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Exploring the latest in intellectual property law
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APA compliant? Board’s use of invalidity basis not raised in IPR petition may be harmless

by and | Sep 17, 2026 |

The US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board’s use of a reference that was not urged by the petitioner in an inter partes review (IPR) petition was harmless since the Court agreed with the Board’s analysis and conclusion that all challenged claims were unpatentable as obvious on alternative grounds raised in the petition. Netlist, Inc. v. Micron Technology, Inc., Case No. 2024-1707 (Fed. Cir. Sept. 2, 2026) (Reyna, Linn, Stark, JJ.)

Netlist owns a patent directed to improving the performance and memory capacity of memory boards. The patent describes using buffers between a memory controller and memory devices. Those buffers contain data paths that can be selectively enabled during read and write operations. Samsung filed a petition for IPR challenging certain claims of the patent as obvious over the combination of two prior art patents, Ellsberry and Halbert. The Board instituted review and determined that Samsung met its burden to show that the challenged claims were obvious over Ellsberry alone or in combination with Halbert. Netlist appealed.

The Federal Circuit reviewed the Board’s decision for compliance with the Administrative Procedure Act (APA) and agreed with the Board’s technical review of the prior art in finding the challenged claims obvious. The APA requires that a Board decision identify the reasons and bases in the record for reaching its conclusions. In an IPR proceeding, this generally requires the Board to proceed in accordance or conformance with the challenge grounds presented in the IPR petition, and the Board may not “depart from the petition and institute a different IPR of its own design.” In the past, the Federal Circuit has found error where the Board held claims unpatentable based on grounds that were not urged by the IPR petitioner.

Netlist argued that even if the Board had substantial evidence to find that Ellsberry taught most limitations at issue, the Board erred by using a Netlist patent in its analysis to fill a gap in terms of a claimed limitation. The Board cited the Netlist patent for its teaching that an additional clock cycle could account for delay as data traveled through a buffer. Netlist argued that it was improper to use the Netlist patent to supply a teaching of a claim limitation when Samsung did not present this reference as an invalidity ground in its IPR petition. Netlist argued that the Board expanded the role of the Netlist patent from being mere evidence of general skill in the art to that of a prior art reference in violation of the APA restriction against departing from the petition to find claims invalid on grounds of “its own design.”

The Federal Circuit concluded that any potential error arising from the Board’s use of the Netlist patent was harmless since the Board found alternatively that Ellsbery alone without relying on the Netlist patent taught the limitations in the challenged claims.

Practice note: The decision leaves unresolved when the Board’s use of a reference not relied on in the [...]

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Resolution impossible: Lower resolution prior art is analogous art to higher resolution claims

by | Aug 27, 2026 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decision finding that prior art disclosing a low-resolution system was analogous prior art to claims directed to a high-resolution system for purposes of obviousness under 35 U.S.C. § 103. The Nielsen Company (US), LLC v. TVision Insights, Inc., Case No. 2025-1371 (Fed. Cir. Aug. 14, 2026) (Dyk, Reyna, Bissoon, JJ.)

Nielsen owns a patent related to audience measurement systems that use cameras to capture images of viewers watching media content. The specification describes a “people counter” that may use low-resolution images to detect audience members and a “person identifier” that uses high-resolution images for facial recognition.

TVision petitioned for inter partes review (IPR), asserting two grounds of obviousness, both of which relied on a scientific publication by Tian as part of the asserted prior-art combinations. The Tian publication, titled “Evaluation of Face Resolution for Expression Analysis,” disclosed experimental results evaluating facial-expression analysis using lower-resolution images “down-sampled from the originals.” The Board held that all challenged claims were obvious on both grounds. Nielsen appealed.

A central issue was whether the Board erred in concluding that Tian qualified as analogous art. Two tests define the scope of analogous art: whether the art is from the same field of endeavor, and if not, whether the reference is still reasonably pertinent to the particular problem with which the inventor is involved. In its petition, TVision asserted that Tian was in the same field of endeavor as Nielsen’s patent. Nielsen responded that Tian was neither in the same field of endeavor nor reasonably pertinent. The Board ultimately concluded that Tian was reasonably pertinent analogous art without reaching the field of endeavor prong. Nielsen argued that the Board violated the Administrative Procedure Act (APA) by applying the reasonably pertinent test when TVision’s petition only argued that Tian was in the same field of endeavor, depriving Nielsen of adequate notice and an opportunity to respond.

The Federal Circuit rejected Nielsen’s APA argument on three independent grounds:

  • The Court explained that although the two analogous-art tests are separate, the evidence and analysis relevant to them may overlap. The Court also explained that an analogous-art theory need not be expressly stated and may instead be implicit in the petition. Here, TVision’s discussion of Tian’s analysis of images for head detection and pose estimation placed Nielsen on notice that reasonable pertinence was at issue.
  • Nielsen had an opportunity to address reasonable pertinence and in fact addressed both analogous-art prongs in its Patent Owner Response.
  • Nielsen conceded that it could not identify any evidence or argument that it had been prevented from presenting. Accordingly, even if there had been a notice error, it was harmless.

On the merits, the Federal Circuit found that substantial evidence supported the Board’s determination that Tian was reasonably pertinent analogous art. The Court rejected Nielsen’s attempt to limit the analysis to prior art that an ordinarily skilled artisan would reasonably search to address the problems specifically identified in [...]

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Same patent, same light: Director vacates IPR decision at odds with ITC decision

by | Aug 13, 2026 |

The director of the United States Patent & Trademark Office (USPTO) vacated a Patent Trial and Appeal Board final written decision finding challenged claims obvious where the US International Trade Commission, considering the same patent, parties, and obviousness theory, had reached the opposite conclusion. The director found that the Board had not adequately justified departing from the Commission’s analysis. Biofrontera Inc. v. Sun Pharmaceutical Industries Inc., IPR2024-01312 (USPTO Dir. July 29, 2026) (Squires, Dir.)

Biofrontera petitioned for inter partes review (IPR) of a Sun Pharmaceutical patent directed to a photodynamic dermatology device. The Board instituted review and ultimately found all challenged claims unpatentable as obvious.

The same patent was also at issue in a Section 337 investigation before the Commission. Sun Pharmaceutical had accused Biofrontera of importing certain photodynamic therapy systems that infringed two patents. An administrative law judge (ALJ) found infringement and recommended an exclusion order. The ALJ also found that Biofrontera had not shown the claims of the patent at issue in the IPR to be obvious.

Before the Board, Biofrontera argued that the ALJ’s determination did not warrant deference because it was not yet final, remained subject to Commission review, and was based on a different evidentiary record and burden of proof. The Board agreed and reached the opposite conclusion on obviousness.

On Director Review, the director rejected the Board’s explanations and vacated the final written decision. The director concluded that the Board had not identified a sufficient basis for reaching a patentability determination inconsistent with the Commission’s assessment of the same obviousness theory.

The director first rejected the Board’s reliance on the non-final status of the ALJ’s determination. By the time of Director Review, the full Commission had upheld the ALJ’s conclusion that Biofrontera had not shown the claims obvious, eliminating the finality concern on which the Board had relied. The director further explained that even a non-final ALJ determination may remain relevant when the Board considers whether parallel proceedings justify terminating or otherwise declining to continue an IPR.

The director also found that differences in the evidentiary records did not adequately explain the conflicting results. Although the IPR included expert testimony that had not been presented at the Commission, the Board did not sufficiently explain why that testimony warranted reaching a different conclusion on the same prior art combination.

Nor did the differing burdens of proof resolve the inconsistency. The director acknowledged that an IPR applies the preponderance-of-the-evidence standard, while a Commission respondent challenging patent validity faces a higher burden. But the difference in standards, standing alone, did not explain why the two tribunals reached conflicting factual conclusions regarding the same claim limitation and prior art combination.

Finding no adequate justification for the divergence, the director vacated the Board’s final written decision and dismissed the IPR petition rather than remanding for further proceedings.

Practice Note: Parties litigating patent validity in parallel Board and Commission proceedings should expect prior findings from one forum to receive meaningful consideration in the other, particularly where the same parties, prior [...]

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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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Missed delivery: Institution decision statutorily unreviewable

by | May 7, 2026 | ,

Addressing the scope of appellate review under the America Invents Act, the US Court of Appeals for the Federal Circuit determined that challenges grounded in 35 U.S.C. § 312(a)(2)’s real-party-in-interest requirement are unreviewable where they are closely tied to the Patent Trial & Appeal Board’s institution decision. Fed. Express Corp. v. Qualcomm Inc., Case No. 24-1236 (Fed. Cir. Apr. 29, 2026) (Hughes, Cunningham, Stark, JJ.)

FedEx owns a patent related to sensor-based logistics systems that provide shipment information and allow customized access controls. After FedEx sued Roambee for infringement in district court, Qualcomm (although not a party to that litigation) filed inter partes review (IPR) petitions challenging the FedEx patent. Qualcomm identified the Roambee litigation as a related matter but did not list Roambee as a real party in interest.

FedEx opposed institution, arguing that Qualcomm’s failure to identify all real parties in interest violated § 312(a)(2), which requires that a petition identify all such parties before it may be considered. The Board instituted review and later denied FedEx’s motion to terminate, explaining that it would not decide the real-party-in-interest issue because doing so was unnecessary to resolve the proceeding absent a time-bar or estoppel concern. In its final written decision, the Board declined to revisit the issue and held the challenged claims unpatentable as obvious. FedEx appealed.

On appeal, the Federal Circuit declined to review FedEx’s real-party-in-interest challenges. Relying on Supreme Court precedent and its own case law, the Federal Circuit explained that § 312(a)(2) is a statutory prerequisite “closely tied” to institution because a petition may be considered only if it identifies all real parties in interest. Thus, challenges asserting that the Board failed to properly apply § 312(a)(2) necessarily attack the institution decision itself and fall within § 314(d)’s bar on appellate review.

The Federal Circuit rejected FedEx’s attempt to reframe its arguments as a challenge to the Board’s post-institution conduct, including the denial of FedEx’s motion to terminate. The Court explained that even when raised later in the proceeding, such arguments “boil down” to whether the Board should have instituted IPR in the first place. Because § 312(a)(2) operates as a prerequisite to institution, those challenges remain unreviewable.

Turning to the merits, the Federal Circuit vacated the Board’s obviousness determination as to several claims. The Board had found those claims obvious based on a combination of prior art because it believed FedEx had not contested that ground. Both parties agreed on appeal that this premise was incorrect: FedEx had in fact disputed the combination. Because the Board’s analysis rested on a mistaken understanding of the record and failed to address FedEx’s arguments or fully evaluate the prior art, the Court concluded that meaningful appellate review was not possible and vacated the Board’s obviousness determination.

The Federal Circuit declined FedEx’s request for outright reversal of the Board. The Court explained that reversal is appropriate only where the record supports a single outcome, but here unresolved factual issues remained, including whether the prior art satisfied the relevant claim [...]

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Tree-mendous award: Damages expert royalty opinions are lit

by | Mar 5, 2026 |

The US Court of Appeals for the Federal Circuit affirmed a damages verdict amounting to tens of millions of dollars. The Court found that the patentee’s damages expert correctly apportioned value to the patented feature and rejected challenges to her methodology. Willis Electric Co., Ltd. v. Polygroup Ltd., Case No. 24-2118 (Fed. Cir. Feb. 17, 2026) (Moore, Stark, Oetken, JJ.)

Willis sued Polygroup for infringing its patent related to pre-lit artificial trees with decorative lighting. In response, Polygroup filed multiple inter partes review (IPR) petitions challenging the asserted claims. Following extensive IPR proceedings, only a dependent claim that required coaxial trunk connectors remained for trial.

A jury found the claim infringed and not obvious, and awarded about $42.5 million in damages, equating to a $4-per-tree royalty. Polygroup moved for judgment as a matter of law of obviousness or, alternatively, for a new trial on damages. The district court denied both motions. Polygroup appealed.

Effect of prior IPR ruling

Polygroup argued that because the independent claim from which the asserted claim depended was held unpatentable, damages should be limited to only the incremental value of the coaxial connectors recited in the asserted dependent claim. The Federal Circuit rejected that argument, explaining that the IPR applied the broadest reasonable interpretation standard, while the district court construed the independent claim under the Phillips standard. Under the district court’s construction, the independent claim required forming simultaneous mechanical and electrical connections regardless of rotational orientation, a feature that was not required under the IPR construction. Because the independent claim had not been held unpatentable under the district court’s construction, the Federal Circuit reasoned that the IPR ruling did not preclude Willis from relying on that one-step functionality in calculating the value attributable to the coaxial connectors recited in the dependent claim.

The Federal Circuit emphasized that what value was attributable to the claimed coaxial connectors was a question of fact for the jury. Substantial evidence supported the jury’s finding that the value included rotationally independent, simultaneous connection functionality, not merely the physical presence of coaxial connectors.

Rule 702 and damages methodology

Willis’ damages expert presented two independent apportionment analyses.

Under an income-based approach, the expert compared profit margins for Willis’ “One Plug” trees and Polygroup’s Quick Set trees against comparable noninfringing trees to derive a royalty range. Under a market-based approach, she analyzed several license agreements to establish a reasonable royalty range, which she combined with her income approach to arrive at an expanded reasonable royalty range. She then applied the Georgia-Pacific factors to select a $5-per-tree royalty, resulting in a jury award of $4 per tree.

Polygroup argued that the expert failed to adequately apportion value and relied on non-comparable licenses and improper averaging methods. The Federal Circuit disagreed, emphasizing the district court’s gatekeeping role under Federal Rule of Evidence 702 while reinforcing the distinction between admissibility and weight.

The Federal Circuit explained that reasonable royalty determinations inherently involve approximation and uncertainty. Where an expert’s methodology is grounded in record evidence, including internal sales [...]

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The meaning is plain as day: Just follow the grammar

by | Feb 26, 2026 |

The US Court of Appeals for the Federal Circuit reversed and vacated a decision by the Patent Trial & Appeal Board, explaining that the Board failed to consider common textual modifier language when applying the plain meaning to a disputed claim term. Netflix, Inc. v. DivX, LLC, Case No. 24-1541 (Fed. Cir. Feb. 13, 2026) (Moore, C.J.; Dyk, Taranto, JJ.)

DivX sued Netflix for infringing its patent directed to systems and methods for streaming partly encrypted media content. The patent uses encryption/decryption, a Digital Rights Management (DRM) technique, to protect streams of media content from unauthorized access or copying. This technique requires that cryptographic information be relayed to the playback device for users to watch streamed media content. The patent explains that encrypting parts of streamed media decreases the resources needed for encryption/decryption and provides the playback device with information on the portions that are encrypted and “common” decryption information.

Netflix petitioned for inter partes review (IPR) of all claims on the basis of obviousness. The Board rejected DivX’s proposed construction of limitation [l] of the representative claim: “locating encryption information that identifies encrypted portions of frames of video within the requested portions of the selected stream of protected video.” DivX’s argued that the “encryption information” must be located “within the requested portions of the selected stream of protected video.” The Board deemed DivX’s proposed claim construction as “too restrictive,” concluding that the claim suggested that the encryption information just needed to identify encrypted portions of frames that themselves were “within the requested portions of the selected stream of protected video.”

In its final written decision, the Board agreed with Netflix that a person of skill in the art would have been motivated to combine the asserted prior art but held that the artisan would not have reasonably expected success in combining the prior art and that therefore Netflix did not establish obviousness of the challenged claims.

The Federal Circuit vacated the Board’s decision on appeal and remanded the matter. On remand, the Board again concluded that Netflix did not demonstrate obviousness but this time accepted DivX’s originally proposed claim construction. Netflix appealed.

The Federal Circuit found the Board’s construction of limitation [l] was erroneous, agreeing with Netflix that limitation [l] was taught by the asserted prior art combination. Using the plain language doctrine, the Court found that limitation [l] was susceptible to two interpretations: “the modifier ‘within the requested portions of the selected stream of protected video’ could modify either ‘encrypted portions of frames of video’ or ‘encryption information.’” Accordingly, the Court relied on the principle that where commas or other textual signals are not used, it is presumed that the modifier is tied to the nearest available semantically plausible modificand. The Court determined that only the “encrypted portions of frames of video” needed to be “within the requested portions of the selected stream of protected video.” The Federal Circuit also determined that the context of the claim itself, the specification, and the prosecution history supported the construction that [...]

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Direct injection fuel dispute fizzles

by | Jan 8, 2026 |

The US Court of Appeals for the Federal Circuit affirmed three Patent Trial & Appeal Board final written decisions finding claims of three related patents unpatentable as obvious and reiterated that challenges to the Board’s authority to institute inter partes review (IPR) proceedings are largely insulated from appellate review under 35 U.S.C. § 314(d). Ethanol Boosting Systems, LLC, et al. v. Ford Motor Co., Case Nos. 2024-1381; -1382; -1383 (Fed. Cir. Dec. 23, 2025) (Chen, Clevenger, Hughes, JJ.)

Massachusetts Institute of Technology (MIT) owns three related patents directed to fuel management systems for spark-ignition engines, which it exclusively licensed to Ethanol Boosting Systems (EBS). The patents disclose systems using both port fuel injection and direct injection to suppress engine knock by injecting an anti-knock agent, with increasing use of direct injection at higher torque levels.

EBS sued Ford for patent infringement. During claim construction, EBS and Ford disputed the meaning of claim terms related to “direct injection” fuel. EBS proposed the plain and ordinary meaning and no constraints on the term. Ford proposed terms requiring a fuel that is different from fuel used in port injunction systems and contains an anti-knock agent other than gasoline. While claim construction was pending, Ford filed IPR petitions using EBS’s proposed claim construction.

While Ford’s IPR petitions were pending, the district court adopted Ford’s construction and entered summary judgment of noninfringement. EBS appealed, and the Federal Circuit vacated and remanded the district court’s decision. Before the Federal Circuit had decided the appeal, the Board denied institution on all three IPR petitions primarily because it, like the district court, construed the direct injection fuel terms to require fuel different from the fuel used in the port injector. After the Federal Circuit decision, the Board granted rehearing, instituted IPRs, and ultimately found the challenged claims unpatentable as obvious. EBS appealed the Board’s final written decisions.

Institution challenge barred under § 314(d)

EBS argued that the Board acted unlawfully by effectively “staying” its decision on Ford’s rehearing request for more than a year while awaiting the Federal Circuit’s ruling on the district court appeal, and that the resulting institution decisions should therefore be vacated.

The Federal Circuit rejected this argument, finding that it was, in substance, an impermissible challenge to the Board’s institution determinations. The Court explained that § 314(d) bars appellate review not only of institution decisions themselves, but also of challenges “closely related” to those determinations. Characterizing the Board’s delay as an ultra vires “stay” did not change the analysis, particularly since no statutory deadline governed the timing of rehearing decisions and no IPR had yet been instituted.

The Federal Circuit further noted that the narrow exceptions to § 314(d), such as colorable constitutional claims, did not apply because EBS failed to raise a viable due process or other constitutional argument.

Claim construction: District court rulings don’t control

EBS next argued that the Board was bound by the district court’s earlier claim construction (applied during the prior Federal Circuit appeal) requiring a non-gasoline anti-knock [...]

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Applicant-admitted prior art may inform but can’t be basis for IPR challenges

by | Jul 24, 2025 |

The US Court of Appeals for the Federal Circuit clarified that while applicant-admitted prior art (AAPA) may be cited as evidence of general background knowledge in inter partes review (IPR) proceedings, it cannot serve as the basis for an IPR ground. The Court also confirmed that the petitioner had Article III standing to cross-appeal based on concrete plans for future activity. Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., Case No. 23-1864 (Fed. Cir. July 14, 2025) (Lourie, Dyk, Cunningham, JJ.)

Shockwave Medical owns a patent directed to treating atherosclerosis using a balloon catheter in combination with shockwaves generated by electrodes and a pulse generator. The patent specification acknowledged that “over-the-wire angioplasty balloon catheters” were well known in the art. Cardiovascular Systems, Inc. (CSI) filed an IPR petition asserting that it would have been obvious to modify a European patent application with the angioplasty balloon catheter disclosed in the AAPA.

The Patent Trial & Appeal Board found all but one claim unpatentable as obvious, relying on the AAPA solely as evidence of background knowledge. Both parties appealed.

Shockwave challenged the Board’s reliance on the AAPA, arguing that 35 U.S.C. § 311(b) prohibits using AAPA as a basis for an IPR petition. The Federal Circuit disagreed, reaffirming its prior decisions in Qualcomm I and Qualcomm II. In Qualcomm I, the Court explained that AAPA cannot be the basis of a ground in an IPR petition but can be evidence of background knowledge. In Qualcomm II, the Court found that the Board erred in determining that the use of AAPA was proper when the petitioner expressly included AAPA in one of its grounds. Relying on these decisions, the Court explained that while AAPA cannot form the basis of a ground in an IPR petition, it may be used to demonstrate the general knowledge of a person of ordinary skill in the art and to supply missing claim limitations.

Shockwave pointed to a table in the Board’s final written decision listing AAPA under “reference(s)/basis” as evidence that the Board improperly relied on AAPA as a ground. The Federal Circuit rejected this argument, distinguishing Qualcomm II and emphasizing that the petitioner, not the Board, defines the grounds for review. Because CSI did not rely on AAPA as a ground, its use was permissible.

CSI cross-appealed the Board’s finding that one claim was not obvious. Shockwave challenged CSI’s standing, but the Federal Circuit found that CSI had Article III standing because it had concrete plans to begin clinical trials and because of Shockwave’s public statements suggesting it would assert the patent. The Court concluded that these facts created a substantial risk of future infringement.

On the merits, the Federal Circuit agreed with CSI that the Board erred by failing to consider the prior art as a whole. The Court reiterated that the obviousness inquiry requires evaluating the combined teachings of the prior art, not individual references in isolation. Finding no evidence to support the Board’s conclusion, the Court reversed the Board’s decision as to the remaining [...]

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Motivation, expectation of success negate obviousness presumption in overlapping range case

by | Jul 17, 2025 |

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the presumption of obviousness does not apply automatically and must be grounded in specific factual findings, particularly regarding a skilled artisan’s motivation and expectations. Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 25-1228 (Fed. Cir. July 8, 2025) (Prost, Reyna, Taranto, JJ.)

Janssen sued Teva under the Hatch-Waxman Act in 2018 after Teva filed an abbreviated new drug application (ANDA) seeking approval for a generic version of Janssen’s drug. Teva stipulated infringement but challenged the patent’s validity, arguing that all claims were obvious in light of prior art. The patent at issue covered a dosing regimen involving two “loading doses” spaced about a week apart, followed by monthly maintenance injections, designed to improve patient compliance compared to traditional oral dosing.

In 2021, the district court rejected Teva’s obviousness arguments, citing key differences between the claims and prior art, including the specific dosage amounts, the sequence of administration, and the requirement for deltoid injections. In 2024, the Federal Circuit initially vacated that decision and remanded for further analysis. On remand, the district court again found the claims nonobvious, and Teva appealed again.

A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. Teva argued that a presumption of obviousness should apply because the prior art disclosed equal loading doses (150 or 100 mg-eq) within the claimed range. The Federal Circuit disagreed, emphasizing that the presumption depends on factual premises (such as a skilled artisan’s motivation to optimize and expectations from routine experimentation), which were not met here. The Court noted that Janssen’s specific choice of a higher first dose followed by a lower second dose did not clearly fall within the presumption’s scope.

Turning to the obviousness analysis, the Federal Circuit found that the three primary prior art references did not disclose a loading-dose regimen. Teva’s additional references, which it claimed taught dose reduction strategies, were also deemed insufficient. The Court found that one expert cited a reference recommending a high first dose for acutely ill patients while another noted that long-acting injectables were not typically used for such patients. The Court found that the prior art taken as a whole undermined Teva’s position.

Teva further contended that the district court improperly considered safety and efficacy (factors not recited in the claims) and erred in finding that the multidose regimen added complexity that would discourage a skilled artisan. The Federal Circuit rejected these arguments, affirming that the district court appropriately considered the motivation to develop a safe and effective regimen and correctly found that the prior art lacked relevant safety or efficacy data for multidose approaches.



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