IP UPDATE
Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
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No venue, no problem: Improper venue doesn’t bar district court from deciding validity challenge

by | Sep 10, 2026 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal on both improper venue and patent eligibility grounds, finding no abuse of discretion in the district court’s decision to decide a Rule 12 (b)(6) patent eligibility challenge after first determining that venue was improper. AML IP, LLC v. Bath & Body Works Direct, et al., Case No. 2025-1280 (Fed. Cir. Aug. 28, 2026) (Prost, Bryson, Reyna, JJ.)

AML IP sued Bath & Body Works Direct in the US District Court for the Eastern District of Texas, alleging infringement of a patent directed to e-commerce methods. The defendants moved to dismiss under Federal Rule of Civil Procedure 12(b)(3) for improper venue and Rule 12(b)(6) for failure to state a claim, arguing that the asserted patent claims were ineligible under 35 USC § 101. The district court first determined that AML had failed to establish proper venue under 28 USC § 1400(b), concluding that “[f]or this reason alone, the case should be dismissed.” It nevertheless proceeded to the defendants’ Rule 12(b)(6) arguments and concluded that the asserted claims were patent ineligible under § 101. AML appealed.

AML did not challenge the merits of either ruling. Instead, it argued that once the district court determined that venue was improper, it should have stopped and dismissed the case solely on that basis rather than addressing patent eligibility.

Because AML’s challenge concerned the district court’s docket-management authority (an issue not unique to patent law), the Federal Circuit applied Fifth Circuit law and reviewed the district court’s decision for abuse of discretion. The Federal Circuit emphasized that AML did not contend that the district court lacked authority to decide the Rule 12(b)(6) motions after finding venue improper. Rather, AML argued only that the district court should have declined to do so.

The Federal Circuit rejected AML’s reliance on cases stating that venue motions should receive “top priority.” Those cases, the Court explained, generally require a district court to address venue before proceeding to substantive matters, but they do not necessarily restrict what a district court may do after determining that venue is improper. The district court here complied with that principle by resolving venue first and even staying the litigation while the dismissal motions were pending.

The Federal Circuit also noted that the “top priority” principle is intended primarily to protect a party challenging venue from being forced to litigate substantive issues in an objectionable forum. Here however, it was AML – the plaintiff that had selected the Eastern District of Texas – that sought to invoke the priority principle, rather than the defendants that had challenged venue.

AML separately relied on district court decisions in which courts resolved venue motions without deciding pending merits motions. The Federal Circuit found those decisions distinguishable. They reflected the “common-sense principle” that district courts ordinarily should decide venue first when transfer may be appropriate so that the transferee court can resolve substantive issues. No transfer was at issue here. The district court dismissed for improper [...]

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Chemical structure, formula, and name support written description of pharmaceutical genus

by | Sep 10, 2026 | ,

The US Court of Appeals for the Federal Circuit affirmed that a patent’s specification provided adequate written description support for genus claims directed to crystalline cabozantinib (L)-malate salts because it disclosed structural features common to the claimed genus. Exelixis, Inc. v. MSN Laboratories Private Ltd., Case No. 25-1236 (Fed. Cir. Aug. 31, 2026) (Stoll, J.; Moore, C.J.; Moore, District J., sitting by designation).

Exelixis holds the New Drug Application for Cabometyx®, a cancer treatment containing cabozantinib (L)-malate. MSN sought US Food and Drug Administration approval to market a generic cabozantinib (L)-malate product. Exelixis asserted three related patents directed, respectively, to crystalline cabozantinib (L)-malate salts, pharmaceutical formulations containing those salts, and methods of treating cancer using the salts. The patents share a common specification. Exelixis also asserted a separate patent directed to cabozantinib (L)-malate compositions containing low levels of a genotoxic impurity. MSN sought FDA approval to market a generic cabozantinib (L) malate product.

MSN conceded infringement of the crystalline malate salt patents but argued that the asserted claims were invalid for lack of written description under 35 USC § 112(a). After a bench trial, the district court rejected that challenge. As to the low-impurity formulation patent, the district court found no infringement and concluded that MSN had failed to establish invalidity based on inherent obviousness. MSN appealed.

Addressing written description, the Federal Circuit applied the framework for genus claims set forth in its 2010 Ariad Pharmaceuticals. v. Eli Lilly & Co decision. A specification may demonstrate possession of a genus by disclosing either a representative number of species or structural features common to the genus that allow a skilled artisan to visualize or recognize its members.

The Federal Circuit found no clear error in the district court’s determination that the common specification adequately disclosed structural features of the claimed genus. In particular, the specification identified the chemical name and formula of cabozantinib (L)-malate and specified that the claimed salt had a crystalline structure. The claims were correspondingly limited to crystalline cabozantinib (L)-malate salts. The specification also disclosed processes for preparing crystalline and amorphous forms, although the Court noted that those disclosures were not dispositive of written description.

The Federal Circuit rejected MSN’s argument that the specification failed to describe the genus because different crystalline polymorphs could possess different properties, such as density, melting point, and solubility. The Court explained that those characteristics were not claimed and that MSN had not shown why differences in unclaimed properties undermined the district court’s finding that the specification identified structural features common to the claimed genus.

The Court therefore affirmed the district court’s determination that the crystalline malate salt claims satisfied the written description requirement.

The Federal Circuit separately addressed MSN’s appeal concerning the low-impurity formulation patent. The district court had found the asserted claim not infringed and not invalid, concluding that MSN failed to prove that the prior art inherently produced a formulation containing no more than the claimed level of a genotoxic impurity. Exelixis initially appealed the noninfringement ruling but later dismissed [...]

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Shared function sufficient for a proper Markush group

by | Sep 10, 2026 |

In a recently designated informative decision, the Patent Trial & Appeal Board reversed an examiner’s rejection of claims reciting structurally distinct microRNAs (miRNAs) as an improper Markush group. The Board found the claimed alternatives sufficiently related because they performed similar functions in the context of the invention. Ex parte Chowdhury, Appeal No. 2025-002261 (PTAB Feb. 5, 2026) (Flax, Katz, Hardman, A.P.JJ.) (designated informative Aug. 25, 2026).

The patent application at issue concerns methods for assessing and treating radiation-induced damage using levels of particular miRNAs in a patient’s serum. The claims recited groups of different miRNAs whose measured levels could be used to assess radiation damage and inform treatment decisions.

The examiner rejected the claims as containing improper Markush groupings. The examiner found that the recited miRNAs did not share substantial structural similarity because each had a different nucleotide sequence. Their only structural similarity was that each comprised nucleotides. The examiner also found that the miRNAs did not belong to a recognized chemical class that would have been expected to behave similarly or to be interchangeable for achieving the same result.

The Board reversed. It explained that a proper Markush group generally requires the listed alternatives to belong to a recognized physical or chemical class or to be sufficiently related by a common property or function. In assessing that requirement, however, the relevant inquiry is whether the alternatives are interchangeable for the purposes of the claimed invention.

The Board found that the claimed miRNAs satisfied that standard. Although the individual miRNAs were structurally different and did not necessarily perform the same biological function, the claims did not depend on those biological functions. Instead, each miRNA served the same claimed purpose: its serum level could be quantified and used as an indicator relevant to radiation-induced damage and treatment.

As the Board explained, the listed miRNAs did not need to function biologically in the same manner or produce the same biological result. They needed only to be quantifiable and interchangeable as markers for the purposes of the claimed method. Because the specification described the recited miRNAs as performing that common function, the Board found that they constituted a proper Markush grouping.



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Result-oriented claims fail to pass § 101 muster; industry standards may prove individual claim limitations

by | Sep 10, 2026 |

The US Court of Appeals for the Federal Circuit concluded that claims broadly directed to optimizing signal constellations for a particular result were patent ineligible, but upheld claims directed to specific constellations. The Court also confirmed that industry standards may be used on a limitation-by-limitation basis to prove infringement. Constellation Designs LLC v. LG Electronics Inc., et al., Case No. 24-1822 (Fed. Cir. Aug. 31, 2026) (Stoll, Lourie, JJ.; Oetken, District J., sitting by designation).

Constellation Designs sued LG for infringement of four patents directed to digital communication systems using signal constellations to transmit and decode data. Constellation accused LG televisions compatible with the ATSC 3.0 over-the-air television broadcast standard, specifically its A/322 protocol. The asserted claims fell into two groups: claims reciting geometrically spaced symbol constellations optimized for capacity using parallel decode (PD) capacity (optimization claims) and claims reciting specific non-uniform constellations (constellation claims).

The district court granted Constellation summary judgment that all asserted claims were patent eligible under 35 USC § 101. Following trial, a jury found that LG willfully infringed the asserted claims and awarded Constellation about $1.68 million in damages. The district court denied LG’s post-trial motions challenging infringement and damages, and entered an ongoing royalty of $6.75 per television. LG appealed.

Addressing patent eligibility, the Federal Circuit distinguished between the optimization claims and the constellation claims. At step one of the Alice framework, the Court concluded that the optimization claims were directed to the abstract idea of optimizing a constellation for PD capacity. The claims recited a desired result (improved capacity at a reduced signal-to-noise ratio) but did not recite how to achieve that result. The Court analogized the claims to the result-oriented claims found ineligible in other cases, explaining that the claims broadly covered essentially all ways of optimizing a constellation for PD capacity.

Although the specification described techniques for performing the optimization, the claims did not recite those details. The Federal Circuit explained that the § 101 inquiry focuses on the claim language and that technical details disclosed only in the specification cannot be imported into the claims to establish eligibility. At Alice step two, the Court found no inventive concept because Constellation’s alleged inventive concept (optimizing non-uniform constellations based on PD capacity) was the abstract idea itself. The Court therefore vacated the district court’s summary judgment of eligibility as to the optimization claims.

The Federal Circuit reached a different conclusion as to the constellation claims. Those claims did not broadly claim optimization but instead recited specific constellations developed using techniques described in the patents. The Court found that this distinction “makes all the difference” because the constellation claims recited a concrete implementation of a technological improvement directed to overcoming limitations in constellation capacity. The Court therefore affirmed the district court’s finding that those claims were patent eligible.

The Federal Circuit also affirmed the denial of LG’s motion for judgment as a matter of law of noninfringement. At trial, Constellation relied on the ATSC 3.0/A/322 standard to establish that the accused device met [...]

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Now you know the limits on patent rights: Diversion of resources doesn’t establish standing

by | Sep 3, 2026 |

Concluding that an organization cannot establish standing to seek prospective relief merely by alleging that it diverted resources in response to challenged conduct, the US Court of Appeals for the Federal Circuit affirmed dismissal of claims brought by inventor-advocacy organizations challenging language on the cover of issued patents because the organizations lacked both organizational and associational standing. US Inventor, Inc. v. Squires, Case No. 24-2378 (Fed. Cir. Aug. 21, 2026) (Moore, Cunningham, Kovner (sitting by designation), JJ.)

The cover of each newly issued patent includes language tracking the Patent Act, stating that the patent “grants to the persons having title to this patent the right to exclude others from making, using, offering for sale, or selling” the invention throughout the United States or importing the invention into the US. Three inventor advocacy organizations – US Inventor, Inventors Association of South Central Kansas, and Inventors Network of Minnesota – sued the United States Patent and Trademark Office (USPTO) and its acting director, alleging that this language was misleading in light of the Supreme Court’s 2006 decision in eBay v. MercExchange.

Plaintiffs contended that eBay eliminated any absolute right of a patent owner to exclude others because injunctive relief is no longer automatic upon a finding of infringement. They sought an order requiring the USPTO to change the patent cover language, an injunction prohibiting the USPTO from representing that patent owners possess an unequivocal right to exclude, and a declaration that the existing language is unlawful. The district court dismissed the complaint for lack of standing. Plaintiffs appealed.

The Federal Circuit affirmed, concluding that plaintiffs had not adequately alleged a real and immediate threat of future injury sufficient to support prospective injunctive or declaratory relief.

First, the Federal Circuit concluded that plaintiffs lacked organizational standing. An organization suing on its own behalf must satisfy the ordinary requirements of Article III standing, including demonstrating a concrete and imminent threat of future injury. Relying on the Supreme Court’s 2024 decision in FDA v. Alliance for Hippocratic Medicine, the Court explained that an organization does not suffer a cognizable injury merely because challenged conduct causes it to spend additional “time, energy, and resources on advocacy and education.”

Plaintiffs relied on a similar diversion-of-resources theory, alleging that the USPTO’s patent cover language required them to devote resources to educating inventors about the effect of eBay, thereby impairing their ability to pursue their organizational missions. The Federal Circuit found those allegations insufficient.

The Federal Circuit also rejected plaintiffs’ reliance on the Supreme Court’s 1982 decision in Havens Realty v. Coleman. In Havens, the challenged conduct directly interfered with the organization’s core activities because racial steering practices caused the organization to receive false housing information that it then passed along to home seekers. Here, by contrast, plaintiffs were aware of eBay and therefore were not themselves misled by the patent cover language. Their alleged injury instead arose from their decision to educate unidentified inventors who might misunderstand that language. Rather than alleging that the USPTO directly impeded their [...]

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Off the mark: NPE licensees must comply with patent marking for pre-suit damages

by | Aug 27, 2026 |

Affirming dismissal of a patent infringement complaint and an award of attorneys’ fees, the US Court of Appeals for the Federal Circuit reiterated that a nonpracticing entity (NPE) seeking pre-suit damages cannot disregard its licensees’ obligations under the patent marking statute, and that a pattern of abusive litigation conduct supports an exceptional case finding under 35 U.S.C. § 285. VDPP, LLC v. Volkswagen Group of America, Inc., Case No. 24-2226 (Fed. Cir. Aug. 19, 2026) (Moore, Lourie, Cunningham, JJ.)

VDPP, an NPE, sued an auto manufacturer for infringement of a patent directed to electrically controlled spectacles. The district court dismissed the complaint under Rule 12(b)(6) and denied leave to amend as futile. Because VDPP sought pre-suit damages, it was required to plead compliance with 35 U.S.C. § 287(a), including compliance by its licensees.

VDPP had entered into 11 settlement agreements that included patent licenses, but its proposed amended complaint did not allege that any licensee had marked its products. Instead, VDPP relied on its status as an NPE and asserted that it had no products of its own to mark. VDPP appealed the district court’s dismissal and fee award.

The Federal Circuit affirmed. Although a patentee that does not make or sell patented products may not have products of its own to mark, its licensees remain subject to § 287’s marking requirements. The Court rejected VDPP’s attempt to distinguish licenses granted through settlement agreements, explaining that a settlement license is no different for marking purposes from any other patent license. The Court noted that all 11 settlement agreements were structured as licenses and that one expressly stated that the licensee had no obligation to mark. Because VDPP could not plausibly allege that it made reasonable efforts to ensure compliance by its licensees, the Court affirmed the denial of leave to amend as futile.

The Federal Circuit also affirmed the district court’s exceptional case determination and fee award under § 285. The district court relied on several aspects of VDPP’s litigation conduct, including seeking future damages and injunctive relief on an expired patent, failing to disclose relevant settlement agreements despite being reminded of them, and advancing positions the district court characterized as frivolous.

The Federal Circuit rejected VDPP’s argument that conduct must independently satisfy Rule 11 before it may support an exceptional case finding. It also concluded that the district court properly considered VDPP’s broader pattern of filing patent infringement suits followed by low-value settlement demands, noting that such a pattern is relevant to an exceptional case determination where adequate evidence of an abusive litigation strategy is presented.

The Federal Circuit dismissed the appeal as to sanctions imposed on VDPP’s counsel for lack of jurisdiction. VDPP’s counsel’s notice of appeal listed only VDPP as the appellant, and the counsel’s name appeared only incidentally within a description of the orders being appealed. Corrected notices filed more than 90 days after entry of the orders came too late. The Court also rejected VDPP’s argument that it had standing to contest its own counsel’s [...]

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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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Ministerial requirements aren’t enough: Post-AIA prior art priority requires § 112 written description support

by | Aug 20, 2026 | ,

The US Court of Appeals for the Federal Circuit vacated a Patent Trial & Appeal Board final written decision finding challenged claims obvious, concluding that the Board applied the wrong legal standard in determining whether an asserted prior art reference could obtain the filing date of an earlier provisional application based only on satisfaction of “ministerial requirements.” Dental Monitoring SAS v. Align Technology, Inc., Case No. 25-1752 (Fed. Cir. Aug. 10, 2026) (Lourie, Stall, Taranto, JJ.)

Dental Monitoring owns a patent directed to a method for acquiring and analyzing an image of a patient’s dental arch. Align Technology petitioned for inter partes review (IPR) of the patent based on three references: Salah, Carrier, and Maninis.

Carrier’s status as prior art was central to the dispute. Carrier claimed priority to a provisional application filed before the effective filing date of Dental Monitoring’s patent, but Carrier’s nonprovisional application was filed afterward. Thus, Carrier qualified as prior art only if it could obtain the benefit of its provisional application’s filing date under America Invents Act (AIA) § 102(d)(2).

Dental Monitoring argued that under the Federal Circuit’s 2015 decision in Dynamic Drinkware v. National Graphics, Carrier could rely on the provisional filing date only if the provisional provided written description support for at least one claim of Carrier. The Board disagreed, concluding that Dynamic Drinkware addressed only pre-AIA law. Instead, relying on its precedential decision in Penumbra v. RapidPulse, the Board determined that a reference patent receives the filing date of an earlier application for AIA prior art purposes if it satisfies the “ministerial requirements” of §§ 119 and 120 and the earlier application describes the subject matter relied upon in the reference. Because Carrier’s provisional described the relied-upon subject matter, the Board treated Carrier as prior art as of the provisional filing date.

On the merits, the Board found the claims unpatentable as obvious over a combination of three references. Dental Monitoring appealed.

The Federal Circuit reviewed the statutory question de novo, concluding that §§ 102(d)(2), 119(e)(1), and 112(a) foreclosed the Board’s ministerial requirements approach.

Section 102(d)(2) provides that a patent or patent application may be effectively filed for prior art purposes as of an earlier application’s filing date if it is “entitled to claim a right of priority” under § 119 or the benefit of an earlier filing date under § 120. Section 119(e)(1), in turn, permits a nonprovisional application to claim priority to a provisional only when the invention disclosed in the later application is disclosed in the provisional “in the manner provided by” § 112(a). The Federal Circuit therefore concluded that § 102(d)(2) incorporates § 112(a)’s substantive written description requirement. The Court also found further support in the phrase “entitled to claim a right of priority,” because an applicant would only be “entitled to claim priority” by fulfilling the statutory requirements, including § 112’s written description requirement.

Align argued that Dynamic Drinkware did not apply because its analysis was limited to the pre-AIA version of § [...]

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Unplugged: Claim construction errors, presumption of harm short-circuit preliminary injunction

by | Aug 13, 2026 |

The US Court of Appeals for the Federal Circuit vacated a preliminary injunction, finding that the district court improperly imported a spatial limitation into the claim term “backplate” and erroneously treated the structural term “pin” as a means-plus-function limitation. The Court also reiterated that in preliminary injunction proceedings, a strong showing of validity and infringement does not give rise to a presumption of irreparable harm. Socket Solutions, LLC v. Import Global, LLC, Case No. 25-1121 (Fed. Cir. Aug. 4, 2026) (Moore, C.J.; Prost, J.; Seeborg, Distr.J. (sitting by designation)).

Socket Solutions owns a patent directed to an indoor electrical outlet cover designed to conceal an outlet’s contact openings while permitting continued use of the outlet. Socket Solutions sued Import Global, alleging that Import Global’s Neat Socket product infringed. Socket Solutions also moved for a preliminary injunction. Adopting a magistrate judge’s reports and recommendations, the district court granted the injunction, barring Import Global from making, using, selling, offering to sell, or importing the accused product. Import Global appealed.

The Federal Circuit first addressed the district court’s construction of “backplate.” The district court construed the term as the component of the cover opposite the frontplate that included at least one set of electrical prongs. Import Global argued that the backplate instead referred to the portion of the cover closest to the wall outlet.

The Federal Circuit rejected both constructions because each imposed a spatial relationship not required by the specification. Looking to the written description, the Court explained that the backplate was used to define the thickness of the outlet cover. The Court therefore construed “backplate” as the component that, together with the frontplate, formed the cover such that the cover’s maximum thickness was measured between the frontplate and that component at the cover’s central portion. The Court also declined to require the backplate itself to include electrical prongs. Because the asserted claim separately recited that limitation, incorporating it into the construction of “backplate” would improperly render other claim language superfluous.

The Federal Circuit next concluded that the district court erred by construing “pin” as a means for making an electrical connection between a wire and a corresponding prong, effectively treating the term as a means-plus-function limitation under Section 112(f). Because the claim did not use the word “means,” the presumption against application of Section 112(f) applied. The Court found that the presumption was not overcome because the specification described a “pin” structurally, and the parties agreed that a skilled artisan would understand a pin to identify structure.

The Federal Circuit rejected Socket Solutions’ proposed purely functional construction as too broad because not every structure capable of connecting a wire to a prong is necessarily a pin. It likewise rejected Import Global’s proposed “mechanical system” construction as unsupported by the specification. Finding neither lexicography nor disavowal, the Court concluded that “pin” should receive its plain and ordinary meaning.

Finally, the Federal Circuit addressed the district court’s irreparable harm analysis. Although the Court did not decide whether Socket Solutions had established irreparable harm, [...]

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Not even a thread left: Single reference anticipation, missing claim limitation entitle defendant to JMOL

by | Aug 6, 2026 |

The US Court of Appeals for the Federal Circuit reversed a judgment of infringement, concluding that the asserted patent claims were anticipated by a single prior art reference and that the accused products did not satisfy a limitation under the district court’s claim construction. As a result, the Court concluded that the defendant was entitled to judgment as a matter of law (JMOL) of both invalidity and noninfringement. Board of Regents of the University of Texas v. Boston Scientific Corp., Case Nos. 24-2062; -2063 (Fed. Cir. July 27, 2026) (Taranto, Bryson, Cunningham, JJ.)

The Board of Regents of the University of Texas (UT) owns a patent directed to a composition containing at least one biodegradable polymer fiber that includes one or more dispersed therapeutic agents. The claimed invention may be used with commercially available stents to deliver drugs at the site where the stent is placed.

In 2017, UT sued Boston Scientific Corporation (BSC), alleging that BSC’s drug-eluting coronary stent systems infringed UT’s patent. Following claim construction, the case proceeded to trial. The jury found that BSC willfully infringed the asserted claims and rejected BSC’s argument in its motion for JMOL that the claims were anticipated by a prior art reference known as Song. The jury awarded damages to UT. The district court subsequently set aside the willfulness finding as legally unsupported but otherwise upheld the verdict. BSC appealed the infringement and validity rulings, and UT cross-appealed the district court’s decision overturning the willfulness verdict.

The Federal Circuit reversed the judgment for UT, finding that BSC was entitled to JMOL that the asserted claims were invalid as anticipated and, independently, that BSC did not infringe.

Addressing anticipation, the Federal Circuit concluded that Song disclosed each limitation of the asserted independent claim. Song taught the claimed biodegradable polymer fiber and disclosed the claimed “second phase” limitation. The Court explained that Song’s noncontiguous drug phases satisfied the requirement for discrete drug-containing regions.

The asserted dependent claims added limitations expressed in Markush-group form. Because Song disclosed at least one member of each claimed Markush group, the Federal Circuit concluded that those claims were also anticipated. The Court further found that Song disclosed the claimed release of a drug at varying rates.

The Federal Circuit separately concluded that BSC was entitled to JMOL of noninfringement. Under the district court’s claim construction, the asserted claims required a “thread-like” structure. The Court determined that UT’s evidence did not establish the presence of such a structure in BSC’s accused stent coatings.

UT’s infringement theory relied on sections of the coating that had been artificially separated for purposes of analysis. The Federal Circuit concluded that no reasonable jury could characterize those artificially isolated portions as the claimed thread-like structure. BSC therefore was entitled to JMOL of noninfringement.



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