This revised version of the Guidelines for Examination will apply as from 1 November 2015. Until then, the September 2014 edition of the Guidelines remains valid.

4.2.2 Methods for screening potential medicaments and clinical trials

The scope of protection of a claim directed to a standard compound screening test carried out on "animals" encompasses preclinical tests carried out with libraries of compounds on human beings. In order for such a claim to be allowable under Art. 53(a), the use of human beings as "test animals" should be clearly excluded from the scope of the claim, e.g. by means of a disclaimer. Although in general a medical claim directed to tests carried out on "animals" should exclude from its scope the use of human beings as "test animals" (e.g. by means of a disclaimer), inIn 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 such trials are ethically acceptable, since they are performed under strictly controlled conditions and with informed consent of the patient concerned. Therefore In such cases, no objection under Art. 53(a) should be raised (see however G‑II,

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