Gilead Sciences IncFourth Circuit upheld injunction blocking illegal imports of Gilead's Biktarvy, a legal/regulatory win protecting its US HIV drug sales.

A federal appeals court ruled in favor of Gilead Sciences on August 13, upholding a preliminary injunction that bars the defendants from importing or facilitating the sale of foreign-market Gilead-branded medications in the United States. The US Court of Appeals for the Fourth Circuit found that the differences between Gilead's HIV medication for the US market and the foreign versions being imported were material, not theoretical. The dispute dates to December 2024, when Gilead sued third-party administrator Meritain Health, pharmacy benefit manager ProAct, and pharmacies Rx Valet and Advanced Pharmacy over illegal imports of its best-selling HIV drug Biktarvy, a case that arose after a patient in Maryland received the medicine by mail from Turkey with label instructions written in Turkish. A federal district court in Baltimore granted the preliminary injunction after finding Gilead likely to succeed on its Lanham Act trademark violation and unfair competition arguments, and the order was later expanded to include new sellers CanaRx, ElectRx, and ScriptSourcing. The Fourth Circuit rejected the defendants' central argument that the imported and domestic versions of Biktarvy are interchangeable, holding that the two differ materially not only in packaging and labeling but also in the quality-control protocols each version undergoes before reaching a patient. A Gilead representative called the decision a patient-safety victory, and patient advocacy groups that filed amicus briefs supporting the company praised the ruling in similar terms.
Gilead Sciences IncFourth Circuit upheld injunction blocking illegal imports of Gilead's Biktarvy, a legal/regulatory win protecting its US HIV drug sales.