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By Tony Dutra
The European Patent Office’s notice March 28 that it was granting a patent on CRISPR gene-editing technology to the University of California, Berkeley does little to resolve the battle to control a foundational invention for the biotech industry.
The Massachusetts Institute of Technology and Harvard University’s Broad Institute already has European patents and successfully fended off a Berkeley challenge to invalidate its U.S. patents. Berkeley will get a European patent and is also on course to get a U.S. patent that could be similar to the European version.
An appeal in the U.S. and multiple opposition proceedings in Europe could delay resolution of the competing inventorship claims for some time. It is still possible that, in the end, both Berkeley and Broad will carve out patent rights in both jurisdictions, and those wanting to use the technology to develop medical products will have to license patents from each.
CRISPR technology allows scientists to edit genomes precisely, potentially leading to cures for inherited diseases and cancer. Analysts call it one of the most important inventions ever and predict a potential value in the billions of dollars.
Edward Penhoet, associate dean of biology at Berkeley, told Bloomberg BNA that other parties have patented and will continue to patent CRISPR technology as related to specific diseases. But commercial entities interested in a specific disease will always have to license “foundational” patents in which, he insisted, Berkeley will ultimately prevail in claiming sole ownership. As of now, though, Broad also claims to own foundational patents.
“Anyone who wants to practice the art of editing DNA will have to look at all the patents and decide what they will need to license,” Penhoet said. “Today, you’d have to say people would have to license from multiple parties, including both UC Berkeley and Broad Institute.”
The different situations in Europe and the U.S. are partly explained by patent law differences. Europe has always had a “first-to-file” system, which means that parties don’t dispute first inventorship. The U.S. switched to a similar system in 2013, but the Berkeley and Broad patent applications were filed before then under the prior “first-to-invent” system.
In the U.S., the parties fought an “interference” battle over first inventorship. The Patent Trial and Appeal Board terminated the dispute, reasoning that they were claiming distinct inventions. Broad’s already-issued patents survived, and the decision appeared to clear the way for Berkeley’s patent application to be granted.
In essence, the PTAB allowed both parties to claim “foundational” patents. Berkeley spearheaded early developments of CRISPR, while Broad “enabled” the technology for eukaryotic (including human) cells. Eukaryotic cells are what make up plant, fungi and animal life.
Penhoet would not say if Berkeley would appeal the PTAB ruling to the U.S. Court of Appeals for the Federal Circuit. But he contended that the university’s patents did enable CRISPR for eukaryotic cells.
By contrast, the EPO does not have an interference proceeding because the first party to file has priority—no matter who claims earlier invention. Any party can file an “opposition” after a patent is issued, but the usual reason is that the EPO failed to consider prior art that rendered the patent non-novel or obvious.
The EPO has already granted eight patents on CRISPR-related technology to Broad. The European Patent Register identifies opposition proceedings for seven of those patents. Penhoet would not confirm that Berkeley has instigated those proceedings, but CRISPR Therapeutics, which is a licensee of the Berkeley patents, is among the list of opponents.
Broad issued a press release March 28 saying that, when the EPO finally grants the Berkeley patent, “It is widely expected that many parties will file oppositions and that [patent claim] adjustments may be required in this case.”
“In Europe we won’t know if this is the same situation as in the U.S. until those oppositions are resolved,” Kevin Noonan, a partner at McDonnell, Boehnen Hulbert & Berghoff, Chicago, told Bloomberg BNA in an email.
But, in effect, Broad’s defense to oppositions to its patents will be the same as it successfully pressed in the U.S.: that the prior art didn’t enable CRISPR for eukaryotic cells and, so, can’t be used to invalidate those patents.
Berkeley’s patent application approved by the EPO mirrors its U.S. filing, but its U.S. status is unclear. A PTO examiner was prepared to allow the same patent claims when the interference was declared, Penhoet said. And the PTAB ruling that its claims were “patentably distinct” from Broad’s claims gives the examiner the option to go ahead with the prior decision.
To contact the reporter on this story: Tony Dutra in Washington at email@example.com
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