Broad Institute CRISPR patent revoked: lack of priority
An EPO opposition division recently revoked The Broad Institute’s patent EP2771468, which is the first of a number of its patents relating to the CRISPR / Cas system to come before the EPO’s opposition divisions.
The opposition division’s written decision was published on 26 March 2018 following oral proceedings earlier in the year. Crucially, it was decided that certain of the patent’s twelve claims to priority are invalid and as a consequence that the patent lacks novelty in view of a number of intervening disclosures.
EP2771468 relates to the CRISPR gene editing technology, which relies on a nucleic acid guide sequence to direct site-specific cutting of a DNA sequence by the Cas9 enzyme. The CRISPR technology promises improved accuracy over earlier gene editing approaches and has been heralded as a significant development in biology with potential uses ranging from gene therapy to the generation of improved crops.
The Broad Institute is currently engaged in protracted patent disputes with the University of California in this field, although the points at issue in this case differ from those that have affected outcomes in the US.
The patent is one of a number of The Broad Institute’s CRISPR-related European patents that have been opposed. Notably, similar objections to lack of priority have been raised against EP2896697, EP2784162, EP2921557, EP2931898 and EP2764103 (according to The Broad Institute’s own submissions). Barring a reversal of the opposition division’s decision on appeal, a similar fate may await these.
EP2771468 was filed on 12 December 2013 and claims priority from twelve US provisional applications.
The earliest two priority applications (P1 and P2) listed eight individuals as inventors/applicants, including Dr Luciano Marraffini. On filing, EP2771468 listed four of the same individuals as applicants, in addition to The Broad Institute, Inc and the Massachusetts Institute of Technology, however Dr Marraffini was absent.
The right to claim priority
The right to claim priority for a European application is governed in part by Article 87(1) EPC, which states:
“Any person who has duly filed […] an application for a patent, a utility model or a utility certificate, or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application.”
In addition, it is established EPO practice and case law that, in the case of multiple applicants, all of the applicants or their successor(s) in title should be among the applicants of the later application.
Importantly, this was not the case for EP2771468. No evidence was available to prove a transfer of priority right from Dr Marraffini to any of EP2771468’s applicants before its filing date.
The opposition division considered three lines of argument advanced by the patentee to attempt to address this deficiency.
First, the patentee submitted that the EPO should have no power to assess legal entitlement to the right of priority. The opposition division dismissed this, noting that if it were presumed that any person filing a later application is entitled to claim priority, the EPO would grant patents based on an unreliable state of the art (that is, the presumed effective date of an application might be incorrect).
Second, it was submitted that in cases of multiple applicants for a first application, the term “any person” under Article 87 EPC should be interpreted as meaning “one or some indiscriminately” of the co-applicants. The opposition division agreed that the wording of the EPC and Paris Convention do not exclude this interpretation, however the opposition division considered it inappropriate to deviate from the EPO’s established practice. The opposition division further noted that doing so could lead to multiple applicants filing separate applications claiming priority from a first application, which may result in multiplication of protection for the same subject matter.
Third, it was submitted that the meaning of “any person who has duly filed” should be interpreted according to national law. In particular, it was submitted that under US law an applicant must have contributed to an application or have derived rights thereto from an inventor. The opposition division also dismissed this, concluding that under the EPC and Paris Convention, the right to claim priority derives from the formal filing of the first application, irrespective of the status of inventors.
Although subject to appeal, this decision emphasises the importance of the formalities of priority claims for European applications.
Commercial sensitivities in this field are clearly apparent: The Broad Institute published a press release immediately following the oral decision stating their disagreement with the assessment of priority and their intention to appeal. Indeed, a notice of appeal has already been filed and acceleration of the appeal proceedings requested in view of the relevance of similar issues for some of The Broad Institute’s other CRISPR-related European patents.
We await with interest the Board of Appeal’s decision in view of the established case law on this issue.