Case I: Meril v Edwards — Court of Appeal, 25 November 2025 (UPC_CoA_464/2024; UPC_CoA_530/2024; UPC_CoA_21/2025; UPC_CoA_27/2025; UPC_CoA_457/2024; UPC_CoA_458/2024; UPC_CoA_532/2024; UPC_CoA_533/2024)
Case II: Amgen v Sanofi/Regeneron — Court of Appeal, 25 November 2025 (UPC_CoA_528/2024; UPC_CoA_529/2024)
Two decisions of the Court of Appeal handed down on the same day – in Meril v Edwards concerning EP 3 646 825 and in Amgen v Sanofi/Regeneron concerning EP 3 666 797 – provide the clearest articulation to date of how the UPC intends to establish inventive step. Both panels refer expressly to the problem-solution approach (PSA) used at the EPO. However, the headnotes and the reasoning in each judgment departs in important aspects from the PSA structure and adopts a broader “holistic” analysis.
Inventive step is assessed holistically, based on the “technical teaching” of the patent, the skilled person’s expectations, and an overall evaluation of whether the claimed solution would have been taken as a next step.
The most striking structural departure from the problem-solution approach is the order of analysis. Under the PSA, the starting point is the “closest prior art”, and the objective technical problem is then derived from the differences between the claim and that closest prior art. By contrast, both Court of Appeal panels start from the object of the invention as such and only then ask which items of prior art qualify as a “realistic starting point”.
In both decisions, the Court first defines the objective problem by asking what the claimed invention “adds to the state of the art”, viewed through the lens of the patent’s technical teaching, the specification and the drawings. The claim is assessed as a whole, in context, and the technical effect(s) that the skilled person would understand from the application are central.
Only in a second step does the Court turn to the prior art and identify one or more “realistic starting points”, i.e. prior-art disclosures that the skilled person would genuinely have considered when trying to solve that already-defined objective problem. This is diametrically opposed to the EPO’s sequence, where the starting point is chosen first, and the problem is then constructed in light of that choice.
In Meril v Edwards, the Court of Appeal uses this structure to frame a more open-textured obviousness analysis.
First, the Court defines the invention’s “object” in terms of the technical teaching of EP 3 646 825, not in terms of incremental feature differences over any single document. The technical effect and the underlying concept of the invention are taken from the patent itself, as understood by the skilled person at the effective date.
Secondly, the Court replaces the EPO’s “closest prior art” with the notion of a “realistic starting point”. A piece of prior art is realistic if it would have been of interest to a skilled person wishing to solve the objective problem and if it already discloses several relevant features and/or addresses a similar underlying problem. The Court expressly accepts that there may be several such starting points; the invention must then be non-obvious from each of them.
Thirdly, obviousness is framed around whether the skilled person would take the next step, not merely whether they could. The skilled person has no inventive skills and no imagination and requires a pointer or motivation that directs them towards the claimed solution. If, prompted by such a pointer or as a matter of routine, the skilled person would have taken the next step and thereby arrived at the claimed invention, inventive step is lacking; otherwise it is present.
Importantly, the Court also clarifies that inventive step does not require an improvement over the prior art. A patent may be inventive if it discloses a non-obvious alternative, even if that alternative is not technically superior in a measurable way.
In Amgen v Sanofi/Regeneron, the same basic structure is repeated, but the Court goes further in elaborating the role of reasonable expectation of success.
Again, the Court first derives the objective problem from the patent’s technical teaching, as understood by the skilled person with common general knowledge at the priority date. Only once this object is established does the Court ask which prior-art disclosures would have represented realistic starting points for a skilled person attempting to solve that problem.
The obviousness analysis is then framed in terms of whether the skilled person would have taken the next step in expectation of finding a solution of their technical problem. The Court links this to two key elements:
– whether the outcome of the next step was clearly predictable, or at least associated with a reasonable expectation of success; and
– whether practical or technical difficulties, uncertainties or costs would have deterred the skilled person from pursuing that step.
The Court expressly notes that the more unexplored the technical field, the more difficult it is to predict a successful outcome and the lower the expectation of success. At the same time, the stronger the pointer towards the claimed solution, the lower the threshold for a reasonable expectation.
