Barr's request for Seasonale patent rejected

By Jennifer Lanning Drey and Elaine Rigoli

Tampa, Fla., May 12 - Barr Pharmaceuticals, Inc. confirmed Friday that the U.S. Patent and Trademark Office rejected its application to reissue U.S. Patent 5,898,032 ('032) for oral contraceptive Seasonale.

Barr said it received a non-final rejection notice, which gives the company three months to respond to the issues raised by the Patent and Trademark Office.

"In terms of the significance, I think the important word is 'non-final,'" said Bruce L. Downey, chairman and chief executive officer of Barr, during a conference call held Friday.

Downey said that while Barr is disappointed in the preliminary ruling, the company is considering strategies to contest the ruling and plans to get the patent reissued.

"We have several avenues available to us, one of which is continuing to pursue the re-issuance, and I can assure you that we'll do everything we can to protect the market," said Downey during Friday's conference call.

However, Barr said it is unlikely, given the timing, that the patent in question could be reissued prior to the Sept. 5, 2006 expiration of Duramed Pharmaceuticals, Inc.'s regulatory exclusivity on Seasonale. Duramed is a subsidiary of Barr.

Barr is also currently in the final stages of receiving approval for Seasonique, its second extended-regiment oral contraceptive, and expects to have the product launched by the end of the fiscal year, according to Downey. Once Seasonique is on the market, the company expects two more extended-regiment oral contraceptive products to follow it.

"We intend to remain a leader in extended-regiment oral contraception long beyond Seasonale," said Downey in the conference call.

Barr filed its application seeking reissue of the '032 patent for Seasonale in July 2004. The '032 patent remains in effect and continues to be listed in the Food and Drug Administration's Orange Book while the Patent and Trademark Office evaluates Duramed's application for reissue.

Based in Woodcliff Lake, N.J., Barr develops generic and proprietary pharmaceuticals, including the manufacture of oral contraceptive products.

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