Intellia Therapeutics said today it received notice from China’s State Intellectual Property Office (SIPO) that it will grant the company a broad patent covering CRISPR/Cas9 single-guide gene-editing methods and compositions.
CRISPR stands for clustered regularly interspaced short palindromic repeats. The CRISPR patent to be issued by SIPO includes claims covering methods for editing DNA in noncellular and cellular settings, including in eukaryotic cells such as human and mammalian cells, Intellia said.
Also included in the patent, the company added, are CRISPR/Cas9 composition of matter and system claims for use in any setting, including claims covering the use of CRISPR/Cas9 in producing medicines for treating disease.
Intellia holds rights to CRISPR intellectual property developed by the Regents of the University of California (UC), the University of Vienna, and Emmanuelle Charpentier, Ph.D., a director at the Max-Planck Institute in Berlin, through a 2014 license agreement with Caribou Biosciences, the exclusive licensee of the UC and University of Vienna. Those rights include human therapeutic, prophylactic, and palliative uses (including companion diagnostics), excluding antifungal and antimicrobial applications.
CRISPR ownership has been at the heart of a bitter legal battle royal with the Broad Institute of MIT and Harvard. A researcher based at the Institute, Feng Zhang, Ph.D., is listed an inventor on 12 patents related to CRISPR technology awarded in the U.S.
In February, the U.S. Patent Trial and Appeal Board (PTAB) sided with the Broad Institute by finding “no interference in fact” between the 12 patents, and a patent application by Dr. Charpentier and Jennifer Doudna, Ph.D., of UC Berkeley. UC, University of Vienna, and Dr. Charpentier are appealing the PTAB decision to the U.S. Court of Appeals for the Federal Circuit.
China’s plans to grant a patent for CRISPR come less than a year after the nation has seen two clinical trials involving the technology. On October 29, You Lu, M.D., and colleagues at Sichuan University’s West China Hospital in Chengdu launched the world’s first CRISPR trial in humans by using the technology to knock out a gene encoding the programmed cell death protein 1 (PD-1) in patients with non-small-cell lung cancer (NSCLC).
The second trial was initiated in April in patients with late-stage nasopharyngeal carcinoma, by researchers led by Jia Wei, M.D., Ph.D., vice director of the Clinical Cancer Institute of Nanjing University. The first U.S. trial is expected to be started later this year by a team led by Carl June, M.D. of the University of Pennsylvania.
“SIPO’s decision further expands our IP portfolio and is further global recognition that Jennifer Doudna, Emmanuelle Charpentier, and their team are the pioneers in the application of CRISPR/Cas9 in all cell types,” Nessan Bermingham, Ph.D., Intellia’s CEO and president, said in a statement.
In March, Intellia and Caribou—co-founded by one of the original CRISPR researchers, Dr. Doudna, of UC Berkeley—joined ERS Genomics and CRISPR Therapeutics in signing a global cross-consent and invention management agreement for the foundational intellectual property covering CRISPR/Cas9 with the Regents of UC, the University of Vienna, and Dr. Charpentier.
That intellectual property underlies patents awarded by the European Patent Office and the United Kingdom’s Intellectual Property Office earlier this year. Those patents were issued from an international patent application based on the same U.S. priority applications filed by UC, University of Vienna, and Dr. Doudna on May 25, 2012.
The EPO acted on European patent application No. 13793997, which had been challenged by parties that include the Broad Institute.
