July 24, 2019
The United States Patent and Trademark Office (“USPTO”) has re-opened the issue of whether the University of California, Berkeley (“Berkeley”), or the Broad Institute of MIT and Harvard (“Broad Institute”) is properly entitled to patents for a key component of CRISPR, a gene-editing technology.
In February of 2019, the USPTO awarded an all-encompassing patent to Berkeley, which covered the use of CRISPR in any setting across all cell types. However, in June, the Patent Trial Appeal Board (“PTAB”) declared an interference between a dozen of the CRISPR-based patents that had already been awarded to the Broad Institute and ten of the CRISPR patent applications that were submitted by Berkeley. The Broad Institute’s CRISPR patents, which are based on the work of Broad Institute biologist Feng Zhang, relate to the use of CRISPR specifically with respect to eukaryotic cells, while Berkeley’s CRISPR patents, which are based on the work of the university’s biochemist Jennifer Doudna, relate the use of CRISPR more generally.
The declaration of this patent interference reopens a 3-year-old dispute between the parties, revolving around the use of CRISPR with respect to eukaryotes (organisms whose genes are enclosed within a cell nucleus, such as animals and plants).
Berkeley researchers first published their research results reflecting their success with the use of CRISPR as a gene-editing tool in June 2012. However, their research was based on the use of CRISPR with respect specifically to bacterial genomes. Broad researchers published their successful results with using CRISPR in eukaryotic cells six months later.
It must now be determined who was the first inventor of CRISPR gene-editing technologies in higher organisms. Berkeley will carry the burden of proof going forward, and will have to convince the PTAB that the Broad team did not invent the eukaryotic use of CRISPR.
This dispute could persist for at least another year. The parties’ next step will be a discussion of the interference in a conference call with the PTAB. If the parties are not able to come to a negotiated settlement of the dispute, the matter will proceed to a hearing, which is likely to take place in approximately eight months.
Authors: Amanda Bertucci and Nargis Fazli