T 1898/23 - (II) Novelty based on patient group

Key points

• At issue is whether a claim is a valid second medical use claim.
• The Board: "4.1 As to whether the claimed use qualifies as a specific use in a method referred to in Article 53(c) EPC which is not comprised in the state of the art, the parties agree that the following three criteria mentioned in the decision T 1491/14 have to be fulfilled for the treatment of the same disease with the same substance in a specific group of patients to be considered a new therapeutic use: (i) the patient group is not disclosed in the relevant prior art; (ii) the patients belonging to the group can be distinguished from those of the prior art by their physiological and pathological status; (iii) there is a functional relationship between the characterising physiological or pathological status and the therapeutic treatment, and thus the selection of the patients is not arbitrary. [formatting added].
• "The Board agrees that a patient group fulfilling these three criteria would render the claimed subject-matter novel."
• As a comment, criterion (i) seems strange: a second medical use claim is no longer a valid second medical use claim if the feature is disclosed in the prior art? Is claim interpretation not a preliminary step before the comparison with the prior art?
• As a further comment, criterion (iii) seems more about inventive step? See T 1688/20 for selection inventions in general ("the Board concurs with the most recent decisions of the Boards of Appeal, including T 261/15, point 2.2.2 of the reasons, according to which this criterion of purposive selection is relevant for the question of inventive step rather than for novelty.")

EPO 

The link to the decision is provided after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t231898eu1