This decision was issued in the framework of the infringement action initiated by Amgen, based on EP 3 666 797 covering antibodies targeting specific epitopes of PCSK9, against Sanofi and Regeneron’s PCSK9 inhibitor evolocumab-based cholesterol-lowering agent Praluent. We have already commented on this case in an earlier article as it gave rise to the first bifurcation before the UPC.
The infringement case is being heard before the Munich Local Division, where Sanofi (electronically) served its Statement of claim on 11 July 2023, but only uploaded its annexes on the CMS on 10 August 2023. The question on which the UPC Court of Appeal needed to rule was whether the delay in providing the annexes justified an extension of the time limit for the defendant to file its Preliminary objection or Statement of defence. This question has important practical implications as the defendant only has a limited period of time to file its response (i.e. one month for a Preliminary objection and three months for a Statement of defence).
In this regard, on the one hand, Rule 13.2 of the UPC Rules of Procedure (“RoP”) provides that the claimant that lodges a Statement of claim “shall at the same time supply a copy of each of the documents referred to in the Statement of claim”. On the other hand, Rules 19.1 and 23 provide that the defendant shall lodge a Preliminary objection or a Statement of defence within “one month” or “three months” of “service of the Statement of claim”. The RoP do not contemplate the case where the annexes in support of the Statement of claim would not be filed simultaneously.
In this context, Sanofi and Regeneron seized the Munich Local Division of a Preliminary objection (pursuant to Rule 19.1 RoP) to rule upon two questions:
- What is the date of service of a Statement of claim whose annexes were only lodged later on?
- Does the delay in lodging the annexes referred to in a Statement of claim justify an extension of the time limit to file the defendant’s response?
Munich Local Division refused to extend the time limit
On 29 August 2023, the Munich Local Division (with Matthias Zigann as Presiding Judge and Judge-Rapporteur) ruled that:
- A Statement of claim is validly served even without its annexes provided that the subsequent submission of said annexes is expressly mentioned in the Statement of claim, and that
- No extension of the time limit to lodge a Statement of defence should be granted when the annexes are filed at a later date if such annexes are already known or publicly available.
Date of service
The Court differentiated between the “Statement of claim” which is served on the defendant (i.e. the pleadings containing the claims and arguments) and the underlying “evidence” referred to in the Statement of claim which, according to Rule 13.2 RoP, must be annexed thereto. The Court reasoned that, when the plaintiff specifically states that the evidence would only be provided at a later date, the Statement of claim did not refer to evidence in the sense of Rule 13.2 RoP. Therefore, it considered that the Statement of claim was validly filed, even if the annexes were not uploaded on the CMS at the same date. According to the Court’s reasoning, if the Statement of claim would refer to annexes, it would be necessary to file those annexes at the same time in order for the Statement of claim, otherwise the time limit would only start on the date on which the defendant had access to both the Statement of claim and the attachments referred to.
Extension of time limit
With respect to the defendants’ request for an extension of time, the Munich Local Division also considered that the delay in making the annexes available did not justify the grant of an extension of time because the annexes were either already available to the defendants or publicly available, or reproduced in the Statement of claim.
The Munich Local Division however granted leave to appeal the decision for both parties (according to Rule 220.2 RoP), and Sanofi appealed the decision.
Court of Appeal does extend the time limit for the defendants’ reply
An oral hearing was held between the parties on 13 October 2023, where the decision was pronounced orally and without reasons. The written decision was published on 16 October 2023.
The Court of Appeal (with Rian Kalden as Presiding Judge and Judge-Rapporteur) ruled that:
- A Statement of claim is validly served, even if the annexes it refers to are not served at the same time, provided that it enables the defendant to assert his rights in court proceedings before the UPC (regardless of whether the statement refers to said annexes or announces their subsequent production),
- The time limit for the defendant to lodge a Preliminary objection or a Statement of defence should in principle be extended by the period during which the annexes were not available.
Date of service
According to the Court of Appeal, a Statement of claim is validly served if it enables the defendant to assert his rights in court proceedings before the UPC (without the annexes). This requires that the defendant is able to ascertain at least the subject matter and the cause of action from the Statement of claim.
Therefore, those annexes that are not indispensable to ascertain this (e.g. annexes which would only have an evidentiary purpose), are not an integral part of the Statement of claim. Consequently, it is irrelevant to determine (i) whether the Statement of claim refers to such annexes or announces their subsequent production or (ii) the moment when the annexes are actually provided to the defendants.
Only those annexes that are indispensable for an understanding of the subject-matter and cause of the action must be served (and if necessary translated) on the defendant together with the Statement of claim in order for latter to be validly served.
The Court of Appeal considered that the Statement of claim filed by Amgen enabled the Defendants to assert their rights in court proceedings, even without the annexes and was thus validly filed on 11 and 19 July 2023.
Extension of time limit
Now, with respect to the defendants’ request for an extension of time, contrary to what the Munich Local Division had ruled, the Court of Appeal considered that, based on general principles of fairness and equality of arms, the time limit to lodge a Preliminary objection or a Statement of defence should in principle be extended by the period during which the annexes were not available. No consideration should be given to the nature of the documents, notably whether some of them are already known to the defendant or publicly available, as soon as they are referred to in the Statement of claim.
The Court here relied on Article 13.2 which specifically provides that the evidence shall be filed “at the same time” as the Statement of claim in order to ensure that the defendant fully benefits from the three months allocated to file its Statement of defence. The Court notably pointed out that Rule 16 RoP expressly provides that failure to comply with the simultaneous filing of evidence according to Article 13.2 could lead to the action being held inadmissible under a judgment by default, and noted that the Munich Local Division should have drawn consequences from this failure on behalf of Amgen (irrespective of the relevance of the documents).
The Court thus concluded that the time limits referred to in Rules 19.1 and 23 RoP should be extended by the period during which the annexes were not available, unless the claimant shows that special circumstances of the individual case justify a different time limit.
As a consequence, Sanofi and Regeneron could benefit from an additional month to respond to Amgen’s Statement of claim.
Key takeaways of this first decision of the Court of appeal
First, this decision is interesting as it shows that the Munich Local Division, which granted leave to appeal its decision, was keen to get the views of the Court of Appeal on these procedural issues. Similarly, the Court of Appeal decided to entertain an interlocutory appeal on said issues, thereby arguably signaling that it intends to play an active role, in the early stages of the operation of the UPC, in sorting out these types of uncertainties.
Second, the judgment of the Court of Appeal ensures that defendants will always have the benefit of the full time period provided by the RoP to defend their case. It also avoids letting the extension of time depend on whether the annexes are already known to the defendants or publicly available, which would have generated a lot of uncertainties and disputes in practice.
Time will tell whether the captivating Amgen vs. Sanofi case keeps bringing new procedural clarifications to the benefit of UPC stakeholders.
This article was co-authored with Marylis Clerc
