UPC Court of Appeal has its say on inventive step (UPC_CoA_464/2024; UPC_CoA_530/2024; et.al.)
UPC Case Law | 26.01.2026
Court docket: Luxembourg (LU), decision of 25.11.2025 UPC_CoA_464/2024; UPC_CoA_530/2024; UPC_CoA_21/2025; UPC_CoA_457/2024; UPC_CoA_532/2024 UPC_CoA_27/2025; UPC_CoA_458/2024; UPC_CoA_533/2024 [EP 3 646 825]
Parties: Meril Italy srl v. Edwards Lifesciences Corp
Contributor: Richard Smith
Headnote
Competence
1. The concept of the “same parties” of Art. 33(4) UPCA must be understood as requiring the parties to be identical. There may be such a degree of identity between the interests of two legal entities that a judgment delivered against one of them would have the force of res judicata as against the other. In such a situation, the entities must be considered to be one and the same party for the purposes of the application of Art. 33(4) second sentence UPCA.
Admissibility of application to amend the patent
2. Under R. 49.2 RoP, the Defence to revocation may include an application to amend the patent. Pursuant to R. 50.2 in conjunction with R. 30.2 RoP, a subsequent request to amend the patent may only be admitted into the proceedings with the permission of the Court. When deciding on a subsequent request to amend the patent, the Court must take into account all the relevant circumstances of the case, including whether the party seeking the subsequent amendment is able to justify that i) the amendment in question could not have been made with reasonable diligence at an earlier stage, and ii) the amendment will not unreasonably hinder the other party in the conduct of the action. The Court of First Instance has a margin of discretion in this respect. The review by the Court of Appeal is therefore limited.
Claim construction
3. As a general rule, a product or process presented as an embodiment by the patent specification may be considered covered by the patent claims. However, there is room for an exception where the patent as a whole clearly teaches the person skilled in the art that the disclosed embodiment is not claimed, e.g. when it only illustrates a technical specification that is not addressed by the teaching of the patent claim.
Inventive step
4. A European patent is only validly granted for an invention if – apart from other requirements – it involves an inventive step. An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art (Art. 56 EPC).
5. National courts of the various EPC countries have different approaches and use different guidelines when assessing whether an invention involves an inventive step. One of those approaches is the so-called ‘problem-solution-approach’ used by the European Patent Office (EPO) and the Technical Boards of Appeal (TBA) of the EPO. In some jurisdictions, such as France, Italy, The Netherlands and Sweden, this approach is applied as well, but not necessarily as the only possible approach. In other jurisdictions, such as Germany and the UK, other approaches – sometimes referred to as more ‘holistic’ – are used. Despite the differences in approach, all of these are merely guidelines to assist in the establishment of inventive step as required by Art. 56 EPC, that, when properly applied, should and generally do lead to the same conclusion.
6. The burden and presentation of proof with regard to the facts from which the lack of validity of the patent is derived and other circumstances favourable to the invalidity or revocation lies with the claimant in a revocation action (Art. 54 and 65(1) UPCA, R. 44(e)-(g), 25.1(b)-(d) RoP). Even though proof of certain facts, if contested, may be required, the assessment of the relevant facts and circumstances is a question of law.
7. The approach taken by the Unified Patent Court when establishing inventive step, which can already be derived from the Order of the Court of Appeal in the Nanostring v 10X Genomics case (UPC_CoA_335/2023, Order of 26 February 2024), is as follows.
8. It first has to be established what the object of the invention is, i.e. the objective problem. This must be assessed from the perspective of the person skilled in the art, with their common general knowledge, as at the application or priority date (also referred to as the effective date) of the patent. 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.
9. In order to avoid hindsight, the objective problem should not contain pointers to the claimed solution. The claimed solution is obvious when at the effective date the person skilled in the art, starting from a realistic starting point in the state of the art in the relevant field of technology and wishing to solve the objective problem, would (and not only “could”) have arrived at the claimed solution.
10. The relevant field of technology is the specific 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 in the art of the specific field must be expected to be aware.
11. A starting point is realistic if the teaching thereof would have been of interest to a person skilled in the art who, at the effective date, wishes to solve the objective problem. This may for instance be the case if the relevant piece of prior art already discloses several features similar to those relevant to the invention as claimed and/or addresses the same or a similar underlying problem as that of the claimed invention. There can be more than one realistic starting point, and the claimed invention must be inventive starting from each of them.
12. The person skilled in the art has no inventive skills and no imagination and requires a pointer or motivation (in German: “Anlass”) that, starting from a realistic starting point, directs them to implement a next step in the direction of the claimed invention. As a general rule, a claimed solution must be considered not inventive/obvious when the person skilled in the art would take the next step, prompted by the pointer or as a matter of routine, and arrive at the claimed invention.
13. For an inventive step to be present, it is not necessary to show improvement of the technical teaching as defined by the patent claims over the prior art. Inventive step may also be found if the patent claims disclose a non-obvious alternative to solutions known in the prior art.
Permanent injunctions
14. Where the proprietor files an infringement action and the Court finds that an intellectual property right has been infringed or is threatened to be infringed, it shall issue an order prohibiting the continuation of the infringement unless there are special reasons for not doing so.
15. A special reason for denying an injunction may apply if, in the circumstances of the particular case, granting an injunction does not comply with the general obligations of Art. 3 of the Enforcement Directive, in particular the obligation that the remedies shall be proportionate.
16. When considering the proportionality of injunctive relief and corrective measures, not only the interests of the parties to the litigation but also the interests of third parties, such as patients, may be taken into account.
Interim award of costs
17. As a general rule, Art. 69(1) UPCA and R. 150(2) RoP do not entitle the successful party to an interim reimbursement of representation costs of more than 50% of the ceiling of recoverable costs as adopted by the Administrative Committee under R. 152.2 RoP.
Relevance of the decision
In this decision relating to a years-long dispute between Edwards Lifesciences and Meril Life Sciences, the Court of Appeal set out the approach to inventive step of the UPC. The decision now provides us with a definitive test for assessing obviousness, which is different in some aspects to the EPO’s established approach. The wording of the test is very similar to that of biotech case Amgen v Sanofi and Regeneron, suggesting that this test will be consistently applied across all fields.
According to the CoA, the “objective problem” of the invention must first be determined. This is assessed from the point of view of the skilled person at the effective date of the patent. The objective problem is determined by comparing the claim as a whole to the state of the art and thus establishing what the invention adds to the state of the art. The inventive concept underlying the claim as a whole should also be considered, which is based on the one or more technical effects that the skilled person would understand are achieved from the disclosure of the application. Similar to the EPO, the CoA confirms that the objective problem should not contain pointers to the solution in order to avoid hindsight.
The claimed solution is then obvious when at the effective date the skilled person, starting from a “realistic starting point” in the state of the art in the relevant field of technology and wishing to solve the objective problem, would (and not only “could”) have arrived at the claimed solution. The relevant field of technology may be the specific field relevant to the objective problem, as well as any other field in which the same or similar problem arises and of which the skilled person must be expected to be aware.
The above steps reverse the first two steps of the EPO’s problem-solution approach, which first determines the closest prior art before assessing the technical effect of the distinguishing features over that prior art. The first step of the UPC test therefore provides broader framing of the objective problem which is less focussed on technical effects over specific prior art documents. If anything the “objective problem” might be closer to the EPO “subjective technical problem” (CLB I.D.4.4.2).
Notably, the CoA states that a starting point is realistic if the teaching thereof would have been “of interest” to a person skilled in the art who, at the effective date, wishes to solve the objective problem. This may be a document disclosing several claimed features or one which addresses the same or a similar technical problem, and there may be multiple realistic starting points. This approach appears to be broader than the EPO’s approach, which requires the starting document to have a similar purpose or effect as the invention or at least belong to the same or a closely related technical field.
Further, in order for a finding of obviousness, the skilled person requires a pointer or motivation that, starting from a realistic starting point, directs them to implement a next step in the direction of the claimed invention. A claimed solution must be considered obvious when the person skilled in the art would take the next step, prompted by the pointer or as a matter of routine, and arrive at the claimed invention. This seems quite different to the EPO, which generally looks for teachings that the effect will be achieved with the distinguishing feature. At the UPC, the “pointer” seems to include more general disclosures in the art directing the skilled person to arrive at the invention, even if they do not teach that doing so achieves the effect of the distinguishing feature.
The CoA also confirmed that an improvement over the art is not essential for inventive step, and a claim may be inventive if it relates to a non-obvious alternative, which is basically in line with EPO practice.
It is also worth noting that the CoA made the general point that the burden of proof for invalidity generally lies with the party asserting invalidity. This differs from the EPO where the burden turns on the grounds and the factual circumstances of the case, which again demonstrates the patentee-friendly approach of the UPC.
In the present case, key to the issue of inventive step was whether there were sufficient motivations/pointers to arrive at the claimed invention. Meril argued that features of a stent would be applied to a prosthetic heart valve. The CoA held that the skilled person would need a “strong motivation” to replace features of a heart valve with features of a stent, given their different functionalities.