The latest skirmish in the bitter legal battle royal over who invented CRISPR (clustered regularly interspaced short palindromic repeats) gene-editing technology played out yesterday before a three-judge panel of the Patent Trial and Appeal Board (PTAB) in Alexandria, VA.
In oral arguments to the judges, the University of California (UC) Berkeley and Emmanuelle Charpentier, Ph.D., of the Helmholtz Centre for Infection Research presented their case for challenging the awarding of 12 patents related to CRISPR technology that list as inventor Feng Zhang, Ph.D., of the Broad Institute of MIT and Harvard. Some of the 12 list additional colleagues as inventors.
The judges heard oral arguments—limited to 20 minutes on each side—as they move to decide whether an “interference” proceeding aimed at resolving the impasse can proceed, as declared in January by Administrative Patent Judge Deborah Katz of the U.S. Patent and Trademark Office (USPTO).
“What was on the table Tuesday was not the ultimate decision of who was the first to invent and who gets the patent,” Robert (Bob) H. Underwood, Ph.D., a partner at the law firm McDermott Will & Emery, told GEN. “It was really preliminary issues of: Do these patents define the same invention? And should the proceeding go forward to determine just who is the first inventor and who is entitled to the patent? Or is it that there is no interference here, and these patents can co-exist.”
Based on news reports of the proceedings, Dr. Underwood said, the PTAB judges may be considering the possibility that the UC application and the Broad/Zhang patents may cover different inventions here.
The UC Berkeley patents state claims covering the use of CRISPR in a bacterial system, while the Broad's patents focus on the use of CRISPR in eukaryotic systems such as plants and higher animals. UC has contended that the application of CRISPR to eukaryotic systems represented an obvious rather than an inventive invention, while the Broad has defended its patents and was thus nonpatentable.
According to several accounts, Broad attorneys sought to counter UC’s argument of obviousness by citing published reports that quoted Jennifer Doudna, Ph.D., at UC Berkeley, as describing unsuccessful attempts to apply CRISPR technology to human cells—while UC noted that within 6 months of the seminal 2012 paper describing CRISPR published by Drs. Doudna and Charpentier and colleagues, six other research teams published papers reporting on the technology’s application in eukaryotic cells.
“From the reports that have come in, the judges were skeptical that moving from a bacterial system into higher plants and animals would have been obvious, and that there was no inventive contribution to make that particular invention,” Dr. Underwood observed.
“So it is possible that these patents could coexist, that there may be bacterial patents and eukaryotic patents that can exist without interference,” he said. “I wouldn't have thought that that was the likely outcome, and without having been there and gone through the merits of all of the arguments, I still think it's likely that the case will go forward. But it's a possible outcome.”
If both parties’ patents can co-exist, Dr. Underwood added, the possibility exists that additional licenses would be required by the numerous companies formed in recent years to commercialize CRISPR technology. One such company, CRISPR Therapeutics, disclosed November 22 in a regulatory filing that it raised aggregate net proceeds of $54.1 million through its initial public offering of 4,429,311 million common shares at $14 per share; the IPO was launched October 19.
Steven R. Trybus of law firm Jenner & Block argued during the oral hearing for the Broad Institute, while Todd Walters of the law firm Buchanan Ingersoll & Rooney presented UC’s case to the judges.