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UPDATE: CRISPR Stakeholders Seek Reversal of Patent Interference Proceeding Decision

This article has been updated to include a statement from the Broad Institute.

NEW YORK (GenomeWeb) – CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences, and ERS Genomics said Tuesday that the co-owners of intellectual property relating to CRISPR-Cas9 gene editing technology and licensed by these firms are seeking reversal of a decision by the US Patent and Trademark Office's Patent Trial and Appeal Board in a patent interference proceeding. 

In an appellate brief to the US Court of Appeals for the Federal Circuit, the University of California, University of Vienna, and Emmanuelle Charpentier are requesting that the court reverse the PTAB's decision to terminate the interference between certain claims in CRISPR-Cas9-related patent owned by them and claims of the Broad Institute, Harvard University, and the Massachusetts Institute of Technology.

In January 2016, the USPTO declared an interference proceeding to settle certain claims related to the CRISPR patent battle between parties led by the Broad and UC. In the interference proceedings, the USPTO said it would collect, consider, and compare historical documentary evidence to establish invention dates, and placed the burden on the Broad to establish that it invented the technology first.

In February 2017, however, the three-judge PTAB panel hearing the interference case issued a judgement of no interference-in-fact, stopping UC's bid for intellectual property underpinning the most lucrative applications of genome editing. In April, UC announced it would appeal the decision.

In its brief to the Federal Circuit, UC asserts that the PTAB's determination that the UC patent claims did not make the Broad's patent claims obvious is based on "a misapplication of controlling legal standards established by US Supreme Court and Federal Circuit precedent," the plaintiffs said in a statement.

"In its decision, the PTAB had concluded that UC's claims covering CRISPR-Cas9 single guide gene editing technology and its application in any cellular or non-cellular setting did not make obvious Broad's claims covering application of the same technology limited to use in eukaryotic cellular settings," the plaintiffs noted.

The brief asserts that the PTAB's decision that the use of CRISPR-Cas9 in eukaryotes is separately patentable as alleged by the Broad is based on several errors, including that the decision goes against US Supreme Court precedent that calls for determinations of this kind to be made based on an "expansive and flexible approach" including consideration of "the inferences and creative steps that a person of ordinary skill in the art would employ." The PTAB, the plaintiffs said, applied "a narrow and restrictive approach that ignored certain key evidence."

The PTAB also ignored the Broad's own use of prior inventions to apply CRISPR-Cas9 to eukaryotes, the brief alleges, and failed to consider that "Broad's alleged invention did not reflect any significant innovation on Broad's part, an important issue under applicable precedent."

The plaintiffs believe that correctly applying legal standards to the case would require a reversal of the PTAB's decision, and are asking the appeals court to reinstate the interference proceedings.

In a statement, the Broad said the plaintiffs' brief "hinges on its argument that, although [the University of California, Berkeley'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. This is inaccurate, as the PTAB noted repeatedly in its decision."

Further, the Broad noted, in order to overturn the PTAB decision, the appeals court will need to decide that the PTAB "committed significant errors of law or lacked substantial evidence to reach its decision," a finding the Broad believes is unlikely.

The Broad's opening brief is due Oct. 25.

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