Barr Confirms Non-Final Rejection Notice From Patent and Trademark Office on Duramed’s Reissue Application for SEASONALE(R) ‘032 Patent
May 31, 2006
Barr Pharmaceuticals, Inc. (NYSE: BRL ) today confirmed that Duramed Pharmaceuticals, Inc. has received a Non-Final Rejection notice from the Patent and Trademark Office (PTO) regarding its application for reissue of U.S. 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 had 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.
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The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
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