Harness Dickey attorneys Jennifer Woodside Wojtala and Jewell Briggs recently published an article in the Biotechnology Law Report discussing an increased need for caution when investing in new technologies using CRISPR-Cas9 gene editing tools. Titled “The Importance of CRISPR-9 Due Diligence,” the article covers the legal and technical implications of the Patent Trial and Appeal Board’s (“the PTAB”) decision in University of California v. Broad Institute, Inc.
The University of California, Berkeley filed patent applications directed to CRISPR-Cas9 technology — a revolutionary technique for gene editing — in 2012. Seven months later, Broad Institute, Inc. filed similar applications. Because Broad used accelerated examination procedures offered by the United States Patent and Trademark Office, Broad’s patents issued first. Not surprisingly, UC filed an interference claim with the PTAB. On February 15, 2017, the PTAB returned a decision of no interference-in-fact focusing on obviousness depending from the inventors contemporaneous statements and functionality in varying prokaryote and eukaryote cells. UC filed a Notice of Appeal with the Federal Circuit Court of Appeals in April and recently filed their opening brief
At stake is a potentially multibillion-dollar market. Use of CRISPR-Cas9 has “exploded” in recent years due to relative ease of use and versatility in gene editing. That versatility comes with a plethora of potential licensing deals for human, animal, and agricultural applications.
Other groups have taken notice of this potentially very lucrative field and have filed patent applications in the same space. With so much overlap in both patent claims and licensing opportunities, it makes for a minefield of legal complications should Broad’s granted patents be determined to be partially or wholly invalid. And as licensing terms become uncertain or unfavorable, Wojtala and Briggs suggest that “it may drive the industry to seek alternative gene-editing tools,” whether independently developed or licensed from other researchers or businesses.
For companies looking to license this technology from any party, Wojtala and Briggs suggest that “ownership and licensing disputes are likely to continue for years to come” and researchers should be appropriately cautious in selecting a gene-editing tool that accounts for potential liability and licensing complexities.