epo defines non patentable diagnostic

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EPO Defines Non-Patentable "Diagnostic Method"

Thanks to Axel Horn at the IPJUR Blog for pointing to a December 16,

2005 opinion from the EPO's Enlarged Board of Appeals regarding what

is a non-patenatble "diagnostic method" under Article 52(4) of the

European Patent Copnvention. According to the opinion headnotes:

1. 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 veterinarydecision 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.

2. 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.

3. 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".

4. 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