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Cortex - Life Sciences Insights

| 3 minute read

Bifurcation before the UPC – who filed it first?

The Unified Patent Court (UPC) launched on 1 June 2023 and has the power to determine infringement and validity of new Unitary Patents (“UPs”) and European Patents (“EPs”) that have not been “opted out” of its jurisdiction.  The UPC is made up of a Central Division (with seats in Paris, Munich and a third due to begin operating next year in Milan), and several Local and Regional Divisions.  In the first decision handed down by the UPC on a Preliminary Objection in a dispute between Amgen and Sanofi-Aventis/Regeneron (together, “Sanofi”), the court has confirmed that where infringement and validity proceedings are filed with different Divisions of the court, the precise time that proceedings are lodged will determine who filed first, and therefore which Division will have jurisdiction over the proceedings. 

Background

The complex procedural rules surrounding the competence of the UPC’s Local / Regional and Central Divisions give rise to the potential for “bifurcated” infringement / validity actions – meaning that the infringement and validity aspects of the action are heard before different courts.  This is the case in Germany, where infringement is heard before Regional Courts and validity before the Federal Patent Court. 

Article 33 of the UPC Agreement (UPCA) sets out that actions for revocation or non-infringement are to be brought before the UPC’s Central Division (CD), unless an action for infringement between the same parties, relating to the same patent, has already been brought before a Local or Regional Division. Where the revocation action is filed first, the UPCA sets out that the Local Division (LD) or Regional Division (RD) handling a subsequently filed infringement claim may ask the CD to transfer the revocation action so that the two may be heard together, may stay the infringement action pending determination of the revocation action by the CD, or may refer the whole case to the CD, if the parties consent to this.  If the infringement action is filed first, the revocation or non-infringement action must be brought before the same Local/Regional Division or refiled as a revocation counterclaim to the infringement action.  

A race to file proceedings – Amgen v Sanofi-Aventis/Regeneron

What happens, then, where parties on opposite sides of a dispute file infringement and revocation proceedings more-or-less simultaneously?  The UPC has confirmed that the precise time that the proceedings were lodged at the court will determine which Division has jurisdiction.

On the very first day of the UPC’s operation, life sciences companies Amgen and Sanofi filed actions against one another in respect of Amgen’s EP 3 666 797 (EP’797), which claims PCSK9-inhibiting antigens (cholesterol-lowering agents).  This is the latest instalment in a long-running dispute between the parties.  Amgen filed a claim before the MunichLD, alleging infringement by Sanofi of EP’797, through Sanofi’s sale of monoclonal antibody drug, Praluent®.  Sanofi filed a revocation action against EP’797 before the CD.

Amgen argued that it filed the infringement action first and applied to have the revocation action before the CD thrown out, which would force Sanofi to file the revocation action as a counterclaim in the Munich LD instead, but this was unsuccessful.  Because of issues with the UPC’s case management system on its first day of operation on 1 June, Sanofi had filed its revocation action in hard-copy at the Registry in Luxembourg at 11:26 CET.  Amgen filed the infringement action in hard-copy at the sub-registry of the Munich LD at 11:54 CET on the same day.

In determining Amgen’s application, the UPC’s Judge Rapporteur held that it is the precise time and date of lodging of the claim that determines which action was “brought” first.  The revocation proceedings had been filed first by a mere 28 minutes (and it did not matter that these were filed in Luxembourg, rather than with the relevant Section of the CD in Munich), so the validity proceedings will be heard by the CD in Munich and the infringement claim in the Munich LD.  There appears to remain a possibility that the Munich LD might use its discretion to stay the infringement claim pending the outcome of the validity proceedings before the CD or transfer the infringement action to the CD so that both infringement and validity are heard together, though transfer of the whole action to the CD requires the agreement of the parties, which appears unlikely in this case.

Key conclusions

This is a reassuring procedural decision from the UPC that the precise time of lodging the claim with the court, rather than the time the UPC processes and accepts the claim, will determine which party filed first.  That this situation arose on the very first day of the UPC’s operation, with a window of less than 30 minutes between filings, is a lesson to parties not to delay in issuing proceedings if they want to gain the upper hand at an early stage and control where the case will be heard.

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unified patents court