Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceuticals Corporation, et al., C.A. No. 14-1268 - SLR, May 18, 2016.
Robinson, J. Defendant’s motion to dismiss plaintiff’s amended complaint is granted.
The disputed product in this ANDA case relates to colchicine for the treatment of gout. After plaintiff appealed denial of a preliminary injunction and lost, it filed an amended complaint alleging induced infringement based on product labels and FDA correspondence. Plaintiff’s drug is approved for treatment and prevention of acute gout flares, while defendant’s product is approved solely to prevent gout flares, and warns that the drug is not indicated for the treatment of acute gout flares. The question is whether the instructions teach an infringing use of the drug in order to infer intent to infringe. The court notes that the Federal Circuit has not found infringement where the product label does not address the patented methods, and finds that on its face defendant’s label does not infringe. Given the lack of factual allegations of infringement, the court cannot find a plausible claim for relief and grants defendant’s motion to dismiss.