g) Interpretation of "substance or composition" 

In T 2003/08 of 31 October 2012 date: 2012-10-31 the board allowed a claim directed to a new use of a column for an extracorporeal treatment. The appellant (opponent) argued, relying on decisions T 227/91 (OJ 1994, 491), T 775/97 and T 138/02, in which the boards defined the term "medicament", that claim 1 did not fulfil one prerequisite to qualify as a second medical use claim, namely that a "medicament" was used in the treatment. Indeed the means used in the treatment were a "column", which was not a "medicament", but a "device". In the board's view, it emerged from the whole reasoning of decision G 5/83 (i) that the Enlarged Board intended to allow the special second medical use-form of protection only for those uses in the medical domain which concerned a "substance" or "composition", (ii) that it was the "substance" or "composition" which achieved the medical effect and (iii) that the terms "substance" or "composition" referred at least to products which were chemical entities or compositions of chemical entities. In the case at issue the medical effect on which the treatment according to claim 1 was based was the removal of immunoglobulin from the plasma of patients suffering from dilated cardiomyopathy. This effect was achieved by the "specific ligand for human immunoglobulin", which was undisputedly a chemical entity. The "column" only served as a carrier for the ligand and was not instrumental in achieving the therapeutic effect. Accordingly, the board held that the means used for the treatment in accordance with claim 1 was to be considered as a "substance" or "composition" within the meaning of decision G 5/83.

In T 1758/15 the patent related to a biocompatible, biodegradable, injectable filler material (e.g. collagen or hyaluronic acid) for use in a specific method. Said use comprised the injection of the filler material into a space between a first tissue of the body and a second tissue, the first tissue being subsequently treated by radiation, whereby the filler within the space reduced the exposure of the second tissue to radiation. The filler "human collagen" was known in the art. In the interpretation of the term "substance or composition" the board referred to G 5/83 (OJ 1985, 64) and T 2003/08 date: 2012-10-31 which interpreted the term "substance or composition" as being "the active agent or ingredient" of the particular specific medical use. Accordingly, the following must be established: (a) the means by which the therapeutic effect is achieved and (b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities. In the present case, the effect of the use of the filler material was the reduction of radiation-treatment-induced side effects on sensitive organs. This effect was constantly ascribed to the physical displacement of the sensitive tissue, i.e. to the 3D structure achieved within the body. The accumulated mass of the filler material did not, however, qualify as a chemical entity or composition of chemical entities in the sense of G 5/83. Therefore, the filler material was not a substance or composition in the sense of Art. 54(5) EPC and its specific use could not be regarded as a differentiating feature. The undisputedly commercially available collagen was thus novelty-destroying.

In T 773/10 claim 1 was directed to a new use of a dialysis membrane for the treatment of multiple myeloma. It was undisputed that document D1 disclosed all the structural features of the dialysis membrane. Art. 54(5) EPC states that Art. 54(2) EPC does not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Art. 53(c) EPC, provided that its use for any such method is not comprised in the state of the art. The board stated that these provisions introduced a special assessment of novelty for purpose-related features. According to the appellant's submissions, the specific use of the dialysis membrane claimed in claim 1 for the treatment of multiple myeloma, i.e. a method of treatment by therapy of the human body, was not comprised in the state of the art. Therefore, it was crucial to determine whether the special assessment of novelty set out in Art. 54(5) EPC might apply to such a membrane and whether the claimed membrane should be considered a "substance or composition" within the meaning of Art. 54(5) EPC. Referring to the "travaux préparatoires" for the EPC 2000 the board had no doubt that decision G 5/83, had focused on new uses of compounds or "substances", i.e. products of the pharmaceutical industry generally referred to as "medicaments" or "drugs". However, showing that the legislative history did not include discussions on new uses of medical products other than compounds or "substances", i.e. products of the pharmaceutical industry generally referred to as "medicaments" or "drugs", could not establish that the legislator had intended to include any such products within the meaning of "substance or composition". The board came to the conclusion that the scope of the term "substance or composition" in Art. 54(5) EPC did not extend to all products for a specific use in a method referred to in Art. 53(c) EPC. The board referred to T 2003/08 date: 2012-10-31 (see above), which allowed a claim directed to a new use of a column for an extracorporeal treatment. However, in that decision it was not the column as such which had been regarded as the "substance or composition" the new use of which could confer novelty according to Art. 54(5) EPC. Rather, the column contained a ligand constituting the "active" ingredient responsible for the "therapeutic effect". In the board's view, the case before it was different. The claimed dialysis membrane did not contain any further substance or composition which might constitute an "active" ingredient within the meaning of decision T 2003/08 date: 2012-10-31. It followed that for the claimed dialysis membrane the exceptional novelty assessment as set forth in Art. 54(5) EPC did not apply. The application was refused.

In T 2369/10 the independent claim was formulated as a use-related product claim, in particular for a device for use in a method of treatment of the human or animal body by therapy. The main issue to be resolved was whether a second (or further) medical use could confer novelty on a known device. The board held that, having regard to the wording of Art. 54(4) and (5) EPC, the ordinary meaning of those provisions could not be extended so as to include something which was not explicitly provided for. It consequently considered that there was no basis on which to contemplate that novelty might be conferred on products other than substances and compositions by virtue of the provisions of Art. 54(4) and (5) EPC.

In T 264/17 the board found that the claimed lubricant for replacing synovial fluid was a substance or composition within the meaning of Art. 54(4) and (5) EPC. The therapeutic effect of the claimed perfluorinated polyethers lay in their acting as a replacement for synovial fluid in diseased joints. In the board's view, this effect was achieved as a result of the claimed lubricant's material properties.