Barr Pharmaceuticals, Inc. confirms that its subsidiary, Duramed Pharmaceuticals, Inc. has received a non-final rejection notice from the Patent and Trademark Office (PTO) regarding its application for reissue of US Patent 5,898,032 ('032) relating to its Seasonale extended-cycle oral contraceptive.
A non-final rejection affords the company with three months to respond to the issues raised by the PTO. The PTO then would have additional time to review the company's response and decide whether the application for reissue of the patent should be allowed. While the company said that it had not the opportunity to review the correspondence from the PTO, it noted that it would be unlikely, given the timing, that the patent in question could be reissued prior to the September 5, 2006 expiration of Duramed's regulatory exclusivity on Seasonale.
"While we are disappointed in the determination by the PTO, we intend to fully review all options available to protect our patentable invention, and will respond to the non-final rejection as quickly as possible," said Bruce L. Downey, Barr's chairman and CEO.
Barr filed its application seeking reissue of the '032 patent with the PTO in July 2004. The '032 patent remains in effect and continues to be listed in the US FDA orange book while the PTO evaluates Duramed's application for reissue.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals. The company currently markets 22 generic oral contraceptive products under its Barr Laboratories, Inc. label and five proprietary (branded) oral contraceptive products under the Duramed Pharmaceuticals, Inc. label.