Zusammenfassung von Article 056 EPC für die Entscheidung T0228/23 vom 24.09.2024

In T 228/23 the appellants-opponents had essentially argued that the alleged improvement of drug release when preparing tablets by dry granulation compared to direct compression would not be encompassed by the technical teaching of the original application nor embodied by the same originally disclosed invention. The board considered that the alleged specific effect of faster and more complete release profile was indeed derivable from the original application in view of the references to immediate release, desired dissolution profiles and dissolution performance. In particular, the description of the immediate release profile in the context of the invention in the original application defined an increase of the release percentage and/or a reduction of the release time. This suggested that a faster and more complete release profile constituted a purpose of the invention. This technical effect was thus encompassed by the technical teaching of the original application as required by G 2/21. It remained to be determined whether the second criteria set in G 2/21 was met, i.e. whether the effect was embodied by the same originally disclosed invention. The board considered that although the original application disclosed the preparation of tablets by direct compression or dry granulation without indicating whether one of these methods was preferred over the other, the fact that all the examples of the original application concerned dry granulation indicated that dry granulation would be preferred over direct compression in general in the context of the application. The board considered that in this specific case of a very limited number of embodiments defined in the original application, one of these being also the subject-matter of the closest prior art and the other one being generally preferred, and in the absence of any legitimate reason at the effective date to doubt that the alleged effect could be achieved with the claimed subject-matter (see T 116/18 of 28 July 2023, point 11.14 of the Reasons), that the appellant-patent proprietor should be entitled to specify a preference for one of said originally disclosed embodiments over the other in connection with said effect. In the present case, the alleged effect of faster and more complete release profile for tablets obtained by dry granulation compared to direct compression thus did not change the nature of the claimed invention, as defined in G 2/21 (point 93 of the Reasons), so that it was embodied by the same originally disclosed invention. In line with G 2/21, the board held that the alleged technical effect of faster and more complete release profile in so far as it was supported by the post-published experimental data on file was thus to be taken into account when assessing the inventiveness of the claimed subject-matter.