EP 2 817 000 B1 relates to oral pharmaceutical compositions comprising dabigatran etexilate mesylate.
Brief outline of the case
The OD decided maintenance according a new MR= MRn.
Opponent 1 withdrew its opposition and opponents 2+3 appealed.
The board held that claim 1 as maintained lacked IS over D1=WO 2012/001156.
The board decided maintenance according to AR3, and remitted for further adaptation of the description.
The case is interesting for two reasons:
- The board decided that the correction under R 139 allowed by the OD was not correct, and that the patent could only be maintained with the correction being rescinded.
- The board admitted D 48.
The proprietor’s point of view on the amendment under R 139
In example 3, paragraph [0088] of the patent, the original reference to US 2006/074056 was replaced by a reference to WO 2003/074056.
The proprietor considered the amendment was the correction of an obvious error and hence allowable. The correction would have been immediately apparent when doing a patent literature search with the name of the active ingredient and the part of the publication number, namely “074056” and any country code and publication year and provided the result of a PatBase search (D29).
The proprietor further argued that also the PatBase search results provided by Opponent 2 (D31) indicated that only the first patent family including the patent WO 03/074056 made sense in the present context.
During the OP the proprietor argued that all the documents of one family would disclose the same subject-matter so that the actual choice made was not critical.
The board’s decision on the amendment under R 139
No literature search should be required to find the correction since an obvious correction in the sense of R 139. It can only be based on the original application and CGK.
The PatBase search performed by the proprietor (D29) using the search term “PN = *074056” was based on hindsight knowledge of the correct publication number.
A further search with the search term “PN = US2006*” retrieved 14 hits (D31). It was therefore not immediately apparent that nothing else than the suggested correction was meant.
Independently of the issue of whether the family 1 of D31 would be the only one relevant in the context of the present patent, it is still the case that said patent family in D29 or D31 includes a very large number of individual patents, including WO03/074056 but also for example US2003/181488. There is therefore more than one possible correction.
The board held that the proprietor’s argument that all the documents of one family would disclose the same subject-matter so that the actual choice made was not critical, is not conclusive.
Firstly this is not a criteria under R 139 and secondly there is no evidence that all the documents of this specific family do indeed have the exact same content.
As a result, the second condition for allowing a correction under R 139 EPC is not met and the amendment thus infringes the requirements of Art 123(2).
Late filing of D48
D48 was submitted by opponent 3 and its admittance had to be decided on the basis of Art 13(2) RPBA.
D48 is a copy of the order of the “Landgericht München I” dated 30.12.2025 to stay the infringement proceedings initiated by the proprietor until the board has decided on the present appeal.
The proprietor argued that the submission of the copy of the decision a few days before the OP, was extremely late and that there was insufficient time for the it to review and react to the submitted order and accompanying arguments of opponent 3.
The board’s decision on the admissibility of D48
The board observed that, while not being bound by decisions of national courts, such decisions are nevertheless taken into account by the boards.
D48 of 30.12.2025 was filed very shortly after its issuance. The board was therefore satisfied that there are exceptional circumstances justifying the filing of D48 only at a late stage.
The proprietor actually initiated the infringement proceedings in front of the “Landgericht München I” and must necessarily have been aware of the content of D48, even before its submission by Opponent 3.
Moreover, neither D48 nor the accompanying letter of Opponent 3 provide any new argument. The objection that the alleged effect would not be technically useful had indeed already been raised by Opponent 3 in their statement of grounds of appeal
Comments
Correction under R 139
The amendment sought by the proprietor related to the identification of a prior art document mentioned in the introductory part of the description.
The decision is interesting in that it makes clear that R 139 applies to any part of the original filing, and reminds that a correction under R 139 is only possible in the absence of any doubts about the correction.
The headnote 1 of G 11/91, makes clear that a correction under R 139 is of a strictly declaratory nature and for this reason, it does not infringe Arte 123(2).
Late filing of D 48
Starting an action before national court and refusing that an opponent informs the board about it, is bordering on bad faith from the side of the proprietor.
On the procedure
The patent bears, inter alia, the classification units A61K9/50 and A61K31/4439.
D1=WO 2012/001156, not mentioned in the ISR carried out by the EPO, bears, inter alia, the classification units A61K9/50 and A61K31/4439.
The title of D1 is “Pharmaceutical oral dosage forms comprising dabigatran etexilate and its pharmaceutical acceptable salts.
It is thus surprising that D1 was not found during the IS carried out by the EPO.
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