Barr announces favorable ruling in Mirapex patent challenge

Barr Pharmaceuticals, Inc. has announced that U.S. District Court for Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, Inc. in connection with Boehringer Ingelheim's Mirapex(R) Tablets (pramipexole dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

In his ruling, District Court Judge Joseph J. Farnan, Jr. found that the patent claims at issue in the litigation were invalid on the grounds of nonstatutory double patenting.

Barr's Abbreviated New Drug Application (ANDA) for a generic Mirapex product received final approval from the U.S. Food and Drug Administration (FDA) in February 2008. Barr believes that it is the first company to file an ANDA with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

"We are very pleased with the Court's favorable decision regarding the patent on Mirapex, and are currently reviewing the opinion in the case and evaluating our options," said Bruce L. Downey, Barr's Chairman and CEO.

Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a paragraph IV certification with the FDA in May 2005 and in June 2005 amended its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. Following receipt of the notice from the FDA of the application's acceptance for filing, Barr notified the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act. In March 2008, the patent infringement case was heard in front of Judge Farnan.

Mirapex (pramipexole dihydrochloride) had annualized sales of approximately $381 million for the twelve months ended April 2008, based on IMS sales data.