May 14, 2009
Gilead Sciences Files Second Patent Infringement Lawsuit Against Teva Pharmaceuticals
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 Atripla before the expiration of both emtricitabine patents.
Gilead now has two lawsuits pending against Teva Pharmaceuticals. The first was filed in December 2008 in response to Teva's attempts to seek approval for a generic version of Truvada based on allegations that these same two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of its generic product.
Gilead has full confidence in the strength of its patent position and plans to vigorously defend the intellectual property rights of Atripla.
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.
Atripla is indicated for use alone as a complete regimen or with other medicines to treat HIV-1 infection in adults, and is currently sold in the United States through a joint venture between Gilead and Bristol-Myers Squibb Company.
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.
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 lawsuits pending 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, 2008 and Form 10-Q for the first quarter of 2009 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)