In determining ownership of the CRISPR-Cas9 technology (a tool that enables gene editing through the alteration of DNA sequences), which may be considered the most significant and important biotech breakthrough of this generation, the PTO issued a win for The Broad Institute.
Relying largely on comments by one of UC’s expert witnesses, but also on statements made by a UC inventor herself, the U.S. Patent and Trademark Office found that the ordinary artisan would not have had a “reasonable expectation” that UC’s generalized CRISPR-Cas9 technique directed to prokaryotic cells (i.e., cells of simple organisms such as bacteria) would work in eukaryotic cells (i.e., cells of higher organisms such as plants and animals). Based on this finding, the PTO concluded that The Broad Institute’s claims directed to CRISPR-Cas9 in eukaryotes would not have been obvious from UC’s earlier filed claims directed to CRISPR-Cas9 in any environment, and therefore that The Broad Institute’s claims do not interfere with UC’s claims.
We can consider this decision as a reminder for academic scientists that balancing patent interests with academic etiquette and protocol is often like walking a tight rope. Here, UC inventor Doudna’s statements made contemporaneously with the June 2012 publication of her work with another inventor in Science played an important role in the PTO’s decision. These statements, which were similar to those made by one of UC’s expert witnesses, were likely the product of the expectation in the biological sciences for researchers to be overly cautious in extrapolating techniques shown to work in cells of lower organisms to cells of higher organisms. This expectation applies even when the scientist reasonably believes the technique will work in human cells, and despite the fact that the methodology for pursuing the technique in human cells may not be overly burdensome to the ordinary artisan.
While the UC inventor (i.e., Doudna) could have easily stated that she fully expected the CRISPR-Cas9 technique to work in eukaryotic cells, such a statement would run afoul of this expectation since no actual data was in hand. Unfortunately for her and the UC, her accurate and professional statement about the scope of the earlier CRISPR-Cas9 research in prokaryotes may end up costing them patent protection for this landmark invention in eukaryotic cells.
Nicole Ballew Chang, Ph.D.
Lauren Schneider, Esq.