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Developments in CRISPR Patent Dispute: EPO Revokes Broad’s CRISPR Patent

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 1/17/2020

On Thursday, [1/16/2020] 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 licensing 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.

SOURCE

https://www.genomeweb.com/business-news/revocation-broad-institute-crispr-patent-upheld-europe#.XiI1V1NKgcg

Other sources

Mixed views on Broad’s fate after EPO revokes CRISPR patent

https://www.lifesciencesipreview.com/news/mixed-views-on-broad-s-fate-after-epo-revokes-crispr-patent-2671

EPO Revokes Broad’s CRISPR Patent

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, 2018) 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.

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.”

SOURCE

https://www.the-scientist.com/?articles.view/articleNo/51395/title/EPO-Revokes-Broad-s-CRISPR-Patent/

An update regarding inventorship and ownership of certain Broad filings relating to the use of the CRISPR-Cas9 system in eukaryotic cells

New York, NY, and Cambridge, Mass., January 15th, 2018

— The Rockefeller University and the Broad Institute of MIT and Harvard have settled their disagreement regarding inventorship and ownership of certain Broad filings relating to the use of the CRISPR-Cas9 system in eukaryotic cells. Rockefeller believed that its faculty member Dr. Luciano Marraffini, co-author with Broad’s Dr. Feng Zhang, on a seminal paper published in Science in 2013, Multiplex Genome Engineering Using CRISPR/Cas Systems, should have been maintained in these Broad eukaryote filings.

SOURCE

https://www.broadinstitute.org/news/rockefeller-university-and-broad-institute-mit-and-harvard-announce-update-crispr-cas9

“That Other CRISPR Patent Dispute”

It’s possible the Rockefeller dispute may work its way in to the interference proceedings involving the Broad and UC Berkeley. Earlier this summer, the patent examiner on the Rockefeller’s application gave an initial rejection to some of the claims because they overlap with UC Berkeley’s patent application. Sherkow said it’s possible the examiner’s decision could be used as evidence to persuade the patent judges that Berkeley was first to develop CRISPR as a gene-editing tool.

SEE

Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decisionruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.

https://pharmaceuticalintelligence.com/2017/04/13/gene-editing-consortium-of-biotech-companies-crispr-therapeutics-crsp-intellia-therapeutics-ntla-caribou-biosciences-and-ers-genomics-uc-berkeley-doudnas-ip-and-university-of-vienna-charpe/

Other potential casualties of the Rockefeller dispute are some of the Broad’s patents overseas, as Catherine Coombs describes today (August 31) in an opinion article. In a nutshell, patents abroad may be compromised if the applicants on US patents are not the same as those listed on corresponding international patents, Coombs explains.

Rockefeller, Marraffini, and Zhang all declined to comment on the ongoing dispute. The Broad offered a statement acknowledging that Rockefeller has been an important collaborator on CRISPR, and that the institutions share a couple of patent applications related to the tool’s application in prokaryotic cells. “Rockefeller has raised the question of whether its interests are more general,” the statement reads. “We appreciate that Rockefeller has raised this question and expect it will be resolved amicably between our institutions. This resolution will likely take some time.”

The disagreement between Rockefeller and the Broad concerns just one of hundreds of CRISPR-related patent families, noted Corinne Le Buhan, the CEO of IPStudies, a Switzerland-based firm that tracks CRISPR patents. Le Buhan said it’s likely more patent fights will arise. “There are lots of very close patents signed by different inventors,” she told The Scientist. “Based on what we’ve seen on the technology side we can anticipate there will be more disputes.”

SOURCE

https://www.the-scientist.com/?articles.view/articleNo/46921/title/That-Other-CRISPR-Patent-Dispute/

CLASHES OVER THE FUTURE OF GENE THERAPY AT THE US’ BIGGEST BIOTECH MEETING, JP Morgan, SF, January 9-12, 2018

Role of Immune system in gene therapy using CRISPR Cas9

https://www.wired.com/story/clashes-over-the-future-of-gene-therapy-at-the-uss-biggest-biotech-meeting/