Substantial procedural violation

The joint patent proprietors ("appellants") lodged an appeal against the opposition division's decision to maintain European patent 2 321 651 ("the patent") in the form of auxiliary request 12.

Claim 1 as granted reads as follows:

"1. A method for predicting the risk of an acute cardiovascular event and/or heart failure as a consequence of a future anti-angiogenesis-therapy 5 with a VEGF-antagonist, comprising the steps of

a) determining the amount of a cardiac Troponin in a sample of a subject; and

b) comparing the amount of a cardiac Troponin as determined in step a) with reference amount for a cardiac Troponin,

wherein the risk of an acute cardiovascular event and/or heart failure of a future anti-angiogenesis therapy with a VEGF-antagonist is predicted for said subject."

Article 113(1) EPC and Rule 111(2) EPC - substantial procedural violation

Rule 111(2) EPC stipulates, inter alia, that decisions of the European Patent Office which are open to appeal shall be reasoned. The purpose of this requirement is to enable the party or parties adversely affected by the decision to understand whether or not the decision was justified and to decide whether or not to lodge an appeal. It likewise ensures that the board of appeal, whose primary task it is to review the decision under appeal in a judicial manner, is enabled to understand the conclusions on which the decision is based and why they have been drawn. On the basis of the reasoning given in the decision under appeal, the board assesses whether the conclusions drawn by the department which took the decision were correct.

For a decision to be reasoned, all facts, evidence and arguments essential to the decision must be dealt with. Moreover, the decision must contain a logical chain of reasoning which led to the relevant conclusion.

Insufficient reasoning of a decision may amount to a violation of the right to be heard under Article 113(1) EPC. The latter provision establishes a party's right not only to present comments but also to have the comments duly considered by the deciding body. By providing adequate reasoning the deciding body can demonstrate that it adhered to this.

In the case at issue, the decision under appeal contains reasons, but the board must conclude that the reasoning is insufficient under Rule 111(2) EPC and that this amounts to a violation of Article 113(1) EPC. The reasons are as follows.

In the appealed decision, the opposition division concluded that the subject-matter of claim 1 of the main request did not involve an inventive step. The opposition division arrived at this conclusion by considering that document D8 represented the closest prior art and by defining the objective technical problem as the provision of a method for predicting an acute cardiovascular event and/or heart failure as a consequence of a future anti-angiogenesis therapy. In the opposition division's view, the solution proposed in claim 1, i.e. the comparison of cardiac troponin values measured in a sample with a reference amount, did not credibly solve this problem, because the skilled person faced with predicting the claimed risk would not have been able to do so in absence of a defined reference amount.

After reaching this finding, the opposition division did not reformulate the objective technical problem and did not assess obviousness of the claimed solution to that reformulated problem in the light of the cited prior art. Nor did the opposition division indicate that and for which reasons it would deviate from the problem-solution approach.

However, Article 56 EPC requires that "an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art". In the case at issue, the board is unable to understand from the decision under appeal why the opposition division concluded that the claimed invention would have been obvious starting from document D8.

The impugned decision is thus not properly reasoned within the meaning of Rule 111(2) EPC, amounting to a violation of the appellant's right to be heard under Article 113(1) EPC. Since the ground for opposition of lack of inventive step was the sole ground invoked by the opposition division against the maintenance of the patent as granted, a substantial procedural violation has occurred and the impugned decision has to be set aside.

The decision under appeal is set aside.

The case is remitted to the opposition division.