G 0001/04 (Diagnostic methods) of 16.12.2005

European Case Law Identifier: ECLI:EP:BA:2005:G000104.20051216
Date of decision: 16 December 2005
Case number: G 0001/04
Application number: -
IPC class: -
Language of proceedings: EN
Distribution: A
Download and more information:
Decision text in EN (PDF, 101.910K)
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Bibliographic information is available in: EN
Versions: OJ | Published
Title of application: -
Applicant name: -
Opponent name: -
Board: EBA
Headnote: 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.
Relevant legal provisions:
European Patent Convention 1973 Art 4(3)
European Patent Convention 1973 Art 52(1)
European Patent Convention 1973 Art 52(2)
European Patent Convention 1973 Art 52(4)
European Patent Convention 1973 Art 57
European Patent Convention 1973 Art 84
European Patent Convention 1973 Art 112(1)(b)
European Patent Convention 1973 R 29
European Patent Convention Art 53(c)
Keywords: Diagnostic methods under Article 52(4) EPC representing inventions excluded from patentability by means of a legal fiction
Proper construction of the terms 'diagnostic methods' and 'practised on the human or animal body' referred to in Article 52(4) EPC - requirements of clarity and legal certainty - difficulty of defining medical and veterinary practitioners on a European level within the framework of the EPC - essential features of a diagnostic method excluded from patent protection under Article 52(4) EPC - qualification of an activity as having a diagnostic character - requirements for a diagnostic method to be regarded as being practised on the human or animal body
Catchwords:

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Cited decisions:
T 0116/85
T 0385/86
T 0603/89
T 0775/92
T 0530/93
T 1165/97
T 0807/98
T 0310/99
T 0964/99
Citing decisions:
G 0001/07
G 0002/08
G 0002/12
G 0002/13
T 0678/90
T 0125/02
T 0663/02
T 1102/02
T 1153/02
T 1197/02
T 0330/03
T 0619/03
T 0990/03
T 0992/03
T 0009/04
T 0143/04
T 0154/04
T 0883/04
T 1262/04
T 1374/04
T 0080/05
T 0623/05
T 0666/05
T 1110/05
T 0238/06
T 0542/06
T 0814/06
T 0826/06
T 0868/06
T 1075/06
T 1123/06
T 1224/06
T 1255/06
T 0170/07
T 1039/07
T 1280/07
T 1546/07
T 1670/07
T 1695/07
T 1814/07
T 2003/07
T 0898/08
T 1328/08
T 1403/08
T 1798/08
T 2003/08
T 2302/08
T 1599/09
T 1635/09
T 0273/10
T 0569/10
T 1016/10
T 2187/10
T 2369/10
T 2091/11
T 0475/12
T 0699/12
T 0809/12
T 1540/12
T 1315/13
T 2098/13
T 2427/13
T 1140/14
T 1180/14
T 1957/14
T 2068/14
T 2135/15
T 0030/16

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