Amgen and Sanofi’s Race to File UPC Actions Ignites Bifurcation Question

The Unified Patent Court has issued its first preliminary opinion. In August, in a case between Amgen and Sanofi, the court examined the admissibility of an action dependent on where and when it was filed. As a result, the corresponding infringement and revocation proceedings will be heard at the UPC's Munich local and central divisions respectively. This is contrary to what the UPC has previously laid out as its generally non-bifurcated approach.

For years, Amgen and Sanofi have battled it out across various European patent courts over cholesterol-lowering medication Praluent. Now the case’s latest twist has played out at the Unified Patent Court, where the two parties were in a race to file infringement and revocation actions via hard copy. This was due to an electronic malfunction of the UPC’s content management system on the first day of operation.

Among other issues, the court examined the issue of bifurcation within the UPC system, which continues to be an area of interest for users. Currently, parties must revocation actions at the central division, unless the opposing party has filed an infringement suit elsewhere. Meanwhile, Amgen continues to assert parent patent EP 2 215 124 against Sanofi – both at the supranational court, as well as at national courts across Europe.

Amgen and Sanofi in race to file

On the first day of the Unified Patent Court’s launch, a new battle played out when Amgen and Sanofi raced to file a revocation and infringement action, respectively, at the UPC’s Munich-based central and local division (case ID: UPC_CFI_1/2023).

The actions are based on Amgen patent EP 3 666 797, which is the third divisional enforced by the biopharmaceutical company belonging to the EP 124 patent family. EP 797 covers active ingredient evolocumab, which uses “antigen binding proteins to proprotein convertase subtilisin Kexin type 9 (pcsk9).”

After the EPO granted EP 797, Amgen chose not to op-out the patent. Instead, the company filed an infringement suit at the UPC’s Munich local division. Sanofi responded in kind by attempting to file a revocation action at the UPC central division’s Munich branch.

However, due to a technical error which led to the crashing of the UPC’s content management system, electronic filing would not go through. Instead, Sanofi filed its submission by hand at the UPC Registry in Luxembourg, and Amgen filed its infringement action at the sub-registry of the Munich local division. As a result, the latter party filed a preliminary objection which claimed that it had filed its infringement action first, thus rendering Sanofi’s revocation action inadmissible.

Consulting the rulebook

Judge rapporteur András Kupecz considered two main points, beginning with the timing of the filing. However, Kupecz found that, by a margin of half an hour, Sanofi had filed its infringement case first.

The second, and main, issue at stake was whether the UPC Rules of Procedure permit Sanofi to file a revocation action at the UPC Registry in Luxembourg, instead of directly to the central division. Under Article 33(4) of the UPC Agreement, a party must file a revocation action with the UPC central division, unless the opposing party’s infringement action has already been filed at a local division. In such an instance, the party must also file the revocation case at the same local division.

However, Sanofi argued that, under rule four, paragraph two of the UPC Rules of Procedure, the court system allows for parties to file a hard copy of an action in any relevant location. On the other hand, Amgen claimed that Sanofi did not lodge its copy at the relevant section, which it said should have been the UPC’s Munich branch of the central division.

Luxembourg is permissible

Ultimately, the court found in favour of Sanofi. The UPC Rules of Procedure state that “where it is not possible to lodge a document electronically for the reason that the electronic case management system of the Court has ceased to function a party may lodge a document in hard-copy form at the Registry or a sub-registry.”

Under the UPC Rules of Procedure, the losing party has two weeks to lodge an appeal. While it is likely that Amgen will appeal the ruling, JUVE Patent has as yet no confirmation if this is the case. The preliminary objection hearing, which took place on 24 August, was conducted via video. According to a case report by Allen & Overy, the current UPC actions between the two parties are worth €100 million.

Destination bifurcation?

According to some observers, the case has led to dicussions around the issue of bifurcation. In principle, the UPC has adopted a system of non-bifurcation, whereby each court has competencies to hear both infringement and revocation actions.

However, this case – and no doubt others – will test the limits of its case law, for example when a defendant files a revocation action after an infringement case has been filed. In such instance, a local division can also refer the revocation case to the central division. Presumably, as the court continues to develop its case law, future cases will streamline the court’s general approach to bifurcation.