Teva challenges two of Gilead's Truvada patents
California, USA-based Gilead Sciences says it has received a Paragraph IV Certification Notice Letter advising that Israel-headquartered Teva Pharmaceuticals Industries has submitted an Abbreviated New Drug Application to the Food and Drug Administration requesting permission to manufacture and market a generic version of Truvada (emtricitabine and tenofovir disoproxil fumarate).
In the communication, Teva alleges that two of the patents associated with emtricitabine - US patent numbers 6,642,245 and 6,703,396 - owned by Emory University and licensed exclusively to Gilead, are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission.
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