Gilead Wins Appeals Court Ruling Blocking Imported HIV Drug Sales
A federal appeals court ruled on August 13, 2026 in favor of Gilead Sciences (NASDAQ:GILD), upholding a preliminary injunction that prevents the importation and sale of foreign-market versions of its HIV drug Biktarvy into the U.S. The Fourth Circuit Court found significant differences between the domestic and imported drugs, including variations in quality-control protocols, which undermined claims by defendants that they were interchangeable. The legal dispute began in December 2024 when Gilead sued several companies for allegedly importing foreign versions of Biktarvy without FDA approval. A district court had previously ruled against these imports on trademark and unfair competition grounds. The appeals ruling reinforces this decision, maintaining the injunction while allowing the case to proceed. Gilead described the outcome as a victory for patient safety by preventing unregulated drugs from entering U.S. supply chains. Patient advocacy groups also supported the ruling in amicus briefs. While the win protects Gilead’s pricing power and revenue stream through Biktarvy, broader cost pressures on drug prices remain an ongoing challenge.
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