Limits on Hard-To-Reproduce Inventions: Process Elements and Biotechnology's Compliance with the Enablement Requirement

Abstract

The Federal Circuit recently held in the en banc Abbott Laboratories v. Sandoz, Inc. decision that a product claim that includes process elements is infringed only if the accused infringer practices process steps recited in the claim, resolving a long-standing split of authority between its panels. Since process elements now unquestionably serve as effective claim limitations in infringement analysis, it is worth examining their potential value in constraining claim scope for the purpose of complying with statutory patentability requirements. This Article advances the proposal that such limitations help to ensure that certain composition-of-matter claims in the field of biotechnology, particularly claims to biosynthetic proteins, comply with the enablement requirement of § 112 ¶ 1 of the Patent Act. For claims to materials whose behavior and utility can be highly process-dependent and whose structure cannot be fully ascertained, process limitations offer a logical solution that improves commensurability between disclosure and claim scope. This solution is consistent with established scientific norms and fits well within the highly developed enablement doctrine that requires disclosure of an adequate number of working species in order to obtain a valid generic claim.

Keywords: patent, enablement, generic claim, product claim, process claim