The battle royal over who invented CRISPR is heading for another round of litigation, with the grantees of a European patent for the gene-editing technology indicating they will appeal a February U.S. court ruling.
The Regents of the University of California (UC), the University of Vienna, and Emmanuelle Charpentier, Ph.D., a director at the Max-Planck Institute in Berlin, have appealed to the U.S. Court of Appeals for the Federal Circuit to overturn a February 15 decision by the Patent Trial and Appeal Board (PTAB).
The PTAB sided with the Broad Institute of MIT and Harvard by finding “no interference in fact” between 12 patents related to CRISPR technology that list as inventor the Broad’s Feng Zhang, Ph.D., and a patent application by Dr. Charpentier and Jennifer Doudna, Ph.D., of UC Berkeley.
After hearing oral arguments in December 2016, the PTAB terminated an “interference” proceeding aimed at resolving the impasse over who invented CRISPR, which stands for clustered regularly interspaced short palindromic repeats. The interference was declared in January 2016 by Administrative Patent Judge Deborah Katz of the USPTO.
However, the PTAB decision did not determine who invented the use of the CRISPR/Cas9 genome-editing technology in eukaryotic cells. The Doudna/Charpentier application states 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 Berkeley, Dr. Doudna, and Dr. Charpentier challenged the Broad patents, contending that the application of CRISPR to eukaryotic systems represented an obvious rather than an inventive invention and was thus nonpatentable. The Broad has defended its patents.
The PTAB concluded that while the claims overlap, the scope of the claims made by the UC and the Broad did not define the same patentable invention. UC and its co-appellants are asking the Federal Circuit to reverse the PTAB’s decision, contending that UC’s earliest patent application describing CRISPR/Cas9 and its use was filed on May 25, 2012, while the Broad’s earliest patent application was filed on December 12, 2012.
The notice of appeal was announced today separately by UC, as well as four companies that have licensed CRISPR technology from UC Berkeley: CRISPR Therapeutics, whose co-founders include Dr. Charpentier; Caribou Biosciences, ERS Genomics, and Intellia Therapeutics.
“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 noncellular settings and within plant, animal, and even human cells,” Edward Penhoet, Ph.D., a special adviser on CRISPR to the UC president and UC Berkeley chancellor, said in a statement. Penhoet is the associate dean of biology at UC Berkeley and a professor emeritus of molecular and cell biology.
Broad Institute Expects to Prevail
The Broad Institute responded to the notice of appeal today with a statement by its chief communications officer Lee McGuire that predicted it will prevail again in the federal court system.
“Given that the facts have not changed, we expect the outcome will once again be the same,” McGuire stated. “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 Broad noted that the Federal Circuit does not independently weigh 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.”
Last month, Dr. Charpentier, UC Berkeley, and the University of Vienna won a significant legal victory when the European Patent Office announced an “intention to grant a patent” broadly covering their CRISPR technology.
The European patent—to be granted to UC on May 10—consists of broad claims directed to the CRISPR/Cas9 single-guide gene-editing system for uses in both noncellular and cellular settings, including in cells from vertebrate animals such as human or mammalian cells—as well as composition claims for use in any setting, including claims for use in a method of therapeutic treatment of a patient. In addition to Drs. Charpentier and Doudna, inventors listed on the European patent are: Martin Jinek, Ph.D., now at the University of Zurich; Krzysztof Chylinski, Ph.D., of the University of Vienna; Wendell Lim, Ph.D., of UC San Francisco; Lei Stanley Qi, Ph.D., now at Stanford University; and Jamie Cate, Ph.D., of UC Berkeley.
UC has also noted that it has been awarded two patents covering CRISPR by the UK Intellectual Property Office.