Barr sues Watson and Sandoz for Seasonale patent infringement

Dec 17 2007

Barr Pharmaceuticals, Inc. has announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc. has filed suits against Watson Pharmaceuticals and against Sandoz, a subsidiary of Novartis for infringement of the patent protecting Duramed's SEASONALE extended-cycle oral contraceptive product.

Duramed has initiated patent litigation in the U.S. District Court for the District of New Jersey seeking injunctive relief.

"We will pursue all means to enforce the patent covering our SEASONALE extended-cycle oral contraceptive, which was reissued by the PTO in September," said Bruce L. Downey, Barr's Chairman and CEO. "We believe that Watson's product should be removed from the market, and that the Company is due monetary compensation from Watson. In addition, we intend to protect our intellectual property from potential generic competition by Sandoz while our patent is in force."

In September 2007, the U.S. Patent and Trademark Office (PTO) reissued Duramed's patent, U.S. Patent No. 5,898,032, for SEASONALE. The reissued patent has a new number, RE39861, and the same expiration date of June 23, 2017.

In June 2004, Barr was notified by Watson that it 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. At that time, the Company 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).

In November 2007, Sandoz notified Duramed that it had filed an ANDA containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Sandoz's generic product.