UPChronicle: Monthly Analysis Of Key Unified Patent Court Decisions

Welcome to the November 2026 (and first) edition of UPChronicle, a Unified Patent Court newsletter. Beginning with this issue, we will publish monthly roundups of key decisions and developments to help you track trends, practical takeaways, and strategic implications across the UPC.

Further guidance on "imminent infringement" in preliminary injunctions

The UPC continues to refine when preparatory acts in the life sciences and medical devices sectors constitute "imminent" infringement under Article 62 UPCA. The Düsseldorf LD's September 2024 decisions in Novartis/Genentech v Celltrion (UPC_CFI_165/2024 and UPC_CFI_166/2024) held that, despite a finding that the omalizumab biosimilar would infringe, the patentee had not shown imminence. Marketing authorisations and product promotion were not, on their own, sufficient where there was no evidence of price negotiations or reimbursement applications having begun.

In August 2025, the Court of Appeal took a firmer view on imminence in Boehringer Ingelheim v Zentiva. Reversing the Lisbon LD, the Court granted a preliminary injunction against Zentiva's generic nintedanib. It held that imminent infringement can be established where the generic manufacturer has "set the stage" for launch, including obtaining a marketing authorisation and completing most pricing and reimbursement steps. While the Local Division had characterised those steps as mere administrative acts insufficient to show likely market entry, the Court of Appeal concluded they demonstrated a sufficiently concrete launch trajectory.

The Hamburg LD's October 2025 ruling in Occlutech v Lepu applied this "set the stage" concept in the context of medical devices. Lepu had obtained CE-mark approval, publicly announced receipt of the CE-mark, and planned to showcase products at trade fairs, with an active presence at key medical conferences. The Court emphasised that CE-marking allows devices to be marketed anywhere in the EU without further national pricing or reimbursement procedures. In that regulatory context, Lepu's conduct amounted to sufficient preparation for launch and established a threat of imminent infringement.

Court of Appeal gives guidance on enforcement of penalty orders

In Kodak v Fujifilm, the Court of Appeal clarified the approach to penalty payment orders under Rules 354.3 and 354.4 of the Rules of Procedure. First, where a penalty order is not included in the decision on the merits, it may be issued subsequently, although including it in the final decision is preferable for legal certainty. Second, when setting the amount, the Court must consider the importance of the underlying order and ensure the penalty is coercive yet proportionate. Third, penalty orders should define, with clarity, the circumstances that trigger payment, any compliance deadlines, the calculation method (lump sum or periodic/per act), and whether upward adjustment is possible. Fourth, where a defendant alleges compliance, the burden lies on the defendant to substantiate the measures taken, recognising that the relevant evidence sits within the defendant's exclusive sphere.

Further elucidation on long arm jurisdiction following BSH v Electrolux

The Hague LD's decision in HL Display v Blacksheep confirms the UPC's jurisdictional reach from a Netherlands-domiciled defendant to claims concerning non-UPC and non-EU states. The Court assumed competence over infringement claims covering all designated states, including Liechtenstein, Ireland, Norway, Poland, Switzerland, and the United Kingdom. For non-contracting EU or Lugano Member States, the Court indicated it will assess whether there is a serious, non-negligible likelihood that a competent national court would invalidate the patent. For non-EU Member States, the Court may render an inter partes validity determination. The Court also recorded that the defendant's revocation counterclaim was limited to contracting member states and no parallel revocation actions were pending in the non-contracting states.

Infringement principles clarified by the Court of Appeal

In Belkin v Philips, the Court of Appeal clarified two key principles. First, "offering" for sale under Article 25(a) UPCA is an economic concept and does not require a binding contractual offer. What matters is whether the presentation enables or invites customers to initiate a transaction. Depending on the facts, online listings, catalogues and advertisements can therefore constitute an offer even in the absence of completed sales. Second, liability for infringement under Article 63 UPCA, read with Article 25, is not limited to direct actors. It may extend to third parties where they act as instigators, accomplices, or accessories. However, a managing director's position alone is insufficient to establish accessory liability. Personal liability may arise only where conduct goes beyond ordinary managerial duties, for instance by deliberately using the company to commit infringement. Obtaining and relying on legal advice on non-infringement or freedom to operate may, at least until a first-instance finding of infringement, weigh against accessory liability.

Court of Appeal aligns added-matter test with the EPO "gold standard"

In Seoul Viosys, the Court of Appeal confirmed that Article 65(2) UPCA follows the EPO's "gold standard" under Article 123(2) EPC. The skilled person, using common general knowledge, must be able to derive the claimed subject matter directly and unambiguously from the original disclosure; implicit disclosure suffices only if it is the inevitable consequence of what is expressly disclosed. For divisionals, the analysis must take into account both the divisional application and the earlier application(s), ensuring support for the claimed subject matter across both filings.

A holistic approach to inventive step

The Paris Central Division's decision in Meril v Edwards Lifesciences provides structured guidance on inventive step. The Court reiterated that the analysis involves identifying the objective technical problem in light of the patent specification, determining the relevant state of the art via one or more realistic starting points, and assessing whether the claimed solution would have been obvious to the skilled person. The Court endorsed a holistic approach that evaluates the invention as a whole, rather than reducing the inquiry to isolated distinguishing features, in order to avoid hindsight and better capture the technical contribution of the claimed combination.

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