Barr Pharmaceuticals receives Notice of Allowance for Seasonale patent

Barr Pharmaceuticals has announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for the reissuance of U.S. Patent 5,895,032 ('032), relating to Barr's Seasonale extended-cycle oral contraceptive.

The issuance of the Notice of Allowance confirms that Barr's reissue patent application has satisfied statutory requirements of patentability and indicates that the PTO will issue the reissue patent in the future.

"The PTO Notice of Allowance is the first step in a two step process. The next step will be formal reissuance of the Seasonale patent which we can then list in the U.S. Food and Drug Administration's (FDA) Orange Book with a patent term expiration of 2017," said Bruce L. Downey, Barr's Chairman and CEO. "The reissued patent confirms our position that we have the exclusive right to market Seasonale."

Barr filed its application seeking reissuance of the '032 patent with the PTO in July 2004. Since this date, the application has been rejected three times, and each time the Company responded with arguments to counter the rejections. The PTO issued the notice of allowance after receiving the Company's third response and a supplement to this response. The PTO has not provided a timeframe for reissuance. When the patent is formally reissued, the reissued patent will replace the '032 patent in FDA's Orange Book and will have the same remaining term as the '032 patent, which expires in 2017.

In June 2004 Barr announced that it had been notified that Watson Laboratories had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification asserting that the patent covering Seasonale was invalid, unenforceable or would not be infringed by Watson's generic product. Barr did not initiate patent infringement litigation with respect to Watson's ANDA. In September 2006, Watson launched a generic version of SEASONALE following final approval from the U.S. Food & Drug Administration (FDA).