The European Patent Office (EPO) has affirmed a patent issued to CRISPR pioneer Emmanuelle Charpentier, PhD, the Regents of the University of California, and the University of Vienna covering the single-guide CRISPR-Cas9 gene editing system—rejecting arguments filed in opposition by the Broad Institute of MIT and Harvard.
The EPO affirmation upholds European patent No. EP280081 (“Methods and Compositions for RNA-Directed Target DNA modification and for RNA-Directed Modulation of Transcription”), which covers uses in both cellular and non-cellular settings—including use in bacteria, plants, animals, and cells from vertebrate animals such as humans.
However, the EPO ended three days of hearings into the matter held February 5–7 by directing modifications be made into two of the patent’s 23 original claims, as well as the removal of two dependent claims.
The patent was issued in 2017 to Charpentier— director and scientific member at the Max Planck Institute of Infection Biology, Berlin—as well as UC and U. Vienna, also known collectively as CVC.
CVC and a licensor of its foundational CRISPR/Cas9 intellectual property, ERS Genomics, characterized the modifications as “very minor,” and stated that the two dependent claims to be removed “hav[e] virtually no impact on the broad coverage of the patent.”
“The outcome of the opposition hearing reinforces the broad and fundamental nature of this patent,” ERS Genomics CEO Eric Rhodes said today in a statement.
The affirmation also marks the second time in less than a month that the EPO sided with Charpentier and colleagues, and against the Broad in their ongoing bitter legal wrangle over who invented the CRISPR gene-editing technology.
On January 16, EPO’s Board of Appeal dismissed the Broad Institute’s appeal of a 2018 ruling of EPO’s Opposition Division that rescinded EP 2771468 (“Engineering of Systems, Methods and Optimized Guide Compositions for Sequence Manipulation,”) a patent related to CRISPR-Cas9 genome editing granted to the Broad Institute in 2015. The Opposition Division contended that the Institute failed to prove novelty and a valid priority claim.
While the Broad relied on its U.S. priority provisional application, the EPO cited rules concerning differences in the names of inventors across international applications, which the Institute termed a “technical formality” and noted was unrelated to the scientific merits of its patent application.
The Institute acknowledged at the time that the Board of Appeal action “may affect nine of Broad’s 21 CRISPR-Cas9 patents in Europe if the EPO does not later harmonize these requirements.”
Rhodes stated that the affirmation, together with the Opposition Division action last month, “further solidifies our position as holding the predominant CRISPR/Cas9 patent portfolio.”
“This decision also validates the choice our licensees have made to work with ERS to enable their commercialization efforts,” Rhodes added. “We are expanding our efforts to make the technology broadly available, so it can be used by as many people as possible.”
David Cameron, a spokesman for the Broad, said the Institute had no comment beyond its recent statements. The most recent of those, issued on January 16, included an appeal for a resolution of the legal wrangle:
“It is time for all institutions to move beyond litigation and instead work together to ensure wide, open access to this transformative technology,” the Broad stated. “The best thing, for the entire field, is for the parties to reach a resolution.”
The Broad added that it has made “many attempts” over the past seven years to engage the University of California-Berkeley, directly and through their exclusive licensee and through patent pools. “These efforts began before UCB licensed its IP exclusively and entirely to commercial entities, and we will continue to pursue a path towards resolution.”