MONTVALE, N.J., June 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today 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 t
|SOURCE Barr Pharmaceuticals, Inc.|
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