A fourth U.S. patent covering CRISPR-Cas9 claims was granted today to the Regents of the University of California (UC), the University of Vienna, and CRISPR pioneer Emmanuelle Charpentier, PhD, director and scientific member at the Max Planck Institute of Infection Biology, Berlin.

U.S. Patent No. 10,266,850, “Methods and compositions for RNA-directed target DNA modification and for RNA-directed modulation of transcription,” focuses on systems and methods for using CRISPR/Cas9 technology in a single guide format, including uses to target and edit or modulate genes.

When those single molecule guide RNAs are combined with the Cas9 protein, they create efficient and effective tools for the targeting and editing of genes, UC said in a statement today.

Charpentier is listed as one of four inventors on the patent. The other three are CRISPR pioneer Jennifer Doudna, PhD, of UC Berkeley; Martin Jinek, PhD, of University of Zurich, a onetime postdoctoral student of Doudna; and Krzysztof Chylinski, PhD, of University of Vienna, a onetime postdoctoral student of Charpentier.

“We are very pleased at the progress we’re making with the issuance of this patent and will continue to promote the intellectual property of the Doudna-Charpentier team’s CRISPR-Cas9 invention,” said Eldora L. Ellison, PhD, lead patent strategist on CRISPR matters for UC and a director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox. “Today’s patent further builds on the numerous CRISPR-Cas9 applications in UC’s portfolio and will support the university’s commitment to utilizing the genome editing technology for the benefit of our society.”

The latest patent covers claims that “provide a DNA-targeting RNA that comprises a targeting sequence and, together with a modifying polypeptide, provides for site-specific modification of a target DNA and/or a polypeptide associated with the target DNA,” according to the abstract furnished by the U.S. Patent and Trademark Office (USPTO).

The patent also covers claims that provide:

  • Site-specific modifying polypeptides
  • Methods of site-specific modification of a target DNA and/or a polypeptide associated with the target DNA
  • Methods of modulating transcription of a target nucleic acid in a target cell, generally involving contacting the target nucleic acid with an enzymatically inactive Cas9 polypeptide and a DNA-targeting RNA
  • Kits and compositions for carrying out the methods
  • Genetically modified cells that produce Cas9; and Cas9 transgenic non-human multicellular organisms

Plants, animals, and human cells

“Importantly, the scope of the patent includes any cellular or non-cellular environment, making it applicable not only in vitro but also across living plants, animals, and human cells,” Eric Rhodes, CEO of ERS Genomics, said in a separate company statement.

ERS holds an exclusive worldwide license from Charpentier for foundational intellectual property covering CRISPR-Cas9 for all applications other than use as a human therapeutic. ERS’ foundational IP covers broad and dominant claims covering CRISPR/Cas9 compositions and methods of genome editing in any organism.

Charpentier has licensed the technology to ERS Genomics as well as CRISPR Therapeutics.

UC noted today that it has encouraged widespread commercialization of its technology through its exclusive license with Caribou Biosciences. Caribou has sublicensed the UC’s patent family to numerous companies worldwide, including Intellia Therapeutics for certain human therapeutic applications.

The new patent is the fourth to be issued to the Doudna-Charpentier inventor team. The other three are:

  • Patent Number 10,227,611, which was issued last month, covers the use of single-molecule RNA guides and Cas9 protein in any cell, with the aim of creating efficient and effective ways for scientists to target and edit genes.
  • Patent No. 10,113,167, issued October 30, 2018, covers “Methods and compositions for RNA-directed target DNA modification and for RNA-directed modulation of transcription.”
  • Patent No. 10,000,772, which was issued in June 2018, 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.

Three more U.S. patents expected

UC stated that the USPTO has issued notices of allowance to UC for three other CRISPR-Cas9 patent applications, which are expected to be granted in the coming months. Those three would bring UC’s total to seven U.S. patents in its CRISPR-Cas9 portfolio.

The application for the newly-issued patent, U.S. Patent Application No. 13/842,859, was previously involved in a terminated interference proceeding before the USPTO’s Patent Trial and Appeal Board (PTAB) focused on invention of CRISPR gene-editing technology. Citing a pending patent application, the Doudna-Charpentier-UC inventor team challenged 12 patents related to CRISPR technology that listed as inventor Feng Zhang, PhD, of the Broad Institute of MIT and Harvard.

The May 25, 2012, priority application broadly encompassed CRISPR-Cas9 genome-editing technology invented by the Doudna-Charpentier team and its applications in any setting, UC said, including in vitro, and cellular and non-cellular environments, as well as single molecule RNA guides, among other inventions. The Broad’s patents focused on the use of CRISPR for genome editing in eukaryotic cells, such as those in plants and higher animals.

The Doudna-Charpentier team contended that the application of CRISPR to eukaryotic systems covered by the Broad’s patents represented an obvious rather than an inventive invention, and was thus nonpatentable

The Broad defended its patent and withstood the challenge. A three-judge panel of the PTAB in 2017 unanimously found there was “no interference in fact” between the Broad’s CRISPR-Cas9 patents and the application filed by the Doudna-Charpentier inventor group. In September 2018, the U.S. Court of Appeals for the Federal Circuit upheld the PTAB three-judge panel’s decision, also siding with the Broad Institute.

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