7.2.2 Evidence of therapeutic effect
Post-published evidence may be taken into account, but only to back-up the findings in the application in relation to the use of the compound(s) as a pharmaceutical (T 609/02, T 950/13).
If the description in a patent specification provides no more than a vague indication of a possible medical use for a chemical compound yet to be identified, more detailed evidence cannot be used later to remedy the fundamental insufficiency of disclosure of such subject-matter (T 609/02). Where the therapeutic effect is a functional technical feature of the claim, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application and evidence filed later cannot be used to remedy a fundamental insufficiency of disclosure (point established in T 609/02, as summarised in T 1045/13).
Referring to T 609/02, the board in T 433/05 recalled that where a therapeutic application was claimed in the Swiss-type form, attaining the claimed therapeutic effect was a functional technical feature of the claim. As a consequence, under Art. 83 EPC 1973 the application had to disclose the suitability of the product to be manufactured for the claimed therapeutic application (see also T 1685/10). Note, however, that according to G 2/08 date: 2010-02-19 (OJ 2010, 456), where the subject-matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so-called Swiss-type claim as instituted by decision G 5/83 (OJ 1985, 64). Following T 609/02, the board in T 801/06 recalled that a claimed therapeutic effect may be proven by any kind of data as long as they clearly and unambiguously reflect the therapeutic effect. Thus, the fact per se that the experiments in the patent were not carried out with a "real" metastasis was not sufficient to deny sufficiency of disclosure.
In T 2571/12 (treatment of schizophrenia with glutathione), the board stated that there was no evidence at all either in the patent or in the available prior art for a therapeutic effect of glutathione precursors for any of the claimed disorders, and hence the post-published document, allegedly supporting such an effect inter alia for bipolar disorders, likewise could not been taken into account for the assessment of sufficiency of disclosure.
In T 1045/13, concerning a second medical use claim worded in accordance with Art. 54(5) EPC, the board stated that the application as filed did not provide any indication of the principle underlying the relationship between the activity of the pharmaceutically active agent, i.e. the NGF, and the therapeutic effect, i.e. the alleviation of the symptoms of the psychological conditions claimed. The description did not provide any information on the mechanism of action of NGF. No background references were cited that linked NGF to the therapeutic effects to be obtained, and no in vitro assays were provided to illustrate any such effect. In the complete absence of such information, the experimental evidence on file was of decisive importance. But the evidence in the application as filed did not constitute a sufficient disclosure. Indeed the experimental evidence consisted of eleven examples relating to various conditions but did not cover all the conditions defined in claim 1; each example related to a single patient only, contrary to the common practice in order to allow statistical analysis of the results. Also, in the absence of a control group, placebo effects could not be excluded. The post-published evidence might be taken into account, but only to back up the findings in the patent application. Post-published evidence could not establish sufficiency of disclosure on its own. They did not need therefore to be discussed. For sufficiency of disclosure, it is not relevant what the respondent (patent proprietor) was aware of, but decided not to disclose.