Zusammenfassung von Article 054(5) EPC für die Entscheidung T1898/23 vom 28.10.2025

In T 1898/23 claim 1 related to a cold atmospheric plasma (CAP) for use in the treatment of therapy-refractory actinic keratosis. It was undisputed that both CAP itself and its use in the treatment of actinic keratosis were comprised in the state of the art. The first question addressed by the board was whether claim 1 concerned a substance or composition within the meaning of Art. 54(4) and (5) EPC. Regarding the interpretation of Art. 54(4) and (5) EPC, the board pointed out that the ordinary meaning of the wording "substance or composition" was broader than that of "medicament" or "pharmaceutical product". This understanding was confirmed by the Travaux Préparatoires EPC 1973, in which the drafters of the predecessor provision to Art. 54(4) EPC deliberately chose a wording which was less restrictive than the term "medicament" (see Travaux Préparatoires on Art. 52E EPC 1973, page 101). The board saw no reason to deviate from the argument of the respondent that a substance or composition within the meaning of Art. 54(4) and (5) EPC had to be understood as a product which qualified as a chemical entity or a composition of chemical entities (T 2003/08 of 31 October 2012, referring to G 5/83). The board explained that while this subgroup of the larger group of "products" (see T 2003/08 of 31 October 2012) excluded medical devices (see T 1252/20), it did not seem justified to say that any product which did not qualify as a medical device because of, for example, a lack of shape automatically qualified as a substance or composition within the meaning of Art. 54(4) and (5) EPC (contrary to what seemed to be indicated in T 1252/20). If that were so, any shapeless physical entity (for example, electromagnetic radiation or ultrasound waves) could qualify as a substance or composition, regardless of whether it is a chemical entity. Having said this, the current board agreed that whether something qualified as a substance or composition within the meaning of Art. 54(4) and (5) EPC should be decided, in the first place, on the basis of what was claimed as such and not on the basis of its mode of action (see T 1252/20; compare also T 264/17). It was undisputed that the claimed plasma contained a variety of components. The board observed that, according to paragraph [0021] of the description, these components included reactive oxygen and nitrogen species, OH radicals, ions, electrons, photons and UV light. While some of these qualified as chemical entities and hence as a substance or composition (for example, reactive oxygen and nitrogen species, OH radicals and ions), others did not (for example, electrons, photons and UV light). On whether the alleged therapeutic effect could be ascribed to the chemical entities in the plasma or (only) to the other entities, the board referred to paragraph [0002] of the patent, which included both photons and UV light in the list of active species of the claimed CAP. In the absence of any further information, the biological mode of action remained "unclear". It could not be ruled out that it was the photons and/or the UV light, i.e. subject-matter other than a substance or composition, which were (exclusively) responsible for the alleged therapeutic effect. For the sake of argument, the board assumed that the alleged therapeutic effect was caused by the parts of the claimed plasma that qualified as a substance or composition under Art. 54(5) EPC. As to whether the claimed use qualified as a specific use in a method referred to in Art. 53(c) EPC which was not comprised in the state of the art, the board agreed that a patient group fulfilling the three criteria in T 1491/14 would render the claimed subject-matter novel. The three criteria were that: (i) the patient group was not disclosed in the relevant prior art; (ii) the patients belonging to the group could be distinguished from those of the prior art by their physiological and pathological status; and (iii) there was a functional relationship between the characterising physiological or pathological status and the therapeutic treatment, and thus the selection of the patients was not arbitrary. With regard to criterion (i), the board agreed that the prior art (D22) did not disclose the treatment of patients diagnosed with therapy-refractory actinic keratosis. On criterion (ii), the board agreed that the actinic keratosis patients who were not successfully treated could be distinguished from patients who were successfully treated. As regards criterion (iii), the board explained that it could be assumed that the technical effect resulting from the treatment of therapy-refractory actinic keratosis with CAP was the successful amelioration of the symptoms in patients whose previous treatment by standard therapies had not resulted in satisfactory clearance. Hence, there was a functional relationship between the physiological or pathological status of the patient group and the CAP treatment. Furthermore, the board observed that it was not required that the technical effect be surprising for criterion (iii) to be fulfilled.