Pages 473-506

INFORMATION FROM THE EPO

Decisions of the examining and opposition divisions

Decision of the opposition division dated 7 November 2001 ^*

Patent proprietor: The President and Fellows of Harvard College

Opponents:

1) The British Union for the Abolition of Vivisection

2) Bundesverband der Tierversuchsgegner - Menschen für Tierrechte e. V. et al.

3) Ökologisch-Demokratische Partei, Deutschland

4) Reinhard Büchner

5) Fraktion Bündnis 90/Grüne im Sächsischen Landtag

6) Ursel Fuchs et al.

7) Die Grünen im Bayerischen Landtag

8) Evangelischer Stadtkirchenverband Köln

9) Bundesland Hessen der Bundesrepublik Deutschland

10) Florianne Koechlin et al.

11) Johannes Voggenhuber et al.

12) Keine Patente auf Leben, Schweiz

13) Sylvia Hamberger et al.

14) Bundeszentrale der Tierversuchsgegner Österreichs

15) Wiener Tierschutzverein und der Zentralverband der Tierschutzvereine Österreichs

16) Helmtrude Helletsberger

17) Deutsches Tierhilfswerk e. V.

Headword: Onco-mouse/HARVARD

Article: 52 (1), (2), (4), 53 (a) and (b), 54, 56, 57, 83, 100 (a) and (b) EPC

Rule: 23c (b) and 23d (d) EPC

Directive 98/44/EG: Recital 31

Keyword: "Animals may constitute patentable subject-matter" - "Sufficiency (yes): same view taken as in T 19/90" - "Claims are directed to specific varieties (no)" - "Animals in general are patentable subject-matter under the morality provisions (yes)" - "Animals for testing, the exploitation of which is allowed in contracting states, is patentable subject-matter under the morality provisions (yes)" - "Allowability of a claim covering any categories of non-test-animals (no)"

Facts and Submissions

I. European patent No. 0169672 is based upon European patent application No. 85304490.7 filed on 24.06.85 and claiming priority from 22.06.84 (US 623774).

The mention of the grant of the patent was published in the European Patent Bulletin 1992/20 of 13.05.92.

Proprietor of the patent is The President and Fellows of Harvard College.

The patent relates to transgenic non-human mammalian animals.

II. Seventeen oppositions were filed against the patent. The Opponents (O1-O17) and the legal basis for these oppositions are as follows:

O1: On 18.12.1992 Compassion in World Farming (now Compassion in World Farming Supporters) and The British Union for the Abolition of Vivisection filed a notice of opposition requesting the revocation of the patent in its entirety on the basis of Article 100(a) EPC, in particular on the grounds of morality under Article 53(a) EPC. O1 made further submissions in a letter dated 05.02.1993.

O2: On 05.02.1993 "Bundesverband der Tierversuchsgegner Menschen für Tierrechte e. V." et al. filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a) EPC on the grounds of lack of a patentable invention under Article 52 EPC, lack of morality under Article 53(a) EPC, and non-patentability of animal varieties under Article 53(b) EPC. O2 made an auxiliary request for oral proceedings.

O3: On 05.02.1993 "Ökologisch-Demokratische Partei" filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a) EPC on the grounds of lack of morality under Article 53(a) EPC and non-patentability of animal varieties under Article 53(b) EPC.

O4: On 11.02.1993 Reinhard Büchner filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a)(b) EPC on the grounds of lack of morality under Article 53(a) EPC, non-patentability of animal varieties under Article 53(b) EPC and insufficiency of disclosure under Article 83 EPC. In his communication of 12.05.1995, the professional representative of O4 declared that in view of a letter from Mr Büchner of 14.02.1995, he would not be representing O4 any longer and asked that the opposition be considered as withdrawn. However, O4 continues to be a party to the proceedings since it follows from the letter of the representative that when he declared the withdrawal he was no longer entitled to represent O4.

O5: On 12.02.1993 Andreas Meinel et al., "Fraktion Bündnis 90 / Grüne im Sächsischen Landtag" filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a) EPC on the grounds of lack of morality under Article 53(a) EPC and non-patentability of animal varieties under Article 53(b) EPC. O5 made an auxiliary request for oral proceedings.

O6: On 31.01.1993 Ursel Fuchs et al. filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a), (b) EPC on the grounds of lack of a patentable invention under Article 52 EPC, lack of morality under Article 53(a) EPC, non-patentability of animal varieties under Article 53(b) EPC and insufficiency of disclosure under Article 83 EPC. O6 made an auxiliary request for oral proceedings.

O7: On 12.02.1993 Ruth Paulig et al., "Die Grünen im Bayerischen Landtag" filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a) EPC on the grounds of lack of a patentable invention under Article 52 EPC, lack of morality under Article 53(a) EPC, non-patentability of animal varieties under Article 53(b) EPC and lack of novelty under Article 54 EPC.

O8: On 12.02.1993 "Evangelischer Stadtkirchenverband Köln" filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a), (b) EPC on the grounds of lack of industrial application under Article 52(1) EPC, that the patent is based on a discovery under Article 52(2) EPC, lack of morality under Article 53(a) EPC, non-patentability of animal varieties under Article 53(b) EPC, lack of novelty under Article 54 EPC, lack of inventive step under Article 56 EPC and insufficiency of disclosure under Article 83 EPC. O8 made an auxiliary request for oral proceedings.

O9: On 12.02.1993 "Bundesland Hessen der Bundesrepublik Deutschland" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made. O9 withdrew his opposition with a letter dated 14.04.2000 and is no longer party to the proceedings.

O10: On 12.02.1993 Florianne Koechlin, Pete Schenkelaars et al., "No patents on life" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made.

O11: On 12.02.1993 Johannes Voggenhuber et al., "Grüner Club im Parlament" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made.

O12: On 12.02.1993 "Keine Patente auf Leben" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made.

O13: On 12.02.1993 Sylvia Hamberger et al., "Kein Patent auf Leben" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made.

O14: On 12.02.1993 "Bundeszentrale der Tierversuchsgegner Österreichs" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made.

O15: On 12.02.1993 "Wiener Tierschutzverein and Zentralverband der Tierschutzvereine Österreichs" filed a notice of opposition requesting the revocation of the patent in its entirety which opposition is based on the same grounds as the opposition of O8. Also, an auxiliary request for oral proceedings was made.

O16: On 12.02.1993 Helmtrude Helletsberger filed a notice of opposition requesting the revocation of the patent in its entirety in accordance with Article 100(a) EPC on the grounds of lack of industrial application under Article 52(1) EPC, claiming methods for treatment of the animal body by surgery or therapy and diagnostic methods practised on the animal body under Article 52(4) EPC, lack of morality under Article 53(a) EPC, non-patentability of animal varieties under Article 53(b) EPC and lack of inventive step under Article 56 EPC. O16 made an auxiliary request for oral proceedings.

O17: On 01.02.1993 "Deutsches Tierhilfswerk e. V." filed a notice of opposition limited to claims 1-10, and 12-22 of the contested patent in accordance with Article 100(a) EPC on the grounds of lack of morality under Article 53(a) EPC and non-patentability of animal varieties under Article 53(b) EPC.

III. The Proprietor in his letter of reply dated 17.06.1994 argued against the Opponents' submissions and originally requested the maintenance of the patent as granted. The Proprietor made an auxiliary request for oral proceedings.

IV. O1 responded to the Proprietor's submissions and further substantiated his case against the contested patent with letters dated 17.10.1994 and 01.03.1995.

V. In addition to numerous protests from individual persons not being parties to the proceedings a third party observation under Article 115 EPC was filed on 17. 11. 1994 in favour of animal patenting.

VI. In the communication dated 08.05.1995 which accompanied the summons to oral proceedings the Opposition Division announced that it has been enlarged by the addition of a legally qualified member. In its communication dated 26.09.1995 the Opposition Division gave its provisional opinion concerning the issues raised by the parties under Articles 83, 52, 54, 56, 57, and 53(b) EPC. In a further communication dated 09.11.1995 the Opposition Division addressed the issue of the right to participate as a party in the oral proceedings.

VII. Following the summons the Proprietor made further submissions with a letter dated 20.10.1995 and O1 responded to the Proprietor's further submissions with a letter dated 16.11.1995.

VIII. Oral proceedings were held during the time from 21.11.1995 to 24.11.1995. At the close of the oral proceedings the Opposition Division announced that the procedure would be continued in writing. Reference is made to the minutes of the oral proceedings forwarded to the parties on 15.04.1996.

IX. Following oral proceedings the Proprietor filed new auxiliary requests with a letter dated 28.11.1995.

With a further letter dated 24.04.1997 the Proprietor filed further observations and slightly modified the auxiliary requests.

X. In the period of time until September 2000 O1, O2, O3, O7, O8-O15, O16, and O17 filed further submissions as outlined in detail in the Opposition Division's communication dated 20.09.2000, item 1. Reference is made to this communication. All of these submissions were further substantiating the case against the contested patent.

XI. In the Opposition Division's communication of 20.09.2000 the parties' attention was drawn to new Rules 23b-23e EPC and to newly issued Decision G 1/98 (OJ 3/2000, 111). The parties were invited to file their observations with regard to these and to clearly state whether they request further oral proceedings in accordance with Articles 113 and 116(1) EPC in view of the fact that the legal situation was no longer the same as before.

XII. With a letter dated 29.09.2000 the Patent Proprietor strongly objected to further oral proceedings whereas O8-O15 requested further oral proceedings in a letter dated 22.01.2001.

XIII. Further observations were filed by O1 (11.01.2001 and 10.10.2001), O3 (10.10.2001), O8-O15 (10.09.2001) and O13 (03.09.2001 and 06.09.2001).

XIV. The Proprietor responded to O1's submission with a letter of 24.01.2001.

XV. Summons to Oral Proceedings was issued on 09.05.2001 followed by a letter dated 28.08.2001 wherein the Opposition Division set out its preliminary views on compliance of the contested patent with Articles 57, 53(b) and 53(a) EPC.

XVI. Further submissions by the Proprietor were filed with a letter dated 06.09.2001.

XVII. The second oral proceedings took place from 06.11.2001 to 07.11.2001 and at the close thereof the decision was announced to maintain the patent in amended form (4th auxiliary request relating to rodents). Reference is made to the minutes which were forwarded to the parties on 23.01.02. Attached to the minutes was a complete list of documents which were introduced into the procedure.

XVIII. Proprietor's requests:

The main request in the proceedings was maintenance of the patent as granted.

Claims 1 and 19 of the patent read as follows:

"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."

The auxiliary requests still maintained by the Proprietor at the time of the decision were as set out in the following. Owing to the maintenance of the original numbering of 24.04.1997 the first auxiliary request is 2/2A followed by 3/3A and 4. Former requests 1/1A were withdrawn in the course of the proceedings.

Requests 2/2A: Request 2 differs from the main request in that method claim 1 and animal claim 19 are restricted to transgenic non-human mammalian animals, "said animal being for experimental or testing purposes". Moreover, method claim 24 being directed to making cell cultures contains the same restriction. Request 2A represents a variant in that the above restriction is limited to testing purposes (experimental purposes do no longer appear).

Requests 3/3A: Request 3 differs from Request 2 in that chromosome claim 23 and cell claim 25 contain the same limitation as imported into claims 1, 19 and 24. Request 3A is the corresponding variant.

Request 4: This request is restricted to transgenic rodents in all aspects.

Copies of the auxiliary requests are appendant to this decision.

Moreover, there is a request for finding inadmissibility of oppositions of O1, O2, O4, O6 and O10-15 as "multiple oppositions" (with more than one Opponent) and of O1-5, O7, O8, O10, O12, O14 and O15 for lack of proof of their status as proper legal persons. The opposition of O17 should be held inadmissible because no ground of opposition in the original opposition brief is discernible. These requests were accompanied by another request that the issue of admissibility be made part of the overall substantive decision.

Specifically, the Proprietor argued on the point of "multiple oppositions" that only one opposition fee had been paid instead of a number of opposition fees corresponding to the individuals involved. Concerning the issue "status as proper legal persons" it was argued that proof should be supplied from each Opponent and that the position of 'supporters' or 'backers' should be clarified. Concerning O17 arguments were advanced that in the letter of 1 February 1993 no admissible ground of opposition had been provided.

XIX. The Opponents' submissions can be summarised as follows:

i) Patentable inventions under Article 52 (1), (2) (discoveries) and (4) EPC

O2 made novelty, inventive step and sufficiency objections under Article 52(1). These arguments will be referred to under the relevant articles of the EPC (Art. 54, 56 and 83).

O2 also pointed out, as did O7, that transgenic mice could not be an invention under Article 52(1) EPC. Moreover, it was argued that the transgenic mice of the patent constituted a discovery because it was discovered that the mice obtained by the patented process had a higher susceptibility of neoplasms.

O6's submissions concerning discoveries went in the same direction and a comparison was made with the discovery of America.

O8-O15 submitted under Article 52(1) EPC that the invention was not industrially applicable. These arguments will be referred to under Article 57 EPC. Moreover, it was argued that claims 1-15 violated Article 52(4) EPC because the chromosomal incorporation of an activated oncogene by microinjection was a surgical process. O16 expanded on this argument by pointing out that the incorporation of a gene into a genome of a living animal also represented a surgical process.

ii) Novelty (Article 54 EPC)

O8-O15 referred to several documents and particularly to Brinster et al., "Cell" 37, pp. 367-379, published in June 1984 (D 26 in the list of documents cited during the proceedings). It was pointed out that it was assumed to be published before the priority date of the impugned patent, i.e. 22 June 1984.

iii) Inventive step (Article 56 EPC)

O8-O15 and O16 argued, by referring primarily to the documents cited in the patent and to Brinster et al., see above item ii) that at the time before the effective date of the patent a considerable number of genes had been introduced and expressed in mice. The mice of the patent contained a known gene linked to a known promoter which had been introduced into mice in a known manner. No surprising effect was obtained by carrying out these known procedures. Thus, the claimed invention represented an obvious continuation of what had been known before. The fact that Brinster et al. arrived at the same result at the same time was also an indication that mere routine work had been carried out.

iv) Industrial application (Article 57 EPC)

In particular O8-O15 argued that industrial application was not shown for any animal other than mice, examples of animals not being susceptible of industrial application were named to be giraffes, elephants or blue whales. Also, the success rate for the production of transgenic animals in the order of 1-3% did not fulfil the criteria of commercialisation. Moreover, the transgenic mice which were on the market turned out to be a commercial failure.

v) Sufficiency of disclosure (Article 83 EPC)

Several Opponents argued that the results obtained with mice could not be extrapolated to other animals, particularly in view of the low success rate in producing transgenic mice and the uncertainties with respect to the introduction and expression of the transgene in various animal species.

vi) Patentability of animals (Article 53(b) EPC)

Almost all Opponents relied on Article 53(b) EPC in their arguments against the patent in suit. The arguments advanced before new Rules 23b-23e EPC came into force and before decision G1/98 was issued were substantially that Article 53(b) EPC must be interpreted to exclude animals in general from patentability because it would not be logical to exclude animal varieties while allowing animals generically. Moreover, claims on animals embraced animal varieties and were therefore not allowable. T 356/93 (OJ EPO 1995, 545) should also be applied to animals. The claimed animals were the products of an overwhelmingly biological process and therefore not patentable.

More recent arguments advanced after the coming into force of Rules 23b-23e EPC and after the issuance of G 1/98 can be summarised as follows: O1 pointed out that the teaching of the patent only related to particular mouse strains and therefore to animal varieties, G 1/98 confirming the non-patentability of specific varieties was therefore still applicable. O8 and O10-O15 argued that the new rules should not be taken into account since the oppositions were filed long before the rules came into force. O13 added that the patenting of animals offended against two generally accepted principles, the principle that man had not invented living beings and the principle that living matter should not be patentable. Moreover, Rule 23c EPC only allowed process claims in view of the language "if they concern" plants or animals.

vii) "Ordre public" and morality (Article 53(a) EPC)

All Opponents relied on Article 53(a) EPC and a multiplicity of arguments was advanced. The arguments were either "categoric", i.e. they supported the non-patentability of animals in general, or they related to the weighing up of certain values with respect to the specific case. The arguments can be summarised as follows.

The impugned patent was granted by applying the balancing test of T 19/90, (OJ EPO 1990, 476), wrongly, thus the "careful weighing up" was not done properly in that the suffering outweighed the usefulness of the invention. In particular, evidence of the limited value of the invention had not been taken into account. The benefit to be gained from using the onco-mouse in research could at best be described as modest. Animal models in cancer research represented a very narrow spectrum only and other alternatives not using animals were available. Moreover, the weighing up approach was generally unsuitable to determine whether a particular development was contrary to morality, more suitable criteria were considerations that it was inherently immoral to alter an animal's genetic structure in order to create a painful disease, that something which was immoral could not become acceptable to morality because it was useful to mankind ("the ends justify the means"), and that animal patenting was out of step with both religious and modern secular beliefs.

The moral values prevalent in a society governed by the rule of law, i.e. what the majority believes to constitute right and wrong, was the decisive factor, even if the law could be seen as the primary embodiment of those moral values. Opinion polls clearly showed a negative attitude towards genetic alterations of animals causing them suffering.

The European Convention for the Protection of Animals in Agriculture, signed in Strasbourg in 1976, referred to the necessity of avoiding unnecessary suffering or injury of animals in agriculture. This applied to other animals as well. Animals as fellow-creatures to man had a right to integrity in their existence.

The special moral status of animals in contrast to inanimate matter had to be taken into account and a sui generis form of protection like the one for plant varieties would be more appropriate. Per se patent protection of animals should not be possible in principle but process protection to alter the genetic structure of an animal was not totally excluded. However, in the present case the suffering clearly outweighed the benefits and therefore also process protection should not be allowable.

XX. The Proprietor's counter-arguments can be summarised as follows :

i) Article 52 EPC:

The Proprietor pointed out that Article 52(4) EPC referred to the treatment of the animal body and a distinction must be made between living cells and an intact organism.

ii) Article 54 EPC

The Proprietor argued that Brinster et al. was published at the priority date at the very earliest, submitted evidence in this regard and pointed out that the onus of proof that publication took place prior to the priority date was on the Opponents.

iii) Article 56 EPC

The Proprietor referred to the viability of the obtained animals which was not predictable at all, that at most the present invention could be considered "obvious to try" but that a "reasonable expectation of success" had not existed.

iv) Article 57 EPC

The Proprietor argued that the requirement of industrial application applied to the invention as a whole and not to every specific embodiment of it. Even if not each and every embodiment was useful, the Proprietor should nevertheless be entitled to a fair protection. Moreover, Article 57 EPC did not require a commercial success but rather that the invention be susceptible of industrial application.

v) Article 83 EPC

In this regard the Proprietor mainly relied on Decision T 19/90 issued on the present case during examination and holding that the claims as later granted complied with the requirement of sufficiency of disclosure.

vi) Article 53(b) EPC

The Proprietor argued that it was a common finding in patent law that a broad claim was potentially interpretable as including within its scope subject-matter, which, if 'isolated' so as to provide a specific claim, might not be patentable. The distinction between animals and animal varieties in this article must have a meaning and it was not assumed that the legislator acted unintentionally. The Proprietor relied on the general finding of T 19/90 which was that Article 53(b) EPC does not exclude the patenting of animals as such. The key issue was the distinction between generic and specific subject-matter. The animals of the contested patent represented a generically applicable invention which was patentable under Article 53(b) EPC.

vii) Article 53(a) EPC

The Proprietor pointed out that morality in terms of exploitation should be interpreted liberally, emphasised the interest of the present kind of inventions to human patients, and submitted that the general views of patient organisations were of at least as much relevance in assessing public reaction as the views of groups the Opponents relied on. Many non-transgenic mice and rats used in toxicology today were characterised by very pronounced strain-specific patterns of cancer, thus the invention did not provide for something which was fundamentally different and morality should therefore be assessed in the same way. Traditional breeding methods had precisely the same objective, namely the production of living things which were tailored to particular human requirements. Moreover, animal testing remained a requirement in all Contracting States to the EPC in certain circumstances, suffering or no suffering being involved.

With reference to T 356/93 (supra) the issue of whether exploitation of an invention was contrary to conventionally accepted standards of conduct in European culture it was argued that the standard must not pick extreme views in either direction, but must seek for a consensus view, the standard must interpret the morality exclusion in a narrow manner, the standard must not attempt to aim for a level of morality which was not generally attained in European states, and must seek to adopt a common approach which was consistent with widely demonstrated current attitudes. Moreover, the assessment must be made with the standard prevalent at the date of the European filing (or the priority date) but not at any later date. The Opponents failed to provide any evidence concerning the public attitude at the filing date. Also in Rule 23d(d) EPC the words "likely to cause them suffering..." indicated examination of likely future events.

Rule 23d(d) EPC could be said to set a test for patentability of animals where suffering was experienced that required medical benefit to humans or animals which was at least potentially of substance and not illusory. However, the rule must not be interpreted such that "acquired rights" of the patentee would be taken away bearing in mind that the patent dated back to 1985 and the rule was a more recent product of the Administrative Council not having the power to override the EPC itself. In such a case the rule would be ultra vires in view of Article 164(2) EPC.

Reasons for the decision

Admissibility

1.1 All oppositions are admissible because they meet the requirements of Articles 99(1) and 100 and Rules 1(1) and 55 EPC.

1.2 In particular reference is made to decision G 3/99 (OJ EPO 2002, 347) of the Enlarged Board of Appeal headnote 1 of which reads "An opposition filed in common by two or more persons, which otherwise meets the requirements of Article 99 EPC and Rules 1 and 55 EPC, is admissible on payment of only one opposition fee." This finding of the Enlarged Board is followed by the Opposition Division and directly responds to the Proprietor's objections concerning the issue "multiple oppositions".

1.3 With regard to the second aspect raised by the Proprietor on admissibility the Opposition Division is satisfied that sufficient proof is available as to the status of legal person of the Opponents. The fact that some of them have indicated that they have supporters does not have a bearing on the legal nature of the Opponents proper.

In particular it is held that:

• The two joint Opponents of O1 have legal capacity under English law (see O1's communication of 16.03.1993).
• The six joint Opponents of O2 are all registered associations ("eingetragene Vereine") having legal capacity under German law (see O2's communication of 25.03.1993).
• O3 is a political party which under the German Parteiengesetz has the capacity to instigate court proceedings (see O3's communication of 10.03.1993).
• The opposition by O4 is a joint opposition by a natural person, a non-registered society consisting of several natural persons ("BGB-Gesellschaft") and a registered association. Under German law a BGB-Gesellschaft also has the capacity to instigate court proceedings (see Baumbach et al., Zivilprozessordnung, 60th ed., 2001, § 50, point 4 C).
• O5 is a parliamentary group ("Fraktion") of the Saxon Landtag which already had the capacity to instigate court proceedings before the Saxon Fraktionsrechtsstellungsgesetz entered into force on 01.01.1999. The travaux préparatoires relating to this law (see Sächsischer Landtag - Drucksache 2/8747 of 13.05.1998) make it clear that its provisions on the legal status of a Fraktion were meant to be declaratory rather than constitutive. The capacity of a Fraktion to instigate court proceedings had been widely accepted by German courts even before the enactment of specific laws (see Hölscheidt, S., Das Recht der Parlamentsfraktionen, 2001, p. 658 ff.).
• The joint Opponents of O6 are more than a thousand natural persons whose names can be identified in a list in the notice of opposition.
• O7 is a parliamentary group ("Fraktion") of the Bavarian Landtag which under Art. 1(2) of the Bavarian Fraktionsgesetz has the capacity to instigate court proceedings on its own behalf (see O7's communication of 13.07.1995).
• O8 is a corporation under public law ("Körperschaft des öffentlichen Rechts") having the status of a legal person (see O8's communication of 05.04.1993).
• O9 is a German Bundesland having the status of a legal person (cf. O9's communication of 05.04.1993).
• Both joint Opponents of O10 are natural persons.
• O11 consists of three joint Opponents who are all natural persons.
• O12 is a Swiss association with the status of a legal person (see annex to O12's notice of opposition).
• O13 consists of three natural persons acting as joint Opponents.
• O14 is a registered association which has the status of a legal person under Austrian law (see O14's communication of 26.03.1993).
• O15 consists of two associations having the status of legal persons under Austrian law (see O15's communication of 05.04.1993).
• O16 is a natural person.
• O17 is a registered association having the status of a legal person under German law.

1.4 O17's letter of 1 February 1993 does indeed not explicitly state an admissible ground of opposition but Article 100(a)/ 53(a) EPC is derivable from the wording of the letter implicitly. In the third paragraph reference is made to causing pain to animals, to the suffering of animals under immoral conditions and to health risks for the population. From this it becomes ascertainable that 'morality', a patentability requirement laid down in Article 53(a) EPC was the underlying motif for opposition under Article 100(a) EPC. The arguments can be reasonably correlated to the claimed subject-matter and it is to be noted that 16 other Opponents also opposed on the same grounds.

The above finding is also in line with the jurisdiction of the Boards of Appeal. In decision T 222/85 (OJ 1988, 128) the Board pointed out that a notice of opposition is sufficient if its content is properly understood to both the patentee and the Opposition Division on an objective basis. Sufficiency of the notice of opposition in this respect has to be distinguished from the strength of the Opponent's case. Confirming the above decision, T 925/91 (OJ 1995, 469) added that the assessment on an objective basis of the question as to whether the Opponent's case is properly understood by the patentee and the Opposition Division, must be made from the point of view of a reasonably skilled person in the art to which the opposed patent related. This is particularly important in the present case. A skilled person would immediately correlate the reasons contained in the opposition statement ('suffering of animals', 'health risks', 'immoral conditions') with criteria established by the Board of Appeal in decision T 19/90 in connection with Article 53(a) EPC, i.e. the so-called balancing exercise according to which the suffering of animals and the risks to the environment must be balanced against the invention's usefulness to mankind.

Article 52 EPC

2.1 Article 52(1) EPC makes reference to 'inventions' (without defining this notion) which have to fulfil certain criteria in order to be patentable. These criteria are novelty, inventive step and industrial application. Moreover in the context of Rule 27 EPC it becomes evident that an 'invention' must relate to subject-matter in a technical context, cf. Rule 27(1)(c) EPC referring to a technical problem and its solution. The present invention relates to transgenic animals and to methods of making and using them. The incorporation of a foreign gene into the genome constitutes a technical method and therefore fulfils the criteria of technicality of the invention. Moreover, the mere fact that living organisms are involved does not make any difference with regard to the technical character of the invention. The Opposition Division has therefore no doubt that the present type of invention is accessible to patent protection under Article 52(1) EPC provided that the above-mentioned other criteria are fulfilled.

2.2 To find a previously unrecognised substance or organism occurring in nature is a discovery. Very importantly, and in sharp contrast to the present situation, the substance or organism as such must occur in nature. The transgenic animals of the present invention having an artificially inserted oncogene do not exist in nature as such but are the result of a technical intervention by man. Therefore, the exclusion from inventions including discoveries under Article 52(2) EPC does not apply to the present case.

2.3 Article 52(4) EPC excludes from patentability (by applying the fiction of negating industrial application as a matter of principle) methods for treatment of the (human or) animal body by surgery or therapy and corresponding diagnostic methods. In this context it is important to note that all these methods must be practised on the animal body itself in order to be subject to this exclusion clause.

In the present case the incorporation of the oncogene into the genome is done at a cellular level, e.g. in the fertilised egg of an animal, and not into a living animal and thus into the animal body as referred to in Article 52(4) EPC. In addition, the incorporation of the oncogene into the genome is a method which is neither surgical nor therapeutic nor diagnostic in nature.

The Opposition Division follows the Proprietor's argument that a distinction must be made between living cells and intact organisms when considering the exclusion of Article 52(4) EPC and that therefore living cells of an animal cannot be equated with the body of an animal. Thus, the objection that claims 1-15 violate Article 52(4) EPC has to be rejected.

Novelty

3. All documents cited in the proceedings are far from being novelty destroying to the claimed subject-matter with the exception of Brinster et al., had it been published prior to the priority date of the present patent. Opponents alleged that it was prepublished on account of the date at which the article was submitted to the publisher but did not provide any evidence to this effect. On the other hand the proprietor was able to submit evidence (facsimile from the British Library dated 17 November 1995, attachment to the minutes of the oral proceedings in November 1995) which makes it plausible that publication occurred on 22 June 1984 (the priority date) at the earliest at the British Library. Further evidence was submitted (letter of Mr. Paul T. Clark dated 16 December 1988, also attached to the minutes) which is in line with the statement of the British Library ("it apparently is not possible that anyone could have received the Brinster article before the 22nd of June 1984"). Consequently, in the absence of any evidence to the contrary the Opposition Division is satisfied that the Brinster article was not published prior to the priority date. The claimed subject-matter of the impugned patent is fully supported by the disclosure in the priority document. This was also not disputed by the Opponents. Consequently, the Brinster article is not relevant to the assessment of novelty or inventive step.

Inventive step

4.1 As already pointed out under Novelty, the Brinster article is not pre-published and cannot be used as a document serving as a basis for inventive step considerations. With the exception of one document (Stewart T.A. et al. (1982), Science 217, 4546 cited by O16) Opponents did not cite pre-published documents with regard to inventive step but several documents were cited for novelty considerations. In the application of the problem-solution approach (requiring the determination of the closest prior art document), documents introduced into the proceedings under novelty will therefore also be considered.

4.2.1 Of the documents introduced into the proceedings the Opposition Division views

Jaenisch R. and Mintz B. (1974), Proc. Nat. Acad. Sci. USA 71, 1250 as the closest prior art. Stewart et al. (supra) has also been considered.

Jaenisch introduced sequences of the tumorigenic Simian virus 40 (SV 40) into mouse blastocysts. Healthy adult mice were obtained without apparent tumours at one year of age, although viral DNA was detectable in various tissues of the animals. The SV 40 genome appeared in some tissue but not in others. Thus, animals were created containing an oncogene in several parts of their bodies. The detectable augmentation of the amount of DNA that was micro-injected into the blastocyst supports the assumption that the SV40 DNA was chromosomally integrated into the host genome. Thus mosaic animals were obtained containing a transgenic oncogene, but no tumours were noted in these animals.

Stewart introduced a recombinant plasmid containing the human β-globin gene into fertilised mouse oocytes which was incorporated into the germline of the resulting mice. The utility of such a system for the in vivo studies of i.a. malignancy was contemplated.

4.2.2 The difference between Jaenisch and the impugned patent is that in the former

injection of an oncogenic DNA into the blastocyst resulted in mosaic mice harbouring the transgene in some tissues but not in others. In accordance with the contested patent the oncogene is injected into fertilised eggs, thus ensuring its presence in all the cells of the resulting animal.

4.2.3 The technical effect resulting from the above differences is the increased susceptibility

to cancer of the animals of the present patent. The technical problem underlying the present invention must therefore be seen in providing animals having this increased susceptibility. The solution to this problem are the animals as claimed in claim 19 and the process of making them as claimed in claim 1.

The Opposition Division has no reason to doubt that the claimed solution does indeed solve the technical problem as indicated above.

4.2.4 Although the generation of mice carrying exogenous transgenes was already known

from the prior art (e.g. Stewart et al.) as was the existence of oncogenes, the Jaenisch publication teaches the skilled person that mice carrying such an oncogene do not develop any tumours. In agreement with the Proprietor's arguments, the Opposition Division takes the view that there was no reasonable expectation of success in providing viable animals with increased susceptibility to tumour formation in accordance with the teachings of the present patent. The Opponents failed to provide convincing arguments to the contrary.

Consequently, Article 56 EPC cannot be considered to be a bar to patentability of the invention as claimed in the patent.

Industrial application

5. Article 57 EPC requires that an invention must be susceptible of industrial application.

This means that there must be a possibility and capability of the invention to be made or used in any kind of industry. As specific embodiments of the present invention, namely transgenic mice, were on the market there is clear evidence that the requirement of industrial application is fulfilled with respect to these embodiments. Whether this commercialisation was successful or not is irrelevant for considerations under patent law. With regard to further animal species covered by the patent the possibility and capability to be used in industry is plausible for many of them. The Opponent's reference to elephants, giraffes and blue whales is inappropriate in the light of the nature of the invention which is the provision of test animals for cancer. Moreover, the proprietor's argument that industrial application need not be demonstrated for each and every embodiment of an invention appears to be reasonable.

It is therefore considered that the requirement of industrial application is fulfilled by the claims of the patent as granted.

Sufficiency of disclosure

6.1 The matter of sufficiency of disclosure was already considered with respect to substantially the same claims as in the later granted patent. A Board of Appeal decided on this issue in the decision T 19/90, (OJ EPO 1990, 476). In view of the fact that the Opponents' arguments go in the same direction as the refusal during examination, consideration of the development at that time is still relevant for the present situation. It must, however, be borne in mind that, contrary to the proprietor's statements, the decision T 19/90 is not binding on the Opposition Division in accordance with Article 111(2) EPC. This article stipulates that the 'department' whose decision was appealed shall be bound by the ratio decidendi of the Board of Appeal in case of remittal. In the present case the 'department' in accordance with this article was the examining division, the newly established Opposition Division in the subsequent opposition proceedings is no longer the same 'department'.

6.2 The examining division, in refusing the corresponding application, inter alia, under Article 83 EPC substantially argued that the support in the description must be considered in order to judge as to whether an invention is sufficiently disclosed and the support related to mice only. Consequently subject-matter was embraced by the claims which could be performed only with undue burden. Thus, the guiding principle was offended which is that a skilled person must always be able to perform the invention over the whole range claimed without undue burden and without needing inventive skills.

6.3 In T 19/90, point 3.3, the Board held that "the mere fact that a claim is broad is not in itself a ground for considering the application as not complying with the requirement of sufficiency of disclosure under Article 83 EPC. Only if there are serious doubts, substantiated by verifiable facts, may an application be objected to for lack of sufficient disclosure." In point 3.8 the Board considered that the ruling of T 292/85 (OJ EPO 1989, 275) can also be applied to the present case. In the latter decision the Board held that a biological invention was considered sufficiently disclosed if it clearly indicated at least one way in which the skilled person could carry it out. Thus, the Board, in deciding T 19/90, upheld the claims under Article 83 EPC.

6.4 As pointed out previously, the arguments of the Opponents do not go beyond the arguments already used in examination proceedings and none of these arguments was at all substantiated by verifiable facts during the opposition proceedings. The Opposition Division, although not being bound by the ratio decidendi of T 19/90, does therefore not see any reason to conclude differently from this decision. Accordingly, the impugned patent complies with the stipulations of Article 83 EPC.

Applicability of Rules 23b to 23e EPC

7.1 With its decision of 16 June 1999, the Administrative Council of the European Patent Organisation implemented the relevant provisions of the Directive 98/44/EC of 6 July 1998 in European patent law and amended the Implementing Regulations of the EPC by adding a new Chapter VI on biotechnological inventions, i.e. Rules 23b to 23e EPC, to Part II of these Regulations. According to Article 2 of the decision, Rules 23b to 23e EPC entered into force on 1 September 1999. The decision does not contain any transitional provision. The question arises whether the new Rules are applicable to the present opposition proceedings which started long before their entering into force but which was concluded only thereafter with the decision taken on 7 November 2001.

7.2 As a general rule, in the absence of transitional provisions administrative and judicial bodies have to apply the law as it stands at the date when a decision is taken. This principle also applies to pending patent cases, be they in examination or in opposition. While it is arguable that under certain circumstances overriding considerations such as the protection of legitimate expectations or the doctrine of acquired rights might speak in favour of not applying new substantive patent law to patent applications already filed or to patents already granted, the Opposition Division adopts a cautious approach in this respect. An administrative or judicial body should restrain from autonomously establishing specific rules of transitional law unless the application of the new law would clearly violate fundamental principles of justice.

7.3 The Opposition Division considers that such an exceptional situation does not exist in the present case. The new Rules 23b to 23e EPC do not constitute a major departure from the previous law, but merely interpret the relevant provisions of the EPC (Articles 52 to 57) the text of which remains as it was before. Insofar as the legal situation has changed, this change remains in the framework of what could have been brought about by normal development of case law. Therefore neither the protection of legitimate expectations nor the doctrine of acquired rights restrict the applicability of new Rules 23b to 23e EPC in the present case.

Patentability of animals in accordance with Article 53(b) EPC

8.1 Legal framework and relevant case law:

8.1.1 Article 53(b) EPC stipulates that plant or animal varieties or essentially biological

processes for the production of plants or animals are excluded from patentability.

Rule 23c(b) EPC relates to the same issue and stipulates that inventions which are concerned with plants and animals are patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. By virtue of Rule 23b(1) EPC, Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation.

8.1.2 Decisions of a Board of Appeal directly addressing the issue of patentability of animals

do not exist with the exception of T 19/90, see supra. With regard to Article 53(b) EPC this decision contains several legal considerations highly relevant to the present issue. Firstly, it was held that exceptions to patentability have to be construed narrowly. Secondly, the appearance of the notions "animals" (in general) and "animal varieties" in the same half-sentence of Article 53(b) EPC is a clear indication that the term "animal varieties" was not intended to cover animals. In using the different terms in this way, the legislators cannot have meant "animals" in both cases. In its conclusion the Board states that if the subject-matter of the claims is not covered by any of the three terms "animal variety", "race animale" and "Tierart", then Article 53(b) EPC constitutes no bar to patentability.

8.1.3 Decision G 1/98, see supra, relates primarily to the patentability of plants under Article 53(b) EPC. It is the last of a series of decisions not all of which arrived at the same result, cf. T 356/93, see supra, and gives authority to the issue of the patentability of plants.

The Enlarged Board held (headnote I): "A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC even though it may embrace plant varieties". In its very detailed reasoning the Board concludes that the purpose of Article 53(b) EPC corresponds to the purpose of Article 2(b) of the Strasbourg Patent Convention (SPC): European patents should not be granted for subject-matter for which the grant of patents was excluded under the ban on dual protection in the UPOV Convention 1961 (point 3.6 of G 1/98).

8.2 The above-recited relevant articles and rules and the case law of the Boards of Appeal lead to the following conclusions:

8.2.1 Living matter and in particular plants and animals are accessible to patent protection. This has been laid down in Rule 23c(b) EPC and it is not only process protection but also product protection which is allowable when Recital 31 of Directive 98/44/EU is taken into account for interpretation. The latter points out that a plant grouping which is characterised by a specific gene (and not its whole genome) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants. Thus, the recital clarifies Rule 23c(b) EPC which admittedly could be interpreted differently by virtue of its language "if they concern plants or animals" in that product protection has been foreseen in the law. Although the recital refers to plants only since it mentions the specific protection scheme for plant varieties, Rule 23c(b) EPC could not be interpreted differently with regard to animals.

8.2.2 There is no doubt that the invention as claimed is applicable to more than just varieties of mice, see the reasoning under sufficiency of disclosure, items 6.1-6.4 above. Therefore, the argument that the patent relates to particular mouse strains and therefore to animal varieties which are not patentable under Article 53(b) EPC must fail. The feasibility of the invention is not confined to a particular animal variety in the meaning of Rule 23c(b) EPC.

8.2.3 Whereas G 1/98 makes reference to plants and not to animals, its holding can also be

transferred to the interpretation of the exclusion of animal varieties in Article 53(b) EPC. As far as plant varieties are concerned the purpose of Article 53(b) EPC, in following the purpose of the SPC, was the ban on dual protection with the UPOV Convention. The question arises then what the purpose of the SPC was in excluding animal varieties as well although no protection was visible at that time, nor at present, for animal varieties as products of animal breeding. The most obvious reason for this must have been the intention or at least the keeping open of the possibility to create such a law for the protection of animal varieties later on.

The argument of the Opponents that the legislator's intention was not to allow patents on animals in general, cannot be followed. If it was the purpose of Article 53(b) EPC to avoid double protection for plant varieties - this is one of the important findings of G 1/98 - the legislator, had he had in mind a different purpose for the exclusion of animal varieties, would have had to make this very clear by using appropriate language in the SPC and the EPC. The legislator has not done so. The equal linguistic treatment of plant and animal varieties in these bodies of law is a clear indication that the purpose of the exclusions must have been the same for both.

8.2.4 The allegedly inconsistent approach to allow protection for animals covering varieties

but not to allow protection on specific varieties was addressed in detail in G 1/98 with respect to plants, see point 3.3.3. The same reasoning can be applied to animals.

8.2.5 As is pointed out in T 19/90, see supra, the use of the different notions "animals"

and "animal varieties" in the same half-sentence of Article 53(b) EPC would be inappropriate if the same grouping of animals were meant to be covered. As this reasonably cannot be the case, the article must be interpreted on the basis of its clear wording, i.e. the exclusion is limited to varieties only and cannot extend to animals in general. The Opposition Division follows the findings of T 19/90.

8.3 For the above reasons it is considered that Article 53(b) EPC is no bar to patentability of the subject-matter claimed in the patent.

Patentability of animals under the morality provisions of Article 53(a) EPC

9.1 Legal framework and relevant case law:

9.1.1 Article 53(a) EPC prohibits the patenting of inventions the publication or exploitation of

which would be contrary to "ordre public" or morality.

9.1.2 Rule 23d(d) EPC addresses a specific item excluded under Article 53(a) EPC and

points out that patents concerning processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also the animals resulting from such processes, shall not be granted.

9.2 One decision of a Board of Appeal, T 19/90 (supra), deals with the issue of patenting

animals in the light of morality considerations, T 356/93 (supra) gives general guidelines concerning the approach to morality.

In T 19/90 the Board concluded that in a case in which suffering of animals and risks to the environment are conceivable there are compelling reasons to consider the implications of Article 53(a) EPC and the Board held that a balancing between certain values would be appropriate. These are the suffering of the animals and possible risks to the environment on the one hand and the invention's usefulness to mankind on the other.

In T 356/93 the Board defined the concept of "ordre public" as covering the protection of public security and the physical integrity of individuals as part of society, and the concept of morality to be one which is related to the belief that some behaviour is right whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture which, in the case of the EPC, is the culture inherent in European society and civilisation. Accordingly, inventions the exploitation of which was not in conformity with the conventionally accepted standards of conduct pertaining to this culture were to be excluded from patentability as being contrary to morality.

9.3 The Opposition Division would like to set out a few underlying principles in its approach to Article 53(a) EPC.

• In following accepted case law of the EPO, Article 53(a) EPC can only apply in exceptional cases. However, in accordance with T 19/90, the present case arguably belongs in this category of exceptional cases.
• Rule 23c(b) EPC in principle declares animals patentable subject-matter provided certain conditions are met. Consequently all arguments pointing out that patents on living matter or patents on animals are generally not allowable under Article 53(a) EPC must fail as a matter of principle.
• The Opposition Division has no intention to apply extreme positions in the assessment of the criteria of Article 53(a) EPC. This means that it will not take into account possible abuse of the invention on the one hand nor will it ignore or consider without due care the fact that the EPC contains "ordre public" and morality as criteria for patentability. It is considered that an approach taking into account both sides will be the right one.
• The balancing test as postulated in T 19/90 is superseded by Rule 23d(d) EPC containing a similar approach.
• For the purposes of Article 53(a) EPC, "ordre public" and morality have to be assessed primarily by looking at laws or regulations which are common to most of the European countries because these laws and regulations are the best indicator about what is considered right or wrong in European society. In so far as such laws or regulations concerning the relevant issue exist, it appears neither necessary nor appropriate to rely on other possible means of assessment such as public opinion polls which were relied upon or requested by several Opponents.

9.4 In applying the above principles to the assessment of "ordre public" and morality under Article 53(a) EPC for an invention which is concerned with test animals in medicinal research, statutory law regulating the use of such animals for testing is highly indicative because it shows whether the exploitation of the invention is de facto prohibited or not. The use of animals for experimental or other scientific purposes is allowed under certain conditions in most if not all of the states being party to the EPC. Directive 86/609/EEC regulates this use for the member states of the EU and similar provisions apparently exist in the remaining countries. It is therefore concluded that patenting of those animals of the present invention being useful as test animals in the sense of this Directive complies with the principle requirement of morality because the exploitation of the invention is explicitly allowed.

9.5 Following this finding of patentability in principle, the criteria of Rule 23d(d) EPC have to be applied as a second round in the assessment of patentability. The two relevant criteria requiring consideration are "suffering" and "substantial medical benefit to man or animal". If it is agreed that there is suffering, in accordance with this rule this suffering must be balanced by a substantial medical benefit. The assessment thereof raises two further issues: How does an Opposition Division ascertain whether there is suffering and whether the medical benefit was substantial and at which date must the assessment be made, at the effective date of the patent application or at the date the assessment is actually carried out.

With regard to the latter question a comparison with all other patentability requirements appears to be appropriate and it is noticed that all of them are to be assessed at the effective date. No reason is apparent to proceed differently under Article 53(a) or Rule 23d(d) EPC. The Opposition Division agrees with the Proprietor's arguments in this respect. Also, the wording of Rule 23d(d) EPC supports this conclusion: "which are likely to cause" hints on a future event and contains an element of probability. Had the legislator had in mind assessment at any given later date this element of probability would have been superfluous.

Concerning the suffering, the Opposition Division agrees with all parties in the proceedings that suffering exists - independent of the assessment date - once the test animals develop tumours.

Concerning the substantial medical benefit, since, as it was found above, it is to be assessed at the effective date of the patent, it follows that this assessment must be made with an element of probability and without taking into account later evidence as to the actual outcome of the exploitation. The decisive question is whether at the effective date the inventor had bona fide reasons to believe that his invention would have a substantial medical benefit. Thus, for the purposes of Rule 23d(d) EPC, the - undisputed - likelihood for suffering of the test animals is to be balanced against the bona fide belief of the inventor in a substantial medical benefit at the effective date of the patent.

In the present case, it cannot be denied that the animals of the invention were made for a good cause, namely progress in cancer research. In view of the new approach the inventor took vis-à-vis the problem of medical cancer testing at the time, there were bona fide reasons at the effective date to expect a substantial medical benefit. Rule 23d(d) EPC is therefore no bar to patentability of those animals covered by the patent which were found to be allowable under Article 53(a) EPC above (item 9.4).

10. The conclusion reached above can be summarised in that claims to animals as such and to processes for making them are allowable under Article 53(a) EPC to the extent that at least representative categories of the animals claimed fulfil the criteria of being test animals in accordance with laws in the member states of the EPC. The claims of the main request which are directed to non-human mammalian animals do not fulfil this condition because many categories of animals are covered by these claims not falling under the provision of being test animals. These claims are therefore not allowable under Article 53(a) EPC.

Auxiliary requests

11. The auxiliary requests 2, 2A, 3 and 3A contain the alleged limitation with respect to the definition of animals "said animal being for (experimental or) testing purposes". The Opposition Division considers that this wording does not limit the claim scope when applying the usual standards of claim interpretation, see Guidelines C-III, 4.8. A product claim to a substance in terms of patent law is normally not limited by indicating its use. This also applies to process claims the scope of which is determined by process features and the definition of the obtained products obtainable by applying the process parameters. Thus, these auxiliary requests must fail for the same reasons as the main request under Article 53(a) EPC.

12. Auxiliary request 4 is directed to rodents instead of non-human mammalian animals in the main request. The auxiliary request is not objectionable under Articles 123(2) and (3) EPC nor is it under Article 84 EPC. For the reasons already discussed, it also complies with the requirements of Articles 52, 53(b), 54, 56, 57 and 83 EPC.

Rodents comprise representative animal species useful for allowable animal testing. The Opposition Division considers that in the assessment of morality under Article 53(a) EPC the exact delimitation between "allowable" and "non-allowable" in the present case is not easily possible and also not absolutely necessary. Important is that representative categories of the claimed animals to be used in testing are allowable, accidental generically claimed non-allowable subject-matter under Article 53(a) EPC can be tolerated, the exploitation of the invention with regard to this subject-matter would not be legally possible anyway. The Opponents' argument that the scope of the claims should be limited to mice cannot be followed because this would exclude from protection categories of animals which are acceptable as test animals in the sense of Directive 86/609/EEC, supra. Thus, it is considered that Article 53(a) EPC does not prohibit the patenting of this invention when the claims are limited to rodents. The 4th auxiliary request is therefore allowable.

Other requests

13. O1, O8, O10-15 and the Proprietor requested an award of costs under Article 104 EPC out of central funds of the EPO. The request was based on the fact that the Opposition Division summoned to second oral proceedings which would not have been necessary had a decision been taken right away. The requests are refused because Article 104 EPC does not provide for such an award. It provides only for a different apportionment of costs between the parties.

14. Opponents' request that the entire "board" be dismissed on the grounds of partiality was rejected as an abuse at the first oral proceedings in 1995.

The Opposition Division endeavoured throughout the proceedings to find a solution in agreement with the EPC. A mere impression of partiality the Opponents might have had at certain stages of the proceedings cannot justify the replacement of the whole Opposition Division with all its necessary consequences, such as the need for re-opening the whole procedure.

Decision

The Opposition Division therefore decides that the patent as amended during the opposition proceedings by introducing auxiliary request 4 is found to meet the requirements of the European Patent Convention. The main request and auxiliary requests 2, 2A, 3 and 3A are rejected under Article 53(a) EPC.