Zusammenfassung von EPC2000 Art 056 für die Entscheidung T0814/19 vom 19.10.2022

In T 814/19 the objective technical problem was found the provision of an olaparib formulation suitable as a pharmaceutical dosage form for administration to patients. The appellant (opponent) contested that this problem was solved across the whole breadth of claim 1 because the claim was drafted too broadly; claim 1 did not define any amounts or weight ratios of olaparib and the matrix polymer, so the claim would encompass formulations with high drug loadings that would not exhibit the required stability and bioavailability for administration to patients. The board disagreed. It was not disputed that the higher the drug loading, the more likely crystallisation was to occur. Crystallisation would reduce bioavailability to some extent, but some degree of crystallisation did not make the formulation necessarily unsuitable for administration to patients. Furthermore, the skilled person could not be expected to work within unreasonable ranges of drug loadings that would result in a massively oversaturated product that would no longer qualify as a solid dispersion. Therefore, the board considered that the formulations proposed in claim 1 were a suitable solution to the objective technical problem. On the issue of obviousness, the appellant cited documents D2 and D3 as prior art to be combined with D5. The board agrees with the respondent (patent-proprietor) that this combination of documents could only be made with hindsight. The board found that gathering the knowledge presented in the patent for the first time required a considerable amount of research and could in no way be derived from D5 (closest prior art). The fact that this research belonged to the common methodology for developing drugs did not render its results obvious. The essential point was that, on the filing date of the patent, the skilled person did not know that olaparib was particularly difficult to formulate because it required high drug loadings and presented bioavailability and stability issues. Therefore, the skilled person would have formulated olaparib in any of the conventional formulations suggested on pages 18 and 19 of D5, rather than as a solid dispersion. They had no motivation to turn to D2 or D3, which were concerned with the issue of improving the bioavailability of sparingly soluble drugs. Concluding, the board found that the skilled person would therefore not have arrived at the solid dispersion of claim 1 without the knowledge made available in the patent. The subject-matter of the main request involves an inventive step, as required by Art. 56 EPC.