Decision G01/04 - Diagnostic methods under Article 52(4) EPC
26.12.2005
On 29 December 2003, the President of the EPO, requested to the Enlarged Board of Appeal : to clarify the meaning of the wording "diagnostic methods practised on the human or animal body" within the meaning of Article 52(4) EPC.
On 29 December 2003, the President of the EPO, requested to the Enlarged Board of Appeal : to clarify the meaning of the wording "diagnostic methods practised on the human or animal body" within the meaning of Article 52(4) EPC.Reasons for the OpinionThe Concept of Diagnostic Methods Practised on the Human or Animal BodyArticle 52(4) EPC provides inter alia that "diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application".The diagnostic methods referred to in Article 52(4) EPC include the method step related to the deductive medical or veterinary decision phase, i.e. thediagnosis stricto sensu¸ representing a purely intellectual exercise.The scope of the exclusion from patentability under Article 52(4) EPC in respect of diagnostic methods is to be interpreted in a narrow manner . Thus, 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 (in view of Article 84 EPC) the feature pertaining to the diagnosis for curative purposes as a purely intellectual exerciseRepresenting the deductive medical or veterinary decision phase, as well as the features relating to (i) the preceding steps which are constitutive for making the diagnosis, and (ii) the specific interactions with the human or animal body which occur when carrying those out among said preceding steps which are of a technical nature.The grant of a European patent in respect of a diagnostic method which includes preceding method steps of a technical nature carried out by a device does not contravene Article 52(4) EPC, because the performance of the respective method steps does not satisfy the criterion "practised on thehuman or animal body". However, in the event of patent protection, it will normally be sufficient to purchase the device in question in order to be entitled to carry out such a method. In cases where the same diagnostic conclusions can be attained by a method not including the use of the device, those carrying it out will not be inhibited by the patent. Therefore, the medical or veterinary practitioners cannot be considered to be hampered by the existence of such a patent.Act Revising the EPCFrom Article 1, items 17 and 18 of the 'Act revising the Convention on the grant of European patents' it follows that new Article 53(c) EPC provides inter alia that, as an exception to patentability, European patents shall not be granted in respect of diagnostic methods practised on the human or animal body, whereas existing Article 52(4) EPC is to be deleted without substitution. Item 6 of the explanatory remarks concerning the 'Transitional provisions' states that shifting "the substance of existing Article 52(4) [EPC] to [new] Article 53(c) [EPC] is a purely editorial change" and that the new wording of the substantive provisions laid down in amended Articles 52 and 53 EPC "does not change the actual legal position". The motive for the change was the realisation that these methods were excluded from patentability for reasons of public health and that, consequently, one should not base the argument on lack of industrial applicability any more.The patent exemption for diagnostic methods practised on the human or animal body under existing Article 52(4) EPC pertains to inventions which are susceptible of industrial application within the meaning of Article 57 EPC, which remains unaltered. The same applies to the patent exemption for such methods laid down in new Article 53(c) EPC. Thus, in this respect, the actual legal position remains unchanged. The present interpretation of the scope of the exclusion from patentability under existing Article 52(4) EPC in respect of diagnostic methods practised on the human or animal body will therefore remain valid when the revised version of the EPC comes into force.ConclusionFor these reasons the point of law referred to the Enlarged Board of Appeal by the President of the EPO is answered as follows: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 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.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.
