Zusammenfassung von EPC2000 Art 056 für die Entscheidung T0215/20 vom 19.01.2023

In T 215/20 the board held that the objective technical problem could be considered to be that of providing a pharmaceutical composition comprising a crystalline form of dapagliflozin which is more stable, i.e. less hygroscopic. As regards obviousness, the appellant (opponent) argued the skilled person would have turned to D4 because it offered solutions to the problem of providing a crystalline form of an API as well as to the problem of providing a form that is less hygroscopic. Consequently, the subject-matter of claim 1 did not involve an inventive step over a combination of D1 and D4. The board stated that for this argument to be correct, the skilled person, in order to take the teaching of D4 into account, would also have had to have had a reasonable expectation of success, i.e. a reasonable expectation that this teaching would solve the objective technical problem. However, the board reasoned that this was not the case. The skilled person would have considered the effect suggested by D4, namely the universal decrease in hygroscopicity, to be a mere allegation. Given the generally recognised high unpredictability of properties of crystalline forms, the skilled person would not have had a reasonable expectation of obtaining a less hygroscopic form of dapagliflozin. The board therefore distinguished the current case from T 777/08 on which the appellant relied. In that case the deciding board held that the skilled person would have had a reasonable expectation that providing a crystalline form of the API would have solved the objective technical problem. The current case was different in that, first, the effect relied on for inventive step was different (filterability and drying characteristics in T 777/08 vs hygroscopicity in the case at hand) and, second, although a solution to the objective technical problem may have been suggested by D4, the skilled person would not have had a reasonable expectation that the solution offered by D4 would have solved this problem. In summary, the board held the subject-matter of claim 1 involved an inventive step over amorphous dapagliflozin as disclosed in D1 in combination with D4 because the skilled person, considering the teaching of D4, would not have had a reasonable expectation of obtaining a form of dapagliflozin which was less hygroscopic than amorphous dapagliflozin. The board concluded the subject-matter of claim 1 involved an inventive step within the meaning of Art. 56 EPC. The reasoning applied, mutatis mutandis, also to the subject-matter of dependent claims 2 to 5. The board ordered the decision under appeal be set aside and remitted the case to the opposition division with the order to maintain the patent in amended form.