4.2 Surgery, therapy and diagnostic methods
4.2.2 Methods for screening potential medicaments and clinical trials
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A revised version of this publication entered into force. |
Although 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), in some infrequent cases, a claim may, in the light of the description, be interpreted 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).