Gene Editing Patent Decision Favors MIT, Harvard, for Now

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By John T. Aquino

Harvard and MIT’s patents for the innovative CRISPR gene editing technology survived a challenge, but more litigation is likely and an accommodation agreement with other patent applicants could be in the cards.

The Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) found the patent application of the University of California, Berkeley, didn’t overlap with the patents of the Broad Institute of MIT and Harvard University, so there was no reason for it to decide who invented which technology first ( Broad Inst. Inc. v. Regents of the Bd. of the Univ. of Cal. , P.T.A.B., No. 106,048, judgment 2/15/17 ). UC Berkeley partners with genome editing company Intellia Therapeutics and the Massachusetts Institute of Technology and Harvard with Editas Medicine.

UC Berkeley needed a win badly: Its patent application is pending while MIT and Harvard hold a dozen CRISPR patents. CRISPR 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 ever and cite a potential value of billions of dollars.

“It’s definitely a win for Broad,” Jacob S. Sherkow, associate professor at New York Law School, told Bloomberg BNA in a Feb. 15 e-mail. “But how much of a win depends on what comes next from Berkeley’s side. If they appeal to [the U.S. Court of Appeals for] the Federal Circuit, that could tip the scales entirely back in Berkeley’s favor. Or it could decisively limit what they’re allowed to get granted by the PTO. We’ve made a big advance today, although things haven’t been settled yet.”

Kevin Noonan, a partner at McDonnell, Boehnen Hulbert & Berghoff, Chicago, told Bloomberg BNA in a Feb. 15 e–mail, “The board’s decision ends, for now, the dispute between the parties. However, it is likely that UC/Berkeley will appeal this determination, a process that will take several months, at least, to resolve. The more important issue, for the public and the development of the technology, is that in so ruling the PTAB permitted both the Broad and UC/Berkeley to have patents to CRISPR.” He suggested the existence of two distinct patents for the technology could make it complicated for those wishing to use the technology to develop medical products. This could conceivably prompt the parties to reach an agreement where all their rights can be accommodated, Noonan said.

UC Berkeley Advantage Vanishes

UC Berkeley appeared to have the advantage going into PTAB oral arguments 10 LSLR, 12/9/16 .

The application for using CRISPR technology by Jennifer A. Doudna and Martin Jinek of UC Berkeley and Emmanuelle Charpentier of Braunschweig, Germany, and the University of Vienna’s Krzysztof Chylinski, was filed March 15, 2013. Rights in the application were assigned to the Regents of the U.C. and the University of Vienna. MIT’s Feng Zhang of Cambridge, Mass., filed an application later, but because the claims were narrower—limited to using CRISPR 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 relevant patent applications were filed before the America Invents Act changed priority determinations from “first to invent” to “first inventor to file.”

In its initial ruling, the PTAB awarded UC Berkeley the presumption of priority. But during oral argument, the judges appeared skeptical of UC Berkeley’s reasoning. When its attorney said that Broad’s claims were unpatentable as obvious because others had been working in the same area at the same time with expectations of success, Judge Richard Schafer said, “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.”

Claims Are Distinct

The judges’ continued skepticism about UC Berkeley’s arguments is apparent in a document on the motions that accompanied the board’s judgment. Broad had moved that the PTAB not go forward with the proceedings because there was no overlap between the claims.

Administrative Patent Judges Schafer, Sally Gardner Lane and Deborah Katz wrote, “Broad has persuaded us that the parties claim patentably distinct subject matter, rebutting the presumption created by declaration of this interference. Broad provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC’s claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment.”

Board’s Reasoning Raises Difficulties

Sherkow told Bloomberg BNA if UC Berkeley chooses to appeal to the Federal Circuit, a decision would likely come down halfway through 2018. “If it goes back to the PTO immediately, the examiner will have an opportunity to limit the claims based on the interference decision today. But they may not.”

Noonan said the PTAB’s reasoning in its decisions on the motions document that Broad/Harvard’s patents are limited to eukaryotic cells and UC Berkeley’s claims, if granted, would encompass the use of CRISPR in all cells could raise difficulties for those who want to use the technology.

“It creates a situation where a third party wishing to exploit the technology commercially may need to obtain a license from both Broad and Berkeley,” Noonan said. “Depending on the use, having a license from the Broad may not be enough to avoid patent infringement liability under UC/Berkeley’s patent. This will make commercialization of the technology more expensive and difficult to achieve”

The parties may recognize this risk to further development and see that it might provoke the government to force licensing more widely and at lower cost, Noonan said. This could lead the parties “to come to an agreement where the rights of all parties can be accommodated. But that remains to be seen.”

UC Berkeley said in a statement that it continues to maintain that its team invented the technology first and was the first to publish and file. It indicated it was considering an appeal.

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 board's one sentence judgment is at http://src.bna.com/mf5 ; its 51-page decision on the motions is at http://src.bna.com/mgz

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