The Role of Objective Indicia in Assessing the Nonobviousness of Pharmaceutical Inventions

Abstract

This article examines the current status of objective indicia in deciding nonobviousness, particularly in the pharmaceutical arts, an area of technology where their weighting can at times prove outcome determinative. The article begins by looking at how these various factors have been applied in the context pharmaceuticals, including numerous specific examples. It then summarizes the current split on the Federal Circuit regarding the role of objective indicia analysis in determinations of nonobviousness, particularly as exposed by divergent opinions issued in Apple v. Samsung. Apple highlights a number of unresolved and highly disputed aspects of the court’s current nonobviousness jurisprudence, including a fundamental disagreement as to the import of the Supreme Court’s most recent nonobviousness decision, KSR v. Teleflex. The judges also voiced strong disagreement as to the use of extra-record evidence in a determination of nonobviousness, the extent to which an appellate court is permitted to make factual findings in a nonobviousness determination, the standard for and scope of appellate review of nonobviousness determinations, and even the appropriate role of en banc proceedings before the Federal Circuit. Of particular relevance to this article, Apple highlights a clear division in the judges’ view on the role of secondary considerations in nonobviousness analysis.

Keywords: nonobviousness, patent, pharmaceuticals, objective indicators, objective indicia, secondary considerations