Zusammenfassung von EPC2000 Art 083 für die Entscheidung T1779/21 vom 19.12.2023

In T 1779/21, the board, stressing that G 2/21 confirmed most of the case law on sufficiency of disclosure, summarised in this respect the contribution of G 2/21 (points 74, 77 of the Reasons) as to whether a therapeutic effect had been shown to be achieved, notably that "it is necessary that the patent at the date of its filing renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application" and that "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 present board noted that the Enlarged Board endorsed the conclusions in T 609/02 (G 2/21, point 75 of the Reasons), and decisions T 754/11 and T 887/14. The expression "proof of a claimed therapeutic effect" in point 77 of the Reasons could therefore not be interpreted as a deviation from the established case law in the context of second medical uses: it did not apply a stricter requirement than the established case law prior to decision G 2/21. Rather, the Enlarged Board confirmed that means other than experimental data in the application as filed could establish proof of a claimed therapeutic effect. What is required, however, in the absence of experimental evidence, is for the patent or the application as filed to provide some information demonstrating that the claimed compound had a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art or demonstrated in the patent itself (see T 609/02, points 5 to 9 of the Reasons). The board also quoted G 1/03 (point 2.5.3 of the Reasons - contribution to the state of the art). The board concluded that a contribution to the state of the art which enabled the skilled person to carry out the invention had to be present in the application as filed. The patent related to the treatment of Dravet syndrome with fenfluramine. Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in infancy. It had in the present case to be decided whether fenfluramine as a monotherapy, i.e. as the sole therapeutic agent, could be considered suitable for the treatment of Dravet syndrome at the relevant date. In the absence of experimental data for fenfluramine monotherapy in the application as filed, the board considered whether achieving the claimed therapeutic effect was made credible in the application as filed in another way. "Monotherapy" was explicitly mentioned in the application as filed as an alternative to combination therapy. However, this mere statement was not in itself sufficient to provide any "proof" in the sense of decision G 2/21. Until the present invention was made, it was not known that fenfluramine's mechanism of action had made it suitable for the treatment of Dravet Syndrome. The board noted that treatment by therapy did not per se necessitate a complete cure of the disease or even the addressing of its cause, but did include the alleviation of symptoms. Although the skilled person could conclude, from the data in the application as filed, that fenfluramine in combination with valproate alleviated some symptoms of Dravet syndrome, it was not clear whether this also applied in a monotherapy. In this particular case, namely a very serious disease for which an established, albeit sub- optimal, therapy exists and where a wrong therapy decision could lead to irreversible damage, the level of proof required had to be at least such that the skilled person had reason to assume that the standard valproate treatment could be discontinued and replaced by fenfluramine without worsening the condition of the patient. From the technical teaching of the application as filed, even taking into account the prior art, therapeutic effect was not credibly achieved. In line with decision G 2/21, the board did not take the post-published data into account. Sufficiency of disclosure was not satisfied. The opposition division's decision was set aside and the patent revoked.