The patent dispute relating to the revolutionary CRISPR-Cas9 gene-editing technology between the Broad Institute (jointly operated by Harvard and MIT) on the one side and UC Berkeley on the other side is followed by the biotech community with great interest .

Broad Institute has been the first one to get a patent issued on CRISPR-Cas9 technology in Europe, namely EP 2 771 468. Against this patent, 9 oppositions have been filed, most of which so-called strawman oppositions. The oral hearing finalizing the first instance of the opposition proceedings has been scheduled to take place on 16-19 January at the EPO in Munich. In the preliminary opinion issued together with the summons to the oral hearing, the oppisition division took a non-binding provisional view that the four priorities P1, P2, P5, and P11 cannot be validly claimed by the patentee, because the priority right had not been validly transferred to the applicants of PCT application forming the basis of the granted EP patent.

The decision was issued already in the early afternoon of the second day of the hearing: The opposition division maintained its position laid out in the provisional opinion and decided that the patent proprietor cannot validly claim priorities P1, P2, P5, and P11. As a consequence the claims as granted (main request) were revoked on the ground of lack of novelty. The 64 auxiliary requests filed by the patent proprietor were not admitted to the proceedings. The patent was thus revoked in full. The course of the oral proceedings can be seen in this twitter thread.

In short, the grounds for losing the essential priority rights are as follows: In order to validly claim priority right of a European patent application either directly filed or as a national phase of a PCT application (as in the present case), either (i) the applicant of the priority application and of the later application are identical or (ii) the applicant of the priority application assigns the application to the applicant of the later application, or (iii) the applicant of the priority application assigns the priority right to the applicant of the later application.

The assignments of the application or the priority right must have occurred before the filing of the later application (here: the PCT application), since, for reasons of legal certainty, a retroactive effect is excluded. However proof of such transfer may be provided later.

Furthermore, in case of more than one joint applicants of the priority application, each applicant of the priority application must either be also applicant of the later application or have assigned the application or the priority right to one of the applicants of the later application before the later application date. This was not the case for the priority applications P1, P2, P5, and P11. One of the applicants (and inventors) of these US provisional priority applications was no longer applicant of the PCT application and did not assign the right to the application or the priority right to one of the applicants of the PCT application. As a harsh consequence, the applicants of the PCT application and proprietors of the European Patent lost priorities P1, P2, P5, and P11. Without entitle-ment to these priorities, the subject-matter of the granted claims lacked novelty over the prior art on record.

The written decision of the opposition division can be expected in approximately two to three months. In a press release issued shortly after the decision on priority and before announcement of the full decision, the Broad Institute already announced to lodge an appeal against the finding of the opposition division.

Disclaimer: Neither I myself nor the patent firm Betten & Resch, of which I am a partner, are involved in any patent cases relating to CRISPR-cas9 technology.

(picture by sporst)   Twitter: @patentlyGerman