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Revocation of Broad Institute CRISPR Patent Upheld in Europe

This story has been updated to include comments from ERS Genomics.

NEW YORK – The European Patent Office (EPO) Board of Appeal has upheld the revocation of a Broad Institute CRISPR patent in Europe.

The issue arose in January 2018 when the EPO decided after an initial review to deny the institute's reliance on a US priority provisional application for a CRISPR-related patent in Europe.

At the time, the Broad said that the issue related to "the current interpretation of rules that dictate what happens when the names of inventors differ across international applications. This interpretation affects many other European patents that rely on US provisional patent applications, and is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe."

The institute said that it intended to appeal the decision to the EPO Board of Appeal and that it hoped the agency would "harmonize" its procedures to be consistent with international treaties.

On Thursday, the EPO appeals board indicated that it planned to refer the issue to an Enlarged Board of Appeals to decide three questions: whether a European patent application can be refused if it claims the same subject matter as a European patent which was granted to the same applicant and does not form part of the state of the art pursuant to relevant articles of European law; what the conditions for such a refusal could be, and how those conditions should be applied depending on certain filing details in the patent in question; and whether an applicant has a legitimate interest in the grant of a patent on the subsequent European patent application in view of the fact that the filing date and not the priority date is the relevant date for calculating the term of the European patent.

A day later, however, the appeals board reversed its decision to send the case to the enlarged board, and made the decision itself, ruling that the initial revocation of the patent for lack of novelty "in view of immediate prior art" was correct.

"This prior art became relevant because the opposition division did not acknowledge the patentee's claim to priority from a US provisional application naming more applicants than the subsequent PCT application from which EP 2771468 is derived," the appeals board wrote in its brief decision. "Since the omitted applicant had not transferred his rights to the applicants of the PCT application the priority claim was considered invalid."

In a statement, the Broad once again noted that the EPO's decision doesn't involve the actual scientific merits of the patent application, but concerns the interpretation of rules that dictate what happens when the names of inventors differ across international applications. The institute noted that up to nine of its 21 CRISPR-Cas9 patents in Europe could be affected by the decision if the EPO doesn't "harmonize" these requirements, but added that the majority of its patents in Europe will not be affected. 

"These include the fundamental claims in EP 2825654B1, as well as others covering certain key therapeutic indications — including for previously untreatable diseases," the institute said. "In addition, Broad has numerous other CRISPR-Cas9 patent applications pending in Europe that are not affected by this formalities issue, as well as granted and pending patents related to CRISPR-Cas12/Cpf1, which are not affected."

The Broad also urged all CRISPR patent holders to "move beyond litigation," and instead work together to ensure that there is wide, open access to the technology. 

In a statement on the decision, ERS Genomics CEO Eric Rhodes said the company is "pleased" to see the appeals board's confirmation of the earlier revocation, adding, To have the issue resolved finally provides some measure of clarity to those companies interested in using and commercializing CRISPR-Cas9 technology. Today's ruling significantly reduces Broad's CRISPR-Cas9 patent footprint in Europe and should make licensing decisions much easier for those looking to utilize CRISPR-Cas9 technology in Europe."

Rhodes also noted to GenomeWeb that the Broad's call for the parties to put litigation aside and make their technology widely available is an admirable goal, but also a complicated one.

ERS was founded to provide access to CRISPR-Cas9 intellectual property held by Emmanuelle Charpentier. This CRISPR IP is shared between her, Jennifer Doudna and the University of California, and the University of Vienna, and is separate from genome editing patents held by the Broad.

Rhodes noted that the company does make its own CRISPR IP widely available through licencing and other avenues, and although it would be better to have the IP held by the Broad and ERS available through only one source, "it's a complicated situation." Both sides involve multiple institutions and companies, making anything involving the pooling of patents a "complex logistical issue," Rhodes added. There's a willingness on both sides, but making it happen will be difficult.