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UPC – Sanofi-Aventis v. Amgen and Regeneron

21 Mar 2024

Florence Plisner


Court of First Instance, Central Division (Munich Section) – 27 February 2024, and UPC_CFI_14/2023, Actions ACT_459505/2023 and CC_586764/2023

This decision was an Order of the judge-rapporteur András Kupecz relating to procedural matters.

As readers may be aware, the Sanofi Claimants brought a revocation action against Amgen in the Central Division on 1 June 2023. On the same date, Amgen filed an infringement action in the Munich Local Division against the Sanofi Claimants and Regeneron relating to the same patent. Regeneron subsequently filed a counterclaim for revocation of the patent.

Several procedural applications were filed in early February 2024. First, the parties requested to have the cases dealt with together by the Central Division, maintaining the hearing date that was fixed in the initial revocation action. Additionally, Amgen submitted an application to hold an interim conference and admit documents into proceedings. Finally, the Sanofi Claimants requested that they be permitted to use demonstrative evidence, including models and slides, at the main oral hearing to produce a case summary pursuant to Rule 104(e) RoP.

A hearing was held by videoconference.

Combining of actions

Five days after the hearing, a decision was issued in which the judge-rapporteur ruled that the Central Division was in principle prepared to deal with the cases jointly and to hear both cases at the oral hearing date fixed in the revocation action (4 June 2024).

It was noted that all parties must be “on the same page” regarding the grounds for revocation, arguments, facts and evidence such that the Court would be able to prepare for and deal with both cases together on the timescale originally envisaged. All facts, grounds, arguments and evidence exchanged (including all pleadings and applications) must be accepted as submitted by the Claimants in both cases and deemed to have been submitted in both actions, and the Claimants must agree to make identical submissions in both cases going forward. Arguments brought forward by the Sanofi Claimants in the revocation action must be deemed to have been submitted by Regeneron in the counterclaim and vice versa. All defences raised by Amgen must be deemed to have been raised in both actions against all Claimants.

Only costs may be dealt with separately.

Further requests

In relation to the further requests made by the Sanofi Claimants, it was agreed that they are allowed to use a number of slides (but not models) as demonstratives at the hearing and the Defendants are permitted to use the same number. The slides may not introduce any new facts or substance to the case and must cite where in the pleadings or evidence the contents of the slides can be found. The slides must be submitted four weeks in advance of the hearing.

In addition, it was agreed that the parties are allowed to submit a case summary limited to 7,500 words, provided that this does not introduce any new arguments, evidence or facts into the case. At the occasion of submitting the case summary, the Claimants were ordered to provide a consolidated list of exhibits/evidence submitted by all parties to allow each document to be referred to by one unique reference during the hearing.

The Defendant also requested the admission of documents into the proceedings. These documents had been inadvertently omitted when submitting the rejoinder and were therefore admitted by the judge-rapporteur.

In view of the current hearing, the judge-rapporteur informed the parties that he did not see the need for an interim conference.

Value of proceedings and costs

At the hearing, the judge-rapporteur informed the parties that he intended to decide the value of the proceedings for the purpose of applying the scale of ceilings for recoverable costs. The parties were in agreement with the value of the proceedings being set at EUR 100,000,000 for each action and the Court set the value accordingly.

In order for the parties and the Court to assess whether costs incurred are reasonable and proportionate, the Court and parties must have access to information showing a detailed description of the number of hours spent working on this particular case, by whom, what for and at what rate. The Court therefore allowed for the filing of additional exhibits relating to costs.

It was noted that separate submissions on costs should be made in both actions and the ceiling for recoverable costs applies in each action separately. The judge-rapporteur informed the parties that the Court will, in principle, respect an agreement between the parties on the amount of costs that is deemed reasonable and proportionate.

Experts and hearing

The judge-rapporteur informed the parties that the Court does not intend to hear any of the party experts given that reports have been exchanged and the Court did not see any added benefit in formally hearing the experts. However, the parties were permitted to bring their experts to the oral hearing, either in person or by video-link. It was noted that, should the Court have a specific question for an expert, it may ask a question to a party expert.

In reference to the hearing date, the judge-rapporteur stated that it is the Court’s firm intention to conclude the hearing in one day. The second day (5 June 2024, reserved as per the Rule 28 RoP Order) is in principle only reserved for unforeseen events, like technical difficulties.

Filing on the CMS

Finally, the parties were advised that, in order to have complete and up-to-date files in the CMS, all documents must be filed in both actions going forward.

A copy of the decision can be found here.