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 control were required, the evidence was sufficient because Meritain and ProAct allegedly referred patients to international suppliers, paid invoices associated with the transactions, and provided data facilitating the importation.
Practice note: Gilead underscores that authentic branded goods intended for foreign markets may still create Lanham Act exposure when they materially differ from authorized US products or fall outside the trademark owner’s quality-control system. The decision also highlights potential contributory infringement exposure for healthcare companies and other intermediaries that continue facilitating gray-market transactions after they know or have reason to know of the underlying infringement.
