The U.S. Patent and Trademark Office has ruled in favor of the Broad Institute of MIT and Harvard in a dispute over the patents around CRISPR gene editing technology.
The decision is part of a long-running legal battle brought by two universities and one of the founders of the gene editing technique, Nobel Prize winner Emmanuelle Charpentier, Ph.D.
Charpentier and fellow Nobel Prize laureate Jennifer Doudna, Ph.D., created a type of genetic scissors that can be used to cut any DNA molecule. This was dubbed CRISPR/Cas9, and it has been used by dozens of biotechs to create gene editing therapies that could someday provide one-time cures for diseases. Editas Medicines is among the companies doing just that using technology licensed from Broad.
The patent office has determined Broad was the first group to invent CRISPR/Cas9 for editing a certain type of human cell that can be used to make medicines—not Charpentier, the University of California (UC) and the University of Vienna. The group is collectively referred to as CVC.
Editas CEO James Mullen said both groups made important contributions to the science that ultimately led to gene editing in medicine, but the decision “reaffirms the strength of our foundational intellectual property,” according to an after-market release Monday. The Editas license covers patents for CRISPR/Cas9 and CRISPR/Cas12a gene editing in all human cells, the company said.
Editas' shares climbed over 10% in after-market trading Monday to $18.90 apiece. The bump helped bring the company closer to the $19 range it was sitting at in February before Chief Medical Officer Lisa Michaels, M.D., was relieved of her duties without explanation.
The decision has had the opposite impact on other gene editing companies. Intellia shares dropped almost 17% on Tuesday morning to $81.92, even though the company dropped some much anticipated data at market close on Monday. CRISPR Therapeutics was down just over 6% to $57.51 as of 11:34 a.m. ET on Tuesday.
Intellia's patents are with UC and cross licensed from CRISPR Tx, ERS Genomics and Caribou Biosciences.
Back in 2018, a federal appeals court found “no interference-in-fact" between CRISPR patents held by the Broad and patents sought by UC. Chardan Research noted that this earlier decision was a risk because it could block IP from companies that hold licenses with the UC group, which would apply to "many if not all of Intellia's programs."
The latest news is not the end of the dispute. The decision could be appealed to the federal circuit court, but for now it ends the “patent interference” in the U.S. by the challengers, according to Editas.
In a statement, UC-Berkeley said the institution holds 40 other patents that were not subject to the ruling that cover various components of CRISPR-Cas9 genome editing systems. At issue in this matter were 13 patents, which UC said "remain under challenge."
"UC is disappointed by the PTAB’s decision and believes the PTAB made a number of errors," the statement said. The group is considering "various options to challenge this decision."
Intellia supports the continued challenge, and said in the meantime, the biotech will focus on continuing to develop CRISPR/Cas9 therapeutics and generating its own IP.
"We are carefully reviewing the decision and are confident CVC will find a path forward to affirm their IP rights, including the possibility of an appeal to the federal circuit," the company said. "CVC remains in a strong IP position in the U.S. and worldwide, and this decision does not impact any of our ongoing research and development plans."
Cambridge, Massachusetts-based Editas presented initial data on its first human clinical trials last year, which were conducted for the vision loss therapy EDIT-101.
The Broad Institute is a genomic research institute that brings together researchers from MIT and Harvard.
Editor's note: This story was updated with commentary from UC Berkeley and additional context about Intellia at 11:34 a.m. ET on March 1, 2022.