On August 13, 2026, Patterson Belknap secured a significant appellate victory for our client, Gilead Sciences, Inc. (“Gilead”), in a trademark lawsuit brought to stop the alleged illegal importation and sale in the United States of international, non-FDA-approved Gilead medicines. The Court of Appeals for the Fourth Circuit affirmed the district court’s issuance of a preliminary injunction against all defendants in the action, enjoining them from violating Gilead’s trademark rights by importing or facilitating the importation of these foreign medicines through illicit and potentially unsafe channels.

The lawsuit was initially filed in the U.S. District Court for the District of Maryland in December 2024, after Gilead received a report from a concerned physician that a Maryland patient had received through the mail bottles of HIV medicine that he could not read because the bottles and patient instructions were entirely in the Turkish language. Gilead’s investigation revealed that the medicine had been manufactured in Turkey solely for the Turkish market, and had been illegally shipped from a pharmacy in Turkey directly to the U.S. patient through the patient’s employer-sponsored health insurance. Gilead filed suit against several Defendants alleged to have been involved in the unlawful importation of Gilead medicines from foreign countries, including the third-party administrator and pharmacy benefit manager (“PBM”) for the patient’s health plan, “alternative funding programs” that source international prescription drugs, and direct importers. Gilead alleged that the Defendants violated Gilead’s U.S. trademark rights by facilitating the importation of Gilead-branded medicines that were materially different from Gilead’s authorized, FDA-approved U.S medicines, including by contravening Gilead’s strict quality-control programs and putting patients at risk by mailing life-saving prescription drugs directly to U.S. patients through an illicit and unsecure channel. 

In June 2025, the U.S. District Court for the District of Maryland awarded a preliminary injunction to Gilead, ordering all named Defendants to refrain from importing or facilitating the importation of all international Gilead medicines into the United States.  The District Court found that the defendants’ importation scheme put patients at risk, and found Gilead likely to succeed on its Lanham Act claims against all Defendants. The lawsuit and the Patterson Belknap team were featured in a report and documentary released by CNBC in November 2025 called “Risky Rx,” which highlighted the dangers of internationally imported medication.

In an August 2026 published opinion, the Fourth Circuit unanimously affirmed the preliminary injunction. The Fourth Circuit found that the differences between Gilead’s U.S. medications and the international medications imported by Defendants were “material, not theoretical,” and that by importing medicines through “unauthorized foreign channels,” the Defendants “bypassed [Gilead’s] secure supply chain,” which Gilead relies upon “to prevent counterfeit, adulterated, or substandard medicine from entering the domestic market.” The opinion affirmed Gilead’s likelihood of success on both its direct and contributory infringement claims, finding the imported medicines were not genuine goods under the Lanham Act. The Court also determined that the importation caused irreparable harm to Gilead.

The opinion represents a first-of-its-kind victory on multiple fronts. The case presented an issue of first impression for the Fourth Circuit, which joined its sister circuits in adopting the material-differences doctrine under the Lanham Act, which allows U.S. markholders to use their trademark rights to combat unlawful diversion of their products. The district court’s opinion and the Fourth Circuit’s affirmance are also the first reported decisions to find imported prescription medicines to violate the Lanham Act.  And in another first, the Fourth Circuit expressly rejected the view, which appears in other circuit decisions, that under the Lanham Act the plaintiff must show a contributory infringer to have sufficient control over the means of infringement (but found that Gilead would have satisfied such a requirement if it existed). In affirming the injunction against the health plan’s administrator and PBM, the Fourth Circuit’s decision makes clear that all those who knowingly facilitate the illegal importation of prescription medicine are also liable under the Lanham Act, even if they never directly order, distribute, or take possession of the infringing product. The decision also provides important precedent that there is no requirement that a markholder provide a warning letter or other prior notice before filing suit against contributory infringers.   

The Fourth Circuit’s decision provides pharmaceutical manufacturers a powerful tool for combatting an increasingly common scheme: commercial health insurers denying legitimate claims for FDA-approved medicine dispensed by U.S. pharmacies, and instead forcing insured patients to rely on non-FDA-approved medicine shipped by foreign pharmacies through unsecure and unmonitored channels. And more broadly, the decision makes clear that rather than waiting for government enforcement action that may or may not occur, manufacturers can utilize their trademark rights to stop the unlawful diversion of their products. 

To read the Fourth Circuit’s opinion, click here.

To read press coverage from Bloomberg Law, please click here [a subscription may be required to view].