The Lilly Written Description Requirement: A Doctrinal Wildcard of Uncertain Effect

Abstract

Section 112 of the US Patent Statute provides the statutory basis for two discrete doctrines of patentability: the enablement and written description requirements. In 1997, a panel of the Court of Appeals of the Federal Circuit (Federal Circuit) charted new doctrinal waters in Regents of the University of California v. Eli Lilly & Co. recognizing for the first time an entirely new branch of the written description requirement, referred to in this chapter as the “Lilly written description” requirement (or LWD) so as to distinguish it from the “traditional written description requirement.” LWD is an odd doctrinal hybrid, purporting to apply the standard for compliance with the traditional written description requirement, but functioning in a manner more analogous to the enablement requirement. Many would argue that the Federal Circuit has yet to articulate a principled distinction between LWD and enablement: former Chief Judge Randall Rader of the Federal Circuit described LWD as nothing more than a subjective doctrinal “wildcard on which the court may rely when it faces a patent that it feels is unworthy of protection.” Empirical studies by this author and others concluded that LWD rarely if ever served as the basis for invalidating claims that could not have been reasonably, and more convincingly, invalidated for lack of enablement. This chapter provides a brief history of LWD, beginning with some background on pre-Lilly enablement and traditional written description doctrine, then describing the development of LWD, focusing on what this author believes to be the three most pertinent Federal Circuit decisions: Lilly, Enzo, and Ariad. The chapter concludes with a brief assessment of the state of LWD as of the time this article was written in 2016.

Keywords: patent, biotechnology, written description requirement, Eli Lilly, Ariad, LWD