Inventive steps: the CRISPR patent dispute and scientific progress: The recent patent decisions about CRISPR tell us a lot about how advances in biology are actually made-and how they are not.

Abstract

Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene‐editing technology, CRISPR/Cas9, have shed light on the importance—and puzzles—of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. In February 2017, the US Patent Trial and Appeal Board (PTAB) found that the work of Feng Zhang, a researcher at the Broad Institute in Cambridge, MA, USA, constituted a “nonobvious” advance over the celebrated work of Jennifer Doudna of the University of California, Berkeley (USA) and Emmanuelle Charpentier, then at Umea University, Sweden [1]. As a consequence, the Broad Institute will be able to keep its US patents covering the technology irrespective of how Doudna and Charpentier's patent application proceeds. By contrast, the European Patent Office (EPO) announced that it had granted Doudna and Charpentier's European patent application covering broad uses of CRISPR/Cas9 in essentially any cell type, despite the US Patent Office's decision to the contrary [2]. Other parties—including the Broad Institute—will be able to challenge Doudna and Charpentier's European patent. But for now, the EPO's decision is an implicit recognition that Doudna and Charpentier's work was, itself, a major “inventive step” over the work that came before it. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions have put those differences on parade. The US decision in particular—and even the nature of the controversy between the two US research institutions—has been widely criticized by scientists. One prominent researcher, Michael Eisen from the University of California, Berkeley, has taken particular issue with the PTAB's articulation of the typical manner in which molecular biologists adapt discoveries to different cell systems. “[O]ne can believe that it was obvious that CRISPR would work in eukaryotic cells, …