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
   presence of the latter.