T 1589/21 (Vaccine comprising non-live antigens/INTERVET) 28-02-2023

Admittance of documents D54 and D55 (Article 13(2) RPBA)

1. Documents D54 and D55 were submitted after the board had issued a summons to oral proceedings and a communication in preparation for the oral proceedings setting out its preliminary opinion.

Admittance of documents D54 and D55 into the proceedings is governed by the provisions set out in Article 13(2) RPBA, in force since 1 January 2020 and applicable pursuant to Article 24 RPBA.

Under Article 13(2) RPBA, any amendment to a party's appeal case made after notification of a summons to oral proceedings is, in principle, not to be taken into account unless there are exceptional circumstances, which have been justified with cogent reasons by the party concerned.

2. According to the appellant, document D54 was submitted as proof that a dose-effect relationship existed for any vaccine, and document D55 was submitted as proof that Mycoplasma hyopneumoniae (Mhyo) only affected pigs. These documents did not need to be filed earlier because Article 123(2) and Article 76(1) EPC were not part of the appeal, the opposition division having decided that Article 100(c) EPC did not prejudice the maintenance of the patent.

3. This argument is, however, not persuasive because the opponent had already argued in opposition that omitting the target animal and the precise nature and dosage of the recited antigens in the claim was an unallowable intermediate generalisation, as evident, for example, from point 2.2.2 of the decision under appeal. Documents D54 and D55 thus could have been submitted in opposition proceedings in response to these objections, irrespective of the fact that the opposition division came to the conclusion that the claims as granted complied with Article 123(2) and Article 76(1) EPC.

4. Moreover, neither the respondent in the reply to the statement of grounds of appeal nor the board in its communication issued in preparation for the oral proceedings had disputed that Mhyo only affected pigs and that a dose-effect relationship existed for vaccines. The appellant's argument that documents D54 and D55 were filed in response to new objections raised in the respondent's reply to the appeal is therefore not persuasive either.

5. In a further line of reasoning, the appellant submitted that a party must be able to rely, at any stage of the proceedings, on common general knowledge and provide proof for that. This argument implies that a board does not have discretion to disregard documents (allegedly) supporting common general knowledge. However, the board cannot derive any such limitation from the EPC or the RPBA. The documents are evidence supporting allegations of fact which, under Article 114(2) EPC, may be disregarded if not submitted in due time by the party concerned. Article 12(3) and (5) RPBA confirms the board's discretionary power in this respect. The board therefore sees no reason for any preferential treatment of evidence for alleged common general knowledge. This is also in line with e.g. decision T 85/93, OJ EPO 1998, 183 (see also Case Law of the Boards of Appeal of the European Patent Office, 10th edition 2022, V.A.5.13.1(c)).

6. In view of the above considerations, none of the reasons submitted by the appellant justified submitting documents D54 and D55 at this late stage of the proceedings. The board therefore decided not to take them into account under Article 13(2) RPBA.

Main request (patent as granted) - claim 1

Amendments (Article 100(c) EPC)

7. For the purpose of assessing whether or not the claim contained subject-matter that extended beyond the content of the application and the earlier application, reference is made only to the application since the relevant disclosures in the descriptions of the application and the earlier application are identical.

8. One of the issues with respect to the amendments was whether or not the application and the earlier application disclosed the purpose recited in the claim, i.e. protection against Lawsonia intracellularis, Mhyo and Porcine circo virus (PCV), in combination with the claimed vaccine and the administration route and scheme recited in the claim (intramuscular administration of the vaccine only once).

9. Example 3 is the only passage in the application that discloses the administration of a composition of the three non-live antigens of the pathogens Lawsonia intracellularis, Mhyo and PCV as defined in the claim to subjects (pigs) intramuscularly and only once. However, as also disclosed in Example 3, after a single intramuscular injection, no Mhyo antibodies could be detected (see page 16, lines 6 to 8 and Table 5 of the application). Mhyo antibodies were only detected when a second ("booster") vaccination was given (ibid.).

10. In the application, however, the suitability of the combination vaccine for protecting against the three pathogens is linked to achieving particular Mhyo and PCV antibody titres. This is evident from page 18, lines 1 to 6 of the application, which discloses that "given the fact that the combination vaccine provided titres for Mhyo and PCV antibodies to a level comparable with the levels obtainable with available single vaccines that are adequate to combat these micro-organisms, it has been demonstrated that a combination vaccine comprising non-live Lawsonia intracellularis antigens in combination with Mhyo and PCV antigens is suitable to combat [the three pathogens]". This passage thus links the effectiveness of the combination vaccine against Mhyo to Mhyo antibody titres comparable with those achieved with prior-art vaccines. As set out in point 9. above, however, such Mhyo antibody titres were only obtained when the vaccine was administered twice (see Table 5 of the application).

11. Thus, the information conveyed to the skilled person by Example 3 of the application is that the claimed vaccine does not confer protection against Mhyo when administered intramuscularly only once, yet the contrary is claimed, i.e. that it does confer such protection (see section I.). The claimed subject-matter hence relates to new technical information which is not directly and unambiguously derivable from the application.

12. The opposition division held that achieving the purpose recited in the claim was only a matter of sufficiency of disclosure, not of added subject-matter. In line with decision T 2593/11 (Reasons 3.4), it was sufficient that the inventors had "thought of" protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the claimed vaccine only once. This was evident from the purpose of Example 3 described in lines 2 to 4 of page 14 of the application and from the vaccination experiment carried out for Group 2 of Example 3 (see the sentence bridging pages 14 and 15 of the application).

13. Line 2 of page 14 of the application discloses that the purpose of Example 3 was "to test" a combination vaccine comprising killed whole cells of Lawsonia intracellularis and antigens of Mhyo and PCV. However, a mere statement that a vaccine test experiment was conducted, without disclosing any results, does not amount to a disclosure of the tested vaccine for a specific therapeutic purpose. As such, lines 2 to 4 on page 14 of the application do not disclose protection against the three pathogens by the test vaccine. The same is true for the sentence that bridges pages 14 and 15 of the application. This sentence merely describes that "Group 2 was vaccinated intramuscularly once with 2 ml combi vaccine at 25 days of age" but does not disclose any results of the vaccination. Hence it also fails to provide a direct and unambiguous disclosure of effective protection against the three pathogens recited in the claim by the claimed vaccine.

14. The board considers that this conclusion is in line with the established case law on novelty of second medical use claims. By way of example, mere statements that a particular therapy is being explored do not amount to a novelty-destroying disclosure of a second medical use claim which includes the achievement of this therapy as a technical feature (T 1859/08, Reasons 13), and a document that describes the administration of a compound to diseased subjects but neither explicitly nor implicitly discloses an effective treatment of the disease by this compound does not directly and unambiguously disclose this treatment (T 239/16, Reasons 5.2 and 5.3). Although this case law is on novelty and not on added subject-matter, the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (G 2/10, OJ EPO 2012, 376, Reasons 4.6, citing G 1/03, OJ EPO 2004, 413, Reasons 2.2.2).

15. In line with this case law, the disclosure in the application that pigs were vaccinated with a combination vaccine comprising antigens of the three pathogens by intramuscular administration of the vaccine only once does not per se amount to a disclosure of protection against these three pathogens by this vaccine via this administration route and scheme. Moreover, as set out above (see point 9.), Example 3 in fact discloses that no protection against Mhyo could be obtained by an intramuscular administration of the combination vaccine only once. Therefore, Example 3 of the application does not directly and unambiguously disclose a vaccine comprising in combination non-live antigens of Lawsonia intracellularis, Mhyo and PCV for use in protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the vaccine only once.

16. As an additional basis for the purpose recited in the claim, the appellant referred to the general disclosure of the object of the invention on page 4, lines 4 to 8 of the application. However, page 4 of the application merely discloses that it was "an object of the present invention to provide a vaccine to combat Lawsonia intracellularis, and at the same time combat one or more other swine pathogens" and that "[t]o this end a vaccine has been devised that comprises in combination non-live antigens of Lawsonia intracellularis, Mycoplasma hyopneumoniae and Porcine circo virus, and a pharmaceutically acceptable carrier".

17. Hence, this passage neither discloses any details on the composition of the vaccines nor contains any teaching on administration schemes, so it is not a basis for the claimed subject-matter whether read alone or in combination with the disclosure in Example 3. The case in hand is therefore different from that underlying decision T 2593/11, in which the deciding board held that a particular feature recited in the claim was disclosed in the general part of the description as an equally suitable option to that exemplified in the application's examples. It was this literal disclosure of the particular feature that was considered sufficient for complying with the requirements of Article 123(2) EPC (see T 2593/11, Reasons 3.3). Since, in the case in hand, the application does not contain any general disclosure of administering a vaccine intramuscularly only once, decision T 2593/11 is irrelevant.

18. In view of the above consideration, claim 1 contains subject-matter that extends beyond the application (and the earlier application). The ground for opposition under Article 100(c) EPC thus prejudices the maintenance of the patent as granted.

Auxiliary requests 1 and 2

Amendments (Article 123(2) EPC and Article 76(1) EPC)

19. Compared with claim 1 of the patent as granted, claim 1 of auxiliary request 1 comprises the additional feature that the vaccine is administered to a pig, and claim 1 of auxiliary request 2 specifies that the vaccine comprises an adjuvant (see section IV.). Claim 1 of each of auxiliary requests 1 and 2 is thus directed to a vaccine comprising in combination non-live antigens of Lawsonia intracellularis, Mhyo and PCV, for use in protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the vaccine only once.

20. The same considerations on added subject-matter as for the claim of the patent as granted apply to the claim of each of auxiliary requests 1 and 2 with respect to the combination of the purpose and the administration route and scheme recited in the claim (see points 7. to 18. above). Claim 1 of each of auxiliary requests 1 and 2 therefore contains subject-matter that extends beyond the content of the earlier application and the application for the same reasons as claim 1 of the patent as granted. It thus does not meet the requirements of Article 76(1) EPC and Article 123(2) EPC.

Auxiliary requests 3 and 4

Admittance (Article 12(4) and (6) RPBA, Article 13(2) RPBA)

21. Auxiliary requests 3 and 4, resubmitted with the statement of grounds of appeal, had first been filed by the appellant during the oral proceedings before the opposition division. The opposition division decided not to admit these requests into the proceedings because they were filed after the final date for making written submissions set under Rule 116 EPC and did not prima facie overcome the lack of sufficiency of disclosure found to be present for the invention defined in the claim of auxiliary request 2.

22. Pursuant to Article 12(6) RPBA, the board does not admit requests, facts, objections or evidence which were not admitted in the proceedings leading to the decision under appeal, unless the decision not to admit them suffered from an error in the use of discretion or unless the circumstances of the appeal case justify their admittance.

23. The appellant did not argue that the opposition division's decision not to admit auxiliary requests 3 and 4 into the proceedings suffered from an error in the exercise of the division's discretion, nor can the board recognise any such error.

24. However, the appellant argued that since the board had a different opinion on added subject-matter from the opposition division, the appellant's situation had changed. The board understands this to mean that in the appellant's view admitting auxiliary requests 3 and 4 was justified by particular circumstances of the appeal case under Article 12(6) RPBA or owing to exceptional circumstances under Article 13(2) RPBA which would justify resorting to these auxiliary requests at a subsequent stage of the appeal proceedings.

25. This argument is, however, not persuasive. The respondent had already argued in opposition that the lack of the definition (and presence) of the adjuvant resulted in an unallowable amendment (see section 2.2 on pages 6 to 8 of the respondent's notice of opposition), so auxiliary requests dealing with this objection could already have been filed during the written proceedings before the opposition division. Furthermore, the respondent had repeated this objection in the reply to the appeal (see the last paragraph of section 3.1.3 on page 7 of the reply). In its preliminary opinion, contained in the communication issued in preparation for the oral proceedings, the board merely agreed with the respondent on this issue. The appellant's situation on appeal had therefore not changed compared with that in opposition, nor had this issue been raised for the first time by the board in its communication issued in preparation for the oral proceedings.

26. In view of the above considerations, the opposition division's decision not to admit auxiliary requests 3 and 4 did not suffer from an error in the use of the division's discretion, nor did the circumstances of the appeal case justify admitting and considering these auxiliary requests under Article 12(4) and (6) RPBA. There were no exceptional circumstances within the meaning of Article 13(2) RPBA either. The board thus decided not to admit auxiliary requests 3 and 4 into the appeal proceedings.

Auxiliary request 5

Admittance (Article 13(2) RPBA)

27. Auxiliary request 5 was submitted after the board had issued a summons to oral proceedings and the communication in preparation for the oral proceedings setting out its preliminary opinion. Admittance of auxiliary request 5 is subject to the provisions set out in Article 13(2) RPBA (see point 1. above).

28. Claim 1 of auxiliary request 5 has been amended compared with claim 1 of the patent as granted in that the claimed vaccine comprises an adjuvant and is administered to a pig (see section VIII.). It was, however, already argued in opposition that the claim lacked several features of Example 3's vaccination protocol necessary for achieving the therapeutic effect recited in claim 1 of the patent as granted. These features included inter alia the definition of the vaccinated animal and the presence of an adjuvant. An auxiliary request in which the animal type was defined and the claimed vaccine comprised an adjuvant could thus have already been filed in the opposition proceedings in response to these objections.

29. In its preliminary opinion, the board had indicated that the (successful) vaccination of an animal appeared to depend on each of several parameters of Example 3 not present in the claim. The board, however, did not point to a specific new combination of missing parameters, as argued by the appellant, but merely provisionally agreed with the respondent's opinion, expressed in the reply to the appeal (see sections 3.1, 3.1.1, 3.1.2 and 3.1.3 on pages 3 to 8 of the reply), that several parameters, including the animal and the presence of an adjuvant, appeared to be necessary for achieving the purpose recited in the claim. The board's communication thus did not raise any new objections, so no new situation arose which could justify filing the claims of auxiliary request 5 at this late stage of the appeal proceedings.

30. The board therefore could not discern any exceptional circumstances that would have justified taking auxiliary request 5 into account at this stage of the proceedings, so it decided not to admit auxiliary request 5 pursuant to Article 13(2) RPBA.