R 0001/19 (Fundamental violation of the right to be heard) 17-10-2019

1. Admissibility.

The petition is timely filed and sufficiently reasoned. The petitioner is also adversely affected by the decision under review. The ground invoked by the petitioner corresponds to a ground mentioned in Article 112a EPC. As regards the obligation to raise an objection during the appeal proceedings in relation to the procedural defect (Rule 106 EPC), the Enlarged Board is satisfied that it could not be raised, as the alleged procedural defect only became apparent in the written reasoned decision. The petition is therefore admissible.

2. Allowability.

2.1 As correctly stated by the petitioner the right to be heard implies that a decision may only be based on grounds or evidence on which the parties concerned had an opportunity to present their comments. A party may not be taken by surprise by the reasons of a decision, referring to unknown grounds or evidence. "Grounds" is to be understood as meaning the essential legal and factual reasoning on which a decision is based. This requirement is fulfilled when the reasons in the written decision correspond to the facts of the case and the arguments put forward by any of the parties to the proceedings, so that they were aware of them and could have commented upon them.

2.1.1 The petitioner firstly alleges that the reasoning of the board contained elements that were unknown to it, and on which it was therefore not heard. The Enlarged Board therefore firstly has to establish whether this allegation is correct.

2.1.2 The petitioner has pointed to a passage from the decision under review, which it alleges contains arguments that were not raised by the opponents, in particular opponent 4, and were never raised by the board. This passage is on p. 23-24 of the decision and reads as follows: "Skin delivery may certainly be regarded as a factor which has an impact on therapeutic efficacy; after all that is why skin permeation data were determined in D46. For that reason, the board agrees with the appellants' argument that it has not been rendered credible by the meta-analysis of document D11 that any non-aqueous composition covered by the scope of claim 1 (...) would provide improved therapeutic benefit over the alternating combination regimen disclosed in document D21".

The petitioner distinguished in this passage 2 distinct arguments:

A. skin delivery may be regarded as a factor which has an impact on efficacy

B. skin permeation data were therefore (that is: to show the impact on efficacy) determined in D46.

Not only are according to the petitioner these arguments incorrect and not backed up by evidence, but they were also not raised by opponent 4 in its grounds of appeal and more importantly not raised during the oral proceedings.

2.1.3 The Enlarged Board disagrees with the petitioner. Argument A corresponds to the argument made in the grounds of appeal of opponent 4, where it reads in paragraph 123 (see page 29) "It can fairly be assumed that these differences in drug delivery will have a significant impact on the efficacy of the respective combination formulations, since the delivery of the drug is a precondition for obtaining a pharmacological effect." The research underlying the results of D46 was described as follows: "In D46, the influence of the vehicle components in topical formulations on the pharmacokinetic behavior of the active components is analyzed. More specifically, the skin permeation parameter is determined for different formulations by measuring the steady state flux as well as the lag time of the active ingredients in an in vitro model using isolated pig skin" (see paragraph 118). It follows that "these differences in drug delivery" were argued to be related to the skin permeation parameters of the different formulations, and thus to skin delivery. From the whole of paragraphs 118-124 of the grounds of appeal and in particular the cited passages the Enlarged Board thus concludes, that argument A of the board corresponds to the argument made in the grounds of appeal of opponent 4.

2.1.4 As regards argument B, the Enlarged Board does not see it as a distinct and additional argument, but as an indication by the board, that it had understood that the data in D46 were introduced by opponent 4 to make the point reflected in argument A. The Enlarged Board is unable to follow the assertion made by the petitioner during the oral proceedings that argument B was causal for the decision, on the ground that it was a precondition for argument A. Argument A is presented in the reasoned decision as the principal argument and not as a consequence of argument B.

2.1.5 The Enlarged Board is therefore not convinced that the reasoned decision is based on ex officio arguments that were unknown to the parties. The objection raised by the petitioner based on that assumption can therefore not be successful. For this reason the two decisions from the Enlarged Board, R2/14 and R16/13, cited by the petitioner in support of its case that the board should have brought its ex officio argument to the attention of the petitioner, are not pertinent. These decisions do not deal with the situation that a decisive argument used by a board corresponds to an argument made by one of the parties.

2.2 A second objection presented by the petitioner, is that the fundamental argument based on D46 was not mentioned by the board at all, was not discussed during the oral proceedings and that the petitioner therefore could not know that it was decisive for the board. As a result there was no reason for the petitioner to address it during the oral proceedings.

2.2.1 In discussing this objection the Enlarged Board wishes to make a distinction between the written phase of the proceedings and the oral phase; see also the summary of the procedural history in the Facts and Submissions part.

2.2.2 As regards the written phase, the petitioner explained during oral proceedings before the Enlarged Board that it had decided not to address the substance of the attack based on D46, because it believed D46 would not be admitted into the proceedings. The communication from the board also did not give an indication that D46 was considered to be admissible and relevant.

2.2.3 As regards the oral phase the petitioner explained with reference to the sworn statements, that D46 was only discussed at a late stage of the oral proceedings and that opponent 4 did not raise the decisive point but only addressed a particular example from D46. The petitioner explained that opponent 4 apparently had confused 2 examples in D46 and that its argument was therefore invalid. There was no reason for the petitioner to address other aspects of D46, as they were not mentioned by the board or one of the opponents. The board should however have indicated to the petitioner that beyond this particular aspect it considered D46 relevant for other reasons.

2.2.4 The Enlarged Board comments this objection as follows. As regards the written phase, as explained above in paragraphs 2.1.3-2.1.5, the D46 argument finally used by the board was made in the grounds of appeal and addressed an issue already discussed in the opposition proceedings. The decision by the petitioner not to rebut the substance of the D46 argument because it assumed D46 would not be admitted, carried the risk that the assumption might be proven wrong and it would have missed an opportunity to present its case. The consequence thereof must be borne by the petitioner and cannot be transferred to the board.

2.2.5 It is true that the board did not address the substance of D46 in its communication, but it did indicate that the admissibility of D46 would need to be discussed during the oral proceedings. That cannot be understood as a confirmation of the assumption of the petitioner that it would not be admitted.

2.2.6 As regards the oral phase, it is also true that D46 was discussed at a later stage. That does not however in itself show that it was only peripheral to the case made by the opponents. It seems to the Enlarged Board, that it was not illogical to discuss D46 only after it had been discussed whether the claimed invention showed an improvement over the prior art at all, as D46 addressed the question whether, if there was an improvement, it was made credible over the whole scope claimed. Anyway, it appears to the Enlarged Board that after opponent 4 had requested to discuss the admission of D46 - which it considered to be highly relevant for inventive step, see the minutes of the oral proceedings - and the decision by the board to admit it, it should have become clear to the petitioner that D46 might be important. The petitioner however decided to only react to the oral submission by opponent 4, which it thought was based on a confusion of examples, and not to address the general arguments presented in the grounds of appeal.

The Enlarged Board notes in this context that it is not convinced that opponent 4 limited itself exclusively during oral proceedings to a specific example. The passage at the bottom of page 1 to the top of page 2 of the Sworn Statement of Mr. Cameron Marshall, seems to indicate that although the intervention focused on a particular example, opponent 4 made the broader argument that the ointment vehicle can have an effect on the efficacy of the drug. This passage reads: "O4 used D46 to argue that any improvement seen in D11 could be due to the different ointment vehicle which was used in the combination product, and in particular could be due to the "Arlamol E" solvent. O4 stated that the "TCF" product in D11 was "ointment 7" in D46, and referred to the data in Figures 1A & 1B. It concluded that the "Arlamol E" solvent affects the bioavailability of calcipotriol and betamethasone, and that this effect could explain any improvement seen in D11." The decision by the petitioner to only reply in a narrow way had as a consequence that the petitioner did not rebut the general line of argument based on D46 (argument A) either in writing or during the oral proceedings.

2.2.7 The Enlarged Board concludes from the above that the decisive D46 arguments were in the proceedings but were not discussed during the appeal proceedings, neither in writing or orally, because the petitioner decided not to address them. The question is not however whether they were discussed, but whether there was an opportunity to discuss them. In light of the above, the Enlarged Board is convinced that there have been several opportunities for the petitioner to present its comments and it therefore fails to see a violation of the right to be heard.

2.3 This conclusion could only be different if, as the petitioner argues, there was an obligation for the board to bring the decisive points for the decision to the attention of the parties and make sure they were properly discussed during oral proceedings.

2.3.1 The petitioner relies for this argument on decision R3/10, in particular the following paragraphs (see paragraph 2.11, page 19): "In a case such as the present, in which the ground of opposition, i.e. lack of inventive step, on which the revocation was based, was not discussed at all in the oral proceedings, it is also irrelevant that that issue was discussed in writing between the parties. The purpose of oral proceedings is to allow each party to make an oral presentation of its arguments, to allow the Board to ask each party questions, to allow the parties to respond to such questions and to allow the Board and the parties to discuss issues, including controversial and perhaps crucial issues. The value of oral proceedings is that matters may as a result be clarified and the Board may ultimately be satisfied that a party's position is the right one, although it was not so satisfied by the written submission alone."

2.3.2 The petitioner sees this decision as relevant for the present case because, although inventive step was discussed, the decisive D46 argument was not discussed. The Enlarged Board does not consider R3/10 to be pertinent. The factual constellation underlying R3/10 was that the patent was revoked for lack of inventive step, after a discussion that had only dealt with novelty. There was thus no opportunity for the losing party to present its case on inventive step orally. In the present case inventive step was discussed, the admission of D46 was discussed, and after admission there was an opportunity to discuss the substance of D46 and its relevance for inventive step.

2.3.3 The petitioner however takes issue with another aspect,

namely that the relevance of D46 for the decision had not been made clear and there was thus no reason to address all the arguments based on it, but only those presented orally. The Enlarged Board is of the view that R3/10 cannot be used to argue that a board has an obligation to make sure that during oral proceedings all decisive points are addressed by each party. Assuming the existence of such an obligation would go against a consistent line in the jurisprudence of the Enlarged Board. Reference is made to the jurisprudence summarized in the Case Law of the Boards of Appeal of the European Patent Office (9**(th) edition 2019), Chapter V.B.4.3.5 " No obligation to provide detailed reasons for a decision in advance", 4.3.6 "Board's obligation to remain neutral" (in opposition appeal proceedings, addition by Enlarged Board) and 4.3.7 "Parties' obligation to participate actively in the appeal proceedings", and the decisions cited in these paragraphs. In particular, attention is drawn to the summarizing sentence in 4.3.6. "By giving a party possible reasons to decide against its requests, by prompting a party to make further submissions, by informing a party of a possible different interpretation of a passage in a prior art document or by suggesting a possible wording of a claim a board would assist a party and compromise its neutrality."

3. Conclusion

In summary, the Enlarged Board is not convinced that the board violated the right to be heard of the petitioner. The board based itself on D46 with an argument that corresponds to an argument made by one of the opponents as early as in the grounds of appeal, the petitioner had several opportunities in the written phase and during the oral proceedings to address that argument but for reasons that are not related to an omission of the board, decided not to do so. For these reasons, the petition must be rejected as being clearly unallowable.