Gilead says Teva challenges US patents for Truvada
This article was originally published in Scrip
Executive Summary
Teva Pharmaceutical Industriesis challenging key US patents held by Gilead Scienceson its HIV therapy, Truvada (emtricitabine and tenofovir disoproxil fumarate), several years before they are due to expire. Gilead said on November 14th that it was notified by Teva of an ANDA filing, and that it has 45 days to begin a patent infringement lawsuit; a lawsuit would put an automatic 30-month stay of approval of the ANDA. In the notification letter, Teva alleges that two of the patents associated with emtricitabine (the '245 and '396) – owned by Emory University but licensed to Gilead – are invalid, unenforceable, and/or will not be infringed by Teva's manufacturer of the product described in the ANDA. Gilead said Truvada is protected by 10 patents listed in the FDA's Orange Book, and all 10 patents would need to be invalidated or expired before a generic version of Truvada could be marketed; these patents are set to expire between 2010 and 2021. The '245 and '396 patents each have been awarded paediatric exclusivity, and are set to lose US exclusivity in May 2021 and September 2021, respectively.