4.2.1 Limitations of exception under Art. 53(c)

Exceptions under Art. 53(c) are limited to methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. It follows that other methods of treating living human beings or animals (e.g. treatment of a sheep in order to promote growth, to improve the quality of mutton or to increase the yield of wool) or other methods of measuring or recording characteristics of the human or animal body are patentable as long as they are of a technical and not essentially biological character (see G‑II, 5.4.2). For example, an application containing claims directed to the purely cosmetic treatment of a human by administration of a chemical product is considered to be patentable (see T 144/83), whereas a cosmetic treatment involving surgery or therapy would not be patentable (see below).

To be excluded from patentability, a treatment or diagnostic method must actually be carried out on the living human or animal body (G 1/04). A treatment of or diagnostic method practised on a dead human or animal body would therefore not be excluded from patentability under Art. 53(c). Treatment of body tissues or fluids after they have been removed from the human or animal body, or diagnostic methods applied on them, are not excluded from patentability as long as they are not then returned to the same body. So the treatment of blood for storage in a blood bank or diagnostic testing of blood samples is not excluded, whereas a treatment of blood by dialysis where the blood is returned to the same body would be excluded.

As regards methods which are carried out on or in relation to the living human or animal body, it must be borne in mind that Art. 53(c) is intended only to free non-commercial and non-industrial medical and veterinary activities from restraint. It must be interpreted in a way that ensures the exceptions do not go beyond their proper limits (see G 5/83, G 1/04, and G 1/07).

Whether or not a method is excluded from patentability under Art. 53(c) cannot depend on the person carrying it out (see G 1/04 and G 1/07, Reasons 3.4.1).

However, unlike the subject-matter referred to in Art. 52(2) and Art. 52(3), which is only excluded from patentability if claimed as such, a method claim is not allowable under Art. 53(c) if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy. In that case, whether or not the claim includes or consists of features directed to a technical operation performed on a technical object is legally irrelevant to the application of Art. 53(c) (see G 1/07, Reasons 3.2.5).

Claims to medical devices, computer programs and storage media which comprise subject-matter corresponding to that of a method for treatment of the human or animal body by surgery or therapy or to that of a diagnostic method practised on the human or animal body are not to be objected to under Art. 53(c), because only method claims can fall under the exception of Art. 53(c).