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Federal Circuit tangles with CRISPR gene-editing patent dispute

Former U.S. Solicitor General Donald Verrilli appeared to struggle in trying to convince a three-judge panel from the U.S. Court of Appeals for the Federal Circuit to give his clients — the University of California and its partners — a win over their rival, the Broad Institute, in a patent fight involving the gene-editing technology CRISPR.

But Broad — a venture between the Massachusetts Institute of Technology and Harvard University — said it was more confident after the April 30 oral arguments that the Federal Circuit would uphold a February 2017 decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board, or PTAB, which ruled that the CRISPR patent granted to the organization in April 2014 did not interfere with UC's patent application.

The party that prevails in the CRISPR patent dispute stands to gain millions, if not billions, of dollars if the promise of the technology is realized in the marketplace.

CRISPR — clustered, regularly interspaced, short palindromic repeats — and the Cas9 tool harness the natural mechanisms of bacteria and use them to identify and then modify and repair mutated or malfunctioning DNA in genes.

The idea is to use the CRISPR/Cas9 technology to treat and prevent diseases and potentially correct genetic defects.

Even though the UC team — led by Jennifer Doudna, a professor of molecular and cell biology and chemistry at UC Berkeley, and Emmanuelle Charpentier, who is now at the Max Planck Institute for Infection Biology in Berlin — was the first to engineer CRISPR/Cas9 and first to file a patent application, Broad beat its competitor in obtaining a patent after paying an extra fee for an expedited review of its application.

Doudna co-founded CRISPR companies such as Intellia Therapeutics Inc., Caribou Biosciences and Mammoth Biosciences.

Feng Zhang, a professor of neuroscience at MIT, who is leading the Broad team, co-founded Editas Medicine Inc.


UC's lawyer, Verrilli, a partner at Munger Tolles & Olson in Washington and U.S. solicitor general during the Obama administration, said that when the university "disclosed the necessary and sufficient components of CRISPR/Cas9 in 2012, researchers immediately understood its revolutionary potential as a simple, elegant and powerful tool for editing genes."

"In just months, six different groups confirmed what UC predicted in 2012, which was that CRISPR/Cas9 could cleave DNA in eukaryotic cells," he told the court. "All six, including Broad, used only conventional techniques and common sense to achieve that predictable result."

Verrilli said Broad based its patent on an "obvious" application of UC's foundational CRISPR/Cas9 technology, and therefore, it should not have been separately patentable.

But Chief Judge Sharon Prost told Verrilli the court needed more convincing the PTAB lacked "substantial evidence" in making its decision and that he must expose some legal error in that ruling.

"The problem you have here is you're trying to convince me there is substantial evidence for the outcome you want," added Circuit Judge Kimberly Moore. "I may agree with you, but that doesn't mean there isn't substantial evidence for the outcome the other side found."

She did not buy Verrilli's argument that the "conventional techniques" Broad and the other organizations used rendered their products obvious.

"That's how science works," Moore said. "You start with the conventional techniques and then when they don't work, you spend the time, energy and money coming up with a new technique. The fact that they started with the easiest off-the-shelf stuff doesn't mean they thought it would work. It means what was most readily and easily available to them at the time."

Prost, however, acknowledged she had some questions about a "couple of legal principles" the PTAB had applied in its 2017 ruling, adding those "may give some [people] pause."

Broad's lawyer, Raymond Nimrod, a partner at Quinn Emanuel, said UC's argument focused on the wrong period for assessing obviousness and a reasonable expectation for success.

"It looks to whether in hindsight after experiments were done whether it took what they were calling innovative techniques to get to the invention," Nimrod said. "But that is not the proper inquiry. It's what they thought before the experiments were conducted."

He insisted that "substantial evidence" supported the PTAB decision and that UC was simply asking the court to second guess the board's ruling.