Bayer sues Teva, Barr in connection with oral contraceptive Gianvi

Jun 16 2010

Today, Bayer HealthCare Pharmaceuticals Inc. and Bayer Schering Pharma AG 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 (17alpha-ethinylestradiol) stabilized by beta-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 No. 5,798,338, which covers offers to sell a drug with an ethinyl estradiol 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™.