6.1.2.2 Patient group  

The treatment of a known clinical indication in a different patient group for example characterised by age, gender, weight, physiological parameters or a biomarker may represent a new specific use under Art. 54(5) EPC. 

The selection of the patient group may be defined  

–in passive terms where the group characteristic is defined (e.g. “being at least X years of age”, “expressing gene X” “having mutation Y in gene X”) or  

–in active terms where the step of determination/selection is explicitly defined as an essential feature of the claim (e.g. “comprising a determination of mutation Y in gene X and selecting a patient having said mutation”).

Passive definition of the patient sub-group

Example:

Compound A for use in the treatment of disease B in a subject positive for biomarker C.

Novelty is established if the claimed patient sub-group is clearly identifiable by its physiological or pathological status. The patient sub-group must either be:

(i)a different and distinct patient sub-group not overlapping with any previously treated group or

(ii)a more specific sub-group of the previously treated patient group or an overlapping group which has not been identified in the prior art in the context of the claimed medical indication.

Active definition of the patient sub-group

The patient sub-group can also be defined actively in the claim. Such a claim typically comprises a determination/selection step allowing the identification of the sub-group to be treated. The treatment regimen is thus construed as comprising said determination step.

Example:

Compound A for use in the treatment of disease B in a subject positive for biomarker C comprising the determination of said biomarker in the patient by step D.

If in such a case the method of determining the biomarker including step D has not previously been disclosed in the context of the claimed therapy, the claim is normally considered novel.