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The Massachusetts Institute of Technology’s Broad Institute may have just lost future market dominance in Europe for a potentially highly valuable gene-editing technology known as CRISPR-Cas9.
The European Patent Office Jan. 17 revoked Broad’s patent because the patent application left off one of the inventors when it was filed, invalidating its claim it was the first to use CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) in complex organisms called eukaryotes, which includes humans. The EPO’s decision could have significant consequences for Broad’s intellectual property rights to CRISPR technology in Europe.
“If they can’t get this reversed, they may lose a dominant market position in Europe,” Brent Babcock, an intellectual property lawyer with Knobbe Martens in Irvine, Calif., told Bloomberg Law in a Jan. 19 telephone call. “It’s a big market and it’s a potentially big deal,” he said.
CRISPR technology uses enzymes to add, remove, or alter genes to cause DNA to behave in specific ways, and there’s significant interest in applying this technique to humans. Eukaryotes are organisms consisting of a cell or cells in which the genetic material is DNA in the form of chromosomes contained within a distinct nucleus.
But Broad downplayed the significance of the ruling in a Jan. 17 statement. “The decision does not involve the actual scientific merits of the CRISPR patent application,” the institute said. Broad said it would appeal the decision to the EPO’s Technical Board of Appeal.
The EPO revoked the patent because the patent application Broad filed in Europe omitted the name of one of the inventors, breaking its chain of priority, meaning it couldn’t claim to have been the first to invent.
The EPO’s revocation decision was based on a technical formality, Broad said. “This technicality concerns the current interpretation of rules that dictate what happens when the names of inventors differ across international applications,” Broad said. “This interpretation affects many other European patents that rely on U.S. provisional patent applications, and is inconsistent with treaties designed to harmonize the international patent process.”
“It’s a technicality and a procedural defect,” Babcock said, “but, at the end of the day, if they don’t get their priority benefit, they’re not the first to invent.” There are other similar Broad European patents that could be revoked on the same grounds, Babcock said. Although not all of Broad’s European patent applications are tainted by defective priority chains, the earlier and more foundational of their patents are likely to have priority defects.
“In Europe, The Broad’s in trouble; they got a setback in the EPO,” Babcock said.
The EPO’s decision doesn’t affect the continuing patent dispute between Broad and the University of California over CRISPR rights.
“They’re still ahead in the U.S. regarding the interference issues,” Babcock said.
In the U.S., the University of California claims the U.S. Patent and Trademark Office issued overly broad CRISPR patents on gene editing to Broad.
The PTO’s Patent Trial and Appeal Board (PTAB) found California’s patent application didn’t overlap with the Broad patents, so there was no reason for it to decide who invented which technology first. California is appealing the PTAB’s ruling to the U.S. Court of Appeals for the Federal Circuit.
The case is the biggest interference case in decades, and the Federal Circuit may not wind up ruling on it until the end of 2018, Babcock said.
Because there are so many patents and patent applications involved in the CRISPR battles in both the U.S. and Europe, “we’re going to see teeter-tottering as to both parties as we go forward” unless they settle, Babcock said.
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