Limitations of exception under Art. 53(c)

Exceptions under Art. 53(c) are confined 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 treatment of 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, provided that such methods 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 as being patentable (see T 144/83). A cosmetic treatment involving surgery or therapy would, however, 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. A treatment of or diagnostic method practised on a dead human or animal body would therefore not be excluded from patentability by virtue of Art. 53(c). Treatment of body tissues or fluids after they have been removed from the human or animal body, or diagnostic methods applied thereon, are not excluded from patentability as long as these tissues or fluids are not returned to the same body. Thus 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 with the blood being returned to the same body would be excluded.

Regarding methods which are carried out on or in relation to the living human or animal body, it must be borne in mind that the intention of Art. 53(c) is only to free from restraint non-commercial and non-industrial medical and veterinary activities. Interpretation of the provision must avoid the exceptions from going 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, in contrast to the subject-matter referred to in Art. 52(2) and (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 may fall under the exception of Art. 53(c).

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