T 0919/21 - Patent maintained as granted and auxiliary requests

Key points

• The opponent appeals the decision to reject the opposition. The OD found claim 1 as granted to be sufficiently disclosed.
• "Claim 1 of the main request (patent as granted) reads as follows: "1. A method for producing coagulation factor IX with an improved glycosylation pattern in a cell culture comprising: culturing mammalian cells that contain a gene encoding a coagulation factor IX in a cell culture medium comprising between 10 nM and 600 nM manganese under conditions and for a time sufficient to permit expression of coagulation factor IX, wherein the glycosylation pattern of the expressed coagulation factor IX is more extensive than the glycosylation pattern observed under otherwise identical conditions in otherwise identical medium that lacks the manganese, "
• The Board, after an extensive technical analysis, concludes that: "the patent does not contain any data that credibly demonstrate that a FIX with a more extended glycosylation pattern can be produced in a cell culture medium comprising between 10 nM and 600 nM manganese than in an otherwise identical medium that lacks the manganese."
• " Claim 1 of each of auxiliary requests 14 and 15 [filed by the patentee with the reply to the appeal] comprises the feature that the glycosylation pattern of the expressed FIX is at Ser-61"
• "Apart from being late filed, contrary to the obligation under Article 12(4) RPBA that a party should provide reasons when filing an amendment, the respondent's reasons are not persuasive. The objection that only the glycosylation at Ser-61 in FIX had been investigated in the patent although FIX contained multiple other glycosylation sites had been raised in the notice of opposition (page 17). Therefore, auxiliary requests responding to this objection could have been submitted in the opposition proceedings.
• As a comment, the Board uses "could". However, Art. 12(6) RPBA uses "should".
• Moreover, since the opposition division maintained the patent as granted, the OD would not have arrived at the requests even when filed before the OD. Hence, for the judicial review of the OD's decision, the filing or not of the auxiliary requests does not matter.
• However, it is not entirely clear to me if the amendment addresses the Board's reasons for finding claim 1 as granted to be insufficiently disclosed. In that case, the Board could have rejected the requests as unallowable.
• See also the consideration of the admissibility of Auxiliary Requests II - IV in case T 1673/22: "Similarly, the appellant (proprietor) chose not to file auxiliary requests II-IV, because claim 1 of these requests corresponds to claim 1 of auxiliary requests 2-4 which was considered unallowable [by the OD]".

EPO 

You can find the link to the decision and an extract of it after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t210919eu1

18. Claim 1 of each of auxiliary requests 14 and 15 comprises the feature that the glycosylation pattern of the expressed FIX is at Ser-61 (see section III.). When submitting these claim requests, the respondent indicated for auxiliary request 14 that the amendment was made "in response to the objections raised by the opponents under A100 (a) and (b) EPC" and that it "may address, if necessary, any argument of the opponent that increasing the extent of glycosylation is not relevant for factor IX as therapeutic agent" (section 7.8 of the reply to the appeal).

19. No further substantiation was given in the reply to the appeal as to why the amendment overcame the objections raised. Only in a later submission (see section V.) and during the oral proceedings before the board, the respondent claimed that this feature overcame the appellant's objection that glycosylation of FIX was only analysed at this amino acid residue and that it had not been necessary to submit auxiliary requests dealing with this objection during the opposition proceedings because the opposition division's preliminary opinion had been in favour of the respondent in this aspect.

20. Apart from being late filed, contrary to the obligation under Article 12(4) RPBA that a party should provide reasons when filing an amendment, the respondent's reasons are not persuasive. The objection that only the glycosylation at Ser-61 in FIX had been investigated in the patent although FIX contained multiple other glycosylation sites had been raised in the notice of opposition (page 17). Therefore, auxiliary requests responding to this objection could have been submitted in the opposition proceedings.

21. The respondent's further argument (submitted in reply to the board's communication) that the amendments did not create any new issues and did not add any complexity cannot be accepted either, at least because the newly added feature that the glycosylation at Ser-61 of FIX is assessed was added from the description of the application and was not present in any dependent claim of the patent as granted. Prior to the filing of auxiliary requests 14 and 15, the appellant therefore did not have to consider the impact of this feature on any of their objections.

22. Consequently, auxiliary requests 14 and 15 should have been submitted in the proceedings before the opposition division. No particular circumstances of the appeal case are apparent or were invoked by the respondent that could justify the filing of these auxiliary requests only in the appeal proceedings. Therefore, auxiliary requests 14 and 15 cannot be considered in the appeal proceedings, pursuant to Article 12(6) RPBA.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.