The Importance of CRISPR-9 Due Diligence

On February 15, 2017, the United States Patent and Trademark Office’s Patent Trial and Appeal Board announced its long-awaited decision finding no interference-in-fact between patents and patent applications directed to CRISPR-Cas9 owned by Broad Institute, Inc. et al. and patent applications owned by Regents of the University of California et al. The decision found that the CRISPR-Cas9 gene-editing system in a eukaryotic environment (as generally claimed by Broad Institute) was found to be patentably distinct from a CRISPRCas9 gene-editing system in any environment, including in prokaryotic cells or in vitro (as claimed by the University of California), ‘‘because one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment.’’ Therefore, no interference of the claims was found and the proceedings were terminated. This decision has been appealed to the Federal Circuit Court of Appeals. The background, implications of this decision, and possible future issues related to the respective patent portfolios are explored herein.