Materialise Mimics 10.01 Crack Cocaine
Calvin Beauchamps
II.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)
IV. 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)
V.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)
VI.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)
VI.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)
VI.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)
VI.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)
VII.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)
VII.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)
VII.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)
I. These appeals are from the decision of the Opposition Division of 16 January 2003 to maintain European patent No. 0169672 ("the patent") in amended form. The patent is based on European patent application No. 85304490.7, entitled "Method for producing transgenic animals", which was filed on 24 June 1985 claiming a priority date of 22 June 1984. Although the title and early versions of the claims refer to animals, the only embodiments disclosed relate to mice and the subject-matter of the patent has come to be referred to as the "oncomouse". In this decision that word is used, as it was by the parties during the proceedings, as a convenient means of denoting the subject-matter.
"1. A method for producing a transgenic eucaryotic animal having an increased probability of developing neoplasms, said method comprising introducing into an animal embyro [sic] an activated oncogene sequence.
17. A transgenic non-human eucaryotic animal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said animal, or an ancestor of said animal, at an embryonic stage, said oncogene optionally being further defined according to any one of claims 3 to 10, said animal preferably being a rodent."
III. The application was refused by the Examining Division on the grounds of Article 53(b) EPC, which prevents patenting of animal varieties, and of Article 83 EPC, since it could not be assumed that the only examples in the application, namely mice, could be extended to all other animals. The Examining Division also considered the application of Article 53(a) EPC, which excludes patents for inventions the publication or exploitation of which would be contrary to "ordre public" or morality, but concluded that patent law was not appropriate for resolving the potential problems thereby raised. The claims in the application as refused corresponding to those quoted above read as follows:
"1. A method for producing a transgenic non-human mammalian animal having an increased probability of developing neoplasms, said method comprising introducing an activated oncogene sequence into a non-human mammalian animal at a stage no later than the 8-cell stage.
17. A transgenic non-human mammalian animal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said animal, or an ancestor of said animal, at a stage no later than the 8-cell stage, said oncogene optionally being further defined according to any one of claims 3 to 10.
IV. The applicant appealed against that decision. In its decision of 3 October 1990 in those previous appeal proceedings (T 19/90 OJ EPO 1990, 476), the Board of Appeal held that Article 53(b) EPC applies to certain categories of animals but not to animals as such; and that, in the absence of serious doubts substantiated by verifiable facts, there was no reason to refuse the application under Article 83 EPC on the ground that it involved an extrapolation from mice in particular to mammals in general. As regards Article 53(a) EPC, the Board expressed the view that, particularly in cases such as the present of genetic manipulation of animals by the insertion of an activated oncogene, there were compelling reasons to consider this Article. The Board remitted the case to the Examining Division for further prosecution.
"1. A method for producing a transgenic non-human mammalian animal having an increased probability of developing neoplasms, said method comprising chromosomally incorporating an activated oncogene sequence into the genome of a non-human mammalian animal.
19. A transgenic non-human mammalian animal whose germ cells and somatic cells contain an activated oncogene sequence as a result of chromosomal incorporation into the animal genome, or into the genome of an ancestor of said animal, said oncogene optionally being further defined according to any one of claims 3 to 10.
VI. Between 18 December 1992 and 13 February 1993 seventeen oppositions were filed against the patent alleging variously several grounds under Articles 100(a) and 52 to 57 EPC including lack of industrial application, lack of novelty and inventive step, the absence of an invention, a non-patentable method for treatment of the animal body, that exploitation of the invention would be contrary to morality or "ordre public", and that the patent was for animal varieties. There were also objections of insufficient disclosure under Articles 100(b) and 83 EPC (in the case of opponents 4, 6 and 8 to 15).
VII. (1) The representative of Opponent 4 - a group consisting of an individual (Mr R. Bchner), a registered association (the "Tierschutzverein Gppingen" - the Gppingen Animal Protection Society), and an unregistered association of fourteen individuals (the Initiative "Kein Patent auf Leben" - No Patent on Life) - informed the EPO in a letter of 12 May 1995 that the unregistered association no longer existed, that his professional fees were largely unpaid, and that he wished his clients' opposition to be considered withdrawn. Although subsequent notifications were sent to this opponent, it played no further part in the proceedings.
(2) Opponent 5, a "Fraktion" (parliamentary party) in the Parliament of the German "Land" (province) of Sachsen (Saxony) ceased to exist, although this fact was only disclosed in a letter of 5 February 2003 sent on receipt of the Opposition Division's written decision. That letter explained that the "Fraktion" ceased activity after the provincial elections in 1994 and the subsequent liquidation was thereafter finalised at an unspecified date.
VIII. The opposition proceedings continued until 16 January 2003. Oral proceedings were held by the Opposition Division from 21 to 24 November 1995 and again from 6 to 7 November 2001. In its decision the Opposition Division rejected the patent proprietor's objections to the admissibility of the oppositions and rejected all the opponents' objections to the patent except those under Article 53(a) EPC. It found that the claims directed to non-human mammalian animals were not allowable under that Article and accordingly maintained the patent in an amended form with independent claims directed to rodents in accordance with the proprietor's fourth auxiliary request filed on 24 April 1997. In the course of its decision, the Opposition Division also decided that Rules 23b to 23e EPC applied to the present case and rejected arguments to the contrary based on the principle of legitimate expectations; rejected as an abuse of procedure a request made at the first oral proceedings that all its members should be disqualified for partiality; and rejected requests from the patent proprietor and opponents 1, 8 and 10 to 15 for an award of costs against the EPO in respect of the second oral proceedings.
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