Daiichi Sankyo Co., Ltd. v. Apotex, Inc.

501 F.3d 1254 (2007)

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Nature of the Case

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Facts

The inventors of the '741 patent were specialists in drug and ear treatments. Inventor Sato was a university professor specializing in otorhinolaryngology. Inventor Handa was a clinical development department manager at P, involved with new drug development and clinical trials. Inventor Kitahara was a research scientist at D engaged in the research and development of antibiotics. The compound they created was ofloxacin. It is used to treat ear infections without damage to hearing. D filed an Abbreviated New Drug Application (ANDA) seeking approval to manufacture a generic ofloxacin ear drop. D included a P IV certification that the '741 patent was invalid and/or not infringed. P sued D for infringement. The court concluded that the '741 patent was not invalid and that D infringed the '741 patent. The 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. D appealed contending that the court had not properly defined a person having ordinary skill in the art. D argues that one having ordinary skill in the relevant art is properly defined as 'a person engaged in developing new pharmaceuticals, formulations and treatment methods, or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.'