It doesn’t look as if Harvard and MIT will have to share its patents on revolutionary CRISPR-Cas9 gene editing technology with the University of California any time soon.
The U.S. Court of Appeals sounded skeptical of the appeal brought Monday by UC and Munger, Tolles & Olson partner Donald Verrilli Jr. The former solicitor general argued that after UC made the breakthrough discovery in 2012, Harvard’s and MIT’s Broad Institute simply applied it to human cells using obvious, conventional techniques.
The Patent Trial and Appeal Board disagreed, finding the Broad Institute’s application represented patently distinct subject matter. On Monday, Federal Circuit Judge Kimberly Moore sounded as if she strongly agreed.
“The problem for you is you have multiple statements by multiple of the UC inventors that are pretty strongly worded about many frustrations getting CRISPR to work in human cells,” she told him. She quoted one researcher’s reaction to Broad’s discovery: “‘I hope you’re sitting down, because CRISPR tuns out to be absolutely spectacular. A Harvard geneticist just figure[d] out how to make it work in human cells.’”
Chief Judge Sharon Prost was sympathetic at times to Verrilli’s arguments, but she pointed out the Federal Circuit must show some deference to the PTAB.
“You’re under substantial evidence review,” she told Verrilli. “The board pointed us to statements, testimony, declarations that used words like ‘very frustrating,’ ‘weren’t the same,’ ‘it’s not known whether’” CRISPR will succeed on human cells, Prost said. “How do you get around that?”
Paul Hastings life sciences IP associate Michael Stramiello, who is not involved in the case but attended Monday’s arguments, said UC faced an uphill battle given the results of the PTAB proceeding. “I’d be surprised if today’s arguments moved the needle at all,” he said.
CRISPR, which stands for clustered regularly interspaced short palindromic repeats, can be used to add or delete DNA from cells in order to fight diseases, reverse genetic mutations or to improve crop resistance to pests and drought. The technique is sparking a gold rush in medical research despite uncertainty over who holds the most valuable patents.
Berkeley said it was first to apply the technique in simple-celled organisms, but Broad argued it was first to expand the technique to multicelled organisms. Berkeley filed its patent first, but the Broad Institute’s patents were approved first, sparking Berkeley’s interference claim.
In the PTAB’s per curiam ruling, the board held there’s “no interference in-fact.” The judges said Broad successfully proved its patents were distinct from Berkeley’s. Broad’s related to editing in an eukaryotic, or multicellular organisms, unlike Berkeley’s, which are limited to prokaryotic, or single-celled organisms.
UC has had more success before the European Patent Office, which ruled recently that a handful of Broad Institute CRISPR patents do not antedate the UC versions. Plus, Stramiello pointed out, the technology is rapidly evolving, opening up opportunities for others. “There’s a lot of attention on innovation in this area, and it hasn’t stopped at Cas-9,” he said.
On Monday, Verrilli tried to get things back on track for UC at the Federal Circuit. He argued the UC researcher statements weren’t negative, but simply neutral. The appeal “has to be decided on the entire record,” not just those few statements, he told the court.
“The problem you have here,” Moore replied, “is you’re trying to convince me there’s substantial evidence for the outcome you want. I may agree with you, but that doesn’t mean there isn’t substantial evidence for the outcome the other side” wants.
Quinn Emanuel Urquhart & Sullivan partner Raymond Nimrod said the researchers were well aware of the challenges facing application of the CRISPR technology to multicelled organisms.
“This is a situation where substantial evidence supports the decision here, and the other side is simply asking your honors to second-guess the PTAB’s decision,” he told the court.
As time was winding down, Verrilli tried one last time to persuade Moore. He argued the PTAB failed to consider evidence that Broad and other researchers used simple, conventional techniques to implement CRISPR-Cas9 on human and animal cells.
“That’s how science works, Mr. Verrilli,” Moore replied. “You start with the conventional techniques, and then when they don’t work you spend the time, energy and money coming up with the new technique. The fact that they started with the easiest, off-the-shelf stuff doesn’t mean they thought it would work.”
“Respectfully, your honor,” Verrilli tried to interject.
“That’s what the board found, Mr. Verilli, and it’s hard for me to say there’s not substantial evidence for that.”