4.2.2 Methods for screening potential medicaments and clinical trials 

In general, a medical claim directed to tests carried out on "animals" must exclude from its scope the use of human beings as "test animals" (e.g. by means of a disclaimer). However, in some infrequent cases, a claim may be interpreted, in the light of the description, as exclusively relating to a clinical trial of an experimental medicament carried out on human beings. It is assumed that unless there is evidence to the contrary, such trials are performed under strictly controlled conditions and with the informed consent of the patient concerned. In such cases, no objection under Art. 53(a) is raised (see, however, G‑II, 4.2.1.2).