Edited by Toshiko Takenaka
Chapter 7: The Lilly written description requirement: a doctrinal ‘wild card’ of uncertain effect
Section 112 of the United States Patent Statute has long served as 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. (‘Lilly’), 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 (‘LWD’). An odd doctrinal hybrid, LWD purports to apply the standard for compliance with the traditional written description requirement, but functions in a manner more analogous to the enablement requirement. 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 from Lilly through the Federal Circuit’s decision in Ariad v. Eli Lilly, in which the en banc court affirmed the continuing vitality of LWD and set forth criteria for assessing compliance with the LWD requirement that are essentially the same as the criteria for compliance with the enablement requirement. The chapter focuses on what this author believes to be the three most important Federal Circuit decisions pertaining to LWD – Lilly, Enzo, and Ariad – and concludes with a brief assessment of the state of LWD as of the time this article was written in 2016.
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