Bayer sues Teva and Barr over advertising
Teva’s generic oral contraceptive Gianvi’s label makes false claims
Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals Inc. have 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) stabilised 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 ‘stabilised 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 stabilised 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 stabilised 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.
