AEGiS-Reuters: Gilead says Teva files to sell generic of HIV drug

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Gilead says Teva files to sell generic of HIV drug

Reuters NewMedia - November 14, 2008


LOS ANGELES, Nov 14 (Reuters) - Gilead Sciences Inc <GILD.O> said on Friday it has been notified that Teva Pharmaceutical Industries Ltd <TEVA.O> 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.

(Reporting by Deena Beasley; editing by Richard Chang)


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