Zusammenfassung von EPC2000 Art 084 für die Entscheidung T0147/22 vom 18.01.2024

In T 147/22 the respondent (opponent) raised several clarity objections, which were mainly directed to the expression "consisting essentially of" and to the fact that the ingredients cited in claim 1 were associated with a function. On the first aspect, the board noted that the expression "consisting essentially of" limited the ingredients in the composition of claim 1 to those defined in components (a) to (d), although further non-active ingredients could be present provided they did not materially affect the chemical stability of TAS-102. The respondent had argued that the expression "consisting essentially of" rendered claim 1 unclear because the skilled person would not know which were the compounds that did not impair the stability of TAS-102 in the composition, and the patent did not contain any information in that respect. According to the board, however, the nature and amount of those additional ingredients was strongly limited by the condition that they must not impair TAS-102 stability. Furthermore, the skilled person confronted with a composition containing components (a) to (d) and additional ingredients could easily determine whether or not the additional ingredients impair TAS-102 stability. Testing the chemical stability of active compounds in a composition was standard practice in the field of pharmaceutical formulations. Such tests were illustrated in Test Examples 1 to 5 of the patent for the particular case of TAS-102. Therefore, the skilled person could easily determine by standard comparative tests whether or not a given composition consisted essentially of components (a) to (d). With regard to the functional definition of the ingredients in claim 1, the board held that the criterion for assessing whether a compound had the function assigned to it was the function (or functions) that the skilled person would assign to that compound in the context of a given formulation. Contrary to the respondent's view, the formulator's intention was irrelevant in that respect. It was undisputed that the functional features "excipient", "disintegrating agent", "binder", "lubricant", "flavouring agent", "colourant" and "taste-masking agent" were standard in the technical field of pharmaceutical formulations. The skilled person would have no difficulty in determining whether a given formulation ingredient fulfils one or more of these functions on the basis of common general knowledge. These were functional features which were generally allowed if the invention could not be defined more precisely without unduly restricting the scope of the invention. Furthermore, in the present case, the main ingredients were not solely defined by functional features. They were further limited by structural features: for instance, the excipient according to component (b) was selected from lactose, sucrose, mannitol and erythritol. In view of common general knowledge and the structural limitations of the functional features, the board considered that the definition of the ingredients in claim 1 was not unclear. The respondent's objection was based on the possibility that an ingredient fulfilled more than one function and, depending on its function, the amount of the compound in the composition could vary. For instance, polyvinyl alcohol was generally known to be a binder and a lubricant. If it was considered a binder, it could be present in an amount of 0.001 to 5% by mass while it could not be present if it was considered a lubricant. The board disagreed. The fact that polyvinyl alcohol was known to be a binder and a lubricant did not render the claim unclear. If polyvinyl alcohol was present in the composition, it necessarily played the role of a binder, even if it also fulfilled the function of a lubricant. Therefore, it should be counted as a binder that may be present in an amount of 0.001 to 5% by mass in the composition. Considering arbitrarily that polyvinyl alcohol could function exclusively as a lubricant and that therefore its presence would render the composition different from the one in claim 1 would be unrealistic. Certainly this was not how the skilled person would read the claim. Moreover, the board stated that the fact that "excipient" was a very broad term did not mean that it was unclear. "Excipient" was a standard term in pharmaceutical formulations.