DANGER IN DELAY (PERICULUM IN MORA) IS STILL A RELEVANT REQUIREMENT IN CERTAIN CASES TO OBTAIN PRELIMINARY INJUNCTIONS IN SPAIN (THREE PI DECISIONS ON FULVESTRANT)
According to the Spanish Civil Procedural Act (CPA), there are two requirements that need to be met in order to obtain preliminary injunctions in the Spanish Courts: danger in delay (periculum in mora) and the presumption of good right (fumus boni iuris).
The requirement for danger in delay is regulated in the following terms in the CPA: preliminary injunctions may only be granted if the plaintiff justifies that situations could arise while the proceedings on the merits are in process of the case that, if the preliminary injunctions were not granted, would prevent the effectiveness of the final judgement. It is also stated that preliminary injunctions may not be granted when they are intended to alter situations that the plaintiff has consented to for a long period of time, unless the plaintiff can justify the reason why preliminary injunctions had not been previously petitioned.
On some occasions, the Spanish Courts have ruled in patent cases that danger in delay is implicit in the likelihood that the infringing conduct is repeated while the proceedings are in process on the merits of the case (Decision of 30 September 2005 of Section 15 of the High Provincial Court of Barcelona). This approach places the defendant in a situation where its defence should only be based on the non–infringement or nullity of the patent (presumption of good right).
However, in other cases, Spanish Courts have pointed out that the circumstances of the specific case must be considered and that the requirement for danger in delay cannot always be limited to the risk of infringement of the patent (Decisions of 20 July 2009 and 27 July 2005 of Section 15 of the High Provincial Court of Barcelona).
This latter approach has recently been upheld in two Decisions dated 19 November 2019 of Section 15 of the High Provincial Court of Barcelona (Appeals 270/2019 and 505/2019).
In one of the cases, the plaintiff invoked two European patents (pharmaceutical formulation patents) against a generic company that was intending to market its medicinal products on the Spanish market. In the other case, the same plaintiff invoked the same two patents and as well as a third European patent (indication patent) against a company in the same group as the defendant in the previous case.
In the first case, the preliminary injunctions were granted ex parte in August 2017 by the Commercial Court Number 4 of Barcelona. However, in the second case, the same Court dismissed the preliminary injunctions ex parte in January 2018 and the parties were summoned to appear at a hearing. One of the main reasons for these different decisions was that, when the Court decided to grant the preliminary injunctions in August 2017, it had already granted preliminary injunctions against a third company in 2016 related to the same formulation patents whereas, in the second petition, in January 2018, it dismissed them because the Appeal Court of Barcelona had already adopted a Decision revoking the aforementioned preliminary injunctions of 2016.
Due to this situation, the plaintiff decided to include a third patent (indication patent) in the second petition (January 2018), which had not been invoked either in 2017 or 2016.
The Commercial Court Number 4 of Barcelona decided to revoke the preliminary injunctions granted ex parte in August 2017 after a hearing had been held and, after a second hearing had been held, it dismissed the second preliminary injunctions that were dismissed ex parte in January 2018. The Court considered that the formulation patents were null and void due to lack of inventive step and the indication patent was null and void due to lack of novelty (presumption of good right).
These two Decisions adopted by the court of first instance were appealed by the patentee. The appeals were ruled by virtue of two Decisions adopted on 19 November 2019 by Section 15 of the High Provincial Court of Barcelona, which we have already mentioned. In these Decisions, the Appeal Court also pointed out that neither of the preliminary injunctions met the requirement for danger in delay.
Regarding the formulation patents, the Appeal Court of Barcelona stated that the preliminary injunctions no longer met the requirement of danger in delay from the time the preliminary injunctions had been revoked on appeal in respect of the third company against which such injunctions had been imposed in 2016. The Appeal Court also pointed out that, apart from that company, another fourth company was in a regulatory position that allowed it to launch its product on the Spanish market without the plaintiff having petitioned any preliminary injunctions against such company.
Regarding the indication patent, the Appeal Court of Barcelona pointed out that this patent was not invoked either against the third company in 2016 or in the preliminary injunctions imposed in August 2017 and therefore it should be deemed that the patentee had tolerated the infringement of such patent, thus it could not invoke it to petition preliminary injunctions. In addition, the patentee did not prove how relevant this indication was on the market due to the fact that the generic medicinal products were also indicated for other therapeutic uses that were not protected by any patent.
Therefore, we can draw the conclusion that the requirement for danger in delay may still be relevant in patent cases to obtain preliminary injunctions and that the compliance thereof must be analysed bearing in mind the circumstances of each case.
Finally, we would like to point out that, during the appeal process, the patentee petitioned preliminary injunctions again based on one of the formulation patents. In order to petition preliminary injunctions again, it claimed that the Technical Board of Appeal of the European Patent Office had just upheld the validity of the patent. The proprietor of the patent considered the EPO’s decision was a new fact that allowed it to petition preliminary injunctions again. The Commercial Court Number 4 of Barcelona, in its Decision of 17 December 2019, ruled that the fact the TBA of the EPO upheld the validity of the patent was not a new fact or circumstance. The facts or factual basis that formed the grounds for the earlier preliminary injunction petition were the same as those alleged and discussed in such new petition. The aforementioned decision of the TBA only implied a new legal assessment of the same facts that had been previously examined by the Spanish Courts. It therefore rejected the new application for preliminary injunctions.