Physiological Steps Doctrine

• Published in: Berkeley technology law journal Vol. 23; no. 4; pp. 1471 - 1505
• Main Author: Torrance, Andrew W.
• Format: Journal Article
• Language: English
• Published: Berkeley Regents of the University of California 01.10.2008; University of California, Boalt Hall School of Law
• Subjects: Claims; Conversion; Courts; Criminal conversion; Damage claims; Ethanol; Federal circuit courts; Federal court decisions; Federal district courts; Human body; Infringement; Inventions; Medical procedures; Metabolites; Patent claims; Patent infringement; Patent law; Pharmaceutical preparations; Physiology; Transformation; United States > US
• ISSN: 1086-3818; 2380-4742

Most inventions exist in the world outside the human body. This article argues that the metabolic products of in conversion by and within the human body fall within one of these unrecognized categories of unpatentable subject matter. Patent claims whose elements involve the physiological functions inside a human being fit uneasily into patent law. The patent laws of the US already include explicit limits on patent claims as they relate to humans and human bodies. This article reviews the judicial decisions that considered infringement by in vivo conversion, including the forerunners of in vivo conversion cases: those involving "natural conversion." A patent claim is invalid for anticipation under 35 USC Section 102 if each and every element of that claim is disclosed by a single prior art reference. Courts in the US have repeatedly considered whether transformation of a drug via in vivo conversion into a metabolite can trigger infringement of patent claims covering the metabolite or methods of using the metabolite.