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

United States Court of Appeals for the Federal Circuit
501 F.3d 1254 (2007)


Facts

Three employees of Daiichi Sankyo Co., Ltd. (Daiichi) (plaintiff) created and patented the compound ofloxacin, used to treat ear infections without damaging a patient’s hearing. The three Daiichi employee inventors were Sato, a professor specializing in ear, nose, and throat issues, Handa, a manager involved with drug development and clinical trials, and Kitahara, a research scientist involved in development of antibiotics. The inventors tested ofloxacin on guinea pigs and found that use did not cause ear damage. Apotex, Inc. and Apotex Corp. (collectively, “Apotex”) (defendant) sought approval to manufacture a generic ofloxacin ear drop. Daiichi sued Apotex for patent infringement. The district court conducted an obviousness analysis of the patent and determined that a person having ordinary skill in the art pertaining to the patent would possess a medical degree, have experience treating ear infections, have some knowledge of the pharmacological use of antibiotics, and be a pediatrician or general practitioner. Following its analysis, the district court concluded that the Daiichi patent was not invalid, and was infringed by Apotex. Apotex appealed, contending that the court improperly defined a “person having ordinary skill in the art.”

Rule of Law

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Issue

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Holding and Reasoning (Archer, J.)

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  • A “yes” or “no” answer to the question framed in the issue section;
  • A summary of the majority or plurality opinion, using the CREAC method; and
  • The procedural disposition (e.g. reversed and remanded, affirmed, etc.).

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