T 0694/16 - Insufficient disclosure of patient group

Key points

• "Since claim 1 is drafted under Article 54(5) EPC, attaining the claimed therapeutic effect is a functional technical feature characterising the claim. Thus, the issue of whether the claimed therapeutic method can be carried out and the purported effect achieved is relevant in the context of the assessment of sufficiency of disclosure (G 1/03, see point 2.5.2). [...] 
• "In the present case, 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. The selection of this patient group is an essential part of the claimed method. To identify these patients, the skilled person has to rely on the technical information in the patent (and the patent application) and on the common general knowledge available at the date of filing. [...] 
• "the patent teaches that prodromal patients are persons who score positively on at least one of a restricted list of criteria. Claim 1, however, does not mention those criteria; rather, it refers to unspecified "characteristics of a prodromal patient".
• "The difficulty in identifying further "characteristics" is highlighted by the fact that the patent acknowledges that other manifestations, such as "mild cognitive impairment" which can be observed before the onset of Alzheimer's disease, are not sufficient to consider a person to be a "prodromal patient" [..]. Thus, an entire research programme would have to be conducted in order to identify further criteria beyond those explicitly identified in paragraphs [0016-0019]. This would put an undue burden on the skilled person wishing to carry out the invention over the entire scope of claim 1. Thus, the invention identified in the main request does not meet the requirement of sufficiency of disclosure (Articles 83 and 100(b) EPC).
• Edit 17.02.2020: the following passage seems also important: “For this reason, the issue of whether patients displaying the markers of claim 1 were present among a population of previously treated patients and were already "inevitably" or "inherently" treated is irrelevant for assessing novelty in the present case. The only thing which counts is that D1 and D3 do not disclose a method whereby a patient or a group of patients displaying the relevant CSF markers but not affected by dementia was purposively and selectively targeted for carrying out the preventive treatment defined in claim 1.” (r. 5.14). (See also the headnote below, which can only be found in the PDF file).

EPO Headnote (only in PDF file)

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.

T 0694/16 -  link

Main request

2. Sufficiency of disclosure

2.1 Claim 1 of the main request is drafted in accordance with Article 54(5) EPC and relates to a composition comprising omega-3 fatty acids, uridine derivatives, a methyl donor and other ingredients, for use in the prevention or delay of the onset of dementia in a person having "characteristics" of a prodromal dementia patient.

2.2 Dementia is a disease induced by a progressive degeneration of the brain cells affecting, for example, the hippocampus. The disease is accompanied by a gradual decrease in the ability to think and remember to such an extent that it interferes with a person's daily functioning. Alzheimer's disease is the most common form of dementia. The pathogenic process of dementia is believed to start long, even decades, before the clinical onset of the disease.

2.3 As explained in the opposed patent, "prodromal (dementia) patients" are subjects who, although not yet suffering from dementia, are bound to develop it. It is the gist of the invention to identify this patient group and to treat it with the claimed composition so that the onset of the disease can be delayed or even prevented (paragraphs [0001], [0007], [0012-0015]). Paragraph [0016] defines "prodromal patients" as persons that display at least one, preferably at least two, of a specific list of criteria. These criteria are listed in paragraphs [0016-0019] of the patent, in dependent claim 2 as granted and on pages 5-6 of the application as filed. They include in particular the presence of specific markers, such as a level of more than 350 ng Total-tau (T-tau) per litre cerebrospinal fluid (CSF) and a weight ratio of abeta-42/Phospho-tau-181 (Aß42/P-tau181) of less than 6.5 in CSF. The patent explains that these markers distinguish prodromal patients from other patients presenting symptoms of mild cognitive impairment who will not necessarily develop dementia.

2.4 Since claim 1 is drafted under Article 54(5) EPC, attaining the claimed therapeutic effect is a functional technical feature characterising the claim. Thus, the issue of whether the claimed therapeutic method can be carried out and the purported effect achieved is relevant in the context of the assessment of sufficiency of disclosure (G 1/03, see point 2.5.2). As already established in numerous decisions of the boards of appeal, unless this effect is already known to the skilled person at the relevant date, the application must disclose the suitability of the claimed product for the specified therapeutic application (see T 609/02, point 9 and T 895/13, point 5). In the present case, 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. The selection of this patient group is an essential part of the claimed method. To identify these patients, the skilled person has to rely on the technical information in the patent (and the patent application) and on the common general knowledge available at the date of filing.

2.5 As explained above (point 2.3), the patent teaches that prodromal patients are persons who score positively on at least one of a restricted list of criteria. Claim 1, however, does not mention those criteria; rather, it refers to unspecified "characteristics of a prodromal patient".

2.6 According to the appellant, in order to identify said "characteristics", the skilled person would turn to the description, and in particular to paragraph [0016]. Relying on the technical teaching presented therein, the skilled person would be able to identify prodromal patients.

2.7 The board does not agree. The expression "characteristics" encompasses the criteria enumerated in the description and in granted claim 2 but is not limited thereto. The patent does not provide any pointer as to how further criteria, other than those that are explicitly mentioned, could be identified. Furthermore, no evidence has been provided that this could be done by relying on the common general knowledge at the relevant date. The difficulty in identifying further "characteristics" is highlighted by the fact that the patent acknowledges that other manifestations, such as "mild cognitive impairment" which can be observed before the onset of Alzheimer's disease, are not sufficient to consider a person to be a "prodromal patient" (see paragraphs [0005], [0007]). Thus, an entire research programme would have to be conducted in order to identify further criteria beyond those explicitly identified in paragraphs [0016-0019]. This would put an undue burden on the skilled person wishing to carry out the invention over the entire scope of claim 1. Thus, the invention identified in the main request does not meet the requirement of sufficiency of disclosure (Articles 83 and 100(b) EPC).