Résumé de EPC2000 Art 083 pour la décision T0025/20 du 11.01.2024

In T 25/20 the invention concerned methods and compositions for treating symptoms associated with Post-Traumatic Stress Disorder (PTSD) using Cyclobenzaprine. Claims 1 and 6 related to second medical uses of a composition comprising cyclobenzaprine. They differed essentially in terms of the therapeutic effect to be achieved. The application as filed stated that cyclobenzaprine was suitable for the treatment of a variety of sleep disturbances, of which those mentioned in the patent were associated with conditions other than PTSD. The patent also stated that disturbed sleep was a central feature of PTSD. The parties agreed that these points were common general knowledge. The parties disagreed, inter alia, as to whether sleep disturbances associated with PTSD - a condition covered by claims 1 and 6 - could credibly be treated with a composition comprising cyclobenzaprine. The board made reference to G 2/21 (point 77 of the Reasons) issued in the course of the present appeal proceedings. The parties agreed that the application as filed did not contain any experimental evidence relating to the therapeutic effect in question. Turning then to the assessment of credibility, the board stated that there was no reference to the mode of action of cyclobenzaprine in the passage of the application relied on by the respondent (patent proprietor). The board concluded that the purported mode of action of cyclobenzaprine relied on by the respondent as a technical concept supporting the achievement of the claimed therapeutic effect had not been disclosed in the application as filed. The board added that even if the respondent's purported mode of action of cyclobenzaprine had been disclosed verbatim in the application as filed, such a disclosure would still not have been tantamount to a credible technical concept, since the application as filed did in fact not demonstrate any mode of action of cyclobenzaprine; there were no investigations or explanations setting cyclobenzaprine apart from other drugs. There was no teaching as to what exactly made a compound, let alone cyclobenzaprine, suitable for the treatment of sleep disturbances associated with PTSD. The application as filed lacked any specificity in relation to cyclobenzaprine: the word "cyclobenzaprine" could simply be replaced by the name of any other drug. The purported mode of action of cyclobenzaprine merely amounted to a guess as to how cyclobenzaprine might work and that it would be suitable for the treatment of sleep disturbances associated with PTSD. Such a guess did not make the purported mode of action of cyclobenzaprine or the technical concept built on it credible. Instead, there were substantiated doubts in the present case about the credibility of the purported mode of action of cyclobenzaprine and the technical concept based on it. According to the respondent, the situation was analogous to that underlying T 950/13. In both cases, the application as filed did not contain experimental evidence. Nevertheless, in each case the mode of action of the drug was disclosed. Hence credibility of the technical concept should also be acknowledged in the present case. However, in the board's view the purported mode of action of cyclobenzaprine in the present case was not a mechanism at the molecular level which was of generally recognised importance for the disease or the symptom to be treated. Instead, the application as filed offered as support for the purported mode of action merely the known suitability of cyclobenzaprine for treating sleep disturbances associated with various conditions other than PTSD. This suitability alone was not sufficient to establish credibility in the present case because there were substantiated doubts about the purported mode of action and the technical concept based on it. This was different from T 950/13, in which the board did not identify such doubts. In the absence of a credible technical concept, the mere allegation in the application as filed that cyclobenzaprine was suitable for treating sleep disturbances associated with PTSD, as covered by both claims 1 and 6, was a mere statement which was not enough to ensure sufficiency of disclosure. This lack of sufficiency could not be remedied by post-published evidence.