IP UPDATE
Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law

A prescription for liability: Injunction in gray-market drug case based on material differences

by | Aug 27, 2026 | ,

Affirming a preliminary injunction, the US Court of Appeals for the Fourth Circuit found that companies importing foreign-market pharmaceuticals for domestic patients were likely liable for trademark infringement, and that healthcare administrators and pharmacy benefit managers that continued facilitating those transactions despite reason to know of the infringement were likely liable for contributory infringement. Gilead Sciences, Inc. v. Meritain Health, Inc., Case No. 25-1828 (4th Cir. Aug. 13, 2026) (Agee, Harris, Keenan, JJ.)

Gilead sued a group of companies involved in filling US patient prescriptions for the HIV drug Biktarvy® with a Gilead-branded version of the drug intended for Turkey. Gilead alleged that the defendants’ importation and distribution of the Turkish-market product infringed its trademarks under the Lanham Act. In addition to suing companies directly involved in sourcing and supplying the prescriptions, Gilead sued Meritain Health, the third-party administrator of the relevant healthcare plan, and ProAct, a pharmacy benefit manager, for contributory infringement.

Shortly after filing suit, Gilead moved for a temporary restraining order and then a preliminary injunction enjoining the defendants from importing gray-market versions of Biktarvy®. The district court granted the requested relief, finding that Gilead had demonstrated a likelihood of success on its direct infringement claims against certain defendants and its contributory infringement claims against others. Meritain, ProAct, and the other defendants appealed.

The defendants first argued that the Federal Food, Drug, and Cosmetic Act (FDCA) precluded Gilead’s Lanham Act claims. Although the Turkish version of Biktarvy® was not US Food and Drug Administration approved, Gilead did not premise its trademark claims on that fact. The Fourth Circuit therefore concluded that adjudicating Gilead’s claims did not require enforcement or interpretation of the FDCA.

The defendants also challenged the district court’s likelihood-of-confusion finding, emphasizing that Gilead itself manufactured the Turkish version of Biktarvy® and that the product bore authentic Gilead trademarks. The Fourth Circuit disagreed, explaining that goods bearing a genuine trademark may nevertheless be considered nongenuine for trademark purposes if they materially differ from the authorized domestic product or are sold outside the trademark owner’s quality-control procedures.

Although the Turkish and US versions of Biktarvy® were chemically identical, the Fourth Circuit found material differences between them. Among other things, the Turkish product contained foreign-language labeling and lacked certain warnings and patient information provided with the US version. The Turkish product also was not transported through Gilead’s quality-control system. Those differences were sufficient to support the district court’s finding of material differences.

The Fourth Circuit also rejected Meritain and ProAct’s challenges to the contributory infringement ruling. The Court explained that contributory infringement does not require actual knowledge of another party’s infringement. Liability may arise where a defendant knew or should have known of the infringement and nevertheless continued supplying products or services that facilitated it.

The Fourth Circuit further rejected Meritain and ProAct’s argument that contributory infringement required proof that they exercised control over the direct infringers. In doing so, the Court declined to adopt the Ninth Circuit’s control requirement. The Fourth Circuit also concluded that even if [...]

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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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Senate passes bill to improve CBP mechanisms to block importation of counterfeit goods

by | Aug 20, 2026 | ,

Blocking the importation of counterfeit goods could soon become easier. On August 7, 2026, the US Senate unanimously passed S 2677, a bill that would allow greater coordination between US Customs & Border Protection (CBP) and relevant stakeholders in determining whether imported goods violate trademark or copyright law.

Sponsored by Senator Chuck Grassley and co-sponsored by Senator Margaret Wood Hassan, S 2677 would amend 19 U.S.C. § 1628a to authorize CBP to share nonpublic information to rightsholders for examination when assessing potential copyright or trademark violations. The bill would also expand the parties with which CBP may share information. While current law permits disclosure only to certain rightsholders, S 2677 would allow CBP to share information with “any other party with an interest in the merchandise, as determined appropriate by the Commissioner.” The bill would also permit such information sharing when CBP has a “reasonable suspicion” of a violation, rather than requiring officials to “suspect” one.

The US House of Representatives passed a very similar bill, HR 4930, on April 27, 2026, and the two versions will need to be reconciled. During House Ways and Means Committee proceedings, Chief Trade Counsel Joshua Snead and Representatives Blake Moore and Bradley Schneider explained that the legislation responds to concerns raised by CBP about constraints under existing law. According to Snead, CBP requested the changes and expressed concerns under both the Biden and Trump administrations that the Defend Trade Secrets Act could prevent it from sharing information useful to intellectual property enforcement. Representative Moore said the legislation would help CBP “recognize and flag patterns of behavior” by repeat offenders.



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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