Résumé de EPC2000 Art 056 pour la décision T1525/19 du 12.04.2024

The decision under appeal in T 1525/19 concerned the opposition division's decision to reject the five oppositions filed against the patent at issue for a solid pharmaceutical dosage form comprising linagliptin as a first active pharmaceutical ingredient in an amount of 5 mg and empagliflozin as a second pharmaceutical ingredient in an amount of 10 mg or 25 mg and one or more excipients. AR 1 (admitted under Art. 12(4) RPBA 2007) was directed to a solid pharmaceutical dosage form comprising 5 mg linagliptin and 10 or 25 mg empagliflozin. The appellants (opponents) had argued that, in accordance with decision G 2/21, the overadditive effect on GLP-1 levels assigned to the combination of linagliptin and empagliflozin could not be taken into account for the assessment of inventive step. The effect was not derivable from the application as filed or from common general knowledge, since empagliflozin could not be expected to have an effect on GLP-1 levels. The board disagreed. The application as filed was generally directed to the combination of linagliptin with a SGLT2 inhibitor for improving glycaemic control compared with monotherapy. The mode of action of linagliptin and SGLT2 inhibitors was common general knowledge and it was also disclosed in the application as filed. The fact that the combination of linagliptin and empagliflozin increases GLP-1 levels in an overadditive manner did not change the nature of the effect assigned to the combination of the invention, it merely related to a difference in intensity, which becomes relevant for comparison with the closest prior art. Therefore, the effect shown in D62 and D64 (post-published evidence) was encompassed by the teaching of the application as filed. The board also found that there was a synergistic interaction between linagliptin and empagliflozin. Therefore, in the light of common general knowledge and Example I of the application as filed, the skilled person would consider it likely that the overadditive glucose excursion observed in Example I of the patent was at least partially due to an increase in the effect on GLP-1 levels compared with linagliptin monotherapy. The effect shown in D62 and D64 was embodied by Example I in the application as filed. G 2/21 did not preclude taking into account the effect merely confirmed by D62 and D64. Appellant 5 argued that the board's conclusion that D62 and D64 could be taken into account was based on an argument raised for the first time by the board at the oral proceedings on 1 September 2023. The board was not convinced; if appellant 5 had needed time to reconsider its case after the board's conclusion on the consideration of D62 and D64, it could have requested this before the debate was closed. However, no requests or comments were made when the board gave the parties the opportunity to do so before closing the debate. The request to be heard on additional arguments was made more than three months after the oral proceedings. Appellants 1 and 5 also argued that a reopening of the debate was justified to avoid divergent case law, since Board 3.3.04 had decided in related appeal case T 314/20 that decision G 2/21 did not allow taking D64 into account, and that at least the present appeal proceedings should be stayed until the written reasoned decision in T 314/20 is issued. Furthermore, if the proceedings were not stayed and the debate not reopened, in view of the diverging views on the interpretation of G 2/21, the present board should refer questions to the Enlarged Board. The board again was not convinced. A decision by a different board in a different case did not constitute exceptional circumstances justifying the reopening of the debate. Even if the appeal cases concerned closely related subject-matter, the decision in one appeal case was not binding on the other. This was particularly true considering that the case in T 314/20 was not the same as that presented in the case at hand, at least with respect to technical arguments. Furthermore, in the absence of exceptional circumstances to reopen the debate, the board saw no reason to stay the appeal proceedings until the written reasoned decision in appeal case T 314/20 was issued. The board rejected the requests to reopen the debate, stay the appeal proceedings and refer questions to the Enlarged Board. The board remitted the case to the opposition division with the order to maintain the patent in amended form with claims 1 to 14 of AR1 as filed with the reply to the statements of grounds of appeal.