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

Court of Appeals for the Federal Circuit
2007 WL 2032123, 84 U.S.P.Q. 2d (BNA) 1285, 501 F.3d 1254 (2007)
ELI5:

Rule of Law:

When conducting a patent obviousness analysis, the level of ordinary skill in the art must be defined by the perspective of one who would solve the problem the patent addresses, such as a pharmaceutical formulator or a medical specialist, not the perspective of an end-user, such as a general practitioner.


Facts:

  • Daiichi's inventors created a method for treating bacterial ear infections (otopathy) by topically administering the antibiotic ofloxacin into the ear.
  • The problem the inventors sought to solve was the creation of a topical antibiotic that did not cause ototoxicity, or damage to the ear, as a side effect.
  • The inventors of the patent were specialists: an otorhinolaryngology professor, a manager of new drug development, and a research scientist focused on antibiotics.
  • Before the patent's effective filing date, a 1986 article by Horst Ganz described the successful and safe use of ear drops containing ciprofloxacin, an antibiotic in the same family as ofloxacin, to treat middle ear infections.
  • The Ganz article specifically noted that in its study, "not one case were side effects of any kind observed," indicating a lack of ototoxicity.
  • Another prior art patent taught the use of ofloxacin in antibiotic compounds in a concentration range that overlapped with the range claimed in Daiichi's patent.

Procedural Posture:

  • Apotex filed an Abbreviated New Drug Application (ANDA) seeking approval to manufacture a generic ofloxacin ear drop, certifying that U.S. Patent No. 5,401,741 was invalid or not infringed.
  • Daiichi, the patent owner, sued Apotex for patent infringement in the U.S. District Court for the District of New Jersey.
  • The district court conducted a Markman hearing to construe the patent's claim terms.
  • Following a bench trial, the district court concluded that the '741 patent was not invalid and not unenforceable.
  • Based on Apotex's stipulation that its product was covered by the patent's claims, the district court entered a judgment finding that Apotex infringed the patent.
  • Apotex (appellant) appealed the district court's judgment to the U.S. Court of Appeals for the Federal Circuit, with Daiichi as the appellee.

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Issue:

Is a patent for a method of treating ear infections with a topical ofloxacin solution invalid for obviousness when prior art taught the safe topical use of a closely related antibiotic, and the person of ordinary skill in the art is a pharmaceutical development specialist rather than a general practitioner?


Opinions:

Majority - Archer, Senior Circuit Judge

Yes, the patent is invalid for obviousness. The district court's conclusion was based on a flawed definition of a 'person having ordinary skill in the art' (PHOSITA). The proper standard for the PHOSITA is not the end-user of the invention (a pediatrician or general practitioner), but rather the person working to solve the underlying technical problem. In this case, that would be a person engaged in developing pharmaceutical formulations or a specialist in ear treatments. This determination is based on the educational level of the inventors, the nature of the problem (formulating a drug safe for the ear, which requires specialized testing), and the sophistication of the technology. When viewed from the perspective of this correctly defined specialist, the prior art, particularly the Ganz article, rendered the invention obvious. The Ganz article taught that ciprofloxacin, a closely related antibiotic, was safe and effective for topical ear treatment. A specialist would have reasonably expected ofloxacin to have a similar safety and efficacy profile, making its use in ear drops an obvious step.



Analysis:

This decision significantly clarifies the standard for determining the 'person having ordinary skill in the art' (PHOSITA) in a patent obviousness analysis. It establishes that the PHOSITA's identity is tied to the problem-solver's perspective, not the end-user's. This is particularly impactful in fields like pharmaceuticals, where inventors are highly specialized scientists, but prescribers are general practitioners. By focusing on the inventor's skill level, the ruling potentially narrows the scope of patentability for inventions that might appear innovative to a generalist but would be considered obvious next steps to a specialist in the field.

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