Gilead Sciences, Inc announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Truvada (emtricitabine and tenofovir disoproxil fumarate).
In the Notice Letter, 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 Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. 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.
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