f you enjoyed the US edition of the CRISPR patent dispute, get ready for the European one: With the announcement last week that the European Patent Office intends to grant a patent to the University of California, Berkeley, and its partners covering a broad range of uses of the revolutionary genome-editing technology, expect a similar plot to unfold on that side of the Atlantic.
In particular, “now we go through opposition proceedings in Europe, where 3d parties can challenge the patent,” patent expert Jacob Sherkow of New York Law School tweeted. “And that could take a while.”
Although the Broad Institute of MIT and Harvard prevailed (so far) in the United States, persuading a patent court that it is entitled to the dozen or so patents it received on the use of CRISPR in plant and animal cells, UC’s important first-round win in Europe shows that patent examiners there saw the dispute differently.
UC’s claims are based on inventions by its biochemist Jennifer Doudna, working with Emmanuelle Charpentier, who was at Sweden’s University of Umea when breakthrough work in 2012 showed that CRISPR-Cas9 can be used to cut and possibly edit DNA in a test tube. The US patent office decided last month that extending that accomplishment to editing genomes in advanced, or eukaryotic, cells, as scientists led by the Broad’s Feng Zhang did, was not obvious; the Broad therefore got to keep the patents it won for Zhang’s work.
Companies associated with the UC side welcomed the win. “We’re very pleased with the decision by the European Patent Office recognizing the broad applicability of our foundational IP,” said Rodger Novak, CEO of CRISPR Therapeutics, which was cofounded by Charpentier and licenses her and Doudna’s CRISPR inventions. “We look forward to pursuing additional cases to grant in other jurisdictions globally.” Important countries in Asia, notably China and Japan, have yet to render CRISPR patent decisions.
The European patent would cover the use of CRISPR-Cas9, an ingenious genome-editing system based on an ancient bacterial immune system, in all kinds of cells, including those of humans and other mammals and in the hoped-for therapeutic applications that CRISPR Therapeutics, Editas Medicine, and Intellia, among other companies, are pursuing.
Although it might seem odd that the European and US patent offices reached opposite decisions on who is entitled to key CRISPR patents, Sherkow said it shouldn’t be. “As a matter of patent law it’s a close case,” he said in an interview. “So the idea that different tribunals should reach different conclusions is not shocking.”
In the US, the basic question in the “interference proceeding,” which was heard by the Patent Trial and Appeal Board (PTAB) and ended last month, was whether Zhang’s invention, using CRISPR in mammalian cells, was sufficiently different from what the UC team invented, using CRISPR in free-floating DNA, to deserve a patent. PTAB said yes. In Europe, in this first round, Sherkow said, the question was whether UC described an invention in sufficient detail as to make it practical. The European office said yes.
“We are excited that this patent will issue based on the foundational research we published with Emmanuelle Charpentier and the rest of our team,” Doudna said in a statement. “We look forward to the continued applications of gene-editing technology to solve problems in human health and agriculture.”
The Broad (and anyone else) has nine months to file its opposition to the European decision. In a statement, it pointed out that the European patent process differs from that in the US, “and may involve adjusting patent claims after a patent has been issued, in response to oppositions.” After considering such oppositions, the Broad said, “the EPO may maintain, revoke or allow amendment to the patent. It is widely expected that . . . adjustments may be required in this case.”
Before issuing its decision, the European patent office considered numerous “third-party observations,” filed as early as 2014 by the Broad and others, essentially registering objections to the granting of the patent. The office said those objections were “found not to be relevant” or “are no longer considered to be relevant.” By filing objections that early in the process, the Broad and others might have reduced their chances of overturning the European patent, said Tyler Dylan-Hyde, chief legal officer of CRISPR Therapeutics: “When you go before the European Patent Office again the examiners might say, no, we already considered that.”
The UC side suggested it might still prevail in the United States, where it has until April 17 to appeal the patent court decision. Despite the objections that the Broad filed in Europe, Dylan-Hyde said in a statement, “patent offices are beginning to recognize both the fundamental significance” of the Doudna and Charpentier work and it “wide applicability to CRISPR/Cas gene editing.” The company, he said in an interview, will continue to press its case in the U.S., where “people read too much into the PTAB decision.”
This story was updated at 1 p.m. on March 28 to include a statement from the Broad Institute and additional interviews.