It should be noted that Art. 52(4) excludes only methods of treatment by surgery or therapy and diagnostic methods. It follows that other methods of treatment of live 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 (as would probably be the case) such methods are of a technical and not essentially biological character (see IV, 3.4) and are susceptible of industrial application. The latter proviso is particularly important in the case of human beings. For example, an application with a claim for a method of contraception, which is to be applied in the private and personal sphere of a human being, is not susceptible of industrial application (see T 74/93, OJ 10/1995, 712). However, an application containing claims directed to the purely cosmetic treatment of a human by administration of a chemical product is considered as being susceptible of industrial application (see T 144/83, OJ 9/1986, 301). A cosmetic treatment involving surgery or therapy would, however, not be patentable (see below).

In order to be excluded, 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. 52(4). 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 insofar 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 should be borne in mind that the intention of Art. 52(4) is only to free from restraint non-commercial and non-industrial medical and veterinary activities. Interpretation of the provision should avoid the exclusions from going beyond their proper limits (see G 5/83, OJ 3/1985, 64).

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. 52(4) 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 or a diagnostic method step to be exercised on the human or animal body. 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. 52(4) (see T 820/92, OJ 3/1995, 113, and T 82/93, OJ 5/1996, 274).

Taking the three exclusions in turn:

Surgery defines the nature of the treatment rather than its purpose. Thus, for example, a method of treatment by surgery for cosmetic purposes or for embryo transfer is excluded, as well as surgical treatment for therapeutic purposes.

Therapy implies the curing of a disease or malfunction of the body and covers prophylactic treatment, e.g. immunisation against a certain disease (see T 19/86, OJ 1-2/1989, 24) or the removal of plaque (see T 290/86, OJ 8/1992, 414). A method for therapeutic purposes concerning the functioning of an apparatus associated with a living human or animal body is not excluded if no functional relationship exists between the steps related to the apparatus and the therapeutic effect of the apparatus on the body (see T 245/87, OJ 5/1989, 171).

Diagnostic methods likewise do not cover all methods related to diagnosis. Methods for obtaining information (data, physical quantities) from the living human or animal body are not excluded by Art. 52(4), if the information obtained merely provides intermediate results which, on their own, do not enable a decision to be made on the treatment necessary. Generally such methods include X-ray investigations, NMR studies, and blood pressure measurements (see T 385/86, OJ 8/1988, 308).