Barr Pharmaceuticals announces favorable ruling in Yasmin patent case

Barr Pharmaceuticals, Inc. has announced that the U.S. District Court for the District of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG in connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive.

In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious.

"We are delighted that Judge Sheridan has invalidated the patent on Yasmin," said Bruce L. Downey, Barr's Chairman and CEO. "We are currently reviewing the opinion in the case and evaluating all of our options. Clearly, this is a positive development for the Company and we are evaluating what the potential impact could be on our earnings guidance for 2008."

Yasmin provides an oral contraceptive regimen consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $572 million for the twelve months ended December 2007, based on IMS sales data.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Yasmin product with the U.S. Food & Drug Administration (FDA) in January 2005, and received notification of the application's acceptance for filing in February 2005. Following receipt of the notice from the FDA, Barr notified Berlex, the New Drug Application (NDA) holder, and Schering AG, the patent owner. In April 2005, Schering AG and Berlex filed a patent infringement suit against Barr in the U.S. District for the District of New Jersey. In June 2006, Bayer AG acquired Schering AG. In November 2007, the patent infringement case was heard in front of Judge Sheridan.