T 0867/23 - Post-published evidence for sufficiency of second medical use claim

Key points

• The case is about a second medical use claim. Can the proprietor rely on post-published evidence to show that the medical method works? 
• The Board: "The Enlarged Board of Appeal in decision G 2/21 did not extend the scope of the referred questions beyond the issues for assessing inventive step to the assessment of sufficiency of disclosure (see points 8-11 of the reasons). Nevertheless, the Enlarged Board of Appeal cited several Board of Appeal decisions addressing the issue of reliance on post-published evidence for a purported technical effect in the context of sufficiency of disclosure, and in particular in the case of second medical use claims (see points 73-76), from which the Enlarged Board concluded the following (see point 77):
• "The reasoned findings of the boards of appeal in the decisions referred to above make clear that the scope of reliance on post-published evidence is much narrower under sufficiency of disclosure (Article 83 EPC) compared to the situation under inventive step (Article 56 EPC). In order to meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, 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."
• In the [TBA's] Board's view, this statement, taken in its context, does not set a new standard for reliance on post-published evidence in the context of sufficiency of disclosure, i.e. a standard which would depart from the previously cited case law it summarises (as noted in T 979/23, see point 13 of the reasons). "
• "Following G 2/21, a reliance on post-published evidence is not ruled out generally in the context of sufficiency of disclosure for second medical use claims. The reliance on post-published evidence can also not be limited to situations where it serves no useful purpose, i.e. it is not limited to cases where the effect is already convincingly proven in the application to such a point that the use of post-published evidence as a superfluous confirmation of the already proven effect would be of no relevance. In other words, the scope of reliance on post-published evidence is not zero.
• "In the present case, the Board considers that the application as filed contains experimental data reflecting an effect on primary negative symptoms of schizophrenia, and thus discloses the suitability of cariprazine for the claimed therapeutic indication (see T 609/02, point 9 of the reasons). In these circumstances, the post-published evidence D13 may be taken into account to backup the findings in the application as filed ".
• The Enlarged Board in G 2/21, point 77 of the reasons, as cited by the TBA, with emphasis added: "In order to meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, 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." (emphasis added).
• T 979/23, cited above, the Board's conclusion was that "From the technical teaching of the application as filed, even taking into account the prior art, it was not credible that fenfluramine achieved a therapeutic effect in Dravet syndrome patients when given as a monotherapy. In line with decision G 2/21, the board has not taken the post-published data (document D3) into account".
• "13. The Enlarged Board of Appeal endorsed the conclusions in decision T 609/02 (see G 2/21, point 75 of the Reasons) and decisions T 754/11 and T 887/14 (see point 76 of the Reasons). The expression "proof of a claimed therapeutic effect" in point 77 of the Reasons cannot therefore be interpreted as a deviation from the established case law in the context of second medical uses: it does not apply a stricter requirement than the established case law prior to decision G 2/21."
• Indeed, the EBA seems to have confirmed T 609/02. I'm not sure if all TBAs considered T 609/02 to be correct in 2021. 
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EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t230867eu19/23