7.2.2 Evidence of therapeutic effect
If a therapeutic application is to be accepted as sufficiently disclosed, the application or the patent, respectively, and/or the common general knowledge has to provide some information rendering it technically plausible for the skilled person that the claimed compounds can be applied for the claimed therapeutic use (T 1599/06 citing T 609/02).
The requirement of sufficiency of disclosure is considered to be fulfilled with respect to a claim to a second medical use if the disclosure in the patent or the common general knowledge enables the skilled person to obtain the compound to be applied and to apply it, and if there is evidence that the intended therapeutic effect can be achieved (T 1437/07 – Botulinum toxin). The board in that case also stated that just because a patent disclosed an effect which had not in reality been achieved, there was no reason – in the absence of convincing evidence that the effect could not be achieved – for it to doubt that the effect could be achieved (point 38.1 of the Reasons).
The board in T 899/14 decided that, contrary to the view taken by the appellant (patent proprietor), it was not sufficient merely to describe an administration regimen to be followed, without any evidence of the therapeutic efficacy of the proposed treatment. The appellant had not argued that it was common general knowledge but instead relied on the examples. The question was thus whether the information presented in the examples could render the alleged efficacy credible, or at least establish its initial plausibility. The board also noted that while results of clinical trials or animal studies were not always necessary to establish sufficiency of disclosure, a mere verbal statement in the application was not enough to establish even the initial plausibility of an alleged therapeutic benefit.
Having reiterated the applicable principles (point 4.2 of the Reasons), the board in T 1959/15, where granted claim 1 was a second medical use claim in the format of a purpose-restricted product claim pursuant to Art. 54(5) EPC, found that the patent in this specific case, besides amounting to an invitation to perform a research programme and thus an undue burden, showed an effect (on cardiomyopathy) for only two exemplary compounds having the desired capability. Since these two compounds were structurally very similar, it was not plausible that all possible (structurally distinct) compounds having this capability would have the same effect.