UPC's Court Of Appeal Overturns First Instance Decision In Amgen V. Sanofi And Regeneron

On 25 November 2025, the Court of Appeal of the UPC (CoA) issued its much-anticipated decision in Amgen v. Sanofi and Regeneron (UPC_CoA_528/2024, UPC_CoA_529/2024), providing guidance on how the UPC will interpret four important legal provisions: claim interpretation, added matter, sufficiency, and inventive step.

Claim Interpretation

One question addressed by the CoA is whether dependent claims can be used to interpret a "main" claim. Although the issue should be considered on a case-by-case basis, the decision provides general guidance that where the dependent claim adds an additional feature without providing a more specific description of the features of the main claim, it argues in general against the possibility of drawing conclusions about the interpretation of the main claim. By extension, it should be possible to use a dependent claim to interpret the main claim where the dependent claim recites more specific information about features that are in the main claim.

The decision also provides guidance on how medical use claims are to be interpreted, given that the use is an inherent feature of the claims. The CoA set out that in case of a use claim, there must be a "therapeutic effect". Therapeutically effective was defined in the decision as "causing a noticeable improvement of the medical condition of the patient suffering from the disease." In other words, the treatment must be meaningful from a therapeutic perspective. The decision sets out that this applies even where the patent does not suggest any minimum required effect. Therefore, any effect must be meaningful.

Added Matter

In accordance with its prior finding in Abbott v. Sibio (UPC_CoA_382/2024, order of 14 February 2025), the court must first ascertain what the skilled person based on his common general knowledge would derive directly and unambiguously from the application as filed. The CoA confirmed that claims must have basis in the application as a whole, and that also matter which is a clear and unambiguous consequence of what is explicitly mentioned, shall also be considered as part of the content. This confirms that verbatim support is not necessarily required, providing that the claimed subject-matter is derivable from the application as a whole.

In addition, the Court confirmed that where an application provides alternatives, this does not per se mean that any selection is arbitrary, provided that it is clear to the skilled person which of the alternatives is preferred based on the application. Therefore, the selection of something which the application indicates is preferred amongst a number of alternatives does not add matter.

The Court's findings on added matter appear to be consistent with the approach taken by the EPO, whilst confirming that the standard is what the application discloses, rather than being an overly legalistic matter.

Sufficiency

The decision also confirms that sufficiency is assessed on the basis of the patent as a whole, taking into account the skilled person's common general knowledge at the effective date of the patent (i.e. at the filing or priority date).

The question that must be assessed is whether the skilled person could reproduce the claimed subject-matter, on the basis of the patent, without any inventive effort and without undue burden. Only a single way of performing the invention (or in the case of functional features, one technical concept) is required in the specification for the patent to be sufficiently disclosed.

In relation to functional features, the decision notes that variants of "specifically disclosed embodiments" that are equally suitable to achieve the same effect, which could not have been envisaged without the invention, should also be protected. In addition, the description is not required to include specific instructions for each and every conceivable embodiment for the patent to be sufficient, provided that the skilled person is able to obtain suitable embodiments within the scope of the claim through the disclosure.

The case includes discussions on whether certain steps taken to identify embodiments falling within the claim at hand resulted in an undue burden being placed on the skilled person. The Court confirmed that a reasonable amount of trial and error is acceptable, and the fact that something is laborious, time-consuming and/or challenging does not automatically constitute an undue burden.

Therefore, the decision provides welcome guidance on how sufficiency should be assessed for UPC proceedings. However, it remains to be seen how the UPC will address concepts such as "equally suitable" and "could not have been envisaged without the invention."

Inventive Step

Finally, the decision provides clear guidance on how inventive step should be evaluated at the UPC.

Prior to this decision, first instance divisions at the UPC had taken varying approaches to the assessment of inventive step. This decision sets out a "holistic approach" for the assessment of inventive step:

• establish the objective of the invention (objective problem) from the perspective of the skilled person;
• starting from a realistic starting point in the relevant field of technology, and wishing to solve the objective problem, asking: would – not only could – the skilled person have arrived at the claimed solution?

Firstly, it must be established what the objective of the invention is. This should be assessed from the perspective of the skilled person, taking into account their common general knowledge, at the effective date of the patent. To do so, it is necessary to establish what the invention adds to the state of the art, by comparing the claim as a whole in context of the description and drawings, whilst also considering the inventive concept underlying the invention. This technical teaching must be based on the technical effects the skilled person understands are achieved on the basis of the application.

The Court clarified that the objective problem should not obtain any pointers to the claimed solution, to ensure hindsight is avoided in the assessment of inventive step.

Secondly, obviousness must be assessed starting from a reasonable starting point in the relevant field of technology. The relevant field is described as "the field relevant to the objective problem to be solved as well as any field in which the same or similar problem arises and of which the person skilled in the art of the specific field must be expected to be aware." This seems to provide some breadth for selecting starting points for the assessment of inventive step. However, it remains to be seen how the concepts of "as any field in which the same or similar problem arises" and where the skilled person "must be expected to be aware" will be interpreted.

The concept of a "realistic" starting point differs from the EPO's "closest prior art." It is described in the decision as any teaching that "would have been of interest to a skilled person who, at the relevant date, wishes to solve the objective problem." The Court gives examples of what could be considered a realistic starting point, including prior art that:

• already discloses several features similar to those relevant to the claimed invention; and/or
• addresses the same or a similar underlying problem.

The decision also clarifies that parties attacking a patent should not be limited to selecting a single realistic starting point. Patentees must establish that the claimed invention would not have been obvious starting from each realistic starting point. Although the EPO's problem-solution approach describes a "closest prior art" document, it is common practice to see attacks run from multiple potential starting points during opposition proceedings, so this may not represent a meaningful distinction between EPO and UPC practice. However, the flexibility in selecting what is "reasonable" may provide further options in revocation proceedings at the UPC than in opposition proceedings at the EPO.

Therefore, although valuable to have confirmation that this is accepted at the UPC, it does not seem to diverge substantially from the EPO. It was noted in the decision that the approaches are guides to assist in assessing inventive step, and should not result in substantially different decisions being reached.

For a finding of obviousness, the skilled person – who has no inventive skills and no imagination – requires a pointer or motivation from the realistic starting point that directs them to implement a next step in the direction of the claimed invention. The decision notes that where the skilled person would (not could) take the next step prompted by the pointer, or as a matter of routine, and would thus arrive at the claimed invention, the solution must be considered obvious.

The decision also considered the assessment of a "reasonable expectation of success," because obviousness would only be found if the skilled person would have taken the next step discussed above in the expectation of finding an envisaged solution. The Court notes that this is generally the case where the results of the next steps were (i) clearly predictable, or (ii) there was a reasonable expectation of success. The reasonable expectation of success was characterised as implying the ability of the skilled person "to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within acceptable time limits."

As may be expected, whether there is a reasonable expectation of success is dependent of the facts of a given case. However, the decision notes that there will be a lower expectation of success in unexplored technical fields, where it is more difficult to make predictions about a successful conclusion of a project, and where there are practical or technical difficulties and costs involved in testing whether the desired result will be obtained. By contrast, a stronger pointer towards the claimed solution lowers the threshold for a reasonable expectation of success.

The CoA set out the same reasoning in its decision in Edwards v. Meril, which was handed down on the same day as the decision in Amgen v. Sanofi.

Concluding Remarks

The decision provides welcome guidance for parties considering using the UPC. In particular, it should result in a consistent approach to inventive step in the first instance divisions across the UPC territories.

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.