Zusammenfassung von EPC2000 Art 056 für die Entscheidung T2086/21 vom 14.05.2024

In T 2086/21 the board found that, as stated by the respondents (patent proprietors), the effects of improved hygroscopicity, high thermodynamic stability and high polymorphic stability represented a beneficial combination of properties possessed by Form B of apalutamide compared to the physical forms disclosed in D1 and D2. The objective technical problem underlying claim 1 starting from either of D1 or D2 was therefore the provision of a form of apalutamide with a beneficial combination of these mentioned properties. On obviousness, the appellants (opponents) submitted that in view of the fact that apalutamide was the subject of an Investigational New Drug (IND) filing before the filing date of the patent, the skilled person would have been motivated to perform routine polymorphic analyses or screening, especially given apalutamide's development stage. They cited various documents to support the argument that polymorphic screening and stability testing were part of common general knowledge and that following such routine guidance the skilled person would have arrived at the claimed Form B in an obvious manner. The board disagreed, emphasising that the appellants' submissions failed to take into account the formulation of the objective technical problem in accordance with the problem-solution approach. Specifically, that Form B displayed a beneficial combination of properties which could not have been expected by the mere provision of a crystalline form per se. The implication from the landmark decision T 777/08 was that when the advantages or effects of the claimed crystalline form were unexpected, i.e. they were not arbitrary and did not follow merely by virtue of being crystalline, then an inventive step was present. In the present case the board held there was no absence of unexpected properties, and that the selection of Form B was not arbitrary, since it possessed a beneficial combination of properties. Although the skilled person could have carried out a polymorphic screening, there was nothing in the prior art motivating the skilled person to have taken a particular path in the expectation of solving the aforementioned objective technical problem. The respondents further relied on T 325/16: "Only if the prior art either contains a clear pointer ...or at least creates a reasonable expectation that a suggested investigation would be successful, can an inventive step be denied", which supported the board's conclusion. The board also addressed the appellants' argument that any unexpected effects associated with Form B, such as improved hygroscopicity, amounted to mere bonus effects. The board clarified that the objective technical problem solved by the claimed subject-matter was the provision of a beneficial combination of properties, not just a single property, and there was no reason for the skilled person to assume that the thermodynamically most stable form would at the same time be also polymorphically stable and in addition display improved hygroscopicity, and no such reason was provided by the appellants. Distinguishing the case in hand from T 41/17, in which the solution was considered obvious because the skilled person would have performed a screening to identify the most thermodynamically stable form, the board highlighted that in the present case, in contrast, thermodynamic stability was only one property from a beneficial combination of properties displayed by the claimed Form B of apalutamide. Even if the effect of thermodynamic stability were to have been considered obvious, the same did not apply to the beneficial combination, since, for example, there was no teaching in the prior art that the effect of lower hygroscopicity could be obtained with the thermodynamically most stable form of apalutamide. The board also disagreed that the skilled person starting from the amorphous apalutamide of D1 would have been in a "try and see" situation, which is predicated on the existence of a pointer to the solution, the existence of such the board had ruled out. In view of the above the board concluded that the subject-matter of claim 1 of the main request (and by extension dependent claims 2-6) involved an inventive step starting from each of the cited documents (D1 and D2). It thus ruled that the appellants' appeals were to be dismissed.