Gilead Sciences Inc has filed a lawsuit in US District Court in New York against Teva Pharmaceuticals USA Inc and Teva Pharmaceutical Industries, Ltd for infringement of US 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 of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), and are licensed exclusively to Gilead Sciences by Emory University.
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 Atripla before the expiration of both emtricitabine patents.
Gilead now has two lawsuits pending against Teva Pharmaceuticals. The first was filed in December 2008 in response to Teva's attempts to seek approval for a generic version of Truvada based on allegations that these same two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of its generic product.
Gilead has full confidence in the strength of its patent position and plans to vigorously defend the intellectual property rights of Atripla.
Atripla is currently protected by 15 patents, which are listed in the FDA's Approved Drugs Products List, and all 15 patents would need to be invalidated or expired before a generic version of Atripla could be marketed.
Atripla is indicated for use alone as a complete regimen or with other medicines to treat HIV-1 infection in adults, and is currently sold in the United States through a joint venture between Gilead and Bristol-Myers Squibb Company.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.