T 0315/03 (Transgenic animals/HARVARD) of 6.7.2004

European Case Law Identifier: ECLI:EP:BA:2004:T031503.20040706
Date of decision: 06 July 2004
Case number: T 0315/03
Application number: 85304490.7
IPC class: C12N 15/85
Language of proceedings: EN
Distribution: A
Download and more information:
Decision text in EN (PDF, 268 KB)
Documentation of the appeal procedure can be found in the Register
Bibliographic information is available in: EN
Versions: OJ | Published
Title of application: Method for producing transgenic animals
Applicant name: THE PRESIDENT AND FELLOWS OF HARVARD COLLEGE
Opponent name: British Union for the Abolition of Vivisection
Bundesverband der Tierversuchsgegner et al
Ökologisch - Demokratische Partei
Büchner Reinhard
Meinel A. et al; Fraktion Bündnis 90
Fuchs U. et al
Fraktion Bündnis 90/ DIE GRÜNEN im Bayer. Landtag
Evangelischer Stadtkirchenverband Köln
Koechlin F., Schenkelaars P. et al. "No Patents on Life"
Voggenhuber J. et al
Keine Patente auf leben
Hamberger Sylvia et al
Bundeszentrale der Tierversuchsgegner Österreichs
Wiener Tierschutzverein und Zentralverband der
Tierschutzvereine Österreichs
Helletberger H.
Deutsche Tierhilfswerk e.V.
Board: 3.3.08
Headnote: 1. Rules 23b to 23e EPC apply to a case such as the present which was pending on the date when, as provided for by the legislator, those Rules took effect. (See Reasons, section 5)
2.1 A case falling within one of the four categories listed in Rule 23d(a) to (d) EPC must ipso facto be denied a patent under Article 53(a) EPC and there is no need to consider that Article further; but a case not falling within one of those categories must be considered further under Article 53(a) EPC. (See Reasons, section 6)
2.2 Thus, in cases falling within it, Rule 23d(d) EPC inserts an objection under Article 53(a) EPC (a "Rule 23(d) type" Article 53(a) EPC objection) which, depending on the facts and thus on the outcome of the test, may be either additional or alternative to an objection under Article 53(a) EPC itself (a "real" Article 53(a) EPC objection) as developed by the case law. (See Reasons, section 6 and paragraph 10.1)
3. Rule 23d(d) EPC is neither ultra vires nor inconsistent with the principle of narrow construction of exclusions or with the previous law. (See Reasons, section 7)
4. Assessment of a "Rule 23(d) type" Article 53(a) EPC objection is to be made as of the filing or priority date of the patent or application in suit. Evidence arising thereafter may be taken into account provided it is directed to the position at that date. (See Reasons, paragraphs 8.2, 9.5 and 9.6)
5.1 The Rule 23d(d) EPC test requires only three matters to be considered: animal suffering, medical benefit and the necessary correspondence between the two in terms of the animals in question. (See Reasons, paragraph 9.1)
5.2 The level of proof is the same for both animal suffering and substantial medical benefit, namely a likelihood. (See Reasons, paragraphs 9.2 and 9.3)
6.1 In the assessment of a "real" Article 53(a) EPC objection, no single definition of morality based on e.g. economic or religious principles represents an accepted standard in European culture. Opinion poll evidence is of very limited value for the reasons given in T 356/93. (See Reasons, paragraphs 10.1 to 10.4)
6.2 In animal manipulation cases, the test in T 19/90 is appropriate. This differs in several respects from the test in Rule 23d(d) EPC, most importantly by allowing matters other than animal suffering and medical benefit to be taken into account. (See Reasons, paragraphs 10.5 and 10.6)
6.3 Since the T 19/90 test is "mainly" the basis of assessment, other arguments as to the appropriate standard of morality or "ordre public" can additionally be considered but all arguments must be supported by evidence. (See Reasons, paragraphs 10.7 and 10.8)
6.4 Assessment of a "real" Article 53(a) EPC objection is made as of the filing or priority date; evidence arising after that date may be taken into account provided it is directed to the position at such date. (See Reasons, section 10.9)
7.1 In an assessment under Article 53(b) EPC, the principle enunciated in G 1/98 (OJ EPO 2000, 111) concerning plants and "plant varieties" should be followed in the case of animals: a patent should not be granted for a single animal variety (or species or race, depending on which language text of the EPC is used) but can be granted if varieties may fall within the scope of its claims. (See Reasons, paragraph 11.4)
7.2 The definition of animal variety (or species or race) by reference to taxonomical rank would be consistent with the position in relation to plant varieties and in the interest of legal certainty, allowing assessment under Article 53(b) EPC as interpreted by Rule 23c(b) EPC to be made by considering whether the technical feasibility of the invention is not confined to a particular animal variety (or species or race). (See Reasons, paragraphs 11.5 to 11.6)
7.3 The different terms used in each official language are inconsistent and denote different taxonomic categories. Thus strict compliance with Article 177(1) EPC would lead to the absurd result that the outcome of an Article 53(b) EPC objection would depend on the language of a case, with German having the highest taxonomic order "species" ("Tierarten") and thereby offering the widest objection. (See Reasons, paragraphs 11.1, 11.2 and 11.7)
Relevant legal provisions:
European Patent Convention 1973 Art 52(1)
European Patent Convention 1973 Art 53(a)
European Patent Convention 1973 Art 53(b)
European Patent Convention 1973 Art 56
European Patent Convention 1973 Art 57
European Patent Convention 1973 Art 83
European Patent Convention 1973 Art 112(1)
European Patent Convention 1973 Art 116(1)
European Patent Convention 1973 Art 125
European Patent Convention 1973 Art 164(2)
European Patent Convention 1973 Art 177(1)
European Patent Convention 1973 R 23b
European Patent Convention 1973 R 23c
European Patent Convention 1973 R 23d
European Patent Convention 1973 R 27
European Patent Convention 1973 R 67
Rules of procedure of the Boards of Appeal Art 10
Directive 86/609/EEC of 24 November 1986
Directive 98/44/EC of 6 July 1998
Convention for the Protection of Human Rights and Fundamental Freedoms Art 6(1)
Keywords: Method for producing transgenic rodents - whether contrary to Rule 23d(d) EPC (yes)
Method for producing transgenic mice - whether contrary to Rule 23d(d) EPC (no) or Article 53(a) EPC (no) or Article 53(b) EPC (no)
Catchwords:

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Cited decisions:
G 0005/88
G 0005/93
G 0009/93
G 0003/95
G 0004/95
G 0003/97
G 0004/97
G 0001/98
G 0003/99
J 0007/90
J 0016/90
T 0320/87
T 0019/90
T 0346/92
T 0356/93
T 0272/95
T 0194/96
T 1054/96
T 0862/98
T 0900/02
Citing decisions:
G 0002/12
G 0002/13
G 0003/19
T 0179/01
T 0866/01
T 0606/03
T 1165/03
T 0168/04
T 0907/04
T 1262/04
T 1374/04
T 0083/05
T 0869/05
T 1384/06
T 0534/07
T 0915/10
T 0823/11
T 1824/15
T 0682/16
T 0789/16
T 2707/16
T 1243/17
T 2377/17
T 0186/18
T 2805/19

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