In this article we will look at the Court’s treatment of the issue of obviousness to date, before turning to the Meril v Edwards decision of 4 April 2025 and considering its implications.

The Problem-Solution Approach

The problem-solution approach has developed from the EPO’s case law to become the de facto framework for the assessment of inventive step in all but a small number of cases. It is seen, by the Boards of Appeal of the EPO, to ensure that the assessment of inventive step is as objective as possible. It has three main stages:

(i) determining the “closest prior art”,

(ii) establishing the “objective technical problem” to be solved, and

(iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.

It is now generally accepted that step (i) permits there to be multiple valid starting points for the assessment of inventive step.

The formulation of the “objective technical problem” in step (ii) is perhaps the most significant step in the problem-solution approach. First, one compares the claim with the closest prior art to determine what are the distinguishing feature(s) of the claimed invention over the cited art. Having done this, one then identifies the technical effect resulting from the distinguishing features, and then formulates the objective technical problem based on the identified technical effect.

Step (iii) then essentially asks whether in seeking a solution to the objective technical problem so defined, the skilled person would think it obvious to solve that problem by implementing the distinguishing features and so arrive at the claimed invention.

A Brief History of Obviousness at the UPC

The UPC, by statute, inherits the patent validity rules of the EPC, and from the outset it was expected that the Court will, to a greater or lesser degree, be informed by the established body of case law at the EPO.

In this context, obviousness has been a key battleground for litigants at the UPC from its earliest cases.

The first order of the Court of First Instance which included reasoning on substantive law concerning patent validity (an order on provisional measures in Nanostring v 10x Genomics, UPC_CFI_2/2023, issued by LD Munich on 19 September 2023) dealt with obviousness.

That decision, like many subsequent decisions on obviousness issued by various divisions of the UPC, eschewed strictly following the EPO’s problem-solution approach.

The first invalidity decision in a merits case (rather than an application for provisional measures) was issued by LD Düsseldorf in Franz Kaldewei v Bette (UPC_CFI_7/2023, 3 July 2024), which related to sanitary tubs/shower trays. Notably, the Court identified an “underlying task” addressed by the patent (providing a sanitary tub device which can be easily formed in different sizes and has good functional properties) before the differences with the prior art were assessed. As such, the Court’s approach was quite different from the problem-solution approach in which (as noted above) the objective technical problem is formulated only after determining the difference between the claim and the closest prior art.

Shortly after, Central Division (CD) Munich issued its decision in Sanofi v Amgen (UPC_CFI_1/2023, 16 July 2024), which related to antigen binding proteins that bind to PCKS9. In that case, too, the Court did not follow the problem-solution approach. Rather, the Court first observed that “the Patent does not formulate a concrete underlying problem” but that “it can be deduced from the Patent description as a whole that the aim of the Patent is to provide a treatment or prevention of hypercholesterolaemia or atherosclerotic disease … targeting PCSK9 to regulate levels of LDLRs (and thereby LDL)”.

Only after identifying the “underlying problem” to which the patent was directed did the Court’s reasoning go on to identify a starting point in the prior art and ask the question of whether it would be obvious to arrive at the claimed solution from that prior art in view of the underlying problem.

Many decisions of the UPC have acknowledged the existence of the EPO’s approach (even if not necessarily applying it in its reasoning). For example, a decision from CD Paris in Meril v Edwards (UPC_CFI_255/2023, 19 July 2024), noted that the EPO’s problem-solution approach “is not explicitly provided for in the ‘EPC’ and, therefore, does not appear to be mandatory.” The Court provided its own assessment of inventive step which did not follow the problem-solution rubric, but went on to state that had it followed the EPO’s approach, the same decision would have been reached.

In some decisions of the Court, divisions have (at least nominally) applied the EPO’s approach. For example, LD The Hague in Plant-e v Arkyne (UPC_CFI_239/2023, 22 November 2024) explicitly sought to apply the problem-solution framework when assessing obviousness – although step (ii) of the EPO’s test is not apparent.

In the round, the UPC has not as a general rule been applying the problem-solution approach. Instead, although obviousness has been considered in terms of whether the claims are an obvious way of addressing technical problems, those technical problems have not been formulated in structured way which would be expected at the EPO, but generally are derived from a more holistic view of the patent specification itself.

Meril v Edwards – LD Munich seeks to enforce a uniform approach?

It is against this background, then, that this recent decision (Meril v Edwards, UPC_CFI_501/2023, 4 April 2025) from LD Munich is quite so notable.

The patent in that case (EP3669828B2) related to a collapsible prosthetic heart valve which has an annular frame and a leaflet structure positioned within the frame, which includes tabs. The claims were characterised by a specific way in which the tabs were folded, with creases in both axial and radial directions, such that portions of the tabs extended in different planes.

With its revocation counterclaim, Meril attacked the independent claim under a number of grounds. In particular, Meril alleged that the independent claim lacked novelty or, in the alternative, inventive step over a particular prior art document, Nguyen.

Nguyen also related to a prosthetic heart valve with a leaflet structure. The Court held, however, that the claim was novel because Nguyen did not disclose fold lines which extended in different directions to each other, nor did it disclose a tab which had portions extending in different planes to each other.

When turning to the issue of inventive step, the Court observed that “The Court of First Instance and the Court of Appeal of the Unified Patent Court have assessed inventive step in various decisions. Some decisions explicitly referred to the PSA [problem-solution approach], used by the EPO, including the BoA, and several national courts; others applied a different approach, that is similar if not identical to the test of inventive step applied by the German Federal Court of Justice.”

The Court noted that the “German” test and the problem-solution approach should lead to the same results in the majority of cases on the basis that both tests require a “realistic starting point” and an “incentive” for the skilled person to amend the technical solution disclosed by the starting point to arrive at the patented solution. The Court also observed that no particular test is enshrined in the EPC.

The Court stated, however, that it would take the decision to “apply the PSA as practiced by the EPO, including and the BoAs, to the extent feasible and to state this explicitly as there is a need for legal certainty for both the users of the system and the various divisions of the Unified Patent Court. Applying the PSA further aligns the jurisprudence of the Unified Patent Court with the jurisprudence of the EPO and the BoA.”

The Court proceeded to assess obviousness in line with the problem-solution framework. The Court held that Nguyen was an appropriate starting point for the assessment of inventive step, since it was from the same field and had similar overall aims as the claimed prosthetic heart valve (step (i) of the EPO test, also present in any UPC assessment of obviousness since the start of the Court).

In formulating the objective technical problem, the Court followed the approach expected under the EPO’s framework – it considered the distinguishing features over Nguyen and the technical effect of those features specifically. The distinguishing features had already been established as part of the novelty assessment, namely the specific folding configuration of the tab. The Court determined the technical effect of the claimed tab configuration based on the discussion in the patent of the effects and functionality specifically attributable to the tab configuration. Based on these effects, the Court formulated the technical problem as being how “to provide a reliable and durable valve”.

The Court then noted that Nguyen also apparently sought to provide a reliable and durable valve, but that the solution provided in Nguyen was structurally completely different from that of the patent, in particular since it did not disclose any “radially extending” folding lines. The Court observed that while the skilled person “could” have provided the claimed folding configuration, Meril had not demonstrated that the skilled person “would” do so without the benefit of hindsight.

Ultimately, the Court found that the claim was not obvious and, consequently, held the patent to be valid. The Court also found that Meril’s competing prosthetic heart valve and associated delivery system infringed claims of the patent in suit, resulting in the award of an injunction against Meril.

Outlook – will the UPC’s approach to obviousness align with the EPO?

This decision of LD Munich is, ultimately, a single decision from one division of the Court of First Instance of the UPC. Going forward, however, litigants before the LD Munich (at least) should be prepared to argue their case on obviousness using the EPO’s problem-solution framework.

Divisions of the Court of First Instance are, generally, open to other first instance decisions providing authority on certain issues (particularly where they have not been settled at the UPC’s Court of Appeal). We can therefore expect to see parties to proceedings citing the headnote in this decision where they feel that the problem-solution approach will support their case.

Ultimately, however, this is one of the many outstanding issues that over time will need to be refined by the UPC’s Court of Appeal. We can imagine that, at some point (and hopefully soon), a case will be referred to the Court of Appeal which demands an answer as to whether the EPO’s problem-solution approach should be followed.

The UPC’s previous practice, generally based on an “underlying problem” derived from the patent, perhaps gives a degree of flexibility to the Court in how it approaches the assessment of obviousness – it is not bound by the prescriptive approach to the determination of the objective technical problem based on the effect of the distinguishing features. And, while the elimination of subjectivity from the assessment of obviousness is a lofty aim, there are still many who say that the EPO’s problem-solution approach fails to be truly objective.

However, the preamble of the UPC agreement itself cites enhancing legal certainty as one of the driving motivations for the foundation of the Court, and converging on a single approach to substantive legal issues would certainly be beneficial in this regard. The vast body of case law provided by the EPO’s practice, and the decisions of its Boards of Appeal in particular, mean that the problem-solution approach is a framework which is well understood by the European legal profession. Its application could therefore result in greater predictability of outcomes from the UPC and may be preferable to the Court developing its own novel approach to the assessment of obviousness, or (perhaps worst of all) allowing different practices to develop within different divisions of the Court.

This decision from the LD Munich, which is the strongest endorsement yet of the problem-solution approach, might be the next step in its widespread adoption by the UPC. As with many things in these first few years of this new Court, however, only time will tell whether or not this will happen.

Footnotes

Originally published in the LSIPR.