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)
