UC Berkeley Appeals CRISPR Decision

The dispute over who has the rights to key CRISPR-Cas9 patents continues. On April 12, 2017 the University of California, Berkeley, in conjunction with the University of Vienna and Emmanuelle Charpentier, filed an appeal to overturn an earlier decision by the United States Patent Trial and Appeal Board (PTAB).

The PTAB decision, according to Berkeley, “terminated the interference” between Berkeley and the Broad Institute. Berkeley said it is appealing the decision in hopes that the PTAB will reinstate the interference-a legal proceeding that aids the court in determining which party first invented a technology.

“Ultimately, we expect to establish definitively that the team led by Jennifer Doudna and Emmanuelle Charpentier was the first to engineer CRISPR-Cas9 for use in all types of environments, including in non-cellular settings and within plant, animal, and even human cells,” said Edward Penhoet, a special advisor on CRISPR to the UC president and UC Berkeley chancellor, in a statement. Berkeley also said it will continue to pursue patent applications in the US and elsewhere for CRISPR/Cas9 in “non-cellular and cellular settings.”

The Broad Institute said it was “unlikely” that the court would overturn the PTAB decision. “Given that the facts have not changed, we expect the outcome will once again be the same. We are confident the Federal Circuit will affirm the PTAB decision and recognize the contribution of the Broad, MIT, and Harvard in developing this transformative technology,” they wrote in a statement.

In the February 2017 decision, the PTAB said that Berkeley and the Broad Institute’s versions of CRISPR-Cas9 are separately patentable. In the 51-page decision, the PTAB wrote that Broad’s CRISPR-Cas9 technology is specific to a eukaryotic environment, while Berkley’s is not restricted to any environment. Berkeley claims that the use of CRISPR-Cas9 in a eukaryotic environment can’t be patented separately. Broad, who currently holds 13 of the 28 patents for CRISPR, argues that these are separate inventions.

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences, and ERS Genomics-all of whom license the technology from Berkeley-released a joint statement about the appeal. Editas Medicine, a biotech company based in Cambridge, MA, licenses CRISPR-Cas9 from the Broad Institute.

What does an appeal mean for companies licensing CRISPR-Cas9?

Although it is still unclear how the results of this case will affect the biotech companies that license CRISPR-Cas9 from Berkeley and Broad Institute, Kevin Noonan, PhD, partner at McDonnell Boehnen Hulbert & Berghoff told BioPharm International the decision could impact commercial applications for CRISPR-Cas9. In some cases, he said, third parties may need a license from both Berkeley and Broad.

“If the court reversed the PTAB and the interference went to a substantive conclusion, one or the other party would have priority and thus have the rights to the technology. Although there may be after-arising variants that become important, in the near term there would be certainty regarding whose patents need to be licensed,” Noonan said. “If the PTAB’s decision is upheld, on the other hand, third parties will need a license from both the Broad [Institute] and the University [of California, Berkeley]; if anyone uses the technology and sells products based on it without a license from both patentees there could be liability for infringement.”

Although it is unlikely, the Broad Institute could file a cross-appeal, Noonan said, but third parties (such as the companies licensing CRISPR-Cas9 from Berkeley or Broad) have no standing to appeal. However, they could file amicus briefs.

“They could file amicus briefs but those would be in the nature of informing the court about the risks of overturning the PTAB’s decision,” he said. “If the Federal Circuit rules in the University’s favor the case would go back to the PTAB for considerations of priority and other matters the parties raised but the Board ruled were outside the scope of its jurisdiction because there was no interference-in-fact.”

*This article has been updated on April 14, 2017 to include comments from Kevin Noonan.

Source: UC Berkeley, Broad Institute