CRISPR: careless talk costs patents
The identification of the clustered regularly interspaced short palindromic repeat (CRISPR)/Cas9 system for gene editing of eukaryotes has led to an explosion of research in this area due to the far-reaching applications of the system. This in turn has led to a race to carve out valuable commercial protection for CRISPR/Cas9 and use of this system in various applications.
In some bacteria, such as streptococci, CRISPR systems are present as part of a protective system against foreign DNA (such as viral DNA). Following invasion by a virus, a portion of the viral DNA is incorporated as a spacer (ie, in the space between two CRISPRs), providing a form of ‘memory’. Following subsequent invasion, the CRISPR system recognises the virus and produces an enzyme, Cas9, to cut up the viral genetic material.
The discovery that this bacterial defence system can be employed in eukaryotes to find, cut and replace DNA at a specific location has resulted in a major breakthrough in gene-editing technology.
Every few years, a breakthrough in science occurs and, much as we are currently seeing with CRISPR/Cas9, scientific groups throughout the world race to (i) lead scientifically and (ii) commercially protect the results of their research. In an ideal world these two aims go hand in hand, with the group that leads the scientific breakthroughs gaining both the scientific accolades and successful commercial protection.
The road to patent rights
Blazing the trail to secure the European patent rights to the underlying CRISPR/Cas9 technology are two groups: one led by Feng Zhang of the Broad Institute and Massachusetts Institute of Technology, the other by Jennifer Doudna of the University of California, Berkeley and Emmanuelle Charpentier of the Helmholtz Centre for Infection Research.
In November 2014, the group led by Doudna and Charpentier received the 2015 Breakthrough Prize in Life Sciences for “harnessing an ancient mechanism of bacterial immunity into a powerful and general technology for editing genomes, with wide-ranging implications across biology and medicine”. However, the interplay between academia and the commercial world requires careful consideration.
Here, we analyse some of the patentability issues arising from what is a fast-moving area of science and pre-grant patentability attacks in the form of third-party observations (TPOs), identified from the publicly available file histories of European patent applications of the two main groups.
Figure 1: Timeline of filings by the Zhang and Doudna groups
