Enablement Invoked as a ‘Super-Written Description Requirement’ to Overturn $2.5 Billion Jury Verdict

Abstract

Conventional wisdom has long held that patent law’s written description requirement functions as a “super-enablement” requirement, particularly with respect to biotechnology. Although the criteria for compliance with the written description and enablement requirements overlap substantially (I have argued that they are essentially redundant), written description has been viewed as the more stringent restriction on patentability ever since the Federal Circuit’s landmark decision in UC Regents v. Eli Lilly dramatically expanded the role of the written description requirement in policing claim scope. A recent Holman Report discusses three Federal Circuit decisions wherein the court invalidated monoclonal antibody genus claims for failure to comply with the written district requirement, while leaving the issue of enablement undecided, implying that written description is the more stringent, or at least the more appropriate, doctrine in the context of antibodies. This Report focuses on an interesting recent district court decision, Idenix v. Gilead, that goes against the conventional wisdom by explicitly invoking enablement as a “super-written description requirement,” i.e., as a limitation on the scope of a chemical genus claim that is more stringent than the written discussion requirement. I will begin by summarizing the Idenix decision, and then provide some commentary and analysis.

Keywords: patents, biotechnology, written description, enablement, Idenix