Expected U. Cal. Victory in Gene Editing Dispute in Question

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By John T. Aquino

Dec. 6 — Expectations that the PTO’s patent board would conclude University of California gene editing patent claims were superior to the Broad Institute’s took a hit Dec. 6 during oral arguments.

The Broad Institute Inc. and UC argued before the Patent and Trademark Office’s Patent Trial and Appeal Board over their claimed advancements in use of CRISPR (clustered regularly interspaced short palindromic repeats)-Cas9 DNA splicing technology. The PTAB initially found that UC’s patent application claimed an earlier priority of invention date.

“Coming into this, with UC having the initial ruling of priority, I had thought that UC was going to [win the iimportant claims],” Jacob S. Sherkow, associate professor at the New York Law School, said at a post-argument briefing at the American University’s Washington College of Law in Washington. “And they still could. But after the intense questioning UC’s attorney underwent, I’m not so sure.”

Sherkow told Bloomberg BNA after the briefing, “I thought Todd Walters [of Buchanan Ingersoll & Rooney, Alexandria, Va., arguing for UC] was in good form and his arguments pretty persuasive, but the court didn’t seem to be buying it.”

“This could be a situation where there is no winner and perhaps two losers or two winners,” Robert Cook-Deegan, a professor at Arizona State University’s the School for the Future of Innovation in Society, said at the briefing.

Cook-Deegan added, “The thing to remember is, this is really important. There are lots of application areas, more than any one company can pursue. And they are worth millions. Human use will be determined first. Agricultural will be concentrated in several companies dueling for dominance.”

First to Invent

The issue before the PTAB was, who was the first to invent sgRNA mediated CRISPR-Cas9 gene-editing in a eukaryotic cell? Eukaryotic cells are characteristic of animals, plants and fungi, while sgRNA stands for single-guide RNA.

CRISPR is a naturally occurring defense mechanism found in a wide range of bacteria. The teams involved in this patent dispute before the PTAB claim advancement through the use of a Type-II Cas9 protein that snips DNA. CRISPR basically tells Cas9 where to snip.

The gene splicing technology allows scientists to efficiently disable or remove genes associated with disease. It has also generated controversy because it can be used to alter genes in embryos that are passed on to subsequent generations.

Jennifer A. Doudna and Martin Jinek of UC in Berkeley, Calif., and Emmanuelle Charpentier of Braunschweig, Germany, and the University of Vienna’s Krzysztof Chylinski of Vienna filed U.S. Patent Application No. 13/842,859 on March 15, 2013. Rights in the application were assigned to the Regents of the UC and the University of Vienna.

The Massachusetts Institute of Technology’s Feng Zhang of Cambridge, Mass., filed an application later but because the claims were narrower the patent, U.S. Patent No. 8,697,359, was issued first on April 15, 2014. The Broad Institute and MIT were the assignees of the ‘359 patent, and 13 patents were subsequently issued. Doudna filed an interference with the PTAB arguing that the ‘359 patent interfered with her and Jinek’s ability to obtain a patent for their claims, which, she said, came before Zhang’s.

The relevant patent applications were filed before the America Invents Act changed priority determinations from “first to invent” to “first inventor to file.”

Sherkow told the briefing, “This may be the last, or at least the last important, interference case we see. If so, it’s going out with a bang.”

Judge Skeptical

Steven R. Trybus of Jenner & Block, Chicago, arguing for Broad during the PTAB hearing, said there was no interference in fact, that is, no priority dispute, due to the differences of the patent claims. He cited the narrower Broad claims and contended that, despite UC’s arguments, not all subsequent claims were descended from UC’s priority patent application.

Walters responded that if there was an interference in fact, “Broad’s claims would be unpatentable as obvious.” He pointed to six groups who over a period of six months after Doudna published a paper “did experiments, wrote papers and filed patents. And Broad is arguing that none had a reasonable expectation that it was going to work. No one does these things without thinking they’re going to work.”

Judge Richard Schafer responded, “I don’t know if I’m buying that. Anyone doing an experiment doesn’t have an expectation it will work. He or she has a hope that it will work.”

Walters persisted: “You shouldn’t allow obvious claims to go forward in this interference when there are proofs that render them obvious.”

Decision Possible by February

At the briefing, Sherkow painted a possible scenario as a result of the oral argument.

“I think the no interference in fact argument will be difficult for Broad to get through given the prior rulings of the Board. The UC patent appears likely to be on the road to get the benefit of its provisional application. Zhang’s [narrower] claims could get de-designated from the interference and Zhang would take them. It could happen that way.”

Sherkow said the board could reach a decision by February, although he added there was a slim possibility there could be further arguments.

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

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