Gilead Sciences, Inc. has filed a lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for infringement of U.S. Patent Numbers 6,642,245 and 6,703,396. Both patents are associated with emtricitabine, a component of Truvada® (emtricitabine and tenofovir disoproxil fumarate), and are licensed exclusively to Gilead Sciences by Emory University. Truvada is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The lawsuit is based on an Abbreviated New Drug Application filed by Teva Pharmaceuticals USA, Inc., which seeks approval to manufacture and market a generic version of Truvada before the expiration of both emtricitabine patents. Gilead has full confidence in the strength of its patent position and plans to vigorously defend the intellectual property rights of Truvada. Truvada is currently protected by 10 patents, which are listed in the FDA’s Approved Drugs Products List, and all 10 patents would need to be invalidated or expired before a generic version of Truvada could be marketed.
