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Broad Institute Responds to UC Berkeley Appeal of CRISPR-Cas9 Patent Interference Decision

NEW YORK (GenomeWeb) – The Broad Institute has filed a brief in the United States Court of Appeals for the Federal Circuit in response to an appeal filed by the University of California, Berkeley in April that aims to continue the fight for rights to intellectual property underpinning the most lucrative applications of genome editing.

In January, the US Patent and Trademark Office declared an interference proceeding to settle certain claims related to the CRISPR patent battle between parties led by the Broad and the University of California. In the interference proceedings, the USPTO said it would collect, consider, and compare historical documentary evidence to establish invention dates. Because the applications were filed before the US moved to a "first to file" patent system in 2013, the patent rights would be granted under the old "first to invent" system.

In February, however, the three-judge panel from the Patent Trial and Appeal Board (PTAB) hearing the interference case issued a judgement of no interference-in-fact, stopping UCB's bid for the IP, and leaving the Broad to control the key IP estate for companies pursuing targeted genome editing applications in several areas, especially gene therapy, drug discovery and development, and ag-bio, which rely on editing in eukaryotic cells.

UCB filed an appeal in April, asserting that the PTAB's decision that the use of CRISPR-Cas9 in eukaryotes is separately patentable as alleged by the Broad was 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 said at that time that correctly applying legal standards to the case would require a reversal of the PTAB's decision, and asked the appeals court to reinstate the interference proceedings.

In its new brief, the Broad notes that in order to be successful, the UCB's argument must persuade the Federal Circuit that the PTAB did not have "substantial evidence" to support its findings, that the PTAB made a material legal error, or that the PTAB failed to consider certain evidence when it closed the interference case. The institute believes, however, that none of these arguments are accurate.

For one thing, the brief states, the PTAB relied on five separate categories of evidence when making its determination, "each of which individually constitutes substantial evidence and collectively provide overwhelming evidence in support of the PTAB's finding of no reasonable expectation of success."

The Broad's brief also claims that UCB is incorrectly claiming that the PTAB made three legal errors in its decision, and that in fact the PTAB reviewed all evidence that UCB claims it ignored.

The institute is asking the appeals court to affirm the PTAB's judgment of no interference-in-fact.