Zusammenfassung von EPC2000 Art 054 für die Entscheidung T0043/18 vom 01.06.2022

In T 43/18 the board agreed with the rationale and the conclusion of T 1085/13 in relation to the assessment of novelty. T 1085/13 was based on the observation that in G 2/10 the Enlarged Board of Appeal had stated that the overriding principle for any amendment to be allowable under Art. 123(2) EPC was that the subject-matter of an amended claim must be at least implicitly disclosed to the skilled person using common general knowledge in the application as filed. The Enlarged Board further referred to decision G 1/03, which stated that the European patent system must be consistent and the concept of disclosure must be the same for the purposes of Art. 54, 87 and 123 EPC. Therefore, the conclusion in T 1085/13 was that a claim defining a compound as having a certain purity lacked novelty over a prior-art disclosure describing the same compound only if the prior art disclosed the claimed purity at least implicitly, for example by way of a method for preparing said compound, the method inevitably resulting in the purity as claimed. Such a claim, however, did not lack novelty if the disclosure of the prior art needed to be supplemented, for example by suitable (further) purification methods allowing the skilled person to arrive at the claimed purity. The question of whether such (further) purification methods for the prior-art compound were within the common general knowledge of those skilled in the art and, if applied, would result in the claimed purity, was not relevant to novelty, but was rather a matter to be considered in the assessment of inventive step. In the present case, claim 1 of the patent in suit was directed to a pharmaceutical dosage form comprising oxycodone hydrochloride having less than 25 ppm of a specific impurity. In the contested decision, the opposition division had concluded that D1-D3 and D15 did not, even implicitly, disclose the purity recited in claim 1. However, the opposition division reasoned that, following T 990/96, the disclosure in D1-D3 and D15 of oxycodone hydrochloride had made this compound available to the public in all desired grades of purity. The exceptional situation whereby, according to T 990/96, novelty could be acknowledged where all prior attempts to achieve the claimed purity by conventional purification processes had failed, was not applicable to claim 1. Furthermore, the opposition division had concluded a lack of novelty despite accepting that the evidence on file demonstrated, at the effective date of the patent, that there was no specific [oxycodone hydrochloride] preparation available on the market which would have met the claimed purity criteria. In view of the above, and in line with T 1085/13, the board established that it was abundantly clear that in the present case, the prior art would need to be supplemented with suitable further purification methods in order to (potentially) arrive at the claimed purity, which could not lead to a lack of novelty of the claimed subject- matter, but was rather a matter to be considered in the assessment of inventive step. The board thus concluded that the subject-matter of claim 1 was novel.