CASELAW-EPO - reviews of EPO Boards of Appeal decisions

EP 2 379 063 B1 relates to a pharmaceutical formulation comprising an erosion matrix.

Brief outline of the case

The petition for review, filed by Opponent 1, concerns the decision T 537/16, according to which the patent could be maintained on the basis of the proprietor’s AR1.

The petitioner claimed that a fundamental violation of its right to be heard occurred since it transpired from the written decision that the board, in acknowledging IS for the subject-matter claimed by AR 1, formulated the objective technical problem (OTP) in a manner that was never put forward by any party or by the board itself.

The EBA, acting pursuant to Art 112a considered the petition admissible, but not allowable under Art 112a(2,c).

The board’s decision T 1537/16

In the present case, a cornerstone of the board’s IS reasoning with respect to claim 1 of AR 1 was the construction of the OTP solved by the claimed subject-matter.

In line with its reasoning concerning the MR, the board did not follow the proprietor’s view that the OTP consisted of the provision of an improved pharmaceutical formulation with reduced variability in its pharmacokinetic parameters, since it considered that a corresponding effect had not been demonstrated.

It also did not follow the petitioner’s view that the OTP was merely the provision of an alternative tablet. Instead, it considered that the OTP solved was the provision of a pharmaceutical formulation with a zero order release profile, in other words a sustained release for a certain length of time. .

The EBA’s decision

The question arises, whether the board’s reliance on an OTP that was never mentioned to the petitioner amounts to a fundamental violation of the right to be heard.

In the EBA’s view, this question cannot generally be answered in the affirmative. The application of the problem-solution approach can be viewed as a method of determining and reasoning whether a claimed invention fulfils the requirement of IS.

The EBA held that there is no obligation to apply the problem-solution approach.

However, regardless of whether and how the problem-solution approach is used, the right to be heard means, at least, that the parties must be heard on the basis of the reasoning used in the decision.

In the context of the problem-solution approach, there should normally have been a discussion on the relevant prior art, the differences between the prior art and the claimed invention, and the technical relevance of these differences.

Within the framework of what has been addressed in the course of these discussions, the deciding organ should be free to apply the problem-solution approach as it sees fit, and even identify an OTP that has not been explicitly spelled out as such during the proceedings. In any case, the OTP eventually used in the reasoning has to be based on technical effects, or the lack of any, and the features of the invention causally linked to such effects, upon which the parties had an opportunity to comment.

In a previous letter and during OP before the EBA, the petitioner basically agreed with this legal analysis. On the one hand, the petitioner accepted that, within the framework of what has been discussed with the parties, the deciding organ should be free to apply the problem-solution approach as it saw fit, and this could include the identification of an OTP that had not been explicitly spelled out. On the other hand, the petitioner argued that the parties should be able to foresee the factual basis on which the deciding organ could base its problem-solution approach, and must not be surprised by the reasoning in the decision.

In this context, the EBA noted that, according to consistent case law, subjective surprise has no bearing on whether a party knew the issues and had an adequate opportunity to comment upon and referred for example, to R 12/09, Reasons 13; R 15/10, Reasons 11; R 5/16, Reasons 19.

In addition, reasoning based on the submissions of another party cannot be surprising,  cf. R 4/08, Reasons 3.3.

For the purposes of Art 113(1), it is sufficient if a reason corresponds to an argument forwarded by another party, cf. R 1/13, Reasons 10. Whether a party can be considered to have been taken by surprise is to be assessed on an objective basis, cf. R 4/14, Reasons 3.

The EBA came to the conclusion that the board based its decision only on grounds that were objectively foreseeable by the parties, in view of their submissions and the board’s statements during the appeal proceedings.

During the entire proceedings leading to the decision under review, the zero order release profile – the provision of which was eventually adopted by the board as the OTP – was discussed, either as a quality of the erosion matrix or as a feature that was desirable per se. In its grounds of appeal, the petitioner stated: “Moreover, zero-order release results in constant plasma concentrations of a drug and is consequently generally desirable for extended release formulation.”

In the decision under review, zero order release was discussed in the context of the question as to whether and in what respect the subject-matter of claim 1 of the MR could be distinguished over example 16 of document D1.

In this context, the Board relied on Figure 1 of the patent, acknowledging that it showed the release of tablets having a zero order release profile. The board, however, pointed out that the figure referred to specific examples of the patent, all of them comprising hydroxy propylcellulose, a water-soluble polymer, as rate-controlling agent. The functional feature “rate-controlling polymer” remained a general term, in the view of the board, which did not reflect the specific type of water-soluble polymer used in the examples of Figure 1.  

In situations in which requests are increasingly restricted in a converging manner, e.g. in view of specific examples or embodiments, the parties should be aware that certain effects of the claimed invention may be acknowledged by the deciding organ only for a higher-ranking request.

The EBA concluded that the facts and evidence underlying the board’s decision on AR 1 were discussed in a way that gave the petitioner sufficient opportunities to be heard. As shown in the board’s reasons concerning the MR, the distinguishing feature “erosion matrix” and the relation of this feature with the release profile was discussed, although with the conclusion that “the erosion matrix and supposedly linked release profile cannot constitute a further difference between the claimed subject-matter and the disclosure of D1″.

However, the board’s reasons concerning the MR indicate how the additional distinguishing feature could be established, namely, by the use of a water-soluble polymer as a rate-controlling agent. In particular, it was noted that the examples depicted in Figure 1 of the patent, which showed a zero order release profile, comprised a water-soluble polymer

The petition was thus rejected as not allowable.

Comments

The EBA is certainly right when it declares that there is no obligation to apply the problem-solution approach. On the other hand, I do not know many decisions of TBA not applying the problem-solution approach. This argument is thus not convincing, as it clearly applied the problem-solution approach.

Boards are very prompt to consider that decisions of first instance deciding bodies not applying correctly and fully the problem-solution approach are not properly reasoned. Whatever the EBA claims, this is objectively the case in the present review proceedings.

When the EBA’s decides that the board based its decision only on grounds that were objectively foreseeable by the parties, this is anything but convincing.

Parties do not have a crystal ball allowing them to foresee that certain effects of the claimed invention may be acknowledged by the deciding organ only for a higher-ranking request. It’s really making a mockery of the procedure.

The present decision shows once more that the EBA acting pursuant to Art 112a will do everything possible to exonerate the board the decision of which is reviewed.

Like for R 5/23, commented in the present blog, the present decision makes again clear that the boards of appeal of the EPO need to be reformed. Members of the LBA or the TBA should not be members of the EBA. The president of the EBA should not be at the same time president of the boards.

R 8/19