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News from Luxembourg: Court of Appeal confirms and details its previous case law on interpretation, inventive step and proportionality
UPC (Court of Appeal), decision of 25 November 2025 – UPC_CoA_457/2024, UPC_CoA_458/2024, UPC_CoA_464/2024, UPC_CoA_530/2024, UPC_CoA_532/2024, UPC_CoA_533/2024, UPC_CoA_21/2025, UPC_CoA_27/2025 – Edwards Lifesciences v. Meril
In the Edwards Lifesciences v. Meril case, the Court of Appeal of the Unified Patent Court published its decision on 25 November 2025. In doing so, it not only confirmed its previous case law on the interpretation of patents, but also detailed its case law on the examination of inventive step and the proportionality of the injunctive relief and other measures.
Facts of the case
Edwards Lifesciences Corporation, the parent company of the Edwards Lifesciences Group, which is active in the development and distribution of artificial heart valves and accessories, among other things, filed a lawsuit with the LD Munich on 1 June 2023 for infringement of European patent EP 3 646 825 (“patent in suit”) relating to a system consisting of an artificial heart valve and an insertion catheter against Meril Life Sciences Pvt Ltd., a medical device manufacturer, and its European distribution company Meril GmbH. On 4 August 2023, the Italian distribution company Meril Italy S.R.L. filed a nullity action against the patent in suit before the CD Paris. On 2 November 2023, Meril Life Sciences Pvt Ltd. and Meril GmbH filed a counterclaim for revocation. In its response to the counterclaim on 9 January 2024, Edwards also submitted a request for amendment of the patent. Edwards filed a corresponding request for amendment (which had already been preceded by an initial request, on which a decision was still pending) on 22 January 2024, but this was rejected on 27 February 2024. The appeal was not allowed, and the discretionary review by the Court of Appeal did not lead to a different result. On 28 March 2024, the LD Munich referred the counterclaim for annulment to the CD Paris. In written submissions dated 11 April 2024 and 12 April 2024, Edwards requested a further amendment to the patent in both the nullity proceedings and the counterclaim proceedings, reducing the number of claims made.
On 19 July 2024, the CD Paris partially dismissed the nullity action and the counterclaim for revocation and upheld the patent in suit on the basis of the second auxiliary request.
In the infringement proceedings, the LD Munich found Meril Life Sciences Pvt Ltd. and Meril GmbH guilty of infringing the patent in suit by distributing the contested embodiments. The XL variant of the attacked embodiment was exempt from recall and destruction insofar as it was already scheduled for the treatment of patients until 15 November 2024. The LD considered the injunction claim to be proportionate only because the XL variant could be distributed in individual cases if a patient required it, provided that a physician had uploaded the relevant patient data to Edwards’ “Medical Device Portal” and an examination by Edwards’ physicians had shown that no Edwards product was suitable for the specific patient.
Both parties lodged appeals against the decisions concerning the action for annulment and the counterclaim for revocation, as well as against the decision concerning the infringement of the patent in suit. In addition, the parties lodged appeals against individual decisions, which will not be discussed in further detail here.
Decision of the Court of Appeal
The Court of Appeal essentially confirms the decisions of the LD Munich and the CD Paris.
Instead of going into the details of the specific case, the following description focuses on the generalizable findings of the Court of Appeal in connection with the interpretation, inventive step and (dis)proportionality of the injunction and other measures.
1. Interpretation of the patent in suit
In its interpretation, the Court of Appeal confirms in abbreviated form the principles of interpretation it had already set out in the case of “NanoString v 10x Genomics” (UPC (Court of Appeal), decision of 26 February 2024 – UPC_CoA_335/2023) (German translation):
“The patent claim is not only the starting point but the decisive basis for determining the protective scope of a European patent under Art. 69 EPC in conjunction with the Protocol on the Interpretation of Art. 69 EPC. The interpretation of a patent claim does not depend solely on the strict, literal meaning of the wording used. Rather, the description and the drawings must always be used as explanatory aids for the interpretation of the patent claim and not only to resolve any ambiguities in the patent claim. These principles for the interpretation of a patent claim apply equally to the assessment of the infringement and the validity of a European patent.”
In addition, the decision contains further principles of interpretation with regard to the interpretation of the relevant features of the teaching of the patent in suit, which are already known from German case law. For example, the Court of Appeal states that terms in the claim must be interpreted in the context of the patent from the perspective of a person skilled in the art, i.e., according to the German diction, the patent in suit forms its own lexicon. In connection with the embodiments of the patent in suit, it states that the claim must not be limited to a specific embodiment by way of interpretation. On the other hand, it can generally be assumed that a device or method described in the patent specification as an embodiment is also covered by the patent claims. Something else can only be assumed if the patent as a whole clearly conveys to the skilled person that the disclosed embodiment is not claimed, e.g. if it merely illustrates a technical specification that is not dealt with.
2. Inventive step
In connection with the examination of inventive step, the Court of Appeal specifies its case law, which formed the basis for the decision in the case of “NanoString v 10x Genomics” (UPC (Court of Appeal), decision of 26 February 2024 – UPC_CoA_335/2023) and how it is now reflected in paragraphs 4 et seq., in particular 7 et seq. (German translation):
“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.”
Based on these principles, the Court of Appeal finds in the present case that the teaching of the patent in suit is inventive in relation to the presented prior art. In some cases, the documents explicitly taught away from the solution according to the invention, in some cases they did not disclose at least one of the relevant features of the patent in suit, and in some cases it was not apparent that the person skilled in the art had any reason to further develop the teaching of the respective pitot art or to combine the teachings of the prior art. In doing so, the Court of Appeal also, among other things, disregards a preliminary opinion of the Opposition Division of the EPO on the lack of inventive step of a patent from the same patent family as the patent in suit, based on a document that was also the subject of the present proceedings.
3. Proportionality of the injunction and further measures
Finally, the Court of Appeal confirms the infringement of the patent in suit by the attacked embodiments. However, it sees a need for correction in the orders.
With regard to both the measures under Article 64 UPCA and the injunction under Article 63 UPCA, the Court of Appeal finds that these were not at the discretion of the court. In the event of an infringement, the measures were generally to be imposed, as already held in “Belkin v. Philips” (UPC (Court of Appeal), decision of 3 October 2025 – UPC_CoA_534/2024, UPC_CoA_683/2024, UPC_CoA_19/2025 – Belkin v. Philips). The same applied to the injunction under Article 63 UPCA. An exception to this rule applied only in exceptional cases where the measures or the injunction proved to be disproportionate.
With regard to the measures under Article 64 UPCA, this followed from Article 10 Enforcement Directive, according to which uniform, high protection is to be ensured throughout the EU. The ordering of measures therefore had to be the rule (see also UPC (Court of Appeal), decision of 3 October 2025 – UPC_CoA_534/2024, UPC_CoA_683/2024, UPC_CoA_19/2025 – Belkin v Philips). In the context of the proportionality test, the circumstances of the individual case were decisive, whereby the seriousness of the infringement and the measures, the willingness of the infringer to bring the form of infringement into a patent-free state, and third-party interests had to be taken into account.
With regard to the injunction under Article 63 UPCA, the same applied under Article 11 Enforcement Directive. In accordance with Articles 17(2) and 47 of the Charter of Fundamental Rights of the European Union, the Enforcement Regulation provided for various means of ensuring a high level of protection. The patentee had to be able to enforce its rights effectively, and the patent user had to obtain a license before use. An injunction was therefore only ruled out if the order was disproportionate, cf. Article 3 Enforcement Directive. Here, too, the interests of the parties and third parties must be taken into account.
On this basis, the Court of Appeal finds that, in the field of medical devices, disproportionality was to be considered if the attacked embodiment is the only available treatment option or represents an improvement on existing treatments, leading to a noticeable improvement in patient care.
As a result, the Court of Appeal agrees with the findings of the LD Munich that the XL variant of the attacked embodiment had to be exempt from the injunction, but nevertheless sieht a need for correction with regard to the order. The Court of Appeal is of the opinion that the availability of the product should not depend on Edwards’ willingness to maintain the portal or on the assessment of Edwards’ physicians. Rather, it should be sufficient for a physician to inform a patient that he or she intends to use the variant and that this is the only way to treat the patient.
Conclusion
The principles of interpretation cited again by the Court of Appeal are derived from Article 1 of the Protocol on the Interpretation of Article 69 EPC. The Enlarged Board of Appeal of the EPO recently summarized the principles of patent interpretation in a similar manner in the case of “Heated Aerosol Generating Article” (EPA (GBK), decision of 18 June 2025 – G 1/24). These principles are also recognized in German case law (see, for example, BGH GRUR 2015, 875 – Rotorelemente). The Court of Appeal clarifies that these principles of interpretation apply both to infringement and to validity.
With regard to the principles for determining the existence or non-existence of inventive step, the Court of Appeal also confirms its previous case law here, but abstracts it in form of a examination scheme.
The Court of Appeal is correct in stating that the different approaches to determining inventive step should lead to the same result. In fact, there are far fewer differences between the problem-solution approach and the approach taken by the Federal Court of Justice than is sometimes assumed (cf. Deichfuß, GRUR 2024, 94). The Court of Appeal now presents its own approach in abstract form. It would have been desirable to have a brief explanation of why the Court of Appeal does not adopt the EPO’s approach. The Court of Appeal does not appear to define the objective problem or objective on the basis of the closest prior art. However, the Court of Appeal does refer to aspects and terminology that can be found in both German case law and that of the EPO. Thus, according to the Court of Appeal, it is not important whether the person skilled in the art could have arrived at the solution according to the invention, but whether he would have arrived at it. Similarly, both the German case law and that of the EPO are familiar with the concept of the starting point, although the EPO refers to the “most promising” starting point and not merely a “realistic” one, as does the Court of Appeal. It remains to be seen how the UPC will apply and flesh out this examination scheme in the future in order to better classify the approach.
Finally, with regard to the question of the proportionality of the injunction and further measures, infringers will take note of the decision in Belkin v. Philips and the present decision. As a result of the finding that, in the event of an infringement, an injunction and further measures are generally to be imposed, the assumption of an “automatic injunction”, as known from German case law, is not far-fetched. It can therefore be assumed that considerations of proportionality will hardly lead to a different result at the UPC in the future. In the field of medical devices, however, the Court of Appeal has clarified that disproportionate measures may be considered in exceptional cases if the form of infringement is the only available treatment option or represents an improvement in existing treatments, leading to a noticeable improvement in patient care.