A three-judge panel of the Patent Trial and Appeal Board (PTAB) has ruled in favor of the Broad Institute of MIT and Harvard in the bitter legal battle royal with University of California (UC), Berkeley, over who invented CRISPR (clustered regularly interspaced short palindromic repeats) gene-editing technology.
The PTAB panel found “no interference in fact” between 12 patents related to CRISPR technology that list as inventor Feng Zhang, Ph.D., of the Broad Institute, and a patent application by Jennifer Doudna, Ph.D., of UC Berkeley, and Emmanuelle Charpentier, Ph.D., of the Helmholtz Centre for Infection Research.
As a result, the application can be returned to the U.S. Patent and Trademark Office (USPTO) examiner who previously determined it allowable for review.
The Doudna/Charpentier application states claims covering the use of CRISPR in a bacterial system, while the Broad's patents focus on the use of CRISPR in eukaryotic systems, such as plants and higher animals. UC Berkeley, Dr. Doudna, and Dr. Charpentier challenged the Broad patents, contending that the application of CRISPR to eukaryotic systems represented an obvious rather than an inventive invention, and was thus nonpatentable. The Broad has defended its patents.
“This evidence shows that the parties’ claims do not interfere. Accordingly, we terminate the interference,” the PTAB panel ruled. “The evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR/Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR/Cas9 system to be successful in an eukaryotic environment.”
In a statement, Broad emphasized the potential of CRISPR technology to generate far more patents than those at issue in the legal dispute.
“CRISPR research is a very large field that involves contributions from talented scientists around the world. We have deep respect for all of these scientific contributions, including the work from Emmanuelle Charpentier, Jennifer Doudna, and their teams, as well as all of those who continue to advance the field and educate the public about this important technology,” Broad stated.
Broad said it would continue to work with partner organizations “to disseminate and share CRISPR genome-editing tools to maximize public benefit, especially by continuing to make this transformative technology widely available to the worldwide academic community and for commercial and human therapeutic research.
“We believe CRISPR should continue to be available to the global scientific community to advance our understanding of the biology and treatment of human disease, and to help lay the groundwork for a new generation of therapies,” Broad added.
The PTAB panel heard oral arguments in December when it considered whether an “interference” proceeding aimed at resolving the impasse could proceed, as declared in January by Administrative Patent Judge Deborah Katz of the USPTO.
In its own statement, UC Berkeley continued to maintain that evidence “overwhelmingly” supports its position that the team of Drs. Doudna and Charpentier was the first group to invent the technology for use in all settings and all cell types. It continues to assert that the team was the first to publish and file patent applications directed toward that invention, and that the Broad Institute’s patents were not patentably distinct from the Doudna/Charpentier invention.
“For that reason, UC will carefully consider all options for possible next steps in this legal process, including the possibility of an appeal of the PTAB’s decision,” UC Berkeley stated. “We will be guided, as always, by the public’s best interest and will continue to support and advance fundamental research, such as CRISPR/Cas9, that can help solve our greatest challenges across human health, agriculture, and the environment.”
Editas Medicine—whose co-founders include Drs. Zhang and Doudna—hailed the PTAB panel decision in a statement lauding Broad’s “innovative and fundamental work” on CRISPR technology. Editas was launched in 2013 to translate their genome editing research into new therapeutics
“This important decision affirms the inventiveness of the Broad’s work in translating the biology of the natural world into fundamental building blocks to create unprecedented medicines,” stated Katrine Bosley, president and CEO of Editas. “We are continuing to invest in this technology to build our business for the long-term and to create genome-editing therapies for patients suffering from genetically-defined and genetically-treatable diseases.”
To learn more listen to GEN's podcast Sorting Out the CRISPR Patent Case as Bill Warren, partner with the law firm Eversheds Sutherland and chair of its biotechnology and life sciences team, discusses the ruling by the PTAB.