G 0001/04 (Diagnostic methods) du 16.12.2005
- Identifiant européen de la jurisprudence
- ECLI:EP:BA:2005:G000104.20051216
- Date de la décision
- 16 décembre 2005
- Numéro de l'affaire
- G 0001/04
- Requête en révision de
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- Numéro de la demande
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- Classe de la CIB
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- Langue de la procédure
- Anglais
- Distribution
- Publiées au Journal officiel de l'OEB (A)
- Téléchargement
- Décision en anglais
- Autres décisions pour cet affaire
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- Résumés pour cette décision
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- Titre de la demande
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- Nom du demandeur
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- Nom de l'opposant
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- Chambre
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- Sommaire
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.
- Dispositions juridiques pertinentes
- European Patent Convention Art 112(1)(b) 1973European Patent Convention Art 4(3) 1973European Patent Convention Art 52(1) 1973European Patent Convention Art 52(2) 1973European Patent Convention Art 52(4) 1973European Patent Convention Art 53(c)European Patent Convention Art 57 1973European Patent Convention Art 84 1973European Patent Convention R 29 1973
- Mots-clés
- 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 - Exergue
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- Affaires citantes
- G 0001/07G 0002/08G 0002/12G 0002/13G 0003/19T 0678/90T 0125/02T 0663/02T 1102/02T 1153/02T 1197/02T 0330/03T 0619/03T 0990/03T 0992/03T 0009/04T 0143/04T 0154/04T 0883/04T 1262/04T 1374/04T 0080/05T 0623/05T 0666/05T 1110/05T 0238/06T 0542/06T 0814/06T 0826/06T 0868/06T 1075/06T 1123/06T 1224/06T 1255/06T 0170/07T 1039/07T 1280/07T 1546/07T 1670/07T 1695/07T 1814/07T 2003/07T 0898/08T 1328/08T 1403/08T 1798/08T 2003/08T 2302/08T 1599/09T 1635/09T 0273/10T 0569/10T 1016/10T 2187/10T 2369/10T 2091/11T 0475/12T 0699/12T 0809/12T 1540/12T 1315/13T 2098/13T 2427/13T 0489/14T 1140/14T 1180/14T 1774/14T 1957/14T 2068/14T 0141/15T 0148/15T 1232/15T 1479/15T 1730/15T 2135/15T 2276/15T 0030/16T 0786/16T 1927/16T 1994/16T 2573/16T 0135/17T 0731/17T 1091/17T 0467/18T 1423/18T 2257/18T 2605/18T 2899/18T 0256/19T 0529/19T 0699/19T 1056/19T 1560/19T 1835/19T 3097/19T 0056/21T 0110/21T 1920/21T 1256/22T 1553/22T 1741/22T 0616/23T 1883/23T 1884/23T 1989/23T 0417/24T 0556/24
CONCLUSION
For 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.