Welcome to the latest edition of our UPC update, which comes shortly after the court celebrated its second birthday. In this edition, we report on the first decision relating to infringement of second medical use patents, as well as a number of important procedural developments.
Latest statistics and updates
In its latest update, the UPC has reported that, by the end of its first two years of operation, it had received 883 cases, suggesting it will not be long before it passes the one thousand cases threshold. The Munich Local Division remains in pole position in terms of the number of cases, and English continues to be the most preferred language, accounting for 55% of proceedings.
Meanwhile, the European Patent Office's Unitary Patent dashboard confirms that there have been more than 61,000 requests for unitary effect, leading to over 60,000registered Unitary Patents.
In other news, the first stage of the new Case Management System (CMS) has been rolled out, focusing on opt-outs and representative registration. The second phase will take place in September, when the new CMS will become fully operational for all users. Given the significant issues that users have faced in navigating the CMS, it is hoped that the new version will be more user friendly and intuitive. Separately, the Patent Mediation and Arbitration Centre (PMAC) has launched a public consultation on its draft Arbitration Rules (closing on 4 August 2025), following an earlier consultation relating to its draft Mediation Rules (closing on 21 July 2025). The PMAC is due to be up and running by early 2026. A particular point of interest will be the role of the PMAC in resolving complex issues such as disputes relating to Standard Essential Patents and FRAND licensing terms.
Second medical use - Sanofi v Amgen, UPC_CFI 505/2024
Sanofi v Amgen is one of the first cases in which the UPC has considered infringement of a second medical use claim in the EPC2000 form. An example of this form is "compound X for use in the treatment of disease Y". The patent related to the use of antibodies that bind PCSK9 (Antibodies). More particularly, the claim was for an Antibody for reducing lipoprotein(a) (Lp(a)) levels in a patient with (a) high Lp(a) levels, (b) who had been diagnosed as being at risk of developing heart disease or blood clots, and (c) who was not taking statins.
At the priority date it was known that Antibodies could reduce the risk of bad cholesterol and therefore reduce the risk of heart disease, but it was not known that such Antibodies could also reduce Lp(a) levels, which was another risk factor.
Sanofi alleged that Amgen infringed the claim by marketing "Repatha" under an SmPC (Summary of Product Characteristics) which recorded that it was approved for use to lower the risk of heart disease by lowering (bad) cholesterol and which also recorded (in the safety information section) that one of the pharmacodynamic effects of the Antibody was to lower Lp(a) levels.
The court dismissed Sanofi's infringement claim because it had failed to prove that Repatha had been prescribed for the purpose of lowering Lp(a) levels, or that there was a substantial likelihood that it would be. The court said that to establish infringement "there must be either a prescription to lower Lp(a) levels, or there must be at least circumstances showing that such a use may be expected to occur". The mere fact that this effect was recorded in the SmPC was not enough.
The court noted that, while the manufacturing of the product and in particular its package insert and SmPC can be important, they are not always the only decisive factors. The extent to which the alleged infringer knows or should have known that the product will be used for the claimed purpose is also relevant.
Interestingly, the court only discussed direct infringement under Article 25 UPCA, and there is no discussion whatsoever of indirect/contributory infringement under Article 26 UPCA, which would seem the more natural basis for an assertion that an EPC2000 claim is infringed.
Court of Appeal confirms long-arm jurisdiction of UPC - TGI Sport & Ors v AIM Sport Development, UPC_CoA_169/2025
Applying the CJEU's important decision confirming the long-arm jurisdiction principle in BSH Hausgeräte v Electrolux (discussed in our article), the Court of Appeal has determined that the UPC has jurisdiction to hear an infringement action relating to non-UPC designations of a European Patent in the EU (Spain and Germany), as well as a third state (the UK).
The claim was brought by AIM before the Helsinki Local Division against a UK domiciled company which was alleged to infringe the patent in Germany, and also a Spanish domiciled company. The Court of Appeal concluded that the UPC had jurisdiction over the UK defendant in relation to its actions in Germany, and the Spanish defendant because other TGI defendants were domiciled in the EU (as 'anchor defendants').
In particular the Court of Appeal found:
- The UK company belonged to the same group as TGI (which included TGI companies based in UPC countries) and the alleged infringements by the UK company were allegedly performed jointly with the other companies, based on the same patent, the same products, and the same facts. There would therefore be a risk of irreconcilable and inconsistent decisions if separate proceedings were lodged against the UK entity, emphasising procedural efficiency.
- AIM was justified in requesting to add Spain as a territory in which infringement was alleged (even though AIM was aware of alleged infringement in Spain at the time of filing its statement of claim) as it could not have made this request at that time, as both the Advocate General's opinion and the CJEU's decision in BSH had not, at that point, been handed down. In addition, to not allow it could risk irreconcilable decisions if AIM started separate proceedings in Spain. On the evidence, this risk outweighed the possibility that adding Spain might lead to a decision to stay and delay the proceedings.
Paris Local Division also confirms long-arm jurisdiction of UPC - Seoul Viosys v Laser Components, UPC_CFI_440/2023
Similarly, the Paris Local Division (in a decision on the merits) has applied the CJEU's BSH decision to conclude that it had jurisdiction to adjudicate on infringement issues committed in the territory of a third state to the EU relating to European patents validated in non-UPC countries - in this case in the UK. However, the court held that the claimant had not provided any evidence of infringement in the UK, so it limited the proceedings to infringements in France.
Hague Local Division has international jurisdiction and competence but will consider long-arm jurisdiction in main proceedings Genevant Sciences & Anor v Moderna & Ors, UPC_CFI_191/2025 & UPC_CFI_192/2025
In this case, which relates to a dispute over Moderna's COVID-19 vaccine, the Hague Local Division considered the following jurisdiction issues:
- International jurisdiction of the UPC: The court held that Genevant had sufficiently substantiated that Moderna Spain, Poland and Norway allegedly infringed the patent in those countries jointly with Moderna Netherlands, which was sufficient for the UPC to have jurisdiction.
- Competence of the Local Division: The court held it had competence to hear cases against defendants based in other UPC states (both in the EU but non-UPC, or outside the EU), in order to avoid the risk of irreconcilable judgments, because: (i) Moderna Netherlands was domiciled where the Local Division was hosted; (ii) the defendants had a commercial relationship (which the court held should not be interpreted too narrowly); and (iii) the action related to the same infringement irrespective of whether the other defendants were in or outside of the UPC or in or outside of the EU.
- Long-arm jurisdiction: The court was also asked to address whether it lacks long-arm jurisdiction (which was dealt with in BSH) for certain defendants and could not extend beyond the UPC territory. The court has said this will be dealt with in the main proceedings.
Expert evidence of little to no value for claim interpretation – Insulet Corporation v EOFlow Co., Ltd, UPC_COA_768/2024
A question that arose even before the UPC began operation is what approach the court would take toward expert evidence, given the vastly differing approaches to such evidence in the national courts of Europe.
In an earlier decision of the Paris Central Division of the UPC (UPC_CFI_338 /2023 and UPC_CFI_410/2023), the court was dismissive of the value of expert evidence in assessing inventive step, stating that "obviousness is not a question of fact but a question of law, hence, it could not be proven by expert and witness evidence".
In its order overturning an earlier decision of the Milan Central Division to not grant provisional measures against EOFlow, the Court of Appeal has now taken a similarly dismissive approach regarding the assistance expert evidence can provide for claim interpretation. The headnote of the Court of Appeal's order reads "interpretation of a patent claim is a matter of law. Therefore, the Court cannot leave the judicial task of interpreting the patent claim to an expert but has to construe the claim independently." This followed EOFlow's submission of expert evidence to support an interpretation of the patent and a prior art document.
Seemingly, the UPC is developing a general scepticism towards the value of expert evidence.
Infringing acts before UPCA in force, and before opt-out is withdrawn – XSYS v Esko-Graphics, UPC_CoA_156/2025
Prior to the UPCA coming into force on 1 June 2023, Esko had opted its European Patent out of the UPC's jurisdiction – it withdrew that opt-out in August 2024, bringing its patent back under the exclusive competence of the UPC. It then issued proceedings against XSYS before the Munich Local Division. The issue was whether the UPC had jurisdiction over alleged infringing activities taking place both before the UPCA entered into force, and also before Esko withdrew its opt-out.
The Munich Local Division ruled that it had jurisdiction but granted leave to appeal. The Court of Appeal upheld that decision. First, the UPCA did not set any temporal limitation of the court's exclusive competence, i.e., whether acts took place before or after the UPCA entered into force (as discussed in the Fives v Reel case – see our February 2025 Update). As for the withdrawal of the opt-out, the court was likewise competent to decide on alleged acts of infringement occurring between the effective date of the opt-out (here, 1 June 2023) and the date of it being withdrawn.
Anti-anti-suit injunction awarded against Disney – InterDigital v The Walt Disney Company, UPC_CFI_445/2025
The Mannheim Local Division has issued its first anti-anti-suit injunction (AASI) in a dispute between InterDigital and Disney. The injunction was awarded in favour of InterDigital against Disney and forms part of a global patent infringement dispute relating to video-codec Standard Essential Patents. The parties are involved in disputes in the Mannheim and Düsseldorf Local Divisions, as well as in the US and Brazil, and the Munich Regional Court.
Disney had itself sought an anti-suit injunction (ASI) in the US District Court for the Central District of California in relation to InterDigital's attempts to obtain preliminary injunctions in Brazil. Disney failed to confirm that it would not seek an ASI in relation to the proceedings before the UPC. The court concluded that it should make the AASI on a without notice basis. The fact that the injunction was of a purely defensive nature and was intended to shield the UPC proceedings was a decisive factor. The court went on to order InterDigital to provide security (at the lower end of the scale) in the sum of €400,000 (but allowing it to enforce the injunction pending payment / bank guarantee being made within 20 days).
Change of language of proceedings before the Court of Appeal – Hybridgenerator v HGSystem ApS, UPC_CoA_233/2025
As noted above, English is now the chosen language in some 55% of proceedings at the UPC. We have also seen a number of cases where one party or the other has sought to have the language of the proceedings changed. It is also possible for the panel hearing a case to change the language of the proceedings to the language of the patent, with the parties' agreement. In this case, the Court of Appeal's Judge-rapporteur proposed to the parties that the language of the appeal be changed to English from Danish (both parties are Danish companies and are represented by Danish lawyers).
The parties agreed to the language change, but there was a question over who should pay for the cost of any translations of relevant documents before the Court of Appeal. The court decided it would make translations for internal use at its own expense (aided no doubt by the fact that the Judge-rapporteur understands Danish).
Düsseldorf Local Division confirms burden on applicant for security for costs to evidence difficulty in enforcing costs order in foreign jurisdiction – Hologic, Inc. v Siemens Healthineers AG & Ors, UPC_CFI_758/2024
Siemens applied for security for costs against Hologic in the Düsseldorf Local Division in relation to both the infringement case and its own counterclaim for revocation (it is noteworthy that the court held, as a matter of principle, Siemens was entitled to apply for security including in respect of its revocation claim).
Siemens argued that enforcing a costs order against Hologic would be unduly burdensome as its registered place of business was in a non-EU state, i.e. Massachusetts in the US, which had not ratified any international agreement regarding recognition of foreign judgments. Further, enforcing in Massachusetts would require another court procedure in that state which would create uncertainty and additional cost. Hologic argued it was commonplace and usual practice for the US to enforce foreign judgments. Furthermore, it was a solvent company listed on the US stock exchange, with significant assets in the EU, negating the need for security.
As the application was based solely on the 'unduly burdensome to enforce' argument, the court held that Siemens bore the burden of substantiating this claim. To do so, it had to: (i) provide evidence of the applicable foreign law where enforcement was sought i.e. in the US; and (ii) demonstrate how that law was applied in practice. This evidence had not been provided, only an argument about such, so Siemens had not met the burden of proof. Furthermore, previous UPC case law (UPC_CFI_514/2023 and UPC_CoA_218/2024) has found that US courts do recognise and enforce judgments of foreign courts. The application for security was refused.
Court of Appeal allows appeal regarding security for costs despite underlying action becoming devoid of purpose – Ballinno B.V. v UEFA & Ors, UPC_CoA_328/2024
In this case concerning a patent for detecting an offside situation, Ballinno previously sought a preliminary injunction (PI) against UEFA and others regarding the alleged use of its technology at the European Football Championships in Summer 2024. The PI was denied because Ballinno had not acted with the necessary urgency, nor had it sufficiently demonstrated its case on infringement. Ballinno was ordered to pay costs. Prior to the PI being refused, it had been ordered to provide security for costs.
Ballinno appealed the PI, costs and security for costs orders. However, before the Court of Appeal had made its decision, Ballinno decided not to pursue the PI appeal as the tournament had concluded, rendering the urgency of the PI to be "significantly diminished". The Court of Appeal held that Ballinno had primarily built its case around the tournament and had to accept that there was an inherent litigation risk that this interest fell away once the event was over and that the PI appeal would likely have been rejected for lack of urgent interest. Ballinno's action had therefore become devoid of purpose and there was no longer any need to adjudicate on it. The Court of Appeal therefore considered Ballinno to be the unsuccessful party.
Despite the withdrawal of the PI appeal, the Court of Appeal ruled this did not affect the admissibility of the security appeal. The security appeal was brought together with an appeal against an order where an action is adjudicated, i.e. the PI order, and Ballinno still had a legal interest in having the security order tried on appeal. The decision on the security appeal is pending.
Court of Appeal refuses claimant's application for security for costs - AorticLab v Emboline, UPC_CoA_393/2025
The Court of Appeal has held that there is no legal basis for granting security to a claimant in an infringement and/or revocation action. The Court of Appeal emphasised the rationale behind the provision of security is to protect a defendant against an insolvent claimant who initiates proceedings without having sufficient means to compensate the defendant for legal costs incurred in those proceedings.
The Court of Appeal further held that this rationale does not apply to a counterclaim for revocation (where the claimant would effectively be in the shoes of the defendant) because, under the UPC Agreement and Rules of Procedure, a defendant cannot bring an invalidity defence against an infringement claim, it has to lodge a separate counterclaim for revocation (see above re the Holologic v Siemens decision). This would not be an action initiated by the defendant but simply a necessary action to defend itself against an infringement action, and the position would be the same if the revocation action was bifurcated.
Notably, this decision appears to suggest that the order made by the Düsseldorf Local Division in 10x Genomics v Curio Bioscience (UPC_CFI_140/2024), directing the defendant to provide security in that case, was wrongly granted.