Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO

Abstract:     
In University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the court established for the first time a new form of patent law's written description requirement, apparently targeted specifically at biotechnology. To this day, the conventional wisdom is that the so-called Lilly written description requirement (LWD) exists as a biotechnology-specific super-enablement requirement, substantially more stringent than the enablement requirement (the conventional standard for patentability), and standing as an impediment to effective patent protection for biotechnology inventions. My objective in writing this article was to test this conventional wisdom, by conducting a comprehensive search for all LWD decisions of the federal courts and the U.S. Patent Office's Board of Patent Appeals and Interferences (BPAI), and collecting and individually analyzing each case. The analysis focuses on the extent to which LWD is actually functioning as a biotechnology-specific super-enablement requirement. For many, the results of this study will likely come as a surprise, because the empirical evidence demonstrates that the impact of LWD in the courts and BPAI has been minimal - for the most part, LWD does not function as a super-enablement requirement but merely as a redundant surrogate for the enablement requirement. The article ultimately concludes that LWD's main impact has been one of doctrinal confusion, rather than imposing any substantial barrier to the patenting of biotechnology inventions, and recommends that the courts effectively discard LWD as redundant and unnecessary. It suggests alternative approaches for addressing the valid policy concerns that implicitly drove the original Lilly decision.

Keywords: Eli Lilly, Enzo, Written Description, patent, biotechnology, lizardtech, Falkner, enablement, DNA, proteins

Accepted Paper Series