Barr fails with patent reissue case
The US Patent and Trademark Office (PTO) has issued Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, with a Non-Final Rejection notice in regard to its application for reissue of a patent on Seasonale, its extended-cycle oral contraceptive.
The US Patent and Trademark Office (PTO) has issued Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, with a Non-Final Rejection notice in regard to its application for reissue of a patent on Seasonale, its extended-cycle oral contraceptive.
Barr sought reissuance of US Patent 5,898,032 in July 2004 following Watson Laboratories" filing of an Abbreviated New Drug Application (ANDA) for a generic version of Seasonale in June 2004. The ANDA asserted that Barr's patent covering the drug was either invalid, unenforceable or would not be infringed by Watson's generic product.
The Non-Final Rejection gives Barr three months to respond to the issues raised by the PTO. While the patent will remain in effect and continue to be listed in the US Food and Drug Administration's (FDA) Orange Book during the reissuance proceedings, Barr has said that, given the timing, it would be "unlikely" that the patent could be reissued prior to the expiration of Duramed's regulatory exclusivity on Seasonale on 5 September 2006, which is when Watson's generic version will be eligible for final FDA approval.
"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, chairman and ceo, Barr.
With Seasonale accounting for around 10% ($125m) of Barr's annual revenue, the announcement caused shares in the company to fall by 5% to $50.98. Barr currently markets 22 generic oral contraceptive products through Barr Laboratories and five proprietary oral contraceptive products through Duramed Pharmaceuticals.