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Bayer sues Teva and Barr for false advertising and patent infringement in connection with Teva’s generic oral contraceptive Gianvi™
Gianvi™’s label falsely claims that its formula and product, now in the US market, contains the same product stabilizer as YAZ® (drospirenone & ethinyl estradiol) Bayer’s oral contraceptive
Suit filed in the Northern District of Illinois (Chicago)
Leverkusen, June 15, 2010 – Today, Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals Inc. sued Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, and Barr Laboratories, Inc. in the Northern District of Illinois (Chicago) for false advertising and patent infringement in connection with Teva’s generic oral contraceptive, Gianvi™. Teva’s product is sold as a generic version of Bayer HealthCare’s leading oral contraceptive YAZ®. YAZ® tablets contain an estrogen (17α-ethinylestradiol) stabilized by β-cyclodextrin (or “betadex”) as a “clathrate“ (a protective molecular cage). Using betadex as a clathrate improves stability and prolongs shelf life of the product. Bayer believes Teva is offering for sale its Gianvi™ product with Physician Prescribing Information that falsely claims that Gianvi™’s ethinyl estradiol is “stabilized by betadex as a clathrate.” Based on testing of tablets now in the US market, Bayer believes that Teva’s Gianvi™ product does not in fact contain ethinyl estradiol stabilized by betadex as a clathrate. Bayer intends to seek a temporary restraining order and a preliminary injunction to stop Teva from making false claims about its Gianvi™ product and from infringing Bayer Schering’s U.S. Patent 5,798,338, which covers offers to sell a drug with an ethinylestradiol that is stabilized by betadex as a clathrate. Bayer also asks that Teva take action in the US market to correct any erroneous impression persons may have derived concerning the nature, characteristics or qualities of Gianvi™. About Bayer HealthCare The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com. About Bayer Schering Pharma Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de. Bayer AG, Investor Relations contacts: Dr. Alexander Rosar (+49-214-30-81013) Dr. Juergen Beunink (+49-214-30-65742) Peter Dahlhoff (+49-214-30-33022) Ilia Kürten (+49-214-30-35426) Judith Nestmann (+49-214-30-66836) Dr. Olaf Weber (+49-214-30-33567) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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