Amgen v. Sanofi, Meril v. Edwards
UPC_CoA_528/20241, UPC_CoA_464/20242, decisions of 25 November 2025
In two decisions issued on 25th November 2025, the UPC Court of Appeal set out extensive guidance on a number of substantive and procedural issues that are of fundamental importance to the majority of actions and applications before the court.
While the decisions were issued on unrelated cases, we report the decisions together here due to the significant overlap in the discussion of the key issues in both.
The first of the decisions was issued in two combined appeals brought by Amgen following revocation of its patent EP3666797 by the Munich Central Division. On 1 June 2023, Sanofi brought a revocation action against the patent in the Munich CD and, on the same day, Amgen brought an infringement action at the Munich Local Division against Sanofi and Regeneron3. Regeneron filed a counterclaim for revocation, which was subsequently referred to the Munich CD, where it was combined with the revocation action lodged by Sanofi. The infringement action was stayed.
The patent relates to antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9 (“PCSK9”) and methods of using and making the antigen binding proteins. The patent survived an EPO opposition without amendment but was revoked by the Munich CD for lack of inventive step in combined revocation actions brought by Sanofi and Regeneron.
The second decision was issued in eight combined appeals brought by Meril and Edwards, all related to Edwards’s patent EP3646825 and derived from multiple decisions and orders of a first instance infringement action brought by Edwards, a counterclaim for revocation brought by the defendants in the infringement action, and a separate revocation action brought by a different Meril subsidiary.
Following the combined revocation action and counterclaim for revocation action, the patent was maintained in amended form by the Paris CD4. The Munich LD subsequently issued its decision in the infringement action, finding that Meril had infringed the patent as amended5.
As set out in both decisions, the approach taken by the UPC when assessing inventive step is as follows:
First, the object of the invention must be established, i.e. the “objective problem”. This must be assessed from the perspective of the skilled person, based on their common general knowledge at the relevant filing or priority date. This is done not by looking at the individual features of the claim, but by establishing what the invention adds to the state of the art, comparing the claim as a whole in context of the description and the drawings. This includes also considering the inventive concept underlying the invention (the technical teaching), which must be based on the technical effects that the skilled person understands, on the basis of the patent, are achieved with the claimed invention.
The objective problem should not contain pointers to the claimed solution in order to avoid hindsight.
The claimed solution is obvious when, at the relevant date, the skilled person wishing to solve the objective problem, would (not could) have arrived at the claimed solution starting from a realistic starting point in the state of the art in the relevant field of technology.
The relevant field of technology includes both the specific field relevant to the objective problem 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.
A starting point is realistic if its teaching would have been of interest to a skilled person who, at the relevant date, wished to solve the objective problem. This may for instance be the case if the 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.
The skilled person has no inventive skills and no imagination and requires a pointer or motivation that directs them to implement a next step in the direction of the claimed invention, starting from a realistic starting point. As a general rule, a claimed solution must be considered obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine and arrive at the claimed invention as a result.
A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution to the technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success.
The burden of proof that the results were clearly predictable, or the skilled person would have reasonably expected success, i.e. that the solution he envisages by taking the next step would solve the objective problem, lies on the party asserting invalidity of the patent.
A reasonable expectation of success implies 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.
Whether there is a reasonable expectation of success depends on the circumstances of the case. The more unexplored a technical field of research, the more difficult it was to make predictions about its successful conclusion and the lower the expectation of success. Envisaged practical or technical difficulties as well as the costs involved in testing whether the desired result will be obtained when taking a next step may also withhold the skilled person from taking that step. On the other hand, the stronger a pointer towards the claimed solution, the lower the threshold for a reasonable expectation of success.
When a patentee brings forward and sufficiently substantiates uncertainties and/or practical or technical difficulties, the burden of proof that these would not prevent a skilled person from having a reasonable expectation of success, falls on the party alleging obviousness.
The fact that other persons or teams were working contemporaneously on the same project does not necessarily imply that there was a reasonable expectation of success. It may also indicate that it was an interesting area to explore with a mere hope to succeed.
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.
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. 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 assessment of inventive step as required by Art. 56 EPC, that, when properly applied, should and generally do lead to the same conclusion. Whatever approach is adopted, tribunals are ultimately always answering the same statutory question – “Is it obvious?”
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. Even though proof of certain facts, if contested, may be required, the assessment of the relevant facts and circumstances is a question of law.
The question of whether conclusions can be drawn from the subject matter of a dependent claim and its features when interpreting the main claim depends on the circumstances of the individual case. If the dependent claim only adds an additional feature that does not provide a more specific description of the features of the main claim, it generally argues against the possibility of drawing conclusions about the interpretation of the main claim from this dependent claim.
When the claims are drafted in ‘medical use-format’, it is an inherent claim feature that the claimed product must be objectively suitable for the claimed use, i.e. be therapeutically effective. This requires that the claimed treatment causes a noticeable improvement of the medical condition of the patient suffering from the disease mentioned in the claim, i.e. the treatment must be meaningful.
The fact that the skilled person does not derive any minimum required effect from the claim or the description does not lead to another conclusion, since the feature of therapeutic effect does not follow from the claim language that is to be interpreted, but from the use of the medical use claim format.
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.
Sufficiency has to be examined on the basis of the patent as a whole, thus on the basis of the claims, description, and drawings, from the perspective of the skilled person with his common general knowledge at the filing or priority date.
The test to be applied is whether the skilled person is able to reproduce the claimed subject matter on the basis of the patent without any inventive effort and without undue burden. An invention is sufficiently disclosed if the patent specification shows the skilled person at least one way – and in case of functional features: one technical concept – of performing the claimed invention.
Where a claim contains one or more functional features, it is not required that the disclosure includes specific instructions as to how each and every conceivable embodiment within the functional definition(s) should be obtained. A fair protection requires 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 by the claim. Consequently, any non-availability of some embodiments of a functionally defined claim is immaterial to sufficiency, as long as the skilled person through the disclosure is able to obtain suitable embodiments within the scope of the claim.
A reasonable amount of trial and error does not prevent the invention from being enabled.
The burden of presentation and proof lies with the party invoking invalidity of the patent.
The assessment of whether there is added matter is a question of law to be decided on the basis of the facts brought forward by the parties. The facts are the relevant claims and the application as filed. Since the test is whether the relevant claims have basis in the application as a whole, the Court is allowed to look at the entire document.
The decision in Meril v. Edwards also addresses procedural issues worth highlighting here.
Where the proprietor files an infringement action and the court finds that a patent 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.
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.
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.
Under R. 150.2 RoP, the court may order an interim award of costs to the successful party in the decision on the merits or in a decision for the determination of damages. According to the decision in Meril v. Edwards, the successful party is generally not entitled 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.
According to Art. 33(4) UPCA, when an infringement action between two parties is already pending, a revocation action between the same parties relating to the same patent may only be brought before the same local or regional division where the infringement action is pending.
The concept of the “same parties” of Art. 33(4) 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.
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.
The approach to inventive step set out in these decisions does not break any new ground but provides helpful discussion that is as close to definitive as we are likely to see.
The EPO is the body responsible for granting all of the patents that fall under the UPC’s jurisdiction, and its approach to inventive step provides the most interesting comparison to the approach set out in these decisions.
While some decisions6 have expressed a preference for using the EPO’s problem-solution approach, this has usually been done when the parties have agreed to it. Indeed, the Court of Appeal’s conclusion—that the different approaches employed by the EPO and national courts are merely guidelines—is the only sensible one. The problem-solution approach is a useful framework in many cases, but it is too rigid to be appropriate in all cases, and it would not have been prudent for the Court of Appeal to attempt to mandate its use.
Nevertheless, some of the aspects of inventive step that are discussed in the decisions, including the “could-would approach”, alternative solutions, and the requirement for a clear pointer or motivation, are essentially identical to the corresponding aspects of the problem-solution approach. There may be room for slight differences when considering a “realistic starting point” compared to the problem-solution approach’s “closest prior art”, but in practice these seem superficial.
One opportunity for divergence may come from the difference between what the UPC (confusingly) calls the “objective problem” and what the problem-solution approach calls the “objective technical problem”. Under the problem-solution approach, the “objective technical problem” is determined based on the technical effect of the features of the claim that are not present in the closest prior art. In contrast, the Court of Appeal explicitly stated that the “objective problem” is established by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim. The “objective problem” as set out here by the Court of Appeal therefore bears more similarity to the “technical contribution” of the UK’s approach to inventive step than the EPO’s “objective technical problem”. Based on experience of both the UK approach and problem-solution approach, the “technical contribution” and “objective technical problem” are in many cases essentially the same. However, there is opportunity for divergence especially in cases where the claimed subject matter goes beyond simply adding additional features to the prior art. Given how much of the discussion around inventive step under the problem-solution approach comes down to the formulation of the objective technical problem, and how decisive this can be for the outcome of the discussion, it would not be surprising to see occasional differing views from the EPO and UPC as a result.
The approaches to many of the other substantive issues outlined above are also similar, if not identical, to the approaches that are familiar from the EPO or national courts. However, one that stands out is the general rule that “a product or process presented as an embodiment by the patent specification may be considered covered by the patent claims”. This may provide further motivation for patent applicants to carefully review and if necessary, amend the description of their patent application before grant in order to avoid unintended effects on claim scope in litigation before the UPC.
[1] Amgen v. Sanofi. See alsocombined case UPC_CoA_529/2024, https://www.unifiedpatentcourt.org/en/node/159788
[2] Meril v. Edwards. See alsocombined cases UPC_CoA_457/2024, UPC_CoA_458/2024, UPC_CoA_530/2024,UPC_CoA_532_2024, UPC_CoA_533/2024, UPC_CoA_21/2025, UPC_CoA_27/2025, https://www.unifiedpatentcourt.org/en/node/159797
[3] This was itself an interestingturn of events given that the revocation action and infringement action werefiled less than 20 minutes apart as report here: https://eip.com/uk/case-reports/which-was-first-to-file-upc-9fbdb
[4] As reported here: https://eip.com/uk/case-reports/paris-central-division-maintains-edwards-patent-in-amended-form
[5] As reported here: https://eip.com/uk/case-reports/edwards-lifesciences-corporation-v-meril-gmbh-meril-life-sciences-pvt-ltd
[6] For example UPC_CFI_501/2023 (Munich LD),decision of 4 April 2025, https://www.unifiedpatentcourt.org/en/node/93167- another case between Meril and Edwards over a different patent.