Gilead Sciences, Inc. has announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.
In the Notice Letter, Teva alleges that two of the patents associated with emtricitabine - U.S. 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. 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.
In November 2008, Teva challenged the validity of these same two emtricitabine patents - U.S. Patent Numbers 6,642,245 and 6,703,396 - with an ANDA filing for Truvada ® (emtricitabine and tenofovir disoproxil fumarate). Gilead subsequently filed a patent infringement lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. in December. The lawsuit is ongoing.