Résumé de EPC2000 Art 056 pour la décision T1356/21 du 05.10.2023

See also abstract under Article 54 EPC. In T 1356/21 the differentiating feature of the invention, namely the increase in insulin glargine concentration from 100 U/mL to 270-330 U/mL, lead to two types of technical effects: reduced discomfort or pain (due to reduced volume of injection), and flatter PK/PD profile, longer duration of action. The parties differed as to which of the two effects should be taken into account in the assessment of inventive step. In the board's view, both effects were mentioned in the patent and were credibly achieved by the claimed subject-matter in comparison with the closest prior art embodiment. Accordingly, the technical problem was to be formulated objectively, taking into account both effects, as the provision of an improved aqueous pharmaceutical formulation of insulin glargine, i.e. the improvement being both a flatter exposure and flatter biological profile together with a longer duration of action, and a reduced discomfort. According to the appellant (opponent), the reduction in the injection volume was the relevant effect, and was, as acknowledged in the patent, the purpose for increasing insulin glargine concentration in the first place. The additional effect of the concentration-dependent change of the PK/PD profile would be inevitably achieved as the result of increasing the insulin glargine concentration for the purpose of reducing the injection volume, and would thus represent a mere bonus effect. The board disagreed. According to established case law, an effect which might be said to be unexpected could be regarded as an indication of inventive step. However, certain preconditions had to be met (see Case Law of the Boards of Appeal, 10th edition, 2022, I.D.10.8; in particular T 21/81 and T 506/92). In the board's view, the case law on bonus effects could not be applied to all situations where a given differentiating feature lead to (or inevitably achieved) two separable technical effects, one of which may be expected. For an additional, unexpected effect to be disqualified as a mere bonus effect, it had to be shown either that the situation was characterised by a lack of alternatives as regards the means for achieving the first, expected improvement (i.e. a "one-way-street" situation as explained in T 192/82), or that, considering the relative technical and practical importance of the effects in the circumstances of the case, the additional unexpected effect was merely accidental (following T 227/89 and T 1147/16). In situations which did not qualify as a "one-way street", the board did not consider it appropriate that a crucial and unexpected technical advantage be disregarded in the assessment of inventive step as soon as any additional obvious effect was mentioned in the patent. The board was aware of the view expressed in T 1317/13 that a "one-way-street" situation was not a mandatory prerequisite for the application of the principle established in T 21/81. However, neither T 1317/13 nor T 21/81 offered a basis for an unqualified application of the bonus effect case law to any situation of plurality of technical effects without regard to their respective technical and practical importance. The board's view in this regard was in agreement with the statement in T 192/82 that the use of means leading to some expected improvements might well be patentable if relying on an additional effect, provided this involved a choice from a multiplicity of possibilities. The board considered that the present case did not qualify as a "one-way-street" situation; the skilled person could have addressed the issue of discomfort caused by the injection of larger volumes of the formulation by other means than an increased concentration. Furthermore, the effects of flatter PK/PD profiles and longer duration of action could not be regarded as merely accidental, but instead represented crucial advantages in the context of basal insulins. Lastly, in the board's opinion, it would also not be appropriate to disqualify the effect of flatter PK/PD profiles and longer duration of action as accidental, i.e. as being of lesser technical and practical importance, on account that these effects may be the result of a serendipitous discovery. What mattered was not in what circumstances the inventors realised the invention, but what the invention achieved. Thus, in the circumstances of the present case, the technical effects of flatter PK/PD profiles and longer duration of action could not be regarded as accidental and had to be taken into account. Similarly, the board was not convinced that the effect of reduced discomfort and injection volume should be regarded as a bonus effect either. For the reasons given above, the board found that the fact that two technical effects arose from the same distinguishing feature did not mean that one of the two effects necessarily had to be regarded as a bonus effect.