13 Feb 2018 | Patents and Utility Models

European Patent Office Revokes Broad Institute’s CRISPR-Cas9 “Gene Editing” Patent

The Opposition Division of the European Patent Office has revoked EP 2 771 468 B1, one of the fundamental CRISPR patents for lack of novelty, in essence due to formal irregularities in the priority claim. An appeal is pending.

CRISPR-Cas9 gene editing is the ground-breaking technology that has in the past 5 years tremendously transformed the field of molecular genetics, and will very likely revolutionize biomedical approaches in the future. The “CRISPR” or “gene editing” technology harnesses a bacterial defense mechanism which identifies and destroys foreign “harmful” DNA as a tool for the targeted manipulation of genomic DNA. Compared to other manipulation approaches gene editing does not leave any undesired traces or footprints in the edited genome and is easy to apply. Gene editing was developed and filed for a patent nearly at the same time by the University of California, Berkeley, and the Broad Institute of the Massachusetts Institute of Technology (MIT). Since then, both institutions bitterly fight over the control and dominance of the CRISPR patent landscape in the US and Europe.

Now, in a first instance decision, the European Patent Office (EPO) revoked Broad
Institute’s CRISPR Gene Editing Patent for a lack of novelty due to formal irregularities in the priority claim. What happened? The Broad institute originally filed a conglomerate of 12 US provisional applications in the name of the inventors disclosing their part of the CRISPR technology. These US provisional applications were then used as a basis for a priority claim in an International (PCT) application of the Broad Institute from which the later European CRISPR patent was derived (opposed European patent No. EP 2 771 468).

A valid priority claim in Europe requires that the applicant is able to demonstrate its right to priority, either through identity of applicants between the prior and subsequent applications, or by proving a transfer of the priority rights with assignment documentation. Remarkably, for the CRISPR patent, the patent owner could not provide evidence for the ownership of the priority rights for a significant number of originally filed US provisional applications. Their priority claim was rejected by the EPO resulting in a loss of the priority date and a subsequent novelty rejection. The patent was revoked during oral proceedings on January 17, 2018. However, the Broad Institute already filed a notice of appeal – so the struggle continues.

This prominent example demonstrates again the importance of a thorough and careful preparation of priority claims for Europe, in particular in cases with multiple priorities.