The US District Court for Delaware has ruled in favor of US generics major Barr Laboratories in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, in connection with the German drugmaker's Mirapex (pramipexole dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg.
In his ruling, District Court Judge Joseph Farnan found that the patent claims at issue in the litigation were invalid on the grounds of non-statutory double patenting.
Barr's Abbreviated New Drug Application for a generic Mirapex product received final approval from the Food and Drug Administration in February. Barr believes that it is the first company to file an ANDA with a paragraph IV certification for Mirapex in these dosages.
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