An artists conception of the DNA-cutting enzyme Cas9.

By Jon CohenJul. 26, 2017 , 9:00 AM

The University of California (UC) has fired another legal salvo in the prolonged patent battle over CRISPR, the revolutionary gene-editing technology that has spawned a billion-dollar industry.

UC leads a group of litigants who contend that the U.S. Patent Trial and Appeal Board (PTAB) wrongly sided with the Broad Institute in Cambridge, Massachusetts, and two partnersHarvard University and the Massachusetts Institute of Technology in Cambridgein February when it ruled that the Broad group invented the use of CRISPR in eukaryotic cells. After that ruling, UC moved the battleground to the U.S. Court of Appeals for the Federal Circuit. In a 25 July brief to the Federal Circuit, the UC group contends that PTAB ignored key evidence and made multiple errors.

The UC litigants indisputably first showed in 2012 that CRISPR could work in DNA of simpler organisms, and soon after filed a patent application on the gene-editing technique. They claim the Broad group learned from that disclosed invention and applied CRISPR to eukaryotic cells. The essential legal question is whether the Broads patent application is a novel, patentable invention, or whether it was obvious in the sense that anyone skilled in the artin other words, any trained molecular biologistwould have a reasonable expectation of success of using the CRISPR system to edit genes in eukaryotic cells.

The UC group contends PTAB ignored key decisions on these general questions made by the U.S. Supreme Court and the Federal Circuit. It reiterated its long-held claim that applying CRISPR to eukaryotic cells was so obvious that six different labs did it in the same time frame, which it complains the PTAB essentially dismissed as irrelevant. And its brief notes that patent examiners rejected similar eukaryotic cell CRISPR patent applications from Sigma-Aldrich and ToolGenfiled before the Broads patent applicationbecause it made claims that were non-novel or obvious in light of UCs disclosed work.

Jacob Sherkow,an intellectual property attorney at the New York Law School in New York City who has closely followed each round in the fierce battle, says the UC groups brief at times overplays these mistakes relative to the PTAB's analysis. He notes that the PTABs decision was thorough and the standards to overturn its decisions are high. While there were some interesting chestnuts in its briefsuch as UC pointing out that the PTAB virtually ignored some important patents pending at the time [the Broad] patent was filedI don't think that's going to be enough to win the day [for] UC, he says.

In a statement, the Broad Institutesuggested the UC will not prevail in its challenge:

Notably, the [UC]brief hinges on its argument that, although [UC]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.

Updated, 7/26/2017, 12:33 p.m.: Statement from the Broad Institute added.

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Ding, ding, ding! CRISPR patent fight enters next round | Science ... - Science Magazine

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