7.2. Second (or further) medical use
7.2.7 Whether there is a therapeutic method
In T 454/08 the board confirmed that if a claim formulated as a Swiss-type claim was not directed to the use of any therapeutic method or was de facto directed to a non-therapeutic use, the feature defining the use was purely illustrative and could not be used to establish novelty over the prior art. In effect, this specific novelty approach applied only to claims directed to the use of a substance or composition intended for use in a method referred to in Art. 52(4) EPC 1973 (now Art. 53(c) EPC). Claim 1 of the main request was based on the model proposed by G 5/83, namely the application of a substance to produce a composition for a particular use. However, nothing in the wording of claim 1 implied use in any of the therapeutic methods within the meaning of Art. 53(c) EPC. The specific novelty approach created by G 5/83 thus did not apply to claim 1 of the main request, the subject-matter of which amounted to a process claim. The step of administering the tablet had to be seen as an illustrative feature of the tablet and not as a limiting feature for a specific mode of administration.
In T 1278/12 the board had to decide whether the main claim constituted a second medical use claim (Swiss-type claim). The appellant argued that the reference to "an infant delivered via caesarean section" implicitly indicated a therapeutic effect. The board stated that an enteral administration to an infant delivered via caesarean only specified the mode of delivery to the patient, but did not relate to any therapeutic effect obtained thereby. The appellant argued that, according to T 1020/03, the therapeutic effect did not need to be specified in a claim for it to qualify as a further medical use claim. The board did not share the appellant's view and observed that the board in T 1020/03 had explicitly stated that the further medical indication had to be specified in the claim with some degree of specificity. Since claim 1 of the main request did not specify any therapeutic effect at all, it represented a non-medical use claim. Therefore, the wording "for enteral administration to an infant delivered via caesarean section" limited claim 1 only in so far as the composition had to be suitable for the enteral administration to caesarean section infants. Since this suitability was given in some documents, these were novelty-destroying for the subject-matter of claim 1.
In T 182/16 the composition was an "infant formula or growing up milk for toddlers" enriched with sn-2 palmitic acid for improving body composition with regard to lean body mass and muscle mass. The board held that irrespective of the fact that the wording of claim 1 did not actually restrict the group of subjects to whom the composition was to be administered to infants and toddlers, and in line with decision T 1278/12, simply referring to infants does not imply a therapeutic use, since feeding an infant is not a therapeutic step within the meaning of Art. 53(c) EPC.
The board in T 884/23, where the claim was directed to a milk fortifier for use in prevention of visceral adiposity and/or decreasing the ratio visceral adipose tissue to subcutaneous adipose tissue in a preterm infant human, the board held that decreasing the ratio of visceral adipose tissue to subcutaneous adipose tissue in a preterm infant was not a method of treatment by therapy pursuant to Art. 53(c) EPC. Consequently, it could not establish novelty over prior art disclosing a composition as defined in claim 1 suitable for the same purpose.
- T 1396/23
In T 1396/23 the appeal was filed by the opponent against the opposition division's decision rejecting the opposition. The appellant contested the opposition division's finding that the invention defined in claim 1 of the opposed patent was sufficiently disclosed. While the appellant did not dispute that claim 1 related to a medical use and was drafted as per Art. 54(5) EPC, it argued that the effect induced by whey protein micelle complexes (WPM complexes) described in the opposed patent was not therapeutic. According to the appellant, the claimed complexes provided nutrition but were unsuitable to prevent the claimed conditions, even less so to treat them.
The board was not persuaded by the arguments of the appellant. The board referred to the opposed patent, which explained that, prior to the filing date, whey protein isolates were considered not only to be essential nutrients but also to be beneficial in reducing the risk of, and treating, metabolic diseases associated with high-fat diets and/or elevated postprandial insulin levels, such as diabetes. On this basis alone, the board found it reasonable to assume that the claimed WPM complexes, which contained whey proteins, could likewise induce these effects..
The board observed that the opposed patent taught that using the claimed WPM complexes rather than conventional whey proteins was beneficial for subjects who were at risk of or suffered from the diseases indicated in claim 1. The board explained that it was immaterial what the underlying mechanism of action was, and also whether the complexes acted on a specific target and whether a comparator such as whey protein isolate or uncomplexed WPM was explicitly mentioned in claim 1. The skilled person would appreciate that the claimed WPM complexes were intended to be incorporated into a nutritional composition in place of whey proteins in order to achieve the stated therapeutic effect. The board concluded that, in the context of the invention, the claimed compositions comprising WPM complexes could thus be regarded as "a substance or composition" within the meaning of Art. 54(5) EPC that was used to carry out the claimed therapeutic method.