UC files opening brief to appeal CRISPR-Cas9 patent decision

Keegan Houser/UC Berkeley/Courtesy

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Last week, the University of California filed an opening brief to appeal a decision by the U.S. Patent Trial and Appeal Board, or PTAB, which denied UC patent claims for CRISPR-Cas9 technology in eukaryotic cells.

In February, PTAB determined that patent claims of campus professor Jennifer Doudna and affiliated researcher Emmanuelle Charpentier are distinct from CRISPR patents previously granted to researchers at the Broad Institute. An appeal to the PTAB’s decision on behalf of the University of California, University of Vienna and Emmanuelle Charpentier was filed in April.

The University of California and University of Vienna seek to reverse the decision, claiming the test used to determine who was first to invent the system — called an “interference”— was “erroneously applied,” according to Lynn Pasahow, a university attorney.

According to the UC’s opening brief, “The PTAB’s ruling flies in the face of core legal principles that govern the interference-in-fact inquiry, and defies common sense.”

The brief alleges that, if uncorrected, the ruling will allow Broad to claim much of the UC’s “transformational invention without Broad demonstrating anything close to the genuine innovation that would justify finding its claims to be separately patentable.”

CRISPR-Cas9 is a gene-editing technology pioneered by Emmanuelle Charpentier and Jennifer Doudna, a campus professor of chemistry and molecular and cell biology.

According to Pasahow, the UC is claiming patents for the application of the CRISPR-Cas9 technique in all environments, including eukaryotic applications, while Broad only claims first adaption of CRISPR-Cas9 for application in eukaryotic cells.

UC argues in its brief that based on Doudna and Charpentier’s 2012 “Science” article, which described the essential elements for applying CRISPR-Cas9 techniques, the work of Broad is an extension of the UC’s published research.

“We believe it was obvious to an ordinary skilled person how to use the techniques in eukaryotic cells,” Pasahow said.

Broad claims CRISPR-Cas9 application within eukaryotic cells was not made obvious by Doudna and Charpentier’s research.

“Notably, the UCB brief hinges on its argument that, although UCB’s work simply involved characterizing a purified enzyme in a test tube, it rendered obvious that genome editing could be made to work in living mammalian cells,” according to a statement released by Broad. “(UCB’s argument) is inaccurate, as the PTAB noted repeatedly in its decision.”

According to Broad’s statement, given the “careful and extensive factual findings and legal analysis” in the PTAB decision, the appeal court will need to find significant errors in the decision in order to proceed.

Broad must submit its opening brief by October 25, after which a three-judge panel will hold arguments before reaching a decision.

“The interference proceedings could take years to resolve,” said Robin Feldman, a law professor at the UC Hastings College of the Law, in an email. “Other cases are likely to follow in which the parties argue over what each of their patents covers. … In the meantime, as the patent system lumbers on, innovation moves forward at its own rapid pace.”

Contact Christine Giuliano at [email protected] and follow her on Twitter at @christinegiul.