On 23 December 2019 Barcelona Commercial Court No 1 refused to grant a preliminary injunction requested by Sanofi against Mylan in relation to an insulin glargine biosimilar product. Sanofi had filed for a limitation of the patent claims in the main proceedings on the merits running parallel, but the court concluded that such an amended form of the patent could be neither asserted nor taken into account in the preliminary injunction proceedings, which had been initiated before based on the patent as granted.
Sanofi is the proprietor of European Patent 2.346.552 (EP'552), entitled "Drug delivery device and method of manufacturing a drug delivery device", which expires on 8 October 2029. The patent does not claim a pharmaceutical invention, but an injectable drug delivery device for the administration of drugs (eg, a syringe or pen) with certain technical features.
Mylan holds a marketing authorisation for a biosimilar insulin glargine product (Semglee®) in the form of a pre-filled pen with an injectable solution.
On 12 July 2019 Sanofi filed an infringement action against Mylan, together with an ex parte preliminary injunction request seeking a court order prohibiting the launch of Semglee®. The case was assigned to Barcelona Commercial Court No 1, which refused to grant any preliminary injunction ex parte and scheduled a hearing instead. In the interlocutory decision of 30 July 2019, the judge found that the validity of the patent as granted appeared doubtful, as the patent had been upheld only in amended form by the European Patent Office (EPO) Opposition Division, with an appeal pending. Further, the judge considered that there was no extreme urgency.
The hearing was scheduled for 31 October 2019.
In the meantime, in the proceedings on the merits, Mylan filed its defence pleadings and counterclaimed the invalidity of the patent (as granted). Further, on 15 October 2019 the EPO Board of Appeal upheld the patent, again in amended form. On 30 October 2019 (ie, the day before the preliminary injunction hearing) Sanofi filed a limitation request in the main proceedings on the merits (together with an auxiliary request), seeking that the amended patent claims upheld by the EPO Opposition Division and Board of Appeal form the basis of the proceedings.
The next day, during the preliminary injunction hearing, Sanofi stated that it no longer asserted the patent as granted, but as amended, as the basis for its preliminary injunction request. In turn, Mylan argued that the amended form of the patent was not yet effective in Spain, whereas a patent cannot be limited within preliminary injunction proceedings, but only in main proceedings on the merits, where the issue was yet to be dealt with. Further, Mylan argued that, in any event, there was no urgency, which would justify a preliminary injunction. Among other factors, Mylan stressed that Sanofi does not even exploit the patent at stake.
In its decision of 23 December 2019, deliberated by the three patent judges of Barcelona, the court dismissed Sanofi's preliminary injunction request and upheld Mylan's allegations. Thus, the decision acknowledged that Sanofi could not alter the grounds of its preliminary injunction request, filed in July 2019 on the basis of the patent as granted, to assert an amended form of the patent, which had not yet been dealt with in the main proceedings on the merits.
In this regard, the court also emphasised that the urgency of a preliminary injunction request does not seem to be compatible with a subsequent request for limitation of the patent in the main proceedings on the merits, the prosecution of which would entail a significant amount of time.
This is the first court decision in Spain dealing with a preliminary injunction motion where the patentee had subsequently requested the limitation of the patent in the proceedings on the merits.
Sanofi has appealed the decision.
