G 0001/04 (Diagnostic methods) of 16.12.2005 - #79

Citation rank: 79
No. of citations: 63

G 1/04 looked at the conditions, under which claims in the field of diagnostics are exempted from patentability under Art. 53(c) (Art. 52(4) EPC1973). Art. 53(c) holds that methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are exempted from patentability.

G 1/04 took a liberal standpoint regarding the exclusion of diagnostic methods. It held that for a method to be excluded under Art. 53(c) for being a "diagnostic method", the method must include not only the steps of gathering medical data/information on the patient (so as to obtain a clinical picture), but also the mental act of attributing a disease to the observed clinical picture, i.e., the "diagnosis in strictu sensu". It is a strict requirement for the exclusion that the steps which serve to gathering medical data are "practised on the human or animal body".

Note: Diagnostic methods, according to G 1/04, are treated very differently than surgical methods. In G 1/07 the Enlarged Board of Appeals held that for surgical methods to fall under the exclusion of Art. 53(c), only a single step of the claimed method needs to be of surgical nature.

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Headnote:  

I. In order that the subject-matter of a claim relating to a diagnostic method practised on the human or animal body falls under the prohibition of Article 52(4) EPC, the claim is to include the features relating to:
(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.
II. Whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC may neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medical or technical support staff, the patient himself or herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it.
III. In a diagnostic method under Article 52(4) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practised on the human or animal body".
IV. Article 52(4) EPC does not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfies the criterion "practised on the human or animal body" if its performance implies any interaction with the human or animal body, necessitating the presence of the latter.