7.2.3 Interpretation of the term "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. 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, in order to justify an extension of the ordinary meaning of "substance or composition" to include any product, it would have rather been necessary to prove that the parties to the EPC intended to do so but failed to reflect this in the wording of Article 54(5) EPC. 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) where a new use of a “column” for an extracorporeal treatment was allowed, although the column as such was not regarded as a "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 468/20, the board was also of the view that the case differed from that in T 2003/08 date: 2012-10-31. The claim was for an "Apheresis column comprising an aptamer according to one of claims 1 to 6 for use in therapy of …" The board assessed whether or not (i) the means used in the treatment of the disease constituted a "substance or composition" i.e. "chemical" substances or compositions and whether (ii) the means achieving the therapeutic effect was a "chemical" substance or composition within the meaning of decision G 5/83 and T 2003/08 date: 2012-10-31. The board stated that the therapeutic effect in T 2003/08 date: 2012-10-31 was based on the specific ligand, for which the column merely served as a carrier. The claim in T 2003/08 date: 2012-10-31 clearly related to the use of a substance or composition (the specific ligand for human immunoglobulin) for the manufacture of a medicament (in the form of a column having said ligand coupled thereto) for a specified new and inventive therapeutic application. By contrast, in the case at hand, the apheresis column is clearly a device and neither a substance nor a composition. It is a carrier for the aptamer through which the therapeutic effect is actually achieved.

In T 2136/15 too, the board took a restrictive view. Here, the board found that an alginate for treating a dilated left ventricle of a heart of a patient suffering cardiomyopathy was not a substance or composition. The appellant had argued that the effect of the invention was a combination of biochemical and physical properties, but the board rejected this, stating that the beneficial effect of the created patterned superstructure is independent of the material from which the space-occupying elements in the pattern are made, as long the space-occupying elements are arranged in the particular therapeutically effective pattern and as long as they are biocompatible, making it a device rather than a substance or composition.

In other decisions, the boards were of a different view.

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.

In T 1252/20 the board decided to depart from the previous case law, which distinguished between substance or composition and device based on the “mode of action” of the claim in question, since it saw no legal basis for it. The previous case law (T 2003/08 date: 2012-10-31, T 1758/15) had taken G 5/83 as a starting point. However, 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. The use of the mode of action as the decisive criterion was also deemed problematic by the board for several reasons:

First of all, 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 generally directed to the administered substance. Since it is this substance which is used in a method excluded under Art. 53(c) EPC, such a claim drafting is entirely in line with Art. 54(4) and (5) EPC.

Secondly, the mechanism of action may not be understood in detail, or original assumptions about the mechanism of action may later turn out to be wrong. Even classical medicaments may trigger a therapeutic physiological reaction without the mechanism for it being fully understood. Nevertheless, this is no hindrance for the application of Art. 54(4) and (5) EPC to such medicaments or to doubt their nature as a "substance or composition".

Thirdly, a material may behave in different ways according to its mode of administration. The board held that it appeared odd to classify the very same material as a "substance or composition" or not depending on extrinsic factors not related to the material itself, but to its way of administration.

Lastly, the result of such a restriction does not achieve the legislative purpose, namely, to provide at least a complementary form of protection for an otherwise recognisably useful invention in a field where, despite its excluded nature, technical development is otherwise highly desirable and beneficial and therefore patent protection should also be available for such development (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. 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.