T 0032/17 (Bispecific antibody/ DIASOURCE) 02-07-2020

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and

Rule 99 EPC and is admissible.

2. An amended version of the Rules of Procedure of the Boards of Appeal (RPBA) came into force on 1 January 2020. The transitional provisions are set out in Article 25 RPBA. In the present case, the statement of grounds of appeal and the reply thereto were filed before 1 January 2020. Therefore,

Article 12(4) RPBA 2007 continues to apply

(see Article 25(2) RPBA). The parties were notified of the summons to oral proceedings before 1 January 2020. Therefore, Article 13(1) and (3) RPBA 2007 continue to apply (see Article 25(3) RPBA).

3. The duly summoned opponents 1, 3, 4 and 5, were, as announced in advance, neither present nor represented at the oral proceedings. The board continued the proceedings in their absence, in accordance with Rule 115(2) EPC.

4. After the board's final decision had been announced at oral proceedings, opponent 4 withdrew their opposition. As the final decision became effective immediately on its announcement, the above mentioned withdrawal did not change opponent 4's status as a party to the appeal proceedings.

Main request - claim 2

The claimed subject-matter - claim construction

5. Claim 2 is drafted as a product-by-process claim. It is directed to a monoclonal antibody which is characterised by the functional feature "able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3**(") and by the process feature "produced from a hybridoma selected from the group consisting of the hybridomas deposited in the BCCM/LMBP under deposit numbers LMBP 7011CB, LMBP 7012CB, LMBP 7013CB, LMBP 7204CB and LMBP 7205CB."

6. In the decision under appeal the opposition division held that, as a consequence of the process feature, the claimed antibodies were characterised by a unique amino acid sequence because "deposit numbers allow to identify specific hybridomas" and "each antibody produced by a different hybridoma will have a different sequence (heavy and light chains) which renders the antibody unique." (see decision under appeal, Reasons, point 4.10).

7. The appellant contested the opposition division's construction of the claim. They argued that the claimed antibodies were only characterised by the functional feature "able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3" while the process feature did not confer any additional technical features on the claimed antibodies. The respondent disagreed and submitted that as a consequence of the process feature the specific amino acid sequence and indeed the entire chemical composition of the antibodies produced by the deposited hybridomas was a feature of the antibodies of claim 2.

8. According to the case law of the boards of appeal a process feature in a product-by-process claim only contributes to the novelty of a product claim insofar as it gives rise to a distinct and identifiable characteristic of the product (see e.g. decision

T 179/03, Reasons, points 3.7 to 3.9). The skilled person following the teaching of the patent must inevitably achieve that characteristic and must be aware of that characteristic so that they can recognise the claimed product and discard any products not having it (see e.g. decision T 412/93, Reasons, point 33 and decision T 1120/00, Reasons, point 7). Furthermore, the Enlarged Board of Appeal held that "[f]or a product-by-process claim to be allowable it needs to be established that (a) it is impossible to define the claimed product other than in terms of a process of manufacture and (b) the claimed product itself meets the patentability requirements of Article 52(1) EPC. Thus, the specific process needed to obtain the claimed product should make it possible to distinguish the inevitable product of the product-by-process claim over the prior-art" (see decision G 2/12, OJ EPO 2016, 27, Reasons, point IV.(5)).

9. At issue in the present case is thus whether or not the process feature in claim 2 "produced from a hybridoma selected from the group consisting of the hybridomas deposited (...)" gives rise to the specific amino acid sequence and chemical composition of the claimed antibodies and furthermore, whether the skilled person is made aware of these structural characteristics of the antibodies by the teaching of the patent.

10. The deposit information recited in claim 2, see

point 5. above, informs the skilled person (i) about the depositary institution, i.e. "BCCM/LMBP" and

(ii) the deposit numbers assigned to the deposited hybridomas by the depositary institution, i.e. "LMBP 7011CB, LMBP 7012CB, LMBP 7013CB, LMBP 7204CB and LMBP 7205CB".

11. From the hybridomas' deposit information the skilled person derives that hybridomas producing the claimed antibodies have been deposited and have been assigned deposit numbers.

12. This deposit information however does not convey any technical information about the chemical composition or molecular structure of the antibodies produced by these hybridomas, such as their amino acid sequence, either explicitly or implicitly.

13. The patent does not provide any information about the chemical composition or amino acid sequence of the antibodies produced by the deposited hybridomas either, e.g. in the form of a sequence listing (see also

Rule 30 EPC).

14. In view of the above considerations it is apparent that the chemical composition and/or the amino acid sequence of the antibodies produced by the deposited hybridomas cannot be inferred by the skilled person from the teaching of the patent in suit.

15. Finally, where a process feature is the only feature allegedly conferring novelty to a product, the burden of proof for showing the fact that the process feature results in a distinct and identifiable characteristic of the product - i.e. in the present case in the chemical composition and/or the specific amino acid sequences of the claimed antibodies - is on the patent proprietor and not on the opponent(s) (see also decision T 179/03, see points 3.9 and 3.14 of the Reasons).

16. The respondent's argument that the appellant could have determined the amino acid sequence of the antibodies produced by the deposited hybridomas can thus not succeed. The respondent has not discharged the burden of proof.

17. The board concludes from the above that the process feature does not impart any identifiable technical feature on the claimed subject-matter. The sole technical feature defining the monoclonal antibodies of claim 2 is thus the functional feature that they are "able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3".

The public prior use of the antibodies disclosed in

document D32

18. Document D32, a sales catalogue, discloses, inter alia, an anti-25 Dihydroxy-Vitamin D3 antibody. Two catalogue numbers, A 1025.1 and A1025.2, are given for the antibody, relating to different concentrations, 10 myg and 100 myg, respectively (see page 3, lines 10 and 11).

19. Based on the submissions before it, the opposition division concluded that the antibodies designated as A1025.1 and A1025.2 in document D32 were one and the same antibody (sold at different concentrations), that these antibodies bind to 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, were available to the public and had been sold before the priority date of the opposed patent (see decision under appeal, Reasons, points 4.1 to 4.8).

20. In other words, the opposition division held that a public prior use of antibodies that fulfil the functional feature characterising the antibodies of claim 2, see point 17. above, had been established by the opponents.

21. Nevertheless, the opposition division acknowledged novelty of claim 2 because they considered that the claimed antibodies were further characterised by their amino acid sequence, see point 6. above, and "based on the evidence provided by the opponents the Opposition Division cannot conclude that the antibodies referred to in D32 are produced by the same hybridoma and have the same heavy and light chains" (see decision under appeal, Reasons, point 4.10).

22. However, in view of the claim construction adopted by the board, see point 17. above, the opposition division's reasoning, see previous point, cannot hold.

23. During the written appeal proceedings, the respondent submitted two lines of argument in support of novelty of claim 2, see section XXII. above. In the view of the claim construction set out in point 17. above, both of these lines of argument fail because neither the antibodies' amino acid sequence nor their potentially different cross-reactivity profile is a feature of the claimed antibodies.

24. As a third line of argument, submitted for the first time during the oral proceedings before the board, the respondent argued that is was doubtful that the antibody disclosed in document D32 was indeed bispecific. In support of this new allegation of fact, the respondent relied on document D13.

25. The opposition division's finding that the antibodies designated as A1025.1 and A1025.2 in document D32 were one and the same antibody that bound to

25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, see point 19. above, had not been contested, either expressly or implicitly, by the respondent during the appeal proceedings before. The third line of argument thus represented an amendment of the respondent's case at the oral proceedings and its admittance into the appeal proceedings was therefore considered by the board.

26. Admittance of the amendment to the respondent's case was governed by the provisions of

Article 13(1) RPBA 2007, see point 2. above.

27. Pursuant to Article 13(1) RPBA 2007, an amendment to a party's case after the filing of the statement of grounds of appeal or reply may be admitted and considered at the board's discretion. That discretion "shall be exercised in view of inter alia the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy".

28. The board considered that admittance of the new line of argument on the basis of document D13 would have raised issues not previously addressed in the appeal proceedings and thus extended the scope of discussion as determined by the grounds of appeal and the respondent's reply at a very late stage of the proceedings.

29. Such an amendment of the respondent's case would normally make remittal to the opposition division necessary and at the very least, would have meant adjourning the oral proceedings in order to give the appellant an opportunity to respond appropriately. Admittance of the new line of argument would thus also not have served the interest of procedural economy.

30. In view of these considerations, the board, in the exercise of its discretion, decided not to admit the respondent's third line of argument into the appeal proceedings.

Conclusion on novelty of claim 2 of the main request

31. Claim 2 of the main request lacks novelty over the public prior use of the antibodies disclosed in document D32.

Auxiliary requests 1 to 3

Admittance into the appeal proceedings

Article 13(1) RPBA 2007

32. These requests were filed during the oral proceedings, after the board had expressed its opinion that claim 2 of the main request lacked novelty, see section XVII. above.

33. In auxiliary request 1, claim 2 of the main request had been amended while in auxiliary request 2, claim 2 of the main request had been replaced by a new claim, drafted as a "use" claim. In auxiliary request 3,

claim 2 of the main request had been deleted.

34. These claim requests represented yet another amendment to the respondent's case and their admittance was again governed by the provisions of Article 13(1) RPBA 2007, see point 2. above.

35. The provisions of Article 13(1) RPBA 2007 have been set out in point 27. above. In the case law of the boards of appeal the following criteria have, inter alia, been established for the consideration of the admittance of new requests pursuant to Article 13(1) RPBA 2007: (i) sound reasons exist for filing the request so far into the proceedings, (ii) the request does not extend the scope of discussion as determined by the grounds of appeal and the respondent's reply, (iii) and the request is clearly and obviously allowable in the sense that it is immediately apparent to the board, with little investigative effort on its part, that the amendments made successfully address the issue raised without giving rise to new ones (see Case Law of the Boards of Appeal, 9th edition 2019, V.A.4.5.1 a)).

36. Auxiliary requests 1 to 3 seek to address an objection, lack of the novelty of claim 2 of the main request, that has been raised in the statement of grounds of appeal of the appellant, see section VI. above and which was maintained by the appellant in the course of the written phase of the appeal proceedings, see section VIII. above. Thus, in light of these procedural circumstances, claim requests aimed at addressing this objection could have been submitted sooner, and no persuasive explanation for not filing auxiliary requests 1 to 3 earlier was provided.

37. Claim 11 as filed was relied on as providing a basis for the feature "wherein said monoclonal antibody has a recognition percentage of 25-hydroxyvitamin D2 and of 25-hydroxyvitamin D3 ranging from 70 and 110%" newly introduced into claim 2 of auxiliary request 1.

38. However, claims 9 and 10 as filed, on which claim 11 as filed depends, do not relate to the antibodies produced by the deposited hybridomas but to a generic monoclonal antibody. Thus, it was not directly and unambiguously derivable from claims 9 to 11 as filed that the antibodies produced by the deposited hybridomas also possessed the claimed level of recognition percentage. As a result, amended claim 2 of auxiliary request 1, raised prima facie an issue of added subject-matter under Article 123(2) EPC. Therefore, admittance into the appeal proceedings would not have served the interests of procedural economy.

39. In auxiliary request 2, a "use" claim had been introduced. Such a claim has not been pursued in the appeal proceedings before (and also not in the opposition proceedings). Due to the change in the claim category and thus, in the claimed subject-matter, it was not immediately apparent to the board, with little investigative effort on its part, that the amendment did not give rise to new issues which the board and the appellant could deal with without adjourning the oral proceedings.

40. In view of the above considerations, the board, in the exercise of its discretion under Article 13(1) RPBA 2007, decided not to admit auxiliary requests 1 and 2 into the appeal proceedings.

41. The board considered that the amendment in auxiliary request 3 - deletion of the claim corresponding to claim 2 of the main request - was straightforward and successfully addressed the novelty issue of the main request without giving rise to any new issues. The respondent explicitly did not object to the admittance of this request into the appeal proceedings.

42. The board decided to admit auxiliary request 3 into the appeal proceedings in the exercise of its discretion under Article 13(1) RPBA 2007.

Auxiliary request 3 - claim 1 (sole claim)

Novelty (Article 54(2) EPC)

43. The appellant raised two objections in the statement of grounds of appeal with regard to that claim, namely that: (i) the claimed hybridomas were not novel "because it was obvious that a monoclonal antibody must have been produced by a hybridoma (...), thus, rendering also the hybridomas producing such antibodies not novel"; (ii) the deposited hybridomas anticipated the claimed subject-matter, see section XXI. above. These objections are dealt with in point 45. and

points 46. to 49. below.

44. During the oral proceedings before the board the appellant raised a third objection, based on an alleged "toxic" priority document. This objection was not admitted into the appeal proceedings, see points 50.

to 53. below.

45. With respect to the appellant's first line of argument, see point 43. above, the board notes that the consistent view in the case law is that for an invention to lack novelty, its subject-matter must be directly and unambiguously disclosed in the prior art, while the question of what may be rendered obvious by that disclosure is not relevant (see also Case Law of the Boards of Appeal, 9th edition 2019, I.C.4.3). As the appellant has not referred to any prior art that directly and unambiguously discloses the claimed hybridomas, the appellant's first line of argument fails.

46. The appellant's second line of argument, see point 43. above, hinges on the proposition that deposits of biological material made pursuant to Rule 31 EPC render the deposited material - here hybridomas - available to the public on the date of that deposit.

47. According to Rule 33(1) EPC biological material deposited in accordance with Rule 31 EPC shall be available upon request to any person from the date of publication of the European patent application and to any person having the right to inspect the files under Article 128, paragraph 2, prior to that date.

48. In the present case, the European patent application was published on 4 May 2011, see section II. above. As of this date anyone knew about the existence of the deposited hybridomas and was entitled to obtain a sample of the deposited hybridomas from the BCCM/LMBP. The appellant provided no evidence that any person obtained a sample before that date.

49. On the basis of the evidence on file, the public availability of the deposited hybridomas thus post-dates the filing date of the application. The appellant's second line of argument thus also fails.

50. During the oral proceedings before the board, the appellant argued for the first time in the appeal proceedings that the first priority document of the opposed patent anticipated the claimed subject-matter, see section XXI. above for the full argument.

51. This new objection represented an amendment of the appellant's case and admittance was governed by the provisions of Article 13(1) RPBA 2007, see point 2. above.

52. The board considered that the objection was not only raised at a very late stage of the appeal proceedings but, in view of the Enlarged Board of Appeal's decision G 1/15 (OJ EPO 2017, 82, see Order), was also prima facie without any merit.

53. The board, in the exercise of its discretion, decided not to admit the appellant's late objection into the appeal proceedings.

Conclusion on novelty of claim 1 (sole claim) of auxiliary request 3

54. The sole claim of auxiliary request 3 meets the requirements of Article 54 EPC.

Inventive step (Article 56 EPC) - admittance of the objection into the appeal proceedings (Article 13(1) RPBA 2007)

55. The statement of grounds of appeal and the further written submissions of the appellant contained no objection of lack of inventive step of the subject-matter of claim 1.

56. It was only during the oral proceedings before the board that the appellant submitted that the claimed subject-matter lacked inventive step in the light of the disclosure of documents D2, D3, D8, D10, D47 and D52. No explanation for not submitting this objection earlier was provided by the appellant.

57. The new objection represented again an amendment of the appellant's case and its admittance was at the board's discretion pursuant to Article 13(1) RPBA 2007, see point 2. above.

58. The board held that the objection amounted to a new line of argument on the basis of new facts, i.e. the evidence in documents D2, D3, D8, D10, D47 and D52, not relied on earlier during the appeal proceedings, see section VI. above.

59. Admittance of such a "fresh case" would have meant remittal of the case to the opposition division to give the respondent the opportunity to adequately consider the appellant's objection and to respond appropriately. Admittance of the new objection would thus not have served the interest of procedural economy.

60. The board decided not to admit the appellant's new objection of inventive step into the appeal proceedings.

Sufficiency of disclosure (Article 83 EPC) - admittance of the objection into the appeal proceedings (Article 12(4) RPBA 2007)

61. Claim 1 is directed to hybridomas which are characterised by their deposit numbers, see sections VII. and XVII. above. In the statement of grounds of appeal the appellant submitted that the requirements of Article 83 EPC were not met because the patent did not provide the necessary guidance for the generation of these hybridomas, see section VI. above. This objection amounts to an allegation of fact.

62. Pursuant to Article 12(4) RPBA 2007, the board has discretion to hold inadmissible facts presented with the statement of grounds of appeal (or the reply thereto) if they could have been presented in the proceedings before the opposition division. The admittance hinges, inter alia, on the question whether a party was in a position to make its submissions earlier, and whether it could have been expected to do so under the circumstances (see Case Law of the Boards of Appeal, 9th edition 2019, section V.A.4.11.1).

63. Before the opposition division the appellant had argued that the requirements of Article 83 EPC were not met because the patent did not provide the necessary guidance to carry out the claimed process for the production of a hybridoma of claim 1 as granted (see section II. above for the wording of claim 1 as granted). With respect to the claimed hybridomas, i.e. the subject-matter corresponding to claim 1 under consideration, the appellant had acknowledged in the opposition proceedings "that the deposition of a hybridoma is an alternative disclosure for the respective hybridoma" (see notice of opposition, point 3.3.4 on page 10).

64. The objection under Article 83 EPC submitted with the statement of grounds of appeal could thus clearly have been raised in the opposition proceedings. Furthermore, no explanation was offered by the appellant why this objection had not been raised earlier. Finally, the board considered that the objection was prima facie without any merit. The disclosure requirement of Article 83 EPC is met by deposit of the hybridomas pursuant to Rule 31 EPC, as was also acknowledged by the appellant during opposition proceedings, see

point 63. above.

65. The board decided to hold the objection under

Article 83 EPC inadmissible under

Article 12(4) RPBA 2007.

Clarity (Article 84 EPC)

66. At the oral proceedings before the board the appellant submitted that claim 1 lacked clarity.

67. The board noted that claim 1 of auxiliary request 3 was a combination of claims 7 and 8 as granted, compare sections II. and VII. above, and thus not open to an objection under Article 84 EPC (see decision G 3/14,

OJ EPO 2015, A102).

Referral to the Enlarged Board of Appeal

(Article 112(1) EPC)

68. In written submissions, in the context of discussion of the board's preliminary opinion on novelty, the appellant submitted that the law, in particular

Rule 31 EPC (in their letter of 5 June 2020 the appellant inadvertently referred to Rule 28 EPC), had been interpreted by the board in a way which diverged from case law. It was argued that the proposed questions had to be answered (apparently in the negative) because otherwise any biological material deposited under Rule 31 EPC would automatically represent patentable subject-matter. During the oral proceedings the appellant reiterated the request to refer the questions filed during the oral proceedings (see section XVIII. above) to the Enlarged Board of Appeal. These questions concern the interpretation of Rule 31 EPC in the context of novelty as well as inventive step.

69. Pursuant to Article 112(1)(a) EPC, the boards of appeal refer questions to the Enlarged Board, either of their own motion or upon request from a party, in order to ensure uniform application of the law or if a point of law of fundamental importance arises, if they consider that a decision is required for the above purposes and if the answer to that question is not obvious.

70. In the board's assessment of novelty of the subject-matter of claim 1 of auxiliary request 3 "non-described characteristic of a biological material deposited under Rule 31 EPC" played no role; furthermore, the objection concerning absence of an inventive step was not admitted into the appeal proceedings. The requirements for a referral were therefore not fulfilled. Accordingly, appellant's request was rejected.

Conclusion

71. Auxiliary request 3 is allowable.