The Regents of the University of California (UC), the University of Vienna, and Emmanuelle Charpentier, Ph.D., of the Max-Planck Institute in Berlin, have been granted a U.S. patent for intellectual property related to CRISPR-Cas9 genome-editing technology.

According to the companies, U.S. Patent No. 10,000,772 covers methods of using optimized guide RNA formats (including single-guide and dual-guide formats) in certain environments, including eukaryotic cells (such as human, animal, and plant cells). The optimized formats modify the part of a guide RNA that interacts with the CRISPR-Cas9 nuclease.

The ‘772 patent claims priority to a U.S. provisional application, filed by UC on May 25, 2012, which broadly encompasses CRISPR-Cas9 genome-editing technology invented by the research teams of Dr. Charpentier and Jennifer Doudna, Ph.D., of UC Berkeley, the companies said.

Both are listed as co-inventors on the ‘772 patent, as are Martin Jinek, Ph.D., of University of Zurich, a postdoctoral student of Dr. Doudna; and Krzysztof Chylinski, Ph.D., of University of Vienna, a onetime postdoctoral student of Dr. Charpentier.

“We believe that the U.S. patent ‘772 granted [yesterday] covers the use of CRISPR-Cas9 genome editing with the RNA guide formats that are widely used throughout the industry,” the three companies said in a statement. “We anticipate this is the first of many patents that will be granted to UC on this foundational CRISPR-Cas9 intellectual property.”

The granting of the patent for “Methods and compositions for RNA-directed target DNA modification and for RNA-directed modulation of transcription” was announced yesterday by three companies that have licensed CRISPR technology based on research by the labs of Drs. Doudna and Charpentier: Caribou Biosciences, whose scientific advisory board includes Drs. Doudna and Jinek; CRISPR Therapeutics, whose scientific founder is Dr. Charpentier; and Intellia Therapeutics, whose co-founders include Dr. Doudna and Rodolphe Barrangou, Ph.D., of North Carolina State University.

Dr. Barrangou is also editor-in-chief of The CRISPR Journal, a new peer-reviewed journal on all aspects of genome-editing research published by GEN publisher Mary Ann Liebert Inc.

Targeting a Single Strand

The patent is the second CRISPR-related patent in as many weeks awarded to UC by the USPTO.

Last week, UC was granted U.S. Patent No. 9,994,831, which covers “methods and compositions for modifying a single stranded target nucleic acid.” UC filed for that patent in 2014.

The U.S. Patent and Trademark Office (USPTO) granted both patents even as UC, the University of Vienna, and Dr. Charpentier remain in a bitter battle royal with the Broad Institute of MIT and Harvard over who invented CRISPR.

The U.S. Court of Appeals for the Federal Circuit recently heard oral arguments in the case. Both UC and the Broad have issued statements expressing confidence that the appeals court would decide in their favor.

The UC and its co-appellants are appealing a February 15, 2017, Patent Trial and Appeal Board (PTAB) finding of “no interference in fact” between 12 patents related to CRISPR (clustered regularly interspaced short palindromic repeats) technology that list as inventor Feng Zhang, Ph.D., of the Broad, and a patent application by Dr. Charpentier and Jennifer Doudna, Ph.D., of UC Berkeley.

The PTAB concluded the UC and the Broad’s technologies to be “patentable distinct” and that “a person of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment.”

As a result, the PTAB held, the application can be returned to the USPTO examiner who previously determined it allowable for review. The UC and partners have argued in their appeal that the PTAB used unreasonably high standards to determine obviousness and the expectation of success of the invention.

In addition to the ‘772 and ‘831 patents, the UC and partners have been found their patent applications allowable in the U.S., and also have been awarded patents in Europe, the U.K., China, Japan, and various countries worldwide. Those patents covered the dual- and single-guide RNA compositions of the widely adopted CRISPR-Cas9 genome-editing technology and their uses in all environments, including plant, animal, and human cells as well as for use in human therapeutics.

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