Gilead Sciences Inc has been notified that Teva Pharmaceutical Industries Ltd is seeking U.S. regulatory approval to sell a generic version of Gilead's HIV drug Truvada.
Gilead said it has 45 days from the receipt of the notification by the U.S. Food and Drug Administration to commence a patent infringement lawsuit against Teva. A lawsuit would restrict approval of the generic drug for up to 30 months or until a court ruling in favor of Teva, whichever occurs first.
Truvada is a combination of Gilead's drugs Viread, known generically as tenofovir, and Emtriva, or emtricitabine. Gilead said Teva has claimed that two of the patents associated with emtricitabine — owned by Emory University and licensed Gilead — are invalid or unenforceable.
The company said Truvada is protected by 10 patents, and all 10 would need to be invalidated or expired before a generic version of Truvada could be marketed.