Janssen Pharmaceuticals Inc., et al. v. Mylan Laboratories Limited

Analysis Group was retained by Patterson Belknap Webb & Tyler on behalf of Janssen Pharmaceuticals Inc., Janssen Pharmaceutica NV, and Janssen Research & Development LLC (“Janssen”), the plaintiffs in a Hatch-Waxman patent infringement action brought against Mylan Laboratories Limited. Mylan filed an abbreviated new drug application with the US Food and Drug Administration (FDA) seeking to market a generic version of Invega Trinza®, a long-acting injectable antipsychotic medication for the treatment of schizophrenia. Janssen alleged that Mylan’s proposed generic drug will infringe on Janssen’s patented reinitiation regimen for patients who missed a dose of the drug, which is prescribed to be dosed once every three months. In response, Mylan asserted that it did not infringe and that Janssen’s patent was invalid.

An Analysis Group team led by Vice President Kate Schofield supported Managing Principal Carla Mulhern, who submitted an expert report and testified at trial on the commercial success of the at-issue patent, including that a causal nexus existed between the invention claimed in the patent and the commercial success of Invega Trinza.

Following a two-week bench trial, a judge in the US District Court for the District of New Jersey ruled in favor of Janssen. The judge stated that Mylan would inevitably induce infringement of Janssen’s patent for its reinitiation regimen, noting that Mylan’s proposed drug labels “expressly instruct[ed]” health care providers to follow Janssen’s patented regimen for patients who missed a dose of the drug by a specified amount of time. The judge also concluded that Mylan did not demonstrate that Janssen’s patent was obvious or otherwise invalid.

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