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The Broad Institute of MIT and Harvard may lose a substantial number of European patent claims covering CRISPR/Cas9, but it has at least one trump card to play before we get to that stage, one European patent attorney has told LSIPR.
Catherine Coombes, patent director at HGF in the UK, said such an outcome would not create a clear IP landscape because those wishing to apply the gene-editing technology would still probably need to seek licences from multiple parties.
The European Patent Office’s (EPO) Opposition Division is holding an oral hearing in January to determine the eligibility of one of ten European patents issued to Broad. In an initial opinion earlier this year, the EPO ruled against the institute.
The ruling will also apply to seven of Broad’s nine other opposed patents, which have been put on hold in light of the hearing.
Under EPO law, third parties have nine months to oppose a patent after it has been granted. In April this year, the EPO issued a preliminary and non-binding opinion in the opposition proceedings that Broad’s European patent number 2,771,469 was invalid.
Coombes will be speaking on the CRISPR topic at Life Sciences Patent Network (LSPN) Europe on December 6 in London, where Broad’s chief business officer Issi Rozen will also be presenting.
Coombes said a key theme in the oppositions is whether the formal requirement for priority has been met.
In Europe, a patent applicant or its successor can enjoy a right of priority to an earlier application, with the later application being able to claim the earlier date.
“This is useful because when the later patent application is examined, if it is entitled to priority, no publications between the filing dates of the earlier and later patent applications can be considered in determining if an invention is novel and inventive,” she said.
“Case law in Europe indicates that, where a later patent application is not filed by the same applicant(s), a transfer of priority must have occurred prior to the filing date of the later application. This provides legal certainty, as the validity of a priority claim can be determined by readily verifiable application data.”
Coombes, who will be speaking in a panel session and hosting a roundtable at the LSPN event, said this is relevant because in the ‘469 opposition, neither the inventor (Luciano Marraffini) nor his institution (Rockefeller University) were named as joint applicants. This was despite Marraffini being listed as a joint applicant in the earlier patent application from which priority was claimed.
“In view of an entitlement dispute in the US, it appears that neither Marraffini nor Rockefeller University assigned their rights to claim priority from the earlier patent applications to MIT/Broad.”
In its preliminary opinion, the EPO’s Opposition Division confirmed this and said Broad is not entitled to claim the priority dates of December 12, 2012 or January 2, 2013. Unless the Opposition Division makes a U-turn in the oral hearing in January, “the result will be that this patent (and all patents in which neither Marraffini nor Rockefeller University were named as a joint applicant at the filing date) will be severely limited, if not revoked”.
The EPO came to this opinion despite declarations by high-profile IP figures, including Lord Hoffmann (former English Court of Appeal judge), John Doll (former commissioner of patents at the US Patent and Trademark Office) and Paul Michel (former chief judge of the US Court of Appeals for the Federal Circuit), Coombes said.
While she thinks Broad has presented some strong counter-arguments since that opinion (final submissions were due on November 16), it is likely that the Opposition Division will rule against the institute, she said.
However, one of the ten PCT patent applications filed did name Rockefeller University as a joint applicant and has given rise to two patents and a pending patent application in Europe, so these do meet the formal requirements for priority, Coombes explained.
Should Broad lose patent rights, one outcome is that some may see it as a victory for the University of California, Berkeley (UCB), another player in the CRISPR patent field, Coombes suggested, although she cautioned against viewing developments in the context of ‘winners’ and ‘losers’.
This is because there are increasing numbers of incremental inventions over the foundational IP and, as with any new technology, “things will proceed regardless”.
If Broad does lose many of its rights, it will be jostling for dominance with parties including UCB and Sigma-Aldrich, both of which have CRISPR patents in Europe, although not as many as Broad.
“There are still going to be a lot of overlapping rights,” Coombes said, noting that multiple licences may be required in Europe.
However, another reason for Broad to be hopeful is a preliminary opinion in a separate EPO case (T239/16) which questioned whether the EPO should assess the formal requirements for priority at all. Broad is using this case to claim that, among other reasons, assessment of priority often involves assessment under national law, and with 177 countries under the Paris Convention, this would be too much of a burden for the EPO, Coombes said.
Regardless of the decision next year, Coombes expects it to be appealed, with questions on the formal requirements for priority possibly being referred to the Enlarged Board of Appeal.
To hear more about this exciting issue and many more in the life sciences field, click here to register for the LSPN event on December 6.
Broad Institute of MIT and Harvard, CRISPR/Cas9, gene editing, patent, European patent, patent claims,