Zusammenfassung von EPC2000 Art 117 für die Entscheidung T1708/18 vom 14.02.2022

In T 1708/18, the argument of the patent proprietor (appellant I) in relation to novelty was that the correct standard for the assessment of novelty was "beyond reasonable doubt", i.e. it had to be beyond doubt, and not merely probable, that the claimed subject-matter was directly and unambiguously derivable from the prior art. The opponents' two-step assessment of novelty was not backed up by case law. The opponents submitted in that respect that novelty was a matter of two questions. An assessment had to be made both as to what matter was known in the art and how the properties of the known matter compared with the claimed subject-matter. The opposition division had considered that the subject-matter of claim 5 was novel over the disclosure of each of the documents cited by the opponents, including D3, irrespective of the interpretation of the expression "binds specifically to". According to the opposition division, the opponents "did not show beyond doubt that one of the antibodies disclosed in documents D3, D5, D6, ... or D35 is able to bind the antigen ...". At least the commercially available antibodies could have been tested experimentally to demonstrate a specific binding. The board disagreed with this assessment. The question of whether or not a given known antibody bound to a particular polypeptide was a question of fact. It was correct that the inherent binding property of the antibody concerned must be demonstrated by the party making the allegation, i.e., in the case at hand, the burden to prove that the antibody disclosed in document D3 bound to the PCSK9b and/or PCSK9c polypeptides laid with the opponents; however, the standard of proof generally applied at the EPO for deciding on an issue of fact was the balance of probabilities. The board under point 2 of its Catchword wrote that: "The standard of proof generally applied at the EPO for deciding on an issue of fact is the balance of probabilities. According to this standard, the EPO must base its decisions on statements of fact which, based on the available evidence, are more likely than not to be true. This standard also applies when examining factual issues in the context of novelty." The board was not persuaded by the arguments of the opposition division and the patent proprietor that, by way of exception, a higher standard must apply in the present case. In its reasoning, the opposition division appeared to mix up two issues which were distinct and unrelated. Indeed, under point 1 of its Catchword the board stated that: "the issue of which standard of disclosure applies when assessing the legal question of novelty and the issue of which standard of proof applies when assessing evidence and factual questions are distinct and unrelated. The fact that the standard of disclosure required for a finding of lack of novelty (or for allowing an amendment to the application under Article 123(2) EPC) is the standard of a direct and unambiguous disclosure is immaterial for the question of what standard of proof applies when considering evidence and factual issues in the context of novelty (or inventive step)." The factual question to be decided upon in the present case was whether it was more likely than not that a known PCSK9 antibody would bind specifically to the PCSK9b and/or the PCSK9c polypeptide. In assessing this question, any evidence submitted by the parties was considered by the board and such evidence did not necessarily have to be in the form of "wet lab" experiments, as argued by the patent proprietor. The board concluded that, based on the applicable standard of proof, the polyclonal antibody disclosed in document D3 also specifically bound to the PCSK9b and PCSK9c polypeptides comprising the same peptide. The subject-matter of claim 5 in each of the claim requests on file therefore lacked novelty over the polyclonal antibodies disclosed in document D3.