On 27 November 2020 Barcelona Commercial Court Number 1 dismissed the second preliminary injunction request filed by Sanofi against Mylan in relation to an insulin glargine biosimilar product.
Sanofi is the owner of European Patent 2.346.552 (EP'552), which does not claim a pharmaceutical invention, but an injectable drug delivery device for the administration of drugs, such as a syringe or a pen, with certain technical features.
Mylan holds a marketing authorisation for a biosimilar insulin glargine medicinal product (Semglee) in the form of a pre-filled pen with an injectable solution.
In July 2019 Sanofi filed an infringement action against Mylan, together with an ex parte preliminary injunction request seeking an order from the court prohibiting the launch of Semglee. The case was assigned to Barcelona Commercial Court Number 1, which refused to grant any preliminary injunction ex parte and scheduled a hearing instead. In her interlocutory decision, 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. Also, 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 counterclaimed the invalidity of the patent (as granted). Also, 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 as upheld by the EPO Opposition Division and Board of Appeal form the basis for the proceedings.
The day after, during the hearing, Sanofi stated that it no longer asserted the patent as granted, but rather 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.
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 (for further details please see "Barcelona patent court dismisses preliminary injunction request based on patent in amended form"). 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.
Sanofi appealed this decision.
Coming back to the main proceedings on the merits, in January 2020 Mylan filed allegations regarding Sanofi's limitation request and argued that it was inadmissible inasmuch as it was extemporaneous and instrumental, contrary to its own actions and abusive. This issue remained pending to be resolved by the court.
The amended form of the patent (B2) was published by the EPO in March 2020 and validated by the Spanish Patent and Trademark Office in June 2020 (T5). A further revised translation of the patent (T9) was published in July 2020, upon which Sanofi requested that the amended form of the patent as published outside the proceedings form the basis for it. Sanofi also filed a new ex parte preliminary injunction request against Mylan.
However, the claims of the B2-T9 form of the patent are identical to those of Sanofi's previous limitation request of October 2019. For this reason, Mylan alleged that, first of all, it was necessary for Sanofi to clarify whether it was abandoning or maintaining, in whole or in part, its previous limitation request (including the auxiliary request).
In the meantime, by means of an interlocutory decision of 20 July 2020, the court again refused to grant any preliminary injunction ex parte and scheduled a hearing for 20 August 2020.
That is when Sanofi clarified that it was abandoning its previous limitation request. Also, it withdrew its appeal against the decision by which its first preliminary injunction request had been dismissed.
During the hearing of 20 August 2020, Mylan argued that Sanofi could not reiterate its previously dismissed preliminary injunction request because the circumstances had not changed. In particular, Mylan claimed that the B2-T9 form of the patent was not the basis for the main proceedings as this had not yet been decided by the court, as the procedural steps required by the Patents Act, including the turn of allegations that corresponded to Mylan, had not been fulfilled.
In its decision of 27 November 2020, the court dismissed Sanofi's preliminary injunction request again, thus concluding that the new alleged circumstances did not justify it. In particular, the decision states that the B2-T9 form of the patent does not form the basis for the main proceedings on the merits, where Sanofi's petition is yet to be prosecuted and decided. In this regard, the court recalled that the claims would be the same as with the former limitation request, now withdrawn, whereas Mylan is opposing Sanofi's petition, arguing that it should be held inadmissible for having been made abusively, with the sole purpose of reiterating a previously dismissed preliminary injunction request.
