The European Patent Office (EPO) yesterday (March 23) announced its intention to award a broad-strokes patent for CRISPR gene-editing technology to the University of California, Berkeley, the University of Vienna, and Emmanuelle Charpentier (formerly of the Helmholtz Centre for Infection Research). The claims include the use of CRISPR across prokaryotic and eukaryotic cells and organisms, hitting upon the point of contention in a recent patent interference decision in the United States. In that case, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) denied UC Berkeley the rights over the use of the technology in eukaryotes—the money-making application for CRISPR—leaving that intellectual property with the Broad Institute of MIT and Harvard.
“We are excited that this patent will issue based on the foundational research we published with Emmanuelle Charpentier and the rest of our team,” Jennifer Doudna, the leader of the UC Berkeley contingent of the international team, said in a statement. “We look forward to the continued applications of gene-editing technology to solve problems in human health and agriculture.”
According to EPO procedures, the international team’s patent is all but granted (a few logistical details, such as finalizing the text and paying fees, remain to be settled). “Substantively, the decision is made,” said Catherine Coombes, a senior patent attorney with HGF Limited in the U.K. who last year wrote an opinion for The Scientist on the CRISPR patent situation in Europe. “The EPO, by granting this [patent], is not being swayed by the PTAB decision in the U.S. . . . The claims are very broad.”
The Broad Institute will now have nine months to file its opposition to the EPO patent’s claims. Coombes said she expects that will happen. “We can, of course, expect multiple oppositions upon grant,” Coombes said. “No doubt, these will concentrate heavily on why UC Berkeley shouldn’t be entitled to their earliest [filing] date” for all the claims listed.
Unlike the parallel process in the U.S., the UC Berkeley–Vienna–Helmholtz Centre team will have multiple opportunities to amend its claims, noted Kevin Noonan, a biotech expert and partner at the Chicago-based IP law firm McDonnell Boehnen Hulbert & Berghoff. The team “could ultimately get more narrow claims,” he said. If that’s the case, he added, the situation in Europe could end up the way the US IP landscape is expected to play out, with UC Berkeley owning rights to CRISPR’s use in prokaryotes, and the Broad Institute owning CRISPR rights in eukaryotes. Otherwise, the UC Berkeley team could end up with intellectual property rights over CRISPR technology in both prokaryotic and eukaryotic cells.
The EPO’s decisions should not have any impact on future proceedings at the USPTO, said Noonan. “The US courts and patents laws don’t care what the Europeans do,” he said.
“It is widely expected that many parties will file oppositions and that adjustments may be required in this case,” the Broad Institute, which in February announced that the EPO intended to grant its first patent for CRISPR-Cpf1, said in a March 28 statement. “Over the next several years, there will be many more patents issued in the CRISPR field, to many inventors from many institutions, in recognition of each individual’s contribution to advancing CRISPR technology.” The University of Vienna confirmed that all that remains is “completion of the necessary formalities,” at which point third parties will have nine months to file an opposition to the grant.
Eric Rhodes, CEO of ERS Genomics, one of the companies started by Charpentier to develop CRISPR-based therapeutics, noted that the new European patent has already withstood some opposition, in the form of at least seven “observations”—which challenge the scope of the patent’s claims—filed between September 2014 and April 2016. Several anonymous third parties as well as the Broad Institute filed observations, including concerns about a “lack of working examples in eukaryotic cells,” Rhodes said. “But the [EPO] believed that, the way we like to say it, the recipe put forth in the patent was enough to enable one of ordinary skill in the arts.”
However the IP for CRISPR gene-editing technology shakes out, it will be critical that the parties “create a transparent, simple licensing framework that gets this technology into as many hands as possible as quickly as possible with as few legal uncertainties as possible hanging over the field,” Bob Cook-Deegan, a science policy expert at Arizona State University, said in an email to The Scientist. “If EPO has different rules, it would further intensify the already long-overdue attention to a cross-licensing framework.”
Cook-Deegan opined that the IP situation in the U.S. will be more consequential. “In the U.S., patents matter more than in Europe for therapeutics, not because of patent law but because of how health systems are organized,” he wrote. Namely, drugs and other treatments typically cost more in the U.S. than in European countries, many of which have ethical oversight of costs or national pricing systems. “The U.S. is, therefore, the market where up until now most therapeutics make by far the most money,” Cook-Deegan noted. “So US patents matter more.”
Clarification (March 24): This story has been updated from its original version to make clear the uncertainty of the future CRISPR patent landscape in Europe. The UC Berkeley team could end up with intellectual property rights over CRISPR technology in both prokaryotic and eukaryotic cells.
Correction (March 27): This article has been updated from a previous version to note that Emmanuelle Charpentier is a co-owner of the European patent in question, not the Helmholtz Centre for Infection Research, as was previously written. The Scientist regrets the error.