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.
Comments
11 replies on “R 8/19 – The is no surprise when a board only gives the OTP in the decision”
How did the TBA not or not fully apply the PSA in your view?
Dear Peter,
By not clearly stating the OTP, the board did not apply the PSA as it should be applied.
That the OTP should be foreseeable from a higher ranking request is, to say the least, a rather odd justification from the EBA.
It can be agreed with the EBA that a board is free to apply the PSA, but when it does, it should do it correctly.
A remittal would in all probability not have changed anything, but the argumentation of the EBA is to be criticised.
Dear Daniel, with the sentence “by not clearly stating the OTP”, do you mean that the Board did not state it during the oral proceedings, or not in the decision? Because in the decision, point 5.3.3, the Board states that “the technical problem is the provision of a pharmaceutical formulation showing a zero order release.” Now I wonder if in your view the PSA also implies explicitly structuring the debate during the oral proceedings according to the three steps of the PSA by the OD (or Board) announcing the CPA and the OTP before the parties are invited to discuss obviousness.
Dear Peter,
Taking into account the formulation “it transpired from the written decision” in Point II of the facts and submissions, the petitioner claimed that he only discovered the OTP when reading the decision. If this would not have been the case, the petition could have been dismissed up front as not being admissible for lack of an objection under R 106. The EBA did not dare go as far as that and admitted the petition.
My reply to your question is yes. There might be justified exceptions, but this is not the case here. Correctly and fully applying the three steps of the PSA is required from parties when they argue the presence or the absence of IS.
Why should deciding bodies of the EPO be dispensed with and like here, the petitioner be referred to what was “foreseeable”? This is unfair as parties do not have a crystal ball. Either the PSA is applied correctly and fully with all its steps clearly set out, or the wording PSA should not be used.
Any argumentation which looks like the PSA, tastes like the PSA, but is not actually the PSA should not be called PSA. I call this kind of pseudo PSA argumentation a “Canada Dry PSA”, in analogy to an old French add for an alcohol free aperitif: le Canada Dry a la couleur de l’alcool, le goût de l’alcool, mais ce n’est pas de l’alcool.
I agree that the using the PSA is not a condition referred to in the EPC, but when it is used, it should be used properly and completely.
Dear Mr Thomas, Dear Peter –
If I may, as a reader of your respective comments, it seems to me that you are “talking past” one another because there seems to be a different understanding of what is meant by “using the PSA”.
I think we can all agree that the Technical Board, in its decision, constructed an objective technical problem which it then used to assess obviousness. Therefore, in the decision, it seems to me therefore that the Board *did* apply the PSA.
The fundamental issue here is that the objective technical problem applied by the Board in the context of the PSA was not the same objective technical problem which was put forward by any of the parties. And that means that the Board applied the PSA differently to any of the parties.
The parties only found this out when they read the decision and discovered that, at the hearing, they had been talking about a different objective technical problem than the one the Board had in mind.
So, to this observer, it seems that the question is not “did the Board apply the PSA?” – because, in the written decision, it did.
The question is instead “does the Board have an obligation to tell the parties *at oral proceedings* if its objective technical problem is different from theirs?” In other words, does the Board have an obligation to inform the parties *how* it is applying the PSA?
On this point, my humble view is that both the Technical Board and the Enlarged Board got this badly wrong. It is difficult to see how the right to be heard can be respected *in substance* if the parties are given no opportunity (in the absence of clairvoyance) to address the Board on the points that it actually considers to be relevant.
The fig leaf for the Technical Board here is that because its different view of the OTP was based on the documents and arguments already in proceedings, there was no violation. The parties “could” or “should” have foreseen all possible OTPs that might have been constructed, and addressed those; in the view of the Board, it is not the Board’s fault if the parties spent the hearing talking about apples when the Board thought that the relevant question related to oranges. For me, this kind of reliance on extreme formality is not convincing in substance.
Furthermore, it does not seem to align with the EPO’s sacred goal of efficiency if the Boards are willing to allow parties to waste their time, by using the hearing to discuss irrelevancies. Of course the Boards should not give the parties any hints that could be seen as favouring one side over another, and it is not their job to tell the parties how to construct their arguments or run their cases. But a simple pointer of the type “we think that the OTP is [X]” seems permissible as it ensures that the discussion from all sides will stay on track. If nothing else, it should also reduce the number of parties who feel that their right to be heard has been violated when they read the decision and are surprised to learn the Board’s OTP for the first time…
Thanks!
Dear Observer
I read your comment with interest and need to reply.
The PSA looks as follows: choice if the CPA-difference-effect of the difference-OTP-is the solution to the OTP obvious or not?
When you look at the PSA the key point to me is a proper definition of the OTP. Without a proper definition of the OTP, how is it possible to decide on IS?
Whether the OTP is that of one of the parties or that decided by the board is not the problem (sorry for the pun), but not defining it, boils down to me as not correctly applying the PSA.
In my humble opinion, in order to correctly apply the TBA, the board has an obligation to make clear during the procedure what is the OTP it has considered.
I agree with you that both the TBA and the EBA are indeed wrong as the parties do not have a crystal ball and cannot foresee what the OTP could be and only discover it when reading the decision.
By not commenting on the applicant’s arguments regarding the definition of OTP to be solved but repeating its own formulation of the technical problem, an ED committed a SPV, see for instance T 1802/17, Reasons 4.3, of 28.10.2021.
The board added that the ED was of course not obliged to accept the applicant’s definition of the OTP, but it should have at least explained why it regarded its own definition more appropriate. From that decision, it is clear that a board can adopt its own definition of the OTP, but it has to explain it and not leave the parties to foresee what it could be.
The EBA’s argument is therefore highly specious, and is designed simply to avoid having to concede that the TBA has not done its job properly. It is not that the decision would probably change after remittal, as out of the 10 cases remitted by the EBA after a petition for review, only 2 have led to a different decision of the board. This does however not excuse the EBA to decide upon what was foreseeable or not.
The fact that members of the boards can at the same time be members of the EBA acting under Art 112a might explain the leniency of the EBA towards the BA.
A reform of the boards and of the EBA guarantying true independence is overdue. Members of the boards and their president should not be members of the EBA.
By the way, the same mistake has been made at the UPC.
Members of the Court of Appeal can be members of the panel sitting on an application for rehearing under Art 81UPCA + RoP 245 UPC. Such an application for rehearing is similar to a Petition for review under Art 112a EPC. There is as well an obligation to raise objections, cf. RoP 248UPC, similar to R 106EPC.
A procedure similar to a referral under Art 112 EPC is also in place at the UPC. It is called a decision to refer and only provided for in RoP 238A UPC and not even enshrined in the UPCA itself.
Mr Thomas
Thanks for your comment. If I understand you correctly, I think we agree.
To recap: the fundamental problem here is that the Board did not tell the parties *at the hearing* what OTP it had constructed. So the parties went off down the garden path only to get a surprise when the written decision explained that the OTP had been different all along.
I don’t think the issue is that “a proper definition of the OTP” was lacking, because the Board did give that definition. It gave it in its decision. So *in the decision* the Board properly applied the framework of the PSA (i.e. it respected the steps that have to be followed, and specified an OTP, even if we disagree with the OTP that it constructed – which I have not studied).
Rather, the issue is that the definition of the OTP was given *at the wrong time point* – because it was only made clear in the decision, and not at the hearing, it was too late for the parties to respond to it.
Do we agree?
Dear Observer,
I took a while until the penny dropped, but now I understand better Peter’s and your comments.
My apologies to both of you for this mishap.
I think we all agree and the problem is not the non-application of the PSA by the board, but the time when it gave its definition of the OTP when using the PSA. The board waited to issue the decision in writing and did not give it during the OP, hence the surprise for the opponent.
I have therefore even amended the title of the blog.
I do however have nothing to change to my criticism of the board and of the EBA. As shown, if an ED does not explains in its decision what is the OTP it started from it commits a SPV. Here the board actually committed a SPV by not announcing during the OP what was the OTP it started from. The positive right right to be heard of the parties during the OP was not respected as they were left in doubt what was the OTP it started with.
Thank you – that is all clear!
And I certainly agree with you that the TBA and the EBA got this one wrong. Their decision can only be correct if one takes the view that the right to be heard is simply an empty, hollow shell of formalities that reduces the “right to be heard” to “a right to be literally heard talking about the documents on the file regardless of whether what is said is relevant”. I do not think any of us here would agree with that position, but it seems to be the position of the Enlarged Board in too many R decisions.
It is difficult to see how the right to be heard is respected in “spirit” or in substance when a party has to have a lucky accident in order to address the points that the Boards think are important.
Dear Observer,
I cannot but agree with your comment.
When looking at the right to be heard as the boards apply it to first instance deciding bodies, they are much more stringent as when it comes to their own understanding of the right to be heard. In other words: do what I tell you, but you are not allowed to do as I do….
Whatever the EBA might say, the right to be heard is best shown when in the written decision, the parties are not surprised with the outcome. This is alas not always the case and the present EBA’s decision is a good example of it.
Minutes of OP before the boards do not have to be as exhaustive as minutes of OP before a first instance decision body, but in lots of situations one wonders whether they have the quality required by R 124 which also applies to the boards. Claiming that a lot of what should be in the minutes are in the part of “Facts and submissions” of board’s decision is not an excuse for minutes of OP’s before the board which do not answer the requirements of R 124.
Members of the boards and their president should not be at the same time members of the EBA, especially not in the case of petitions for review. It reminds me of a German say: one crow does not peck out another’s eye.