/ Created by Dr. Natalie Kirchhofer

Patent battle over CRISPR

EPO revokes foundational patent of the Broad Institute in last instance for formal priority defects

Düsseldorf, January 17, 2020 - After four days of oral proceedings, the Board of Appeal 3.3.08 of the European Patent Office (EPO) revoked the first European CRISPR/Cas9 patent of the Broad Institute on 16 January 2020 in final instance. The CRISPR/Cas9 method allows genome editing in a targeted and simple manner. Hereditary diseases such as cystic fibrosis or sickle cell anemia, but also chronic infectious diseases such as hepatitis C or HIV, could be cured. The method is considered one of the key technologies of the future not only in medicine, but also in agriculture and microbiology. However, it is also controversial because it can be used to modify embryonic stem cells.

In January 2018, the EPO had already revoked the patent in question (EP 2 771 468) of the Broad Institute, MIT and Harvard in first instance due to formal deficiencies in the priority claim. The invalid priority led to a lack of novelty over the inventor’s own publications published in the priority year. According to the current EPO case law, the applicants of the priority and the subsequent application must either be identical or the former must have already transferred the priority rights to the latter before the filing date of the subsequent application. In the present case, the priority application had been filed in the name of i.a. one inventor (Luciano Marraffini of Rockefeller University) who was not named as applicant in the later European patent application and who had not transferred his rights. The Broad Institute argued that, on the basis of the relevant provision in the European Patent Convention (Article 87(1) EPC), it was entitled to claim the priority of the US provisional application nevertheless. This provision states that "anyone" who has filed a patent application may enjoy the right to priority. According to the Broad Institute, this wording would also include a subgroup of applicants in case of multiple applicants on the priority application. The EPO took a different view and revoked the patent without referring this fundamental question of law to the EPO's Enlarged Board of Appeal, which many observers had expected.

The Broad Institute’s further granted European CRISPR patents have also been challenged by several parties in opposition proceedings. In addition, proceedings are pending before another Board of Appeal of the EPO (3.3.04, see T 2190/16 and T 2749/18), which concern very similar legal issues relating to priority. "The pending proceedings could still lead to a future independent referral of questions to the EPO's Enlarged Board of Appeal. It remains to be seen whether Article 87(1) EPC will then be interpreted differently and the case law change accordingly," says Dr. Natalie Kirchhofer, patent attorney and partner at COHAUSZ & FLORACK, who attended the oral proceedings as an observer.

The decision is also relevant for many other patents. While priority applications in the USA are often (and had to be until 2013) filed in the name of the inventors, subsequent applications are usually filed in the name of companies. Priority rights are not always transferred timely and in a formally correct way. "Thus, many other patents could be held invalid for the same or similar formal reasons," Kirchhofer continues. A harmonization of international patent law could eliminate this conflict. In addition to the patent in question, Broad holds other CRISPR patents from the same family, which, however, do not have the priority problem. Thus, the patent battle over the CRISPR foundational IP is far from having been decided.

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