University of California to Fight CRISPR Gene Editing Decision

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By John T. Aquino

The University of California at Berkeley will keep fighting for its patent application covering CRISPR-Cas-9 gene editing technology in a high-stakes patent battle ( The Broad Institute, Inc. v. The Regents of the University of California , Fed. Cir., Interference No. 106-048, notice of appeal 4/13/17 ).

UC Berkeley filed a notice April 13 that it’s appealing in federal court the Patent Trial and Appeal Board’s decision not to rule on who invented which technology first in a dispute over patents on the CRISPR technology. The board found UC Berkeley’s patent application didn’t overlap with the patents of the Broad Institute of the Massachusetts Institute of Technology and Harvard University, so there was no reason for it to rule on the case. Broad and Harvard own 11 issued patents; the Patent and Trademark Office hasn’t yet issued a patent based on UC Berkeley’s application.

CRISPR-Cas-9 technology allows scientists to edit genomes precisely and could lead to cures for inherited diseases and cancer, among other applications. Analysts call it one of the most important inventions in recorded history and cite a potential value of billions of dollars.

UC Berkeley partners with genome editing company Intellia Therapeutics and Harvard with Editas Medicine.

No Reason Not to Appeal

“Appealing to the [U.S. Court of Appeals for the] Federal Circuit is the better strategy for UCB because it is the only avenue available to it to get a CRISPR patent other than going back to the PTO to obtain one based on its filed application, which the Broad Institute would likely challenge,” Jacob S. Sherkow, associate professor at New York Law School, told Bloomberg BNA in an April 13 phone interview.

Brian Nolan, a member of Mayer Brown’s intellectual property group in New York, told Bloomberg BNA in a phone interview, “The law has changed so that [patent board] appeals can no longer be filed with a federal district court. All things considered and given what’s at stake, there was no reason for UCB not to appeal. The university evidently wants to press forward to secure the available rights.”

The substantive documents of appeal weren’t yet posted by the Federal Circuit.

PTAB: Inventions Distinct

In its notice filed with the PTAB, UC Berkeley said it would appeal the board’s judgment and a number of other motions the board decided during the proceedings. UC Berkeley was joined in the filing by the University of Vienna and Max Planck Institute for Infection Biology Director Emmanuelle Charpentier. “It’s a kitchen sink approach, so that they don’t waive anything going forward,” Sherkow said.

The application for using CRISPR technology by Charpentier, Jennifer A. Doudna and Martin Jinek of UC Berkeley and the University of Vienna’s Krzysztof Chylinski was filed March 15, 2013. MIT’s Feng Zhang of Cambridge, Mass., filed an application later, but because the claims were narrower—limited to using CRISPR-Cas-9 in eukaryotic cells in higher organisms like animals, plants and humans—the patent, U.S. Patent No. 8,697,359, was issued first on April 15, 2014. The ‘359 patent was licensed to the Broad Institute and MIT, and 11 patents emanating from the same applications were subsequently issued to Harvard.

The PTAB ruled that because the Broad’s patents specified use in eukaryotic cells, it was a separate and distinct invention from that claimed by Charpentier, Doudna, Jinek and Chylinski.

Broad: Nothing Has Changed

“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,” Edward Penhoet, a special adviser on CRISPR to the UC president and UC Berkeley chancellor and the UC Berkeley associate dean of biology, said in a statement.

Broad said in its own statement: “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.”

The Federal Circuit doesn’t independently weigh the facts determined by the PTAB. Broad said, and to overturn the board’s decision the court would need to decide that the PTAB committed an error of law or lacked substantial evidence to reach its decision. “Given the careful and extensive factual findings in the PTAB’s decision, this seems unlikely,” Broad said.

UC Berkeley said it intends to pursue continuing applications in the U.S. and globally to obtain patents claiming the CRISPR-Cas9 technology and its application in noncellular and cellular settings, including eukaryotic cells. It said the U.K. already has granted patents to UC, and the European Patent Office will grant UC’s patent on May 10. Nolan noted to Bloomberg BNA that the EPO announced it would issue claims, which would be subject to opposition.

The notice of appeal was filed by Buchanan Ingersoll & Rooney PC, Alexandria, Va., and Marshall Gerstein & Borun LLP, Chicago. UC Berkeley said the law firm of Munger, Tolles & Olson LLP will be handling the appeal, with Don Verrilli, former U.S. solicitor general, as lead counsel.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The notice of appeal is at http://src.bna.com/nUB.

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