As the patent trial to determine ownership of the world’s most significant gene editing technology continues, the tides seems to have turned for the Broad Institute.
The trial, in the US Patent and Trademark Office in Virginia, will determine which of two groups is entitled to the patent for the CRISPR/Cas 9 gene-editing technology, which could be used to change the genetic composition of crops, disease-carrying bugs and people. It’s estimated to be worth billions to whichever side wins: either UC Berkeley, or the Broad Institute of MIT and Harvard.
Arguments began Dec. 6, and since then each side has been debating whether the patent application UC Berkeley filed in early 2012 applies to eukaryotic cells, which make up humans and other complex life. Whichever side gets that patent will have the rights to human gene editing, which is far more lucrative than a smaller patent for editing genes in prokaryotic cells such as bacteria.
Throughout the week, the Broad Institute’s council has been emphasizing that its work into editing the genes of human and mice cells began a year before UC Berkeley’s researchers filed their patent application. A key document was released this week that indicates the Broad Institute ““is prepared to offer proof that its scientists’ achievement in mouse and human cells was done without guidance from Doudna’s results,” STAT+ reported.
In oral arguments this week, the tone of questioning appeared to be harsher toward UC Berkeley than Broad, indicating the decision could sway toward Broad. “My gut-level impression is that the questioning of the Broad’s attorney was really light, but they grilled UC a lot more,” Jacob Sherkow, a patent expert at New York Law School, told Stat News.
The big question that’s been debated so far is whether UC Berkeley’s initial patent only covered procaryotic cells or whether eukaryotic cellular use could also be inferred from the application. At the time, CRISPR gene editing tools had only been used to alter procaryotic cells, but the big money is in eukaryotic cells—particularly the potential to alter human fetuses to remove disease or add desirable traits.
UC Berkeley’s council has argued this week that extrapolation to eukaryotic cells relied entirely on a research paper published in summer 2012 by the university's researchers, which they said was key to their patent application, The Scientist reported.
UC Berkeley’s council also argued that within six month of that paper being published in Science, six groups had been able to use CRISPR tools to alter eukaryotic cells. Their council stated this meant a “person of ordinary skill” in genetics could use the researchers’ techniques to alter eukaryotic cells. Their council also said the researchers had documented four proteins used on prokaryotic genetic altering that could also be used in eukaryotes.
On the other side, the Broad Institute’s council argued no paper, not even UC Berkeley’s researchers, had established a road map to editing eukaryotic cells, so the Broad Institute’s patent regarding eukaryotic cells should stand. They also stated Broad Institute researchers had started working on ways to apply CRISPR tools to eukaryotic cells before the 2012 paper was released, The Scientist reported.
The Broad Institute's council also stated it took intense work by “extraordinary” people to achieve eukaryotic genetic edits after the 2012 paper was released, and many of these groups used different molecules than stated in that paper. At the core of their argument was eukaryotic application wasn’t obvious, even when UC Berkeley’s work was considered.
A decision hasn’t been reached in the case, and the court is expected to make a ruling in January.
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