Solving the Non-Obvious: Biotechnology Patents and the Inventive Step Requirement

Abstract

The requirement that a claimed innovation have an inventive step in order to be granted a patent presents particular difficulties for biotechnology. It is notoriously difficult to predict what an examiner or the court will deem to be inventive, creating uncertainty for biotechnologists. Despite the difficulties in predicting the application of the inventive step, the requirement can play an important gatekeeper role, limiting the number of biotechnology innovations that receive patents to those whose contribution outweighs the social costs of imposing a monopoly. This paper will discuss how the inventive step requirement has been interpreted for biotechnology papers, and the role that the requirement plays in the biotechnology industry, comparing it to the other patent requirements. It argues that despite the difficulties in application of the inventive step, and the difficulties it creates for biotechnologists, biotechnology as an industry benefits from its imposition as without it there is the risk of patents on products or processes that are obvious developments hindering future research.