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news.Bayer HealthCare Pharmaceuticals and Bayer Schering Pharma have sued Teva Pharmaceuticals USA, Barr Pharmaceuticals and Barr Laboratories, for false advertising and patent infringement in connection with Teva's generic oral contraceptive, Gianvi.
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Teva’s product is sold as a generic version of Bayer HealthCare’s oral contraceptive YAZ, a progesterone and estrogen combination birth control pill. It works by preventing ovulation, thickening the mucus in the cervix, and changing the lining of the uterus.
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.’
Bayer said that based on testing of tablets now in the US market, it believes that Teva’s Gianvi product does not in fact contain ethinyl estradiol stabilised by betadex as a clathrate.
Further, Bayer plans 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 US Patent No 5,798,338, which covers offers to sell a drug with an ethinyl estradiol that is stabilised by betadex as a clathrate.