Patent office renews dispute over patent rights to CRISPR-Cas9


CRISPR-Cas9 molecule

Schematic representation of the CRISPR-Cas9 system. The Cas9 enzyme (orange) cuts the DNA (blue) in the location selected by the RNA (red). (Image courtesy of Carlos Clarivan/Science Photo Library/NTB Scanpix)

The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) has declared an interference between 10 University of California patent applications and multiple previously issued Broad Institute patents.

The action jeopardizes 13 of the Broad’s 15 CRISPR-Cas9 U.S. patents and one patent application, and signals that the USPTO will take up the issue of who first invented CRISPR-Cas9 genome editing in eukaryotic cells, that is, plant and animal cells.

The CRISPR-Cas9 DNA-targeting technology was invented by Jennifer Doudna and Martin Jinek at the University of California, Berkeley; Emmanuelle Charpentier, then of Umea University in Sweden; and Krzystof Chylinski at the University of Vienna.

“The initiation of this interference proceeding highlights that previous decisions involving the Broad did not determine who was the first to invent this technology, and it lays out a pathway for resolving this important issue,” said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR matters for UC and a director at Sterne, Kessler, Goldstein & Fox. “We are confident that the USPTO will ultimately recognize that the Doudna and Charpentier team hold the priority of invention specific to eukaryotic cells, as well as other settings covered by previous patents.”

In September 2018, the United States Court of Appeals issued a ruling that upheld a Patent Trial and Appeal Board (PTAB) judgment that had found no interference-in-fact between UC claims and patents already issued to Broad, stating that the claims were not directed to the same subject matter. That ruling made no specific determination regarding priority of invention of genome editing within eukaryotic cells. UC was subsequently issued six U.S. patents for CRISPR technologies in other cellular or non-cellular settings, with six additional applications set to issue in the coming weeks and holds more than 50 CRISPR patents worldwide.

“The University of California and other public universities are critical sources for innovation across many industries,” said Edward Penhoet, special advisor to the UC Berkeley chancellor and special assistant to the president of the University of California. “We are committed to protecting the intellectual property of the groundbreaking inventions of UC faculty, like the CRISPR-Cas9 breakthrough. Today’s declaration of interference reinforces the importance of the university’s role in protecting discoveries and their pursuit.”

Today’s declaration of interference affects 13 of the Broad’s 15 U.S. patents, as well as one application – essentially all of its CRISPR patents involving eukaryotic cells. The six U.S. patents received to date by UC are not included in this interference. Based on current PTAB interference schedule, the interference is likely to be completed within two years.

In addition to six U.S. patents, UC has received four patents from the European Patent Office (representing more than 30 countries), as well as patents in the United Kingdom, China, Japan, Australia, New Zealand, Mexico and other countries.

The international scientific community has widely acknowledged the pioneering invention by the Doudna-Charpentier team on CRISPR-Cas9 genome editing through numerous awards, including the Breakthrough Prize in Life Science, Japan Prize, Gruber Prize in Genetics, BBVA Frontiers of Knowledge Award, and Kavli Prize in Nanoscience.

UC has a long-standing commitment to develop and apply its patented technologies, including CRISPR-Cas9 genome editing, for the betterment of humankind. Consistent with its open-licensing policies, UC allows nonprofit institutions, including academic institutions, to use the technology for non-commercial educational and research purposes.

UC encouraged widespread commercialization of the CRISPR-Cas9 technology through its exclusive license with Caribou Biosciences, Inc. of Berkeley, California, which has sublicensed the technology to many companies internationally, including Intellia Therapeutics, Inc. for certain human therapeutic applications. Additionally, Charpentier has licensed the technology to CRISPR Therapeutics AG and ERS Genomics Limited.

The ten UC patent applications in the proceeding are: US 15/947,680; US 15/947,700; US 15/947,718; US 15/981,807; US 15/981,808; US 15/981,809; US 16/136,159; US 16/136,165; US 16/136,168; and US 16/136,175.

The Broad patents affected include patents 8,697,359; 8,771,945; 8,795,965; 8,865,406; 8,871,445; 8,889,356; 8,895,308; 8,906,616; 8,932,814; 8,945,839; 8,993,233; 8,999,641; 9,840,713; and application 14/704,551.

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