DAIICHI SANKYO CO., LTD. (formerly known as Daiichi Pharmaceutical Co., Ltd.) and DAIICHI SANKYO, INC. (formerly known as Daiichi Pharmaceutical Corporation), Plaintiffs-Appellees, v. APOTEX, INC. and APOTEX CORP., Defendants-Appellants., 501 F.3d 1254

Summary

The patent holders sued the generic drug manufacturer and its subsidiary after they filed an Abbreviated New Drug Application seeking approval to manufacture a generic ofloxacin ear drop and claimed that the '741 patent was invalid or not infringed. The district court found that the '741 patent was not invalid, and that the generic drug manufacturer and its subsidiary infringed the patent. In reaching its decision, the district court found that the ordinary person skilled in the art pertaining to the '741 patent would be a pediatrician or general practitioner, and that the patent was not obvious to someone skilled in the art. The court of appeals reversed the district court. The proper level of ordinary skill in the art of the '741 patent was that of a person engaged in developing pharmaceutical formulations and treatment methods for the ear, or a specialist in ear treatments who had training in pharmaceutical formulations, and the district court's error in determining the level of ...