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In this article we will refer to the Judgment of the Barcelona Court of Appeals (15th Section) 1610/2021 of 27 July (ECLI:ES:APB:2021:8276). We do not intend to provide a critical commentary on the Judgment, but simply to refer to some aspects that we have considered to be of interest in patent matters and, in particular, to the legal analysis of the plausibility of a technical effect on which the inventive step of patent EP 1 203 761 (EP’761) was based. This was the basic patent of the SPC on the product cinacalcet.
In this judgment, the Court confirms the first instance judgment upholding the claim for patent infringement and dismissing the counterclaim for invalidity of the patent for lack of inventive step. The appeal Judgment commented herewith can be downloaded from the following links: Appeal #42/2021-3.
- Closest prior art
Although this is an issue not strictly related to the aspect we wish to address in this commentary (plausibility) it is indeed a decisive aspect in the present case. In this regard, the choice of the starting point determines the reformulation of the objective technical problem and, consequently, the inclusion of a technical effect that in the end is decisive for the Court to accept the inventive step of the contested patent.
In determining the closest prior art, the Court rejects the patentee’s argument that only that compound which can be described as “leading”, i.e. the compound with the best properties, should be considered as the closest prior art.
The Court accepts the patent challenger’s proposal to start from a compound that was also identified as a preferred compound in the prior art document from which the patentee also started to identify its “lead” compound. This was despite the fact that no specific data on its activity were provided. The Court further recalls that this is the compound that is structurally most similar to the claimed compound and that there would be no reason for the person skilled in the art to disregard it (paragraphs 8-13 of the Fourth Legal Ground of the Judgment). This compound is identified in the decision as R-646.
- The reformulation of the objective technical problem: inclusion of a technical effect not described in the patent application (improvement of bioavailability).
The judgment acknowledges that the EP’761 patent application did not refer to the improved bioavailability of cinacalcet. This aspect was introduced during the examination before the EPO and as a consequence of having to compare cinacalcet with the compound that was in fact considered to be the closest prior art, R-646.
The Court notes that during the examination additional evidence was presented to justify the improved bioavailability of the compound cinacalcet compared to compound R-646. The question is therefore whether this improved bioavailability can be considered as a technical effect in the reformulated objective technical problem.
Under the EPO Guidelines for Examination, the Court accepts that the objective technical problem can be reformulated by including the bioavailability-enhancing effect by considering it as an effect closely related to the original problem presented in the patent application. In reaching this conclusion, the Court relies on the evidence adduced and, in particular, the expert opinions, while noting that it is for the party challenging the patent to show that there is no such relationship (paras. 20-37 of the Fourth Legal Ground of the Judgment).
- Plausibility of the new technical effect (the improvement of bioavailability)
The Court’s approach to this aspect is precisely related to the previous point, i.e. the acceptance of including improved bioavailability as a technical effect in the reformulation of the objective technical problem.
Thus, the party challenging the patent pointed out that it was not plausible that cinacalcet had an improved oral bioavailability, since nothing was said about this characteristic in the original patent application as filed.
However, the Court’s reasoning is that if, in fact, it is accepted to include as a technical effect in the reformulated objective technical problem an effect not disclosed in the original application, as closely related to the original technical problem, and, therefore, it is accepted that subsequent evidence aimed at showing such technical effect is submitted, then, in the Court’s words, “it makes no sense for us to consider or analyse its plausibility“, since the advantages are proven before the examiner and are subsequent to the patent application.
In other words, and following the argument of the Judgment, if the new technical effect is considered to be closely related to the original problem, a conclusion of plausibility of such technical effect is reached (paras. 8, 10 and 11 of the Fifth Legal Ground of the Judgment).
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