German drugmaker Bayer (BAYG.DE) sued Israeli generic competitor Teva (TEVA.TA) in a U.S. court for infringing its patent covering “Levitra".
The patent at issue in the suit is Bayer Schering Pharma's U.S. Patent No. 6,362,178, expiring in 2018." Levitra, was first approved by U.S. regulators in 2003, and is sold by Schering-Plough and GlaxoSmithKline Plc in the U.S. and competes with Pfizer Inc.’s Viagra and Eli Lilly & Co.’s Cialis.
The drug, whose active ingredient is vardenafil hydrochloride, generated $341 million in sales last year for Bayer, the company said in its annual report.
Teva is seeking U.S. Food and Drug Administration approval to sell a generic version of the drug. Teva filed ANDA application with Paragraph IV certification, in which Teva contends that it won’t infringe any valid or enforceable patent on this medicine. Under federal law, Bayer’s suit triggers an automatic 30-month period in which the FDA can’t approve Teva’s application, unless a judge rules in the generic-drug maker’s favor before then.
Denise Bradley, a spokeswoman for Petak Tikva, Israel-based Teva, said the company has no comment on the suit, which was filed in federal court in Wilmington, Delaware. Teva is the world’s biggest generic-drug maker.
Lets wait and watch who will win!!!!!!!!!!!
