Zusammenfassung von EPC2000 Art 083 für die Entscheidung T1210/20 vom 30.11.2023

In T 1210/20 independent claim 15 was a "Swiss-type" second medical use claim directed to the use of eltrombopag in the manufacture of a medicament for the treatment of precancerous syndrome. Independent claim 18 was a second medical use claim pursuant to Art. 54(5) EPC directed to a pharmaceutical composition comprising eltrombopag for use in the prevention of cancer in a precancerous syndrome. The board explained it was established case law that in a second medical use claim, the therapeutic effect, in the present case the prevention of cancer in a precancerous syndrome, was a technical feature of the claim. It was undisputed that the issue of whether this effect is achieved is a question of sufficiency of disclosure under Art. 83 EPC. The application comprised examples with data. The credibility of this data was not called into question by the appellant (opponent) insofar as the treatment of cancer was concerned. The appellant argued however that the data in the application as filed did not constitute proof that eltrombopag was effective specifically in preventing a precancerous syndrome from progressing to cancer as required by claims 15 and 18. Such proof was required according to G 2/21 (point 77 of the Reasons). Since the application as filed was absent any proof of the claimed effect, the invention defined in claims 15 and 18 was not sufficiently disclosed. Point 77 of G 2/21 cited by the appellant in support of its argument that proof was required reads as follows : "...the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post- published evidence." The board acknowledged that as stated by the appellant, the data in the application as filed, which concerned the treatment of cancer, did not represent direct proof. However, the appellant's contention that according to G 2/21, proof of a technical effect was unconditionally required in the application as filed, was not correct. Rather, point 77 of the Reasons in G 2/21 referred to the requirement for proof in the application as filed in particular if it would not be credible to the skilled person that the claimed therapeutic effect was achieved on the basis of the application as filed. It explained that the corollary of this statement was that if a therapeutic effect was rendered credible by the application as filed, then such proof - in terms of concrete experimental data - might not be necessary. This understanding was also supported by point 74 of the Reasons (final paragraph) of G 2/21, which the board found to be consistent with point 77 of said decision in that it did not state that proof in the application as filed was a requirement for sufficiency of disclosure to be acknowledged. Hence, in order to fulfil the requirements of sufficiency of disclosure, it was enough that the application as filed rendered the claimed therapeutic application credible. General knowledge could be taken into account. D9, a journal article, represented the common general knowledge. The board concluded that the data in the application as filed credibly demonstrated the anti-proliferative effect of eltrombopag. Since it was known at the filing date of the patent that precancerous conditions were also at least in part characterised by abnormally proliferating cells, it was credible on the basis of this data that eltrombopag was also effective in the treatment of precancerous syndromes by prevention of cell proliferation, and hence the prevention of cancer. No evidence to the contrary was submitted by the appellant. Consequently, the invention defined in claims 15 and 18 satisfied Art. 83 EPC.