- within Food, Drugs, Healthcare and Life Sciences topic(s)
It has now been over two years since launch of the UPC. A key question for users was what the court's approach to assessment of validity would be in practice. In this briefing, we review the approach the UPC has taken to inventive step thus far and prospects for future closer alignment with the EPO. We also discuss potential drafting considerations.
Background
The EPO applies a particular approach to assessment of inventive step, the "problem-solution approach" (PSA), as set out in the EPO's Guidelines for Examination. The PSA involves three stages: (i) determining the "closest prior art", (ii) establishing the "objective technical problem" to be solved and (iii) considering obviousness of the claimed invention starting from the closest prior art and the objective technical problem.
The PSA does not have a specific statutory basis in the European Patent Convention (EPC), but is long-established and familiar to users. European national courts diverge in the extent to which they apply the PSA, with some using quite different approaches (e.g. Germany, the UK).
It has been of interest to see the extent to which the UPC's approach to assessment of inventive step thus far aligns with that of the EPO. Divergence in approach could give rise to distinct outcomes in assessment of inventive step of the same patent at the UPC and in a parallel EPO Opposition. There are thus potential strategic implications for patentees and challengers, given the EPO and UPC's shared jurisdiction over validity of EP patents in UPC participating states during the EPO's Opposition period.
The prior art starting point
A fundamental aspect of the assessment of inventive step is the piece of prior art from which obviousness of the claimed invention is to be evaluated. The EPO's PSA requires determination of the closest prior art, which represents the most promising starting point for arriving at the invention. The closest prior art is selected based on having a similar purpose or effect to the invention, also typically having the most features in common. While the EPO does permit attacks based on several equally valid starting points (each qualifying as a closest prior art), often only a single document will be chosen as being closest. This choice may have a significant impact on whether an invention is considered obvious, for example if there is a teaching away from the invention in the relevant document.
In contrast, various UPC decisions thus far have applied a more flexible approach to the selection of a prior art starting point. The UPC Court of Appeal (CoA) referred in their first decision dealing with substantive validity, UPC_CoA_335/2023 (10x v Nanostring), to prior art that "would have been of interest to the person skilled in the art" (Emphasis added). This led to a selection of a different starting point by the CoA as compared to the Munich Local Division as Court of First Instance (CFI), who referred in their decision UPC_CFI_2/2023 to the "most promising starting point", and in turn a different conclusion regarding inventive step. This case illustrates the potential for different outcomes on inventive step depending on how a prior art starting point is selected.
Another early decision from the Munich Central Division, UPC_CFI_1/2023 (Sanofi v Amgen), referred to the concept of a "realistic starting point" (equating this with it being "of interest to the skilled person") and specifically found it unnecessary to identify the most promising starting point. It was also stated that there can be several realistic starting points. In later decision UPC_CFI_308/2023 from the Paris Local Division (NJOY v VMR), realistic starting points were defined as "documents which disclose the main relevant features as those disclosed in the challenged patent or which address the same or a similar underlying problem".
Other decisions of the UPC have frequently applied the "of interest" and "realistic" criteria when assessing whether a prior art starting point is appropriate, and thus it appears the UPC to date has in general been more permissive than the EPO in allowing attacks from different starting points. The approach of focussing on a closest prior art has though not been dismissed entirely. In particular, the Paris Local Division in UPC_CFI_315/2023 (NJOY v Juul) indicated that although there is a risk of subjectivity, for reasons of procedural efficiency, it may be justified to focus on a certain element/elements of prior art.
Definition of the problem
Following identification of a closest prior art, the EPO's PSA involves formulation of an objective technical problem to be addressed starting from that art. This problem is formulated based on the differences between the claimed invention and the closest prior art, and the technical effects thereof. Accordingly, the problem specifically depends on the closest prior art.
UPC decisions to date have also commonly referred to the concept of a "problem" when assessing inventive step. Thus, the Paris Local Division in UPC_CFI_395/2023 (Dexcom v Abbott) stated that "Inventive step is defined in terms of the specific problem encountered by the person skilled in the art". The Düsseldorf Local Division in UPC_CFI_7/2023 (Kaldewei v Bette) framed the question of inventive step by identifying a task which the skilled person was faced with, related to provision of particular technical effects.
However, various UPC decisions have framed the nature of the problem without reference to a prior art starting point, in marked contrast to the EPO. These decisions highlight a potentially more important role to the description of the invention (and discussion of background art) in the patent specification in the assessment of inventive step at the UPC.
In particular, in UPC_CFI_1/2023 (Sanofi v Amgen), the Munich Central Division stated that an "underlying technical problem" is to be established from the background section of a patent, failing which from the patent description as a whole. Similarly, decision UPC_CFI_311/2023 (Njoy v VMR) from the Paris Local Division defined the underlying problem by reference to provision of a particular device described in the patent specification. Another decision of the Paris Local Division (UPC_CFI_315/2023, Njoy v Juul) did derive the problem based on a difference over the prior art, but did so specifically because the patent itself did not specify a problem.
The UPC's current approach to formulation of the problem means there may be potential advantages to including discussion of a problem addressed by the invention in the description when drafting a patent application, to support how inventive step will be assessed at the UPC.
Obviousness
The final step of the EPO's PSA is to assess whether the claimed solution would have been obvious with respect to the closest prior art, taking into account the technical problem. Reasoning for obviousness/non-obviousness in UPC decisions thus far has often been based on similar principles to those applied by the EPO, and thus this appears to be an area of reduced divergence.
An early general test for obviousness was provided by the Munich Central Division in UPC_CFI_1/2023 (Sanofi v Amgen), as being met "if the skilled person would be motivated to consider the claimed solution and would implement it as a next step in developing the prior art". The UPC CoA similarly referred in UPC_CoA_335/2023 (10x v Nanostring) to "an incentive or confirmation for thinking in this direction" resulting from an indication in the prior art. These remarks echo the EPO's "could/would" approach, which requires a motivation to combine prior art disclosures. Indeed, in UPC_CFI_239/2023 (Plant-E v Arkyne) and UPC_CFI_501/2023 (Meril v Edwards), it was held that the prior art at issue could be altered but would not be.
On the other hand, in UPC_CFI_1/2023 (Sanofi v Amgen), it was stated that the existence of other ways of solving the underlying problem did not establish non-obviousness. Instead, it was stated that "it is sufficient (but also necessary) for denying inventive step that the skilled person would without inventive contribution arrive at a result which is covered by a claim". This is again broadly in line with EPO practice, where a feature selected arbitrarily from several possibilities cannot generally contribute to inventive step. Similarly, a feature that was considered a design choice without effect was not considered inventive in UPC_CFI_233/2023 (Dexcom v. Abbott). In contrast, and again in line with EPO practice, it was stated in UPC_CFI_1/2023 (Sanofi v Amgen) that a technical effect or advantage may be an indication for inventive step.
Finally, the UPC has confirmed in various decisions that hindsight is to be avoided in assessment of inventive step, in line with the EPO's caselaw. The Düsseldorf Local Division stated this as follows in UPC_CFI_363/2023 (Seoul Viosys v expert e-commerce): "One-sidedness must be avoided. The question of inventive step should not be answered by searching retrospectively for (combined) prior art disclosures from which this solution could be derived when the patented subject-matter or the patented solution is known."
In summary, in contrast to selection of a prior art starting point and definition of a problem, the UPC's approach to assessing obviousness has in general been more closely in line with the approach of the EPO.
Possibilities for future alignment with EPO
While various UPC decisions to date have eschewed the PSA in favour of a distinct approach, it is of interest that some decisions have nonetheless considered both approaches. Thus, in UPC_CFI_54/2023 (Avago v Tesla), the Hamburg Local Division applied both approaches and concluded they would lead to the same outcome. In UPC_CFI_255/2023 (Meril v Edwards), the Paris Local Division, while noting that the PSA does not appear to be mandatory since it is not explicitly provided for in the EPC, nonetheless confirmed that applying the PSA would not have led them to a different conclusion.
More recently and potentially significantly, the Munich Local Division, the most active UPC division to date, has stated explicitly in their decision UPC_CFI_501/2023. (Edwards v Meril) issued in April 2025 that they intend to henceforth apply the PSA to enhance legal certainty and align UPC jurisprudence with that of the EPO. This statement followed a discussion of the varying approaches taken in UPC jurisprudence on inventive step to date.
It remains to be seen whether and when the UPC Court of Appeal will provide more definitive guidance on the approach that should be taken to assessment of inventive step. In the meantime, there have already been divergent decisions from the UPC Court of First Instance and the EPO Opposition Division on inventive step in parallel cases, with UPC cases also being stayed in some instances pending a final decision on validity from an EPO Board of Appeal. One example of such a case is UPC_CFI_1/2023, as discussed in more detail in our previous news item.
Conclusion
The approach to assessment of inventive step remains an evolving area at the UPC and there is not yet harmony with the EPO, although a call for closer harmony has been made by the Munich Local Division. One particular area of current divergence to the EPO is how the problem to be considered when assessing inventive step is to be identified, which may be influenced at the UPC by how a patent application is drafted. Other aspects of the determination of inventive step are more similar to the EPO, and outside of the control of the applicant at the drafting stage.
Pending more guidance from the Court of Appeal, users of the UPC should be prepared to assess inventive step under both the UPC and EPO approaches and there may be the possibility of divergent outcomes at the UPC and EPO in parallel cases.
J A Kemp LLP acts for clients in the USA, Europe and globally, advising on UK and European patent practice and representing them before the European Patent Office, UKIPO and Unified Patent Court. We have in-depth expertise in a wide range of technologies, including Biotech and Life Sciences, Pharmaceuticals, Software and IT, Chemistry, Electronics and Engineering and many others. See our website to find out more.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
