By Kevin E. Noonan --
In February, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office rendered judgment that there was no interference-in-fact between the claims in interference between the Regents of the University of California/Berkeley and the Broad Institute. Yesterday, UC/Berkeley filed a Notice of Appeal at the Federal Circuit, challenging the PTO's decision.
The University's position is set out in a press release posted on-line saying that "[u]ltimately, 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," according to their spokesman, Edward Penhoet, associate dean of biology at Berkeley, professor emeritus of molecular and cell biology, and a special adviser on CRISPR to the University of California president and Berkeley chancellor. The press release also states that the University will continue to pursue related applications both in the U.S. and abroad, for "CRISPR-Cas9 technology and its application in non-cellular and cellular settings, including eukaryotic cells." Recently, the European Patent Office announced its intention to grant the University an EP patent on May 10, 2017.
Former Solicitor General Don Verrilli will be lead counsel for the University.
For its part, the Broad also issued a press release setting forth its position:
UCB has filed a Notice of Appeal asking the United States Court of Appeals for the Federal Circuit, based in Washington DC, to review the recent decision by the PTAB (Patent Trial and Appeals Board) that there is no interference between the Broad Institute, MIT and Harvard claims concerning the use of the CRISPR system in eukaryotic cells and the patent application of UCB because the claims are patentably distinct.
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.
Importantly, the Federal Circuit does not independently weigh the facts determined by the PTAB. To overturn the PTAB 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.
Regardless of the likelihood that the PTAB's decision might be reversed, the matter will not be resolved even if the Federal Circuit sends the case back to the Board. The Office determined only that there was no interference-in-fact between the parties' claims-in-interference (see "PTAB Decides CRISPR Interference in Favor of Broad Institute -- Their Reasoning"), not the substantive questions of priority and patentability raised by the parties in their preliminary motions. The PTAB's reasoning was based on the University's failure to establish that the Broad's claims would have been obvious in view of the University's application, because inter alia the University had not established that there would have been a reasonable expectation of success that the CRISPR technology would be effective in eukaryotic cells in view of the University's disclosure of the technology's use in prokaryotic cells. The Federal Circuit's review of this question under Dickinson v. Zurko would be to give the PTAB's factual determinations deference under the substantial evidence standard, and to review de novo the ultimate legal question of obviousness.
Should the University prevail, the case would be remanded to the PTAB for further proceedings. These would include a determination of which group of inventors had priority (where the Broad is junior party and would bear the burden of establishing earlier invention). Any further PTAB action should also include rendering decisions on several motions submitted by both parties (see "CRISPR Interference Motions Set").
Should the University's appeal fail, however the status quo will remain: the Broad will maintain its extensive CRISPR patent portfolio and the University's patent application (reciting claims broader than the Broad's and encompassing CRISPR without regard to the cells in which it is practiced) should grant as a patent in due course. Under these circumstances a third party wishing to practice the technology in eukaryotic cells (encompassing everything from yeast to man) would need a license from both the University and the Broad (absent the parties coming to an agreement on how their overlapping technologies will be licensed). This circumstance cannot fail to retard commercial adoption of the techniques, providing further impetus for some sort of settlement to be forged.
For additional information regarding this topic, please see:
• "PTAB Decides CRISPR Interference in Favor of Broad Institute -- Their Reasoning," February 16, 2017
• "PTAB Decides CRISPR Interference -- No interference-in-fact," February 15, 2017
• "Guest Post -- The Patient Side of the CRISPR Patent Battle," December 19, 2016
• "CRISPR Interference Motions Set," March 23, 2016
• "CRISPR Interference Declared," January 28, 2016