7.2.4 Novelty of the therapeutic application
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According to the established case law of the boards of appeal, the use of the same compound in the treatment of the same disease for a particular group of subjects, can nevertheless constitute a novel therapeutic application, provided that it is carried out on a new group of subjects which is distinguished from the former by its physiological or pathological status (see T 19/86, OJ 1989, 24; T 893/90, T 233/96, T 1399/04, T 734/12).
In T 19/86 (OJ 1989, 25) the board had to decide whether the application of a known medicament for the prophylactic treatment of the same disease in an immunologically different population of animals of the same species could be considered a new therapeutic application from which novelty for the claims could be derived. According to decision T 19/86 the question of whether a new therapeutic use was in accordance with decision G 5/83 should not be answered exclusively on the basis of the ailment to be cured but also on the basis of the subject (in the case in question, the new group of pigs) to be treated. A therapeutic application was incomplete if the subject to be treated was not identified; only a disclosure of both the disease and the subject to be treated represented a complete technical teaching. The proposal according to the application to protect animals which could not hitherto be protected from the disease in question, by intranasally administering to them a known serum, could not be considered disclosed in the prior art and therefore constituted a novel therapeutic application in accordance with G 5/83.
In T 233/96 the board held that if the use of a compound was known in the treatment or diagnosis of a disease of a particular group of subjects, the treatment or diagnosis of the same disease with the same compound could nevertheless represent a novel therapeutic or diagnostic application, provided that it was carried out on a new group of subjects which was distinguished from the former by its physiological or pathological status (T 19/86, OJ 1989, 25; T 893/90). This did not apply, however if the group chosen overlapped with the group previously treated, or the choice of the novel group was arbitrary which meant that no functional relationship existed between the particular physiological or pathological status of this group of subjects (here humans who were unable to exercise adequately) and the therapeutic or pharmacological effect achieved.
- T 694/16
If a claim is directed to a known compound or composition for use in a therapeutic method of treatment or prevention of a disease, and the claim specifies that the subject to be treated displays a clearly defined and detectable marker, which is not displayed by all subjects affected by or likely to develop that disease, then the purposive selection of the patients displaying the marker for the specified treatment is a functional feature characterising the claim. (Points 5.1-5.21 of the Reasons)
- Case law 2019
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In T 694/16 the claim was directed to a food composition for prodromal dementia patients. The board held that for the therapeutic method to be carried out and the effect to be achieved, the skilled person must, in the first place, be able to identify patients that are in need of treatment and will benefit from the administration of the claimed composition. "Prodromal (dementia) patients" are subjects who, although not yet suffering from dementia, are bound to develop it. The patent defined "prodromal patients" as persons that display at least one, preferably at least two, of a specific list of criteria, which included in particular the presence of specific markers. Claim 1, however, did not mention those criteria; rather, it referred to unspecified "characteristics of a prodromal patient". The difficulty in identifying further characteristics was highlighted by the fact that the patent acknowledged that other manifestations, such as mild cognitive impairment, which could be observed before the onset of Alzheimer's disease, were not sufficient to consider a person to be a "prodromal patient". The board thus held that the patient group was insufficiently disclosed. It held that if a claim is directed to a known compound or composition for use in a therapeutic method of treatment or prevention of a disease, and the claim specifies that the subject to be treated displays a clearly defined and detectable marker, which is not displayed by all subjects affected by or likely to develop that disease, then the purposive selection of the patients displaying the marker for the specified treatment is a functional feature characterising the claim.