Gilead Sciences Files Patent Infringement Lawsuit Against Teva Pharmaceuticals

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry
Article Date: 15 Dec 2008 - 4:00 PDT

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Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has filed a lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for infringement of U.S. Patent Numbers 6,642,245 and 6,703,396. Both patents are associated with emtricitabine, a component of Truvada® (emtricitabine and tenofovir disoproxil fumarate), and are licensed exclusively to Gilead Sciences by Emory University. Truvada is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

The lawsuit is based on an Abbreviated New Drug Application filed by Teva Pharmaceuticals USA, Inc., which seeks approval to manufacture and market a generic version of Truvada before the expiration of both emtricitabine patents.

Gilead has full confidence in the strength of its patent position and plans to vigorously defend the intellectual property rights of Truvada.

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.

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 the infringement lawsuit against Teva Pharmaceuticals USA, Inc. will 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, 2007 and its Quarterly Report on Form 10-Q for the first, second and third quarters of 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.

Truvada is a registered trademark of Gilead Sciences, Inc.

Gilead Sciences, Inc.

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