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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(R) (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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including uncertainty related to whether Gilead will file a patent infringement lawsuit against Teva and whether such a lawsuit or the lawsuit that is currently pending related to Teva's ANDA filing for Truvada would be successful. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2008 as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O'Brien, 650-522-1936 (Investors)Cara Miller, 650-522-1616 (Media)
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