A consumer watchdog group is calling for a revote by a Food and Drug Administration (FDA) advisory panel, after discovering that some members of the panel had ties to drug companies that made the pills under review.
The family of a 15-year-old North Carolina girl who was taking the birth control pill Yasmin to treat her acne and then died of a pulmonary embolism, are suing the drug’s maker Bayer, claiming the company did not adequately warn users of the potentially deadly health risks associated with its oral contraceptive.
Europe’s biggest drug company, Bayer AG, has won a lawsuit in the United Kingdom, protecting the patent on its birth control pill Yasmin against a challenge by Hungary’s Gedeon Richter Nyrt. Justice Christopher Floyd ruled in the High Court of London that the inventions the patents covered for Yasmin would not have been “obvious” to experts in the industry. The ruling is in contrast to a case in the United States in 2008, in which the Yasmin patent was found to be invalid because it was “obvious” to other experts in the field. That ruling opened the door for Israel’s massive generic drug manufacturer, Teva Pharmaceuticals Industries Ltd., to sell a version of Yasmin, known as Ocella, in the United States.
Sales of Yaz birth control pills fell 15 percent in the second quarter of 2010, which Bayer Corp. blames on increased competition from generics marketed in the United States by Teva Pharmaceutical Industries. Teva introduced its Yaz copycat, Gianvi, earlier this year only to be slapped with a patent lawsuit by Bayer. It’s not the first lawsuit Bayer has filed against Teva in hopes of protecting the multimillion dollar market share it has enjoyed with Yaz.
Bayer has dropped its patent suit in Delaware against Teva Pharmaceuticals Industries Ltd., and Barr Pharmaceuticals for infringing on its multi-million-dollar-selling oral contraceptive Yaz. Bayer had filed the lawsuit claiming TVA’s generic version of Yaz, known as Gianvi, infringed on Yaz. However, Bayer says it is maintaining its patent suit against Teva and Barr in Nevada District Court.
District Judge David Herndon is ordering sales representatives who pushed the oral contraceptives Yasmin, Yaz, Ocella and Gianvi to produce all their files and communications for national litigation. The order covers “all written materials, video and/or audio tapes” and includes training materials, e-mails, voice mail transcripts, summaries of meetings, incentive and goal plans, and all communications between representatives and managers. Herndon also ordered Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Barr Laboratories, and Teva Pharmaceuticals to produce records from their facilities.
Bayer’s multimillion dollar birth control pill, Yaz, will go head-to-head with generic competition with the introduction of Teva Pharmaceutical Industries’ Gianvi. Teva was awarded a 180-day marketing exclusivity period for Gianvi by the Food and Drug Administration after being the first company to file an Abbreviated New Drug Application (ANDA). Bayer isn’t taking the news lightly. The company says it plans to sue Teva for prematurely launching the new “girl” on the block, which Bayer says they are not legally permitted to do until July 2011.
