7.2.6 Novelty of the therapeutic application

In T 295/22 claim 1 of "Main request A" was formulated in the "compound for use" format of Art. 54(4) and (5) EPC, wherein the utility as a medicament was further specified as the use as a medicament which is administered orally. The Guidelines G-VI, 6.1.2 – March 2024 version (see example 2: "Composition comprising X for use in therapy by topical administration") suggest with reference to T 51/93 that in a claim which only defines the mode of delivery but no specific therapeutic effect, the definition of the mode of delivery is merely illustrative and not a restrictive technical feature capable of establishing novelty. However, the board in this case held that the requirement underlying the specificity of the use within the meaning of Art. 54(5) of the EPC 2000 was according to the explicit conclusion in G 2/08 (see point 5.10.3 of the Reasons) to be construed merely by contrast to the generic broad protection conferred by the first claimed medical application of a substance or composition, and was in principle not confined to a particular medical indication.

Contrary to the suggestion in the Guidelines, the board stated that the decision in T 51/93 actually recognized without reference to any requirement regarding the definition of a specific medical condition that the definition of the mode of administration of a medicament represented a characterizing feature of a claim formulated in the so-called "Swiss-type" format as approved according to G 5/83 for defining inventions relating to new medical uses of known pharmaceuticals under the provisions of the EPC 1973 (see T 51/93, point 3.1.2 of the Reasons).

According to the board, the decision in T 51/93 further confirmed that in a claim formulated as a "Process for making X for use Y comprising the steps of..." the definition of a specific medical purpose under Y illustrated what X could be used for, but did not further characterize the claimed subject-matter under the provisions of the EPC 1973 (see T 51/93, point 2.2.2 of the Reasons). However, the format of the claim discussed in this part of T 51/93 neither corresponded to the "Swiss-type" format as approved according to G 5/83 for defining inventions relating to new medical uses nor to the format outlined in Art. 54(5) EPC 2000.

In line with the considerations in G 2/08 (see point 5.10.3 of the Reasons) the board therefore considered that the oral administration as defined in claim 1 of "Main request A" represented, in accordance with Art.54(5) EPC, a characterizing feature of the claimed subject-matter.