Zusammenfassung von EPC2000 Art 056 für die Entscheidung T1045/21 vom 05.09.2023

In T 1045/21 the board held that the technical problem could not be formulated as the provision of an effective and thus improved treatment of ALS with edaravone, wherein the improvement resides in the provision of a further (new) treatment option for ALS, because D1 already described an effective treatment of ALS with edaravone. The fact that the claimed treatment might be confirmed, in the patent, to be effective in the claimed patient population could not be regarded as an improvement. The alleged confirmation, i.e. by a phase III study as opposed to a phase II study, of the efficacy of edaravone in the treatment of ALS was not a technical effect resulting from the differentiating feature, namely the %FVC of 80% or more. The appellant further relied on the achievement of an improved efficiency in relation to the selection of patients having a %FVC of 80% or more, based on the data for subgroups (3) and (5) in table 5 of the patent. The board explained that according to established case law, if comparative tests were chosen to demonstrate an inventive step on the basis of an improved effect over a claimed area, the nature of the comparison with the closest state of the art had to be such that the alleged advantage or effect was convincingly shown to have its origin in the distinguishing feature of the invention compared with the closest state of the art (see Case Law of the Boards of Appeal, 10th edition, 2022, I.D.4.3.2). The board held that it rested with the proprietor to properly demonstrate that the purported advantages of the claimed invention had successfully been achieved (see G 2/21, OJ 2023, A85, point 26 or the Reasons). Further, in the board's opinion, no meaningful conclusion could be drawn from a comparison of these subgroups (3) and (5), because there was no demonstration that these subgroups actually differed only by a %FVC of 80% or more, and that any improvement in the outcome had its origin in this differentiating feature. It was also neither shown nor credible that the characteristics of subgroups (3) and (5) were sufficiently similar to allow a comparison and draw conclusions as to the effect of the sole %FVC feature. It was accordingly concluded that no improvement was convincingly shown to arise over D1, i.e. D1 credibly showed the efficacy of the edaravone treatment, and the selection of the claimed patient population was not associated with any improvement. The technical problem was therefore the provision of an alternative application of edaravone in the context of treating ALS. The board held that considering the formulation of the problem as the provision of an alternative, the solution consisting in selecting a subgroup of patients characterised by the claimed %FVC of 80% or more did not involve an inventive step.