Résumé de EPC2000 Art 054 pour la décision T1252/20 du 06.02.2024

In T 1252/20 claim 1 of the applicant's main request related to "a composition for use in reducing or eliminating cancerous cells" by blocking the blood supply to the tumour. The claim defined the composition as a peptide solution forming a hydrogel once inside the body. The peptide was defined by its specific amino acid sequence. The examining division had set out in its decision, that the peptide solution did not constitute a "substance or composition" according to Art. 54(4) and (5) EPC. Referencing the Guidelines for Examination (G-VI, 7.1) as well as T 1758/15, according to which, if the therapeutic effect of a product is based exclusively on the "macroscopic 3D-structure formed by a composition once inside the body", the product should be considered a device, the examining division found that the peptide hydrogel had a physical mode of action and was thus a device and not a substance or composition. The board held that whether a material or an object is a substance or composition in the sense of Art. 53(c) and 54(4) or (5) EPC should be decided, in the first place, on the basis of the claimed material or object as such. The claim at hand does not define the material by any technical features which would be characteristic for a device, e.g. its shape. When the material is administered to the patient, the material does not yet have the crucial shape of the plug fitting to the blood vessel, which will in the end, result in the therapeutic effect aimed at. Thus, the material defined in the claim is evidently a "substance or composition". It is a shapeless liquid mixture of chemical entities and, already for this reason alone, it is not a device. The board decided to depart from previous case law, which distinguished between substance or composition and device based on the "mode of action" of the claimed product in question, since it saw no legal basis for it. The previous case law (T 2003/08, T 1758/15) had taken G 5/83 as a starting point. However, the board held that Art. 54(4) and (5) EPC are not limited to therapeutic applications, but also cover surgical and diagnostic uses, unlike G 5/83. Moreover, the mode of action as the relevant criterion for judging whether a material is a "substance or composition" was not derivable from G 5/83 according to the board. The case underlying G 5/83 had related to the use of a specific chemical compound, so the definition of "substance or composition" and generally the scope of this expression had not been addressed in the decision in any detail. Furthermore, for the Enlarged Board, the subject-matter deserving protection was the invention that the known substance could be used for new therapies. This was fully comparable to the case in question. Taking the mode of action as the decisive criterion was also deemed problematic by the board for several reasons: Firstly, the material defined in the claim and the material acting inside the body may differ in composition or in some other relevant property. However, second medical use claims are directed to the substance as administered. Since it is this substance which is used in a method excluded under Art. 53(c) EPC, such claim drafting is entirely in line with Art. 54(4) and (5) EPC. Secondly, the mechanism of action may not be understood in detail and knowing the mechanism of action is not required under the EPC (point 10.2 of the Reasons). Thirdly, a material may behave in different ways according to its mode of administration. It then appears odd to classify the material according to extrinsic factors not related to the material itself, but to its way of administration. Lastly, the result of a restriction based on the mode of action does not achieve the legislative purpose behind Art. 54(4) and (5) EPC (similarly in T 1020/03). The board noted that distinguishing devices from substances for the purposes of Art. 54(5) EPC was required, and this article should not be used to circumvent the usual assessment of novelty of devices. A pacemaker or a surgical scalpel made of a particular stainless steel alloy do not qualify as a "substance or composition", even if they are claimed for use in an arguably novel therapeutic or surgical method. However, there was no apparent reason to disqualify a solution of a peptide without any device-like features, from the scope of Art. 54(5) EPC. The board held that whether a material or an object is a substance or composition in the sense of Art. 53(c) and 54(4) or (5) EPC should be decided, in the first place, on the basis of the claimed material or object as such. If this analysis leads to the conclusion that indeed a substance or composition is present, this requirement of Art. 54(4) or (5) EPC is fulfilled. No additional restrictions relating to its mode of action are derivable from the EPC.