted practice in patent law for one to be able to claim a method of treatment disclosing a range of doses to be administered, without showing actual clinical data,” “[t]he problem with these patents is that, perhaps because of close prior art, their claims are limited to dosage forms to be administered to patients, yet they disclosed only a broad range of doses some of which were shown to be toxic, and they disclosed no actual dosages for any compound within the scope of the claims, thereby leaving it to a practitioner of the claims to perform undue experimentation.”
3. TRACKTIME, LLC v. AMAZON.COM SERVICES LLC [OPINION] (2024‑1102, 07/02/2026) (Prost, Taranto, Kovner)
Taranto, J. The Court vacated the district court’s ruling that claims of U.S. Patent No. 8,862,978 are indefinite and remanded for further proceedings, but affirmed the judgment that the only remaining asserted claim of U.S. Patent No. 8,856,638 is invalid as anticipated. The patents relate to methods and systems for use on a mobile device to navigate within a multimedia file by using a time-correlated transcript.
As to the ’978 patent, the district court had held claims invalid for indefiniteness after finding that the two “executable program code” limitations are means-plus-function terms and that the specification lacks adequate disclosure of corresponding structure. Applying intervening precedent, particularly Dyfan, LLC v. Target Corp., 28 F.4th 1360 (Fed. Cir. 2022), the Court explained that a means-plus-function analysis requires consideration of the “structure/function principle built into § 112(f)…[which] calls for analysis of this case that goes beyond what has already been done by the parties and the district court as the case comes to us.” The Court emphasized this analysis requires examining the claim terms in context, and an inquiry into both the intrinsic record and “extra-patent usage that can be essential to determining whether an alleged means-plus-function phrase, including the recitation of the claimed function, names or describes at least a class of structures sufficient to perform the function.” Because the district court did not adequately address that inquiry and made no pertinent factual findings regarding industry understanding of the claimed code, the Court remanded for a renewed § 112(f) analysis.
As to the ’638 patent, the Court held that substantial evidence supported the jury’s finding that claim 9 was anticipated by a prior-art LiveNote system described in three Amazon trial exhibits (a written installation guide, tutorial, and user guide). The Court rejected TrackTime’s argument that there was insufficient evidence of the “performing a data lookup,” “mobile computing device,” and “touch-sensitive input interface” limitations. For the “performing a data lookup” limitation, the Court found that TrackTime failed to set forth an explanation as to why the jury could not find this limitation met. For the remaining two limitations, the Court relied on LiveNote user guides disclosing operation on tablet computers, which the patent itself identified as examples of mobile computing devices, and credited testimony of Amazon’s expert that LiveNote’s disclosures would have been understood by a relevant artisan to be operable on a touchscreen device “with a pen or a finger.” The Court also rejected TrackTime’s request for a new trial, concluding that the anticipation verdict reflected a conventional dispute between competing experts and did not so contradict the weight of the evidence to warrant disturbing the jury’s verdict.
4. OTSUKA AMERICA PHARMACEUTICAL, INC. v. HETERO LABS LIMITED [OPINION] (2025‑2016, 07/01/2026) (Dyk, Bryson, Stoll)
Bryson, J. The Court affirmed the district court’s grant of a preliminary injunction preventing Hetero from launching its generic version of Nuedexta but vacated the district court’s waiver of the Federal Rule of Civil Procedure 65(c) bond requirement. In granting the preliminary injunction, the Court upheld the district court’s finding that patentee was likely to succeed in proving that Hetero’s product would infringe U.S. Patent No. 7,659,282, which relates to a method for treating pseudobulbar affect or emotional lability involving administration of the drug dextromethorphan in combination with a second drug, quinidine.
On appeal, the principal issue was whether the district court properly construed the terms “dextromethorphan” and “quinidine” in a limitation requiring a weight-to-weight ratio of 1:0.5 or less. Hetero argued that the ratio should be calculated using only the active-moiety portions of the compounds, excluding the weights of any accompanying salt forms. Otsuka contended that the ratio should instead be determined based on the form in which the compounds are administered, whether free-base or salt form. The Court agreed with Otsuka, finding that the claims, dependent claims, specification, prosecution history, and other intrinsic evidence consistently used “dextromethorphan” and “quinidine” as encompassing both free-base and salt forms. The Court further noted that Hetero’s construction would exclude Nuedexta itself from the scope of the asserted claims, a result the Court found implausible. Applying that construction, the Court concluded that Otsuka was likely to succeed on the merits of its infringement claim and therefore upheld the district court’s grant of preliminary injunctive relief.
Judge Dyk dissented in part, arguing that the majority’s claim construction improperly treated salt-form weights as equivalent to active-moiety weights and was inconsistent with the purpose of the invention, which sought to reduce quinidine exposure while maintaining therapeutic dextromethorphan levels.
The Court also separately considered the district court’s decision to waive Rule 65(c)’s bond requirement. Applying Third Circuit law, the Court held that waiver was improper because the injunction restrained a commercial, revenue-generating activity—namely Hetero’s launch of a generic pharmaceutical product. While Rule 65(c) permits limited exceptions in certain circumstances, the Court explained that Third Circuit precedent treats the bond requirement as effectively mandatory in commercial disputes. The Court therefore vacated the bond waiver and remanded for the district court to determine an appropriate security amount.
5. RIDGE CORP. v. KIRK NATIONALEASE CO. [OPINION] (2025‑1254, 07/13/2026) (Dyk, Mayer, Taranto)
Mayer, J. The Court reversed the district court’s grant of a preliminary injunction in favor of Ridge Corp. and Cold Chain, LLC and remanded for further proceedings. The asserted patent, U.S. Patent No. 9,151,084, relates to an insulated overhead door. The district court had concluded that plaintiffs were likely to succeed on their infringement claims and enjoined defendants from manufacturing and selling the accused roll-up doors.
On appeal, the Court held that defendants raised substantial questions of noninfringement under several disputed claim limitations. First, the Court found a substantial question whether the accused door satisfied the requirement that the panel be “flexible along the entire length of the panel.” The Court rejected plaintiffs’ argument that the limitation plainly requires only a door capable of traversing curved tracks, explaining that the claim separately requires flexibility along the entire panel length and that the prosecution history emphasized a panel made entirely of flexible material rather than alternating flexible and rigid sections. Second, the Court also concluded that defendants raised a substantial question whether the accused “sandwich” panel—consisting of foam between two thermoplastic membranes—met the limitation requiring “foam insulating material form[] the second outermost surface of the door” and rejected plaintiffs’ attempt to bring the accused door within the scope of claim 1 by pointing to the language of an unasserted dependent claim. Finally, the Court held that defendants raised a substantial question whether the accused product met the claim limitation “insulated overhead door,” which is most reasonably interpreted as a door with insulating properties that make it suitable for cold storage applications.
The Court further held that plaintiffs failed to establish irreparable harm. While plaintiffs asserted alleged price erosion as a basis for irreparable harm, the Court found this argument speculative because plaintiffs failed to show a causal nexus between defendants’ sales and plaintiffs’ pricing decisions. The Court likewise found that plaintiffs’ allegations that one of the defendants “incorrectly stated that the accused door was patented” and another “interfered with [its] business relationships” interference did not support prospective injunctive relief because plaintiffs presented no credible evidence that the challenged conduct was likely to recur. Because plaintiffs failed to demonstrate a likelihood of success on the merits or irreparable harm, the Court reversed the district court’s grant of preliminary injunction.
6. BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM v. BOSTON SCIENTIFIC CORP. [OPINION] (2024‑2062, 2024‑2063, 07/27/2026) (Taranto, Bryson, Cunningham)
Taranto, J. The Court reversed the district court’s denial of judgment as a matter of law in favor of Boston Scientific and held that the asserted claims of U.S. Patent No. 6,596,296 are both invalid as anticipated and not infringed. The patent relates to compositions containing biodegradable polymer fibers capable of the controlled delivery of therapeutic agents and was asserted against Boston Scientific’s drug-eluting coronary stents. Following trial, a jury found infringement, including willful infringement, rejected Boston Scientific’s anticipation defense, and awarded damages. The district court later set aside the willfulness finding but otherwise upheld the verdict.
On appeal, the Court first held that no reasonable jury could have found that the prior-art Song patent failed to anticipate the asserted claims. The Court concluded that Song expressly disclosed each disputed limitation of claim 1, including a biodegradable polymer fiber composed of two immiscible phases where one is “the polymer portion of the fiber” and the other is “the discrete drug-containing regions dispersed throughout the fiber.” The Court rejected the patentee’s attempt to distinguish Song by arguing that the manner of biodegradation in Song is different from the manner of biodegradation in the asserted patent. The Court further found that Song’s disclosure of noncontiguous active-agent regions satisfied the requirement for “discrete drug-containing regions dispersed throughout the fiber.” The Court likewise held that Song anticipated dependent claims 11 and 17 through express disclosure of at least one member of each claim’s Markush group and anticipated claim 26’s requirement that therapeutic agents be released at “varying rates” over time. In particular, the Court relied on unrebutted expert testimony that all drug-delivery systems release drugs at changing rates and found no evidence from which a reasonable jury could conclude otherwise.
The Court also held that Boston Scientific was entitled to judgment as a matter of law of noninfringement. Under the district court’s construction, a “fiber” required a “thread-like structure of any length or shape.” The Court concluded that no reasonable jury could find that the accused stent coating satisfied that requirement. The patentee’s infringement theory relied on isolating a portion of the coating from the metal stent frame and characterizing it as a fiber, but the Court found that no reasonable jury could find that artificially separated section of the stent coating to be “thread-like.” Because no reasonable jury could find either that the asserted claims were not anticipated by Song or that the accused products contained the claimed “fiber,” the Court reversed the judgment in its entirety and did not reach the remaining issues on appeal, including the patentee’s cross-appeal concerning willfulness.
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