The Board of Appeal at the European Patent Office (EPO) hearing the opposition appeal case on The Broad Institute’s CRISPR patent EP2771468 has dismissed the appeal and upheld the decision of the first instance opposition division to revoke the patent in its entirety.
CRISPR is a genome editing technique that has been hailed as the biggest biotech breakthrough of the century. The CRISPR/Cas9 system promises a precise, relatively simple and versatile method for editing DNA. Investment in this technology has been huge since it potentially has wide applicability in the lab and may even have a role in eradicating genetic disorders in humans and other animals.
The question of who owns and can control the use of the CRISPR/Cas9 system is consequently of pressing importance and is under intense debate. It is claimed to have been developed independently by two separate research groups – both of which sought patent protection and published data from their work creating a complex IP situation, as the patent filing and article publication dates are closely interweaved. It is difficult for anyone wanting to use this technology to know who to seek a licence from.
Multiple oppositions were filed against EP2771468 co-owned by The Broad Institute, Inc., Massachusetts Institute of Technology, and the President and Fellows of Harvard College. The conclusion of the opposition was that the patent was revoked for lack of novelty after it was determined that the Applicants were not entitled to claim priority from the earliest of their claimed priority dates and so intervening prior art was citable.
The appeal proceedings have been heavily focused on how to correctly claim priority when there are multiple applicants named on priority applications but not all of them, or not all of their successors in title, are named as applicants on the priority claiming application.
The Board of Appeal initially indicated that they intended to refer three questions to the Enlarged Board of Appeal (leading to some “fake news” reporting that a referral had been made). However, in an interesting turn of events, the Opponents were able to convince the Board of Appeal that it was unnecessary to refer any questions to the Enlarged Board because their questions could be answered by the existing body of EPO case law. Therefore, the Board of Appeal upheld the decision of the first instance Opposition division that the patent is not entitled to its earliest priority dates, lacks novelty over intervening prior art, and thus is revoked.
Despite the excitement around this high-profile case, the decision is not particularly surprising since it follows well-established EPO case law. Nevertheless, it serves as a reminder of the importance of getting priority formalities correct at the outset, before any priority-claiming applications are filed.