7. Erfolgserwartung, insbesondere auf dem Gebiet der Gen- bzw. Biotechnologie

In case T 136/24, the therapeutic effect of claim 1 was the treatment of prostate cancer in the specified patient group. Claim 1 was intended to define a new treatment option for mCRPC patients in the form of a cabazitaxel-based combination treatment.

The phase III clinical study (TROPIC) presented in the application was addressed with very detailed reasons in respect of assessment of sufficiency of disclosure, novelty and inventive step. Concerning inventive step, given the TROPIC study as the starting point and the formulation of the technical problem in view of the claimed therapeutic effect being credible, the issue decisive for obviousness was whether the person skilled in the art would have had a reasonable expectation of success with regard to the experimental arm of the TROPIC study.

The opponents argued that, for a second medical use claim, where the prior art disclosed that a clinical study with the same active agent(s) for the same therapeutic indication had been proposed or was underway, a reasonable expectation of success was generally implied by the mere fact that the study had been authorised, unless there was some evidence of a dissuading teaching in the prior art. In other words, the announcement of a clinical study established a legal presumption of reasonable expectation of success. No dissuading element (negative pointer) was known in the prior art. In addition, the opponents mentioned positive pointers..

The board was not convinced. The skilled person's expectation of success had to be considered in particular in relation to the TROPIC study's primary endpoint, which was overall survival. Success in the context of a clinical study means meeting the primary endpoint. The board reviewed the large body of decisions dealing with reasonable expectation of success, including in cases of second medical use where clinical studies were announced in the prior art. This case law mainly focused on balancing positive and negative pointers. The probative value of a clinical study announcement always depended on the particular circumstances of the case. Thus, contrary to the opponents' argument, the analysis of the jurisprudence of the boards did not lead to the conclusion that ongoing clinical studies automatically establish a legal presumption of success..

The approval of a clinical study does, therefore, not necessarily imply an expected positive outcome. As a consequence, the question of whether there was a reasonable expectation of success must be answered on the basis of the specific circumstances of the case. The case in hand related to a new cancer drug used in a new indication, and the situation was complicated by the further issue of resistance to taxanes. The crucial issue was whether, in view of the available information in the prior art, the skilled person had a reasonable expectation that cabazitaxel in combination with prednisone would be effective to improve overall survival..

The board examined in detail the positive pointers (a) to (f) and on this occasion inter alia addressed that under usual circumstances, the fact that a phase III clinical trial was carried out might indeed provide a pointer indicating a successful development path of a new drug/new drug application, however in the case in hand, the usual path of drug development was only poorly reflected. The board also stated that the fact that a study was nearing completion per se, in the absence of knowledge of the parameters selected for monitoring, was neither a positive nor a negative pointer when assessing expectation of success. In conclusion, the facts brought forward by the opponents as positive pointers would not have given rise to a reasonable expectation of success.