The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)

Abstract

In applying patent law’s enablement and written description requirements to police the scope of chemical genus claims, there can at times be a marked divergence between what the Federal Circuit says the law is on the one hand, and what the court actually does. For example, although the Federal Circuit has repeatedly stated that a patentee must enable the “full scope” of a patent claim in order to comply with 112(a), that is clearly not literally true - rarely if ever does a patent enable every conceivable embodiment that would fall within the scope of a patent claim, a task that would be impossible in most (if not all) cases, given the open-ended nature of most patent claims. Furthermore, there are some generally unstated rules that can be gleaned from a reading of Federal Circuit decisions with a view towards the substance of the issues. For example, although as a formal matter the questions of validity and infringement are distinct, in practice I think that in some cases the nature of the accused product or process can have some bearing on the ultimate question of claim validity under 112(a). As another example, although the Federal Circuit has at times disavowed the notion that, for purposes of US patent law, there is a relevant “gist” or “heart” of invention, in fact the perceived heart of the invention can play a critical role in assessing whether the scope of a claimed genus exceeds the boundaries set by 112(a). In this article, I expand upon some of these ideas, providing a number of examples taken from the case law.

Keywords: patents, pharmaceuticals, 112(a), enablement, written description