With a significant number of cases decided at both the Court of First Instance and the Court of Appeal, the UPC has continued to develop its case law at a fast pace. We have selected the five decisions from 2025 that we believe stand out the most – which was no easy task! These decisions address issues relating to inventive step, imminent infringement, cross-border jurisdiction, pharma, and anti-interim licensing in FRAND cases.

Boehringer Ingelheim/Zentiva: imminent infringement and "setting the stage" in PI

We start our review with one of the most important UPC decisions as of yet, certainly in the context of preliminary injunctions. This Court of Appeal decision establishes crucial principles for determining when an "imminent threat of infringement" exists (here in the context of generic pharmaceutical launches). The "setting the stage" test is certain to guide future UPC preliminary injunction cases.

Boehringer Ingelheim's patent related to nintedanib in Portugal, with the patent expiring on 21 December 2025. Zentiva obtained Portuguese marketing authorisations for generic medicines containing nintedanib on 30 August 2024 and applied for a Prior Evaluation Procedure (PEP) in Portugal, which was granted by INFARMED (the Portuguese National Authority of Medicines and Health Products) on 12 December 2024. The key question was whether this action resulted in imminent infringement.

The Court of Appeal ruled that imminent infringement can take place if:

• the infringement has not yet occurred;
• the potential infringer has set the stage for infringement to occur;
• the infringement is only a matter of starting the action; and
• the preparations for infringement have been fully completed.

In this connection, the Court of Appeal held that the mere application for a marketing authorisation does not amount to imminent infringement, and nor does the grant of that authorisation. However, completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case.

Applying the legal standard to the case at hand, the Court of Appeal found it more likely than not that the PEP approval will enableZentiva to offer the generic nintedanib product to hospitals in Portugal without any further administrative steps. According to the court, Zentiva had not offered any credible explanation why, absent patent infringement, it would be useful for it to obtain the PEP more than one year before the patent expired. The Court of Appeal concluded that the only way a completed PEP could be of any use to Zentiva from an objective point of view was for the offering of the generic product. This made infringement only a matter of starting the action because preparations for it had been fully completed.

Amgen/Sanofi and Meril/Edwards: "realistic starting point" test for inventive step confirmed

These two landmark decisions handed down by the Court of Appeal on 25 November 2025 (here and here) set out the approach taken by the UPC when establishing inventive step.

The Court of Appeal acknowledged that the national courts of the various EPC countries have different approaches - and use different guidelines - when assessing if an invention involves an inventive step. But this does not matter as these guidelines are merely there to assist in the establishment of inventive step as required by Art. 56 EPC. When properly applied, all these methods should (and generally do) lead to the same conclusion.

According to the "UPC test" on inventive step, the objective problem must first be established. It must be assessed from the perspective of the skilled person, with their common general knowledge, on the patent's application or priority date. This assessment must be done by establishing what the invention adds to the state of the art. As part of this, the inventive concept underlying the invention (the technical teaching) must also be considered, based on the technical effect(s) that the skilled person, on the basis of the application, understands is (are) achieved with the claimed invention. Also, the objective problem should not contain pointers to the claimed solution.

The claimed solution is obvious when – at the relevant date – the skilled person, starting from a realistic starting point in the state of the art in the relevant field of technology and wishing to solve the objective problem, would (not just could) have arrived at the claimed solution.

A starting point is realistic if the teaching of it would have been of interest to a skilled person who wishes to solve the objective problem. Importantly, there can be more than one realistic starting point and the claimed invention must be inventive starting from each of them. The claimed solution is not inventive if prompted by the pointer or as a matter of routine.

The Amgen/Sanofi decision provides guidance on how to assess inventive step in fields where (scientific) uncertainty may play a role, such as pharmaceuticals and biotechnology. A claimed solution is obvious if the skilled person would have taken the next step in the expectation of finding an envisaged solution of their technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a "reasonable expectation of success". The Court of Appeal provided practical guidance with respect to relevant circumstances, which include predictability, unexplored technical field, practical or technical difficulties, and even costs involved in testing. A stronger pointer generally means a lower threshold.

According to the Meril/Edwards decision, inventive step may also be found if the patent claims disclose a "non-obvious alternative" to solutions known in the prior art.

Whether the UPC's "realistic starting point" approach will consistently lead to the same conclusions on inventive step as the various national approaches, remains to be seen in practice.

TGI/AIM: cross-border jurisdiction expanded

This decision in the case between TGI (previously: Supponor) and AIM is only one of many cases in 2025 confirming the UPC's long arm jurisdiction. But it stands out for being the first decision at the Court of Appeal level after the CJEU's landmark BSH/Electrolux decision of 25 February 2025.

The Court of Appeal upheld the Local Division Helsinki's decision to accept AIM's request to add Spain to the proceedings, even though it was acknowledged that this request was made late. The Court of Appeal held that AIM could not have been expected to include this non-UPC territory in its statement of claim before the BSH/Electrolux decision came out. The Court of Appeal also found that without the addition, there was a risk that AIM would start separate proceedings for Spain, potentially leading to irreconcilable decisions. As a result, the territorial scope was extended to a non-UPC member state.

In 2025, following BSH/Electrolux, we saw many similar decisions by the UPC. This confirms that the UPC assumes jurisdiction outside the UPC CMS territory, both in preliminary injunction cases and in main proceedings.

Sanofi/Amgen: second medical use claims and infringement

In 2025 the UPC handed down its first decision on infringement of second medical use claims. These types of claims are known to be highly valuable for pharmaceutical companies as they can lead to patent protection for new therapeutic applications of known compounds.

Here, the Local Division Düsseldorf (LDD) found the contested patent valid, but held that there was no infringement. In this context, the LDD established some principles and practical guidance for assessing when a second medical use claim is infringed:

• As an objective element, the alleged infringer must offer or place the product on the market in such way that it leads or may lead to the claimed therapeutic use, and the alleged infringer knows or reasonably should have known that it does; there must thus be a prescription for the claimed use, or circumstances showing that such use may be expected to occur.

• As a subjective element, the infringer must know this or reasonably should have known.

The LDD further held that the requirements of such behaviour cannot be defined in an abstract manner but require an analysis of all relevant facts and circumstances. These may include: the extent or significance of the allegedly infringing use; the relevant market, including what is customary on that market; the market share of the claimed use compared to other uses; what actions the alleged infringer has taken to influence the respective market, either "positively", de facto encouraging the patented use, or "negatively" by taking measures to prevent the product from being used for the patented use.

The LDD furthermore states that the manufacturing of the product and in particular the package insert and the SmPC of a pharmaceutical product can be important. However, they are not always the only decisive factor to be taken into account. Although the claimed effect (reducing Lp(a) levels) was explicitly included in defendant Amgen's (the alleged infringer) SmPC, the LDD found that Amgen did not place its product on the market in an infringement-relevant manner. The LDD considered it relevant that the claimed effect of reducing Lp(a) levels was included in the "pharmacodynamics properties" section of the SmPC (that is, without reporting any clinical relevance of this), but not in the "therapeutic indications" section (which includes such reporting). Another key finding was that a "windfall effect" – effect A may have the windfall effect to have effect B (that is, the claimed use) – is irrelevant in the context of infringement of a second medical use claim.

Furthermore, there was no evidence of prescriptions having already been made or a substantial likelihood that these would be made.

In short, according to this decision, for a finding of infringement of second medical use claims in the UPC, the patentee must prove that the defendant's market placement leads or may lead to the claimed therapeutic use (and not merely as a windfall effect) and that the defendant knows or should know this.

InterDigital/Amazon: anti-interim-licence injunctions

We end this list of "not to miss" decisions of 2025 with the UPC's most recent decision in the "interim and anti-interim licences" saga that is playing out between the UPC and the UK in FRAND cases.

In the UK, interim licenses are known to have been used by implementers to obtain temporary court orders in standard essential patents (SEP) matters while the final licence is being negotiated or litigated. Interim licenses are intended to prevent hold-up tactics by SEP owners and to ensure that the implementer can continue to use the technology while discussions or litigation(s) are pending, but they can simultaneously block infringement actions across Europe - including at the UPC - as a result, which gives them the effect of anti-suit injunctions.

To counter a potential interim licence, the Local Division Mannheim (LDM) showed that it was willing to issue an "anti-interim licence injunction". In the case between patentee InterDigital and implementer Amazon, the LDM granted an ex parte injunction on 30 September 2025, prohibiting Amazon from seeking interim licences or anti-suit injunctions, with significant penalties involved in the case of non-compliance with the order.

The ex parte injunction was confirmed by the LDM on 22 December 2025. According to the LDM, UK interim licenses (or "adjustable licenses") equated to an anti-suit injunction directed against patentee InterDigital to enforce their IP rights in foreign jurisdictions and therefore also before the UPC. According to the LDM, there was no justifiable ground for such an order, which is directed against a party turning to a foreign court to have it assess that party's patent rights. The LDM considered an interim licence to violate the ordre public of the European Union and therefore also the ordre public of the UPC contracting member states. This rendered the interim licence null and void and, for that reason, unenforceable in UPC contracting member states. In any event, InterDigital had a legal interest in defending itself against such order.

The decision is currently in an appeal stage, with Amazon asking for suspensive effect, which was rejected on 29 December 2025. Whether the interim/ant-interim licenses discussion reached its boiling point in 2025 or will escalate further in 2026, remains to be seen.

Looking ahead: 2026

By now the UPC has cemented its position as the go-to patent court in Europe and an important player on the world stage. Furthermore, the growing body of Court of Appeal case law is resulting in increasingly harmonised UPC law. As this case law continues to develop, we can expect further refinement and guidance in 2026. And while we cannot predict the future, there may be important decisions on topics such as cross-border jurisdiction, pharma, FRAND, the role of the prosecution history, and equivalence.