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In this brief note we refer to the Order of the Barcelona Provincial Court (15th Section) 59/2022 of 22 April, which confirmed the Order of the Barcelona Commercial Court No. 1 of first instance rejecting precautionary measures in relation to the product sorafenib. Although the Order is dated 22 April, it has not yet been published in the Judicial Documentation Centre (CENDOJ –Centro de Documentación Judicial), so we believe that it may be of general interest to make some comments on its content.
The Order concerned an application for interim relief under claim 12 of European patent EP 2 305 255. The subject matter of this claim is as follows: “12. Aryl urea compound, which is a tosylate salt of N-(4-chloro-3-(trifluoromethyl)phenyl-N’-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea”.
In summary, the Order considered that the evidence “is sufficient to show that [claim] 12 of the patent is likely to be invalid due to a lack of inventive step“. In order to reach this conclusion, the Court analysed the evidence, in particular the technical reports of the parties, the prior art and the common general knowledge of the person skilled in the art.
We find interesting to comment the way in which the decision deals with the assessment of the validity of the patent, in particular, the requirement of inventive step, in the context of precautionary measures.
The Court acknowledges that the analysis of claims in interim proceedings must be “provisional and indicial”. However, it points out that this does not mean that the validity of the patent cannot be analysed in interim relief proceedings because it would have to be done when assessing the merits of the case. The Court notes that this (the assessment of the validity of the patent) is the only way to reach to a provisional and indicial opinion favourable to the merits of the plaintiff’s claim (fumus boni iuris).
In this regard, the Court recalls that, in any event, this assessment, which is aimed at the validity of the patent, is not definitive but provisional, for two reasons: it does not end the dispute, but only determines whether interim measures can be adopted; and it is carried out with a possible restriction of evidence. For this reason, it does not leave the question closed, nor does it bind the judge to carry out the same analyse and reach the same conclusions in proceedings on the merits.
The Court indicates that “[t]he plaintiff has a valid title that gives it a presumption of validity“, but this does not prevent that “the existence of compelling evidence of nullity of the title must also be assessed and may lead to the dismissal of the measures, without prejudice to the analysis and the evidence to be provided in the [proceedings on the merits]“.
It is therefore clear, firstly, that the Court indicates that the presumption admits evidence to the contrary and that this evidence to the contrary, also in the case of interim measures, may relate to the invalidity of the patent.
However, secondly, in addition to the Court’s reasoning, we could consider that the presumption of validity, as a possible judicial presumption (which is not legal, as it is not recognised by any legal text in patent Law), should not limit the evidence to the contrary exclusively to the nullity of the title, but also to the basic fact of the presumption or, even, to the causal link between the basic fact and the presumed assertion, the validity of the patent.
What we are saying is that there may be additional grounds for overcoming the alleged presumption, other than evidence to the contrary aimed at proving the invalidity of the patent. For example, if the plaintiff bases his presumption on the grant with prior examination of its patent, the defendant should also be able to provide evidence of any mistake that may have been made in granting the patent in accordance with its prosecution file and thus destroy the presumption (contradictory EPO decisions, omissions of prior art, experiments incorrectly presented by the applicant, incorrectly assessed, etc.).
This is unquestionable the result of Articles 385.2 and 386.2 of the Civil Procedure Act, relating to presumptions, which allows, even in the case of legal presumptions, that the affected party may oppose them by proving both the contrary fact (nullity) and the lack, in the specific case, of a sufficient logical link between the concession and the presumption of its validity.
According to this approach there are still a number of issues to be considered: the scope of the evidence to the contrary to be assumed by the defendant; the scope of the burden of proof to be assumed by the owner; and what should be the outcome, once the evidence in precautionary measures has been assessed, there are doubts about the validity of the patent or, which is the same thing, if there are doubts about the granting of the precautionary measures.
Surely, the debate over the issue can extend much more than this brief commentary.
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