The U.S. Patent and Trademark Office denied Barr Laboratories' request to reissue its patent on its extended-cycle oral contraceptive Seasonale, the AP/Houston Chronicle reports (AP/Houston Chronicle, 5/12). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003. Women take 84 active pills consecutively and then take seven placebo pills compared with the usual regimen of 21 active pills with seven placebos (Kaiser Daily Women's Health Policy Report, 4/7). According to the AP/Chronicle, Barr's subsidiary Duramed Pharmaceuticals received a non-final rejection notice from the patent office, which gives the company three months to reply to issues raised by the government before the company's three-year product exclusivity runs out on Sept. 5. Watson Pharmaceuticals -- which in 2004 filed a marketing application with FDA saying that Duramed's Seasonale patent was unenforceable and void -- has a generic version of Seasonale ready for final FDA approval after Duramed's exclusivity expires. Barr has not filed a lawsuit against Watson for patent infringement, according to the AP/Houston Chronicle. Barr on Friday said it is evaluating its options (AP/Houston Chronicle, 5/12).