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Introducing the 'Person Having Ordinary Skill in the Art' (PHOSITA) into Pharmaceutical Patent Prosecution at the EPO and USPTO

A “person having ordinary skill in the art” (PHOSITA) or “a person skilled in the art” is a legal construct that is extensively used in patent law as a tool to homogenize and standardize the estimation and evaluation of patentability requirements i.e. nonobviousness, insufficient disclosure, interpretation of the claimed invention in the prosecution of patent applications, patent litigation, and infringement proceedings. Currently, the legal definition and average experience of a hypothetical claim of the PHOSITA for any invention field is not clearly defined. In this article we discuss the theoretical fundamental role played by the PHOSITA in the prosecution process of the patent application at both the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO), and show the impact of the person skilled in the art in a number of cases in the patent prosecution process for the heavily regulated pharmaceutical industry. Introducing the definition and average knowledge of the PHOSITA into the patent application prosecution process could provide a quality control mechanism that would improve the reliability of pharmaceutical patent prosecution decisions and minimize the risk of bias and conflict of interest at the claimed invention.