Munich, February 27, 2025 - Vossius & Partner previously successfully filed oppositions against two patents of Sigma-Aldrich Co. LLC (EP-B1 3138911 and EP-B1 3360964) which claimed the use of CRISPR-Cas9 for eukaryotic genome engineering. Oral proceedings before Technical Board of Appeal 3.3.08 were held on November 11 and 12, 2024. After the Technical Board announced lack of inventive step findings during the oral proceedings in EP-B1 3138911, Sigma-Aldrich Co. LLC withdrew their appeal. When the Board intended to hear the second case (EP-B1 3360964), Sigma-Aldrich Co. LLC withdrew their appeal also in this case. Thereby, the first instance decisions of the Opposition Divisions to revoke the patents became entirely final.
In another CRISPR patent from The Broad Institute, Inc. et al. (EP-B1 2825654) that claimed CRISPR-Cas9 for eukaryotic embodiments, oral proceedings before Technical Board of Appeal 3.3.08 were scheduled to take place on March 3 to 5, 2025. The Board issued their preliminary opinion on January 24, 2025. Therein, the Board thoroughly analysed the issues at stake.
Regarding novelty of the Main Request, the Board preliminarily found that the claimed subject-matter is not novel pursuant to Article 54(3) EPC in view of WO 2013/176772, “essentially for the reasons provided in the decision under appeal” (the preliminary opinion at point 44). Importantly, the Opposition Division found that besides a direct and unambiguous disclosure of the claimed subject-matter in WO 2013/176772, CRISPR-Cas9 genome engineering is disclosed in an enabling manner in the relevant priority document of WO 2013/176772. None of patent proprietor’s arguments was considered convincing, in line with the Opponents’ arguments. When coming to the lack of novelty decision, Cas9 from S. pyogenes was found to have internal NLSs which anticipate the definition in claim 1 that the CRISPR enzyme comprises at least one NLS.
Regarding inventive step, the Board in their preliminary opinion focused on Auxiliary Request 3, which contained the definition that the CRISPR enzyme comprises one or more NLS at the amino-terminus and one or more NLS at the carboxy-terminus. This definition was considered non-obvious in the first instance by the Opposition Division. However, the Board in their preliminary opinion indicated at points 77 to 79 that the Opposition Division’s assessment of non-obviousness is questionable. In particular, the Board indicated that if there is an improvement observed for using more than one NLS, this would merely be a dosis effect, while an improvement is in any case not attributable to the positioning of the NLSs at the CRISPR enzyme when considering the data in the patent (preliminary opinion at point 78). Moreover, the Board pointed out in point 81 of the preliminary opinion that it is “not convinced by the patent proprietor’s submissions that the skilled person would have had no reasonable expectation of success starting from document D33 in view of alleged obstacles” (D33 is the publication Jinek et al., Science, 2012, 337:816-820).
Thus, in their preliminary opinion, regarding novelty and inventive step, the Board followed the arguments from Vossius & Partner and our co-Opponents. As a reaction, with submission of February 20, 2025, the patent proprietor (The Broad Institute, Inc. et al.) no longer approved the text of EP-B1 2825654, withdrew all pending requests and requested that the patent be revoked. Thus, the Board of Appeal with Communication of February 25, 2025 cancelled the oral proceedings scheduled for beginning of March and the patent is finally revoked in its entirety.
The above confirms that broadly claiming CRISPR-Cas9 for genome engineering will in all likelihood not be considered inventive by the Boards of Appeal in view of the publication from Jinek and co-workers in 2012. When considering the revocation of the patents from Sigma-Aldrich Co. LLC (EP-B1 3138911 and EP-B1 3360964) and the assessment of Board 3.3.08 in their preliminary opinion in EP-B1 2825654, additional definitions such as integration of a donor polynucleotide, using specific promoters (such as the polymerase III promoter U6) and the use of more than one NLS in different constellations will very likely not render the claimed subject-matter inventive. This is fully in line with the arguments that Vossius & Partner as Opponent has set forth in writing and during oral proceedings.
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