The Broad Institute of MIT and Harvard University is at risk of losing its dominant position over the intellectual property covering CRISPR gene-editing technology in Europe
1. EPO [European Patent Office] revokes Broad’s CRISPR patent
2. ERS Genomics responds to revocation of Broad Institute European patent
1. EPO revokes Broad’s CRISPR patent
By Jef Akst
The Scientist, January 17, 2018
* Shortly after ruling out the earliest priority dates on a foundational patent for CRISPR gene-editing technology, the European Patent Office rescinded the patent entirely — and more are likely to follow
The Broad Institute of MIT and Harvard University is at risk of losing its dominant position over the intellectual property covering CRISPR gene-editing technology in Europe, after the European Patent Office (EPO) ruled today (January 17) that a foundational patent is revoked because the Broad did not meet EPO requirements to establish that its researchers were the first to use CRISPR in eukaryotes.
In addition to the highly publicized patent dispute between the Broad and the University of California over the rights to CRISPR gene editing in the U.S., the Broad has been fighting to maintain a number of patents over the technology in Europe. The issue revolves around a disagreement between the Broad and Rockefeller University over who should be named as inventors. The majority of patent applications filed by the Broad in Europe failed to name Rockefeller University itself, as well as Rockefeller researcher Luciano Marraffini, both of which were named on several of the documents filed to establish a priority date for the patent as early as December 2012. Changing the listed inventors goes against the EPO’s formal requirements for priority, leading the agency to rule this morning that the priority documents with the full list of inventors did not count toward establishing priority of the more-limited European filings.
“If you’ve got more than one person on a priority document, they are a singular legal unity,” explains Catherine Coombes, a senior patent attorney with HGF Limited in the U.K. “If you’re going to drop numbers . . . you need to transfer priority from everybody on the first.” Given the ongoing arbitration between the Broad and Rockefeller, it’s not surprising that the Broad did not procure this transfer, she adds.
The ruling resulted in the loss of the Broad’s first two priority documents, and the next earliest date associated with the patent’s priority was the end of January 2013, Coombes explains, by which time a handful of key papers had been published. “Anything before your earliest date can be cited against your patent,” Coombes says, making it difficult for the Broad to demonstrate that the novelty and inventive steps needed to bring CRISPR from use in prokaryotes to eukaryotes were first completed by Broad researcher Feng Zhang and colleagues. As a result, “it wasn’t surprising the patent ended up being revoked” shortly after the priority decision was made.
Now, the Broad may have to focus on other facets of the CRISPR technology, Coombes adds. “There might be something specific [the Broad] can get [patent] protection for, but that very broad, foundational protection scope is going to be difficult.”
Today’s decision is the first opposition heard in Europe, but at least 10 other Broad patents have been challenged, many of which have the same issue of leaving out certain inventors from those listed on the documents filed to establish priority. The EPO had put those other proceedings on hold while it looked into this first patent, Coombes says, but now it can apply its ruling to the other cases. “What we will expect to see over the next year or so is a number of the other Broad’s patents in Europe either being completely revoked or being severely limited in Europe.”
The Broad has announced that it will be appealing the EPO’s decision, but “I personally think it’s unlikely that we’ll see a change in direction,” Coombes says. She adds, however, that the institution does have one patent application that does name Rockefeller and Marraffini. “What I would suspect their patent attorneys would be doing is looking over the patent that doesn’t have this [priority] issue and trying to get more claims in that one.”
2. ERS Genomics responds to revocation of Broad Institute European patent
Business Wire, January 18, 2018
ERS Genomics announced that yesterday, the European Patent Office (the “Office”) revoked in its entirety the first of several Broad Institute patents that are facing opposition there. The Office determined that the Broad Institute’s European patent No. EP 2,771,468 claimed inventions that lack novelty over prior art. The Office rejected the Broad Institute’s position that its patent was entitled to a priority date pre-dating the prior art. In originally obtaining the patent, the Broad Institute, according to the Office, failed to follow rules and established caselaw for properly establishing an earlier priority date. This patent is the first of the Broad Institute CRISPR patents to face opposition in Europe. Many other Broad patents granted in Europe suffer from the same failure to comply with the priority requirements.
This patent was opposed by multiple groups on a variety of grounds. The priority defect was simply one of those grounds of opposition which was quickly found to be sufficient for the EPO to make the ‘revocation in its entirety’ ruling, and subsequent grounds were not even considered.
Eric Rhodes, CEO of ERS stated, “We have always felt confident that the Broad’s patents would be overturned in Europe based on lack of novelty in light of the Charpentier/Doudna patent filings, but the simple confirmation of this technical deficiency in the Broad’s priority claims made it unnecessary for the European Patent Office to pursue this line of questioning in their revocation decision. The technical fault was sufficient for the patent office to quickly come to a determination that the Broad claims to their earlier priority dates were not legitimate and therefore their claims lacked novelty in light of several publications which predated their allowed priority date.”
The Broad Institute is expected to appeal the decision and commented in a statement on their website that they expect the EPO to ‘harmonize the EPO procedures to be consistent with international treaties and compatible with the fundamental principles of the Paris Convention’. However, they failed to point out that the language pertaining to these procedures in both the European Patent Convention and the Paris Convention are identical. “Any such change as expected by the Broad would require a change in the law itself.” Rhodes continued, “The vast majority of the Broad Institute’s CRISPR patents in Europe are also affected by this same deficiency and we expect them to meet a similar fate.”
ERS Genomics was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property held by Dr. Emmanuelle Charpentier. Non-exclusive licenses are available for research and sale of products and services across multiple fields including: research tools, kits, reagents; discovery of novel targets for therapeutic intervention; cell lines for discovery and screening of novel drug candidates; GMP production of healthcare products; production of industrial materials such as enzymes, biofuels and chemicals; and synthetic biology. For additional information please visit www.ersgenomics.com.