Inventive step: the UPC forges its own test

The UPC Court of Appeal has determined the test to be applied for the assessment of inventive step at the UPC.

In what appears to be a coordinated effort, the appeal decisions in two of the earliest cases at the UPC, Amgen v Regeneron/Sanofi and Meril v Edwards Lifesciences, were handed down on 25 November 2025, by the second and first panels of the Court of Appeal, respectively.  The two decisions reaffirm the approach taken by the UPC Court of Appeal in Nanostring v 10x Genomics (UPC_CoA_335/2023, 26 February 2024) and using the same wording outline the approach to be taken by the UPC for the assessment of inventive step.

The approach established by the Court of Appeal is arguably closer to the “holistic” approach taken in the UK and Germany than the problem-solution approach adopted by the European Patent Office (EPO). Nevertheless, influences of the EPO approach and the relevant case law are also apparent in the Court of Appeal’s new test.

Background

The requirement that an invention be new and involve an inventive step are fundamental requirements for patentability, and indeed are part of the public understanding of what an “invention” means.

The requirement to be new (i.e. novel) is relatively easy to conceptualise – if not always factually easy to analyse – and simply requires there to be some difference between the claimed invention and what has been previously made available to the public. It is an inherently objective test.

For the sake of legal certainty, the requirement for inventive step must also be judged objectively. However, the plain meaning of the language here invites an element of subjectivity. How innovative does something new need to be to also be inventive? How do you judge if that threshold is passed?

The underlying provisions of the European Patent Convention (“EPC”) only take us so far, providing that “an invention “involve[s] an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art” (Article 56 EPC). In no small part, the effect of this is merely replacing ambiguity in the term “inventive” with the same degree of ambiguity in the word “obvious”.

It is unsurprising that the courts and the EPO have long histories of looking to build a framework around these terms that is intended to ensure consistent analysis. It is also perhaps unsurprising that these different forums have not always agreed on the framework, although they have tended to argue that their different approaches are sufficiently aligned to provide the same outcomes (at least in most cases).

The EPO’s “problem-solution” approach starts by determining the “closest prior art” and then formulating an “objective technical problem” using a technical effect derived from any differences between the claimed invention and that closest prior art.  Once the objective technical problem has been formulated, the critical question becomes whether, starting from the closest prior art and the objective technical problem, the skilled person would (rather than could) have been prompted to modify or adapt the closest prior art so as to arrive at something falling within the scope of the relevant claim.

The problem-solution approach is well established at the EPO, and broadly speaking has been adopted in France, Spain, Italy, Switzerland and the Netherlands, as well as many other EPC contracting states.

Two prominent examples of EPC contracting states which consciously do not adopt the EPO problem-solution approach wholesale are Germany and the UK.  The German approach is called the problem and solution approach (“Aufgabe- und Lösungskonzept”), while the UK approach is defined by the Windsurfing-Pozzoli test.

A common feature of both the German and UK approaches is that the “inventive concept” in the language of the Windsurfing-Pozzoli test or the “objective technical problem” in the language of the German test are established before determining the relevant prior art document against which obviousness is considered.  This contrasts with the EPO approach in which the “objective technical problem” is established by considering differences between the claimed invention and the closest prior art.

Inventive step at the UPC

It is fair to say that, up to now, the UPC’s approach to the assessment of inventive step has been somewhat scattered.  On the whole, many decisions have taken a more flexible and less formulaic approach, borrowing aspects from the various approaches used in the different national courts.

One may attempt to classify these various approaches based on whether they begin by determining the underlying problem or inventive concept (as with the UK and German approaches) or whether they begin by determining the relevant prior art against which the invention is to be judged (as with the EPO approach).  However, even here the lines can be blurred.  In a recent decision (Advanced Cell Diagnostics v Molecular Instruments, UPC_CFI_187/2024, UPC_CFI_507/2024, 18 November 2025 [49]), the Hague Local Division noted that while the parties agreed that the “holistic” approach adopted by the Munich Central Division in Amgen v Regeneron/Sanofi (UPC_1/2023, 16 July 2024) should be applied, in practice the parties rather applied a test that was more akin to the EPO’s problem-solution approach.

The Munich Local Division attempted to create a harmonised approach in its decision in Meril v Edwards Lifesciences (UPC_CFI_501/2023, 4 April 2025), a dispute involving another Edward Lifesciences patent and not the subject of the most recent appeal.  In this decision, the Court advocated the use of the EPO’s problem-solution approach “as a tool … to enhance legal certainty and further align the jurisprudence of the [UPC] with the jurisprudence of the [EPO] and the Boards of Appeal” ([HN 2]).  However, in a recent decision on yet another dispute between Meril and Edwards Lifesciences (UPC_CFI_189/2024, UPC_CFI_434/2024, 20 October 2025), the Paris Central Division appeared to attempt to establish, as the UPC test, the Court of Appeal’s “holistic” approach in Nanostring v 10x Genomics (UPC_CoA_335/2023, 26 February 2024), which it had been using consistently for the assessment of inventive step.

A firm conclusion on inventive step at the UPC?

In its most recent decisions, the Court of Appeal seems to leave no room for any doubt as to what approach should be used at the UPC.  As noted above, using the same wording, both panels, chaired respectively by Klaus Grabinski, the President of the Court of Appeal, and Rian Kalden, explain that the national courts of various EPC contracting states use different approaches to the assessment of inventive step, before outlining the “approach taken by the Unified Patent Court …, which can already be derived from Nanostring/10x Genomics” (Amgen [126], Meril [HN 5]).

First, “the object of the invention …, i.e. the objective problem” has to be established “from the perspective of the person skilled in the art, with their common general knowledge, as at the application or priority date ….   This must be done by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in the context of the specification and the drawings, thus also considering the inventive concept underlying the invention (the technical teaching), which must be based on the technical effect(s) that the person skilled in the art, on the basis of the application, understands is (are) achieved with the claimed invention” (Amgen [HN 11], Meril [HN 8]).

The “objective problem should not contain pointers to the claimed solution” (Amgen [HN 12], Meril [HN 9]) and once established, the relevant question is whether “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, wishing to solve the objective problem, would (and not only: could) have arrived at the claimed solution” (Amgen [HN 13], Meril [HN 10]).

“A starting point is realistic if the teaching thereof would have been of interest to a skilled person who, at the relevant date, wishes to solve the objective problem. This may for instance be […one that] already discloses several features similar to those relevant to the invention … and/or addresses the same or a similar underlying problem …. There can be more than one realistic starting point and the claimed invention must be inventive starting from each of them” (Amgen [HN 15], Meril [HN 12]).  In this sense a realistic starting point should not be conflated with the EPO test’s “closest prior art”, which is the “most promising starting point for a development leading to the invention” (EPO Guidelines for Examination, G-VII, 5.1, emphasis added).

Discussion

Based on the guidance given by the Court of Appeal, the UPC test for inventive step may be summarised as:

(i) identify the skilled person and the common general knowledge at the priority date;

(ii) establish the object of the invention, i.e. the objective problem;

(iii) consider whether the skilled person starting from a realistic starting point in the state of the art in the relevant field of technology, wishing to solve the objective problem, would (and not only: could) have arrived at the claimed solution.

As highlighted above, the approach is closer to the “holistic” approaches used in Germany and the UK in that the problem or object of the invention is first determined before the relevant prior art is considered.  Nevertheless, the last step appears to be influenced also by the EPO’s could-would approach (see EPO Guidelines for Examination, G-VII, 5.3).  Moreover, the decision in Meril refers to the Case Law of the EPO Boards of Appeal for authority for an invention as a “non-obvious alternative solution” (Meril [139]) and to the Enlarged Board of Appeal in G 2/21 for reliance on a purported technical effect for inventive step (Meril [143]).

Both decisions also provide useful guidance on many aspects of claim interpretation and the assessment of validity. Amgen v Regeneron/Sanofi is particularly relevant for how to approach the question of reasonable expectation of success in the context of second medical use claims.

We will continue to provide updates on these topics, but in the meantime one of the big early questions on substantive law at the UPC appears answered: we have a definitive UPC approach to inventive step.