Zusammenfassung von EPC2000 Art 056 für die Entscheidung T0258/21 vom 24.07.2023

In T 258/21 the appeal was filed by the applicant against the decision of the examining division to refuse the patent application. Claim 1 of main request read as follows: "1. A medicament comprising an effective amount of a short acting dihydropyridine compound wherein the short acting dihydropyridine compound is clevidipine or a pharmaceutically acceptable salt or ester thereof for use in a method of reducing ischemic stroke damage [...]." D1 (closest prior art) disclosed the use of dihydropyridines for lowering blood pressure in hypertensive crises resulting from complications such as hemorrhagic stroke, cerebral ischemia, encephalopathy or myocardial ischemia. The claimed subject- matter differed from D1 in that the management of hypertension with clevidipine occurred in a patient with an ischemic stroke to reduce ischemic stroke damage. The board observed that the original application did not provide any experimental data. No technical effect directly linked to the identified distinguishing feature, namely the reduction of ischemic stroke damage, had thus been demonstrated in the application documents. In this context, the board underlined that the choice of clevidipine over nicardipine did not constitute the distinguishing feature over D1 as identified by the appellant. In its letter dated 14 July 2023, the appellant referred for the first time to the achievement of "an optimal balance of efficacy, precision (titrability) and safety". In the same letter, the appellant also argued that clevidipine would have higher activity and lower side effects than other hypertensive agents. In particular, it would not show the drawbacks in terms of hypoperfusion of nicardipine, which was indicated as preferred anti-hypertensive agent in case of acute ischemic stroke in D1. According to the appellant these surprising effects would be substantiated by the post-published Annex 3 and Annex 4. In the board's view, the effect of an improved activity and reduced side-effects using clevidipine compared to other antihypertensive agents, in particular nicardipine in patients with specifically ischemic strokes, was not to be taken into account nor convincingly demonstrated. The board noted with reference to G 2/21, point 2 of the Order, that this effect had neither been contemplated nor even suggested in the original application. Indeed the original application did not mention any comparison to other anti-hypertensive agents and it encompassed the treatment of both hemorrhagic and ischemic stroke. It followed that this technical effect relied upon by the applicant could not be taken into account for the assessment of inventive step in accordance with G 2/21. Moreover, even if said technical effect had been derivable from the original application, the board observed that Annex 3 and Annex 4 were merely abstracts reporting results of "ongoing" studies. These documents did not provide any detailed results nor any details on the protocols used. The meaningfulness of the appellant's exploitation of the data provided in these abstracts was therefore prima facie questionable. Furthermore, the study of Annex 4 appears to be a retrospective case study which was not designed as a clinical trial. As a result, starting from D1, the board held the objective technical problem could thus be formulated as the provision of a medicament that can be used in a method of reducing ischemic stroke damage in a subject with an ischemic stroke.