Résumé de EPC2000 Art 054 pour la décision T1356/21 du 05.10.2023

See also abstract under Article 056 EPC. In T 1356/21 claim 1 of the main request pertained to an aqueous pharmaceutical formulation characterised in particular in that "the concentration of insulin glargine is 270-330 U/mL being equimolar to 270-330 IU human insulin". This feature of claim 1 defined the concentration of insulin glargine in the composition, expressed as (international) units (U or IU). Claim 11 was identical to claim 1 with the addition of "for use in the treatment of Type I and Type II Diabetes Mellitus in a patient". Claim 23, pertaining to the "aqueous formulation according to any of the foregoing claims for use in the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus", related to the same subject-matter as claim 11. Thus, both claims 11 and 23 were drafted in the format of Art. 54(5) EPC, i.e. as claims directed to the same composition as in claim 1 for a specific use in a method referred to in Art. 53(c) EPC. According to the appellant, the subject-matter of claims 11-23 of the main request lacked novelty over D12, because the insulin glargine concentration defined in said claims fell within the broad meaning of the term "dosage regimen" as used in G 2/08, and yet was not characterised by any technical effect that would be particular to said sub-range compared to other concentrations within the range disclosed in D12. The appellant did not, however, object to the novelty of claim 1. The board held that the fact that the compositions of claims 11 and 23 were limited, in comparison with claim 1, by the feature pertaining to their specific use in a method of treatment of Type I or II Diabetes Mellitus, did not entail that the features pertaining to the concentration of insulin glargine should no longer be regarded as defining the composition, but merely its use. Neither decision G 2/08 nor its reference to T 1074/06 (where the claims related to doses, and not concentration) justified reading the word "concentration" of claims 11 and 23 as a dosage regimen. In claims 11 and 23 just as in claim 1, the concentration feature defined the composition itself, i.e. the amount of insulin glargine in the composition, and not the use of the composition, i.e. the dose given to a patient at particular times or time intervals. This concentration feature thus established novelty for the subject-matter of claims 11 and 23 for the same reasons as for claim 1. Additionally, considering the case law in the general situation of selections from numerical ranges, the board was not convinced by the appellant's argument that in the case of purpose-limited product claims pursuant to Art. 54(5) EPC relying on a dosage regimen defined by a numerical range, a selection from the prior art must be purposive for it to be novel. In point 6.3 of G 2/08 the Enlarged Board of Appeal had stated that "the claimed definition of the dosage regime must therefore not only be verbally different from what was described in the state of the art but also reflect a different technical teaching". However, under the same point of the Reasons the Enlarged Board of Appeal explained that "for the assessment of novelty and inventive step of a claim in which the only novel feature would be the dosage regimen, the whole body of jurisprudence relating to the assessment of novelty and inventive step generally also applies". In the board's view, this indicated that G 2/08 did not seek to establish different novelty criteria for numerical ranges in the case of dosage regimen. Thus, the case law in the general situation of numerical ranges, as it has evolved over the years, must apply also in the case of dosage regimen. Consequently, the appellant's objection had to fail for the additional reason that, even if the concentration features of claims 11 and 23 were arguendo seen as a dosage regimen, the former criterion of a purposive selection should no longer be regarded as a requirement under G 2/08 for a dosage regimen to represent a novel selection from a broader range known in the prior art. Accordingly, the claimed subject-matter was novel.