On August 13, a federal appeals court ruled in favor of Gilead Sciences, Inc. (NASDAQ:GILD), upholding a preliminary injunction that bars the defendants from importing or facilitating the sale of foreign-market Gilead-branded medications in the US. 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 controversy began in December 2024 when Gilead Sciences, Inc. (NASDAQ:GILD) filed suit against a number of companies, including third-party administrator Meritain Health, pharmacy benefit manager ProAct, and pharmacies Rx Valet and Advanced Pharmacy, alleging illegal imports of its best-selling HIV drug Biktarvy.
The dispute dates back to December 2024, when Gilead Sciences, Inc. (NASDAQ:GILD) sued a group of companies, including third-party administrator Meritain Health, pharmacy benefit manager ProAct, and pharmacies Rx Valet and Advanced Pharmacy, alleging illegal imports of its top-selling HIV drug Biktarvy. The lawsuit arose from a specific instance in which a patient in Maryland received the medicine in the mail from Turkey, with label instructions written in Turkish.
A federal district court in Baltimore ruled in Gilead's favor and ordered a preliminary injunction, determining that the company was likely to succeed on its Lanham Act trademark violation and unfair competition arguments. As the case continued, the injunction was increased to include new sellers like CanaRx, ElectRx, and ScriptSourcing. The defendants filed an appeal with the Fourth Circuit, and the district judge declined to suspend the injunction while the appeal was pending, thus the import restriction has been in effect the entire time. The recent ruling maintains the order rather than overturning it.
In court documents, Rx Valet stated that the Turkish-sourced Biktarvy was chemically identical to the US version, which was offered at a significantly higher price. Meritain, for its part, said that it has never supported getting non-FDA-approved pharmaceuticals from outside the US and denies the claims, despite being named as a defendant.
The Fourth Circuit rejected the defendants' main argument that the imported and domestic versions of Biktarvy are interchangeable. The court's judgment that the two versions differ materially, not just in packaging or labeling, but also in the quality-control protocols that each version goes through before reaching a patient, challenges the basic argument that these alternative funding programs have used to support their business model.
#gild
The dispute dates back to December 2024, when Gilead Sciences, Inc. (NASDAQ:GILD) sued a group of companies, including third-party administrator Meritain Health, pharmacy benefit manager ProAct, and pharmacies Rx Valet and Advanced Pharmacy, alleging illegal imports of its top-selling HIV drug Biktarvy. The lawsuit arose from a specific instance in which a patient in Maryland received the medicine in the mail from Turkey, with label instructions written in Turkish.
A federal district court in Baltimore ruled in Gilead's favor and ordered a preliminary injunction, determining that the company was likely to succeed on its Lanham Act trademark violation and unfair competition arguments. As the case continued, the injunction was increased to include new sellers like CanaRx, ElectRx, and ScriptSourcing. The defendants filed an appeal with the Fourth Circuit, and the district judge declined to suspend the injunction while the appeal was pending, thus the import restriction has been in effect the entire time. The recent ruling maintains the order rather than overturning it.
In court documents, Rx Valet stated that the Turkish-sourced Biktarvy was chemically identical to the US version, which was offered at a significantly higher price. Meritain, for its part, said that it has never supported getting non-FDA-approved pharmaceuticals from outside the US and denies the claims, despite being named as a defendant.
The Fourth Circuit rejected the defendants' main argument that the imported and domestic versions of Biktarvy are interchangeable. The court's judgment that the two versions differ materially, not just in packaging or labeling, but also in the quality-control protocols that each version goes through before reaching a patient, challenges the basic argument that these alternative funding programs have used to support their business model.
#gild
2 months ago
