Judge Faith S. Hochberg of the District Court of the District of New Jersey lately ruled in the favor of Boehringer Ingelheim and found Boehringer’s US Patent Number 4,886,812 infringed and violated by Mylan’s generic version of Mirapex product. Earlier in May 2009, the same judge dismissed the Boehringer’s infringement case for alleged infringement of the ‘812 patent after judge agreed with Mylan that the ‘812 patent had already been declared invalid by a separate court.
Mirapex patent dispute trails back to the year 2008 when Mylan Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) for generic pramipexole and Boehringer responded by filing a lawsuit against Mylan (and Barr Labs, which also filed ANDA for generic pramipexole, and was originally joined in the lawsuit but later settled with Boehringer). In its defense, Mylan argued invalidity of the ‘812 patent on the ground of obviousness-type double patenting based on the then-expired US Patent Number 4,843,086. Boehringer attempted to overcome the double patenting argument by filing a terminal disclaimer but the US District Court for the District of Delaware held that Boehringer’s terminal disclaimer was ineffective and also rejected Boehringer’s argument that the safe-harbor provision of 35 USC 121 shielded against the double patenting defense.
On appeal, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District Court’s decision that the terminal disclaimer was ineffective but reversed that decision that 35 USC 121 did not shield Boehringer against the double patenting defense. Following the Federal Court ruling, Mylan filed petition to have all of the circuit judges rehear the case but the Federal Circuit declined to give a panel rehearing or en banc rehearing to Mylan.
Labels: 'Patent-Drug Regulatory' Linkage, 107A (b), Barr, Boehringer, Mirapex, Mylan, Pramipexole
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