Background
Edwards Lifesciences holds European patent EP 3 646 825 in the field of transcatheter heart-valve delivery technology, which in this case it asserted against the Meril group (Meril Italy Srl, Meril Life Sciences Pvt. Ltd., and related entities). The case generated multiple appeals across infringement and validity proceedings before the UPC, all of which the Court of Appeal consolidated into a single decision dated 25 November 2025. Together with the same-day Amgen v. Sanofi/Regeneron ruling, this decision sets out the core UPC doctrines on competence, claim construction, and inventive step.
The Court’s Holding
The Court of Appeal issued headnotes on five doctrinal questions:
1. Competence under Art. 33(4) UPCA — “same parties.” The concept of “same parties” must be understood as requiring the parties to be identical, but there may be such a degree of identity of interests between two legal entities that a judgment delivered against one 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 purposes of Art. 33(4) second sentence UPCA. Practical effect: a corporate group with shared interests can be treated as a single party even where the formal corporate identity differs.
2. Admissibility of patent amendment. 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. The Court of First Instance has a margin of discretion in deciding whether to allow a subsequent amendment, considering whether the requesting party can justify why the amendment was not made earlier with reasonable diligence and whether allowing it would unreasonably hinder the other party. Court of Appeal review of that discretion is limited.
3. Claim construction — embodiments. As a general rule, a product or process presented as an embodiment in the patent specification is considered covered by the patent claims. There is, however, room for an exception where the patent as a whole clearly teaches the skilled person that the disclosed embodiment is not claimed (for example, where the embodiment only illustrates a technical specification not addressed by the patent claim’s teaching). The default presumption protects patentees against arguments that disclosed embodiments fall outside the claim.
4. Inventive step — framework. The Court of Appeal restated and confirmed its inventive-step framework, originally derived from the order in Nanostring v. 10X Genomics (UPC_CoA_335/2023, Order of 26 February 2024) and now developed further: identify the objective problem from the skilled person’s perspective; choose a realistic starting point; ask whether the skilled person would (not merely could) have arrived at the claimed solution starting from that point. The Court of Appeal acknowledged that national EPC courts use different guidelines — the EPO’s problem-solution approach in some jurisdictions, more “holistic” approaches in Germany and the UK — but emphasized that all approaches, properly applied, should and generally do lead to the same conclusion.
5. Inventive step — non-obvious alternatives. Crucially, for an inventive step to be present, it is not necessary to show that the patent’s technical teaching improves on the prior art. An inventive step may also be found where the patent claims disclose a non-obvious alternative to solutions known in the prior art. This is favorable to patentees: even where prior-art solutions exist that work as well as the claimed invention, the claimed invention can still be patentable if the alternative path was not obvious to the skilled person.
The Court also confirmed the burden of proof: the burden and presentation of proof regarding facts from which lack of validity is derived (and other circumstances favorable to invalidity or revocation) lies with the claimant in a revocation action. Even though proof of certain facts may be required if contested, the assessment of those facts is a question of law.
Key Takeaways
- Identity-of-interests trumps formal corporate identity for Art. 33(4) UPCA “same parties.” Group companies with aligned interests will be treated as one party. This affects forum shopping and jurisdictional gamesmanship via group entities.
- Disclosed embodiments are presumed covered by the claims unless the specification clearly teaches otherwise. Patentees rarely need to fight to keep disclosed embodiments inside the claim scope; defendants need a clear specification-based exclusion to argue otherwise.
- The inventive-step framework now applies uniformly across UPC local divisions and the Court of Appeal. National-court divergence (problem-solution vs. holistic approaches) is acknowledged but treated as procedural rather than substantive.
- Non-obvious alternatives can be patentable. The patent does not need to outperform the prior art — it just needs to disclose a non-obvious different path. This protects “alternative-route” pharmaceutical and engineering patents that improve flexibility or robustness of an existing solution rather than performance.
- Subsequent claim amendments during revocation must clear a high bar: the amending party must justify why the amendment was not made earlier with reasonable diligence and the amendment must not unreasonably prejudice the other party.
- Burden of proof on invalidity rests on the challenger, even where specific factual proof is required.
Why It Matters
The Meril v. Edwards decision, paired with Amgen v. Sanofi/Regeneron, gives the UPC its first full doctrinal toolkit for inventive step and claim construction. The non-obvious-alternative formulation is particularly consequential for pharmaceutical, materials, and medical-device patents that were vulnerable to obviousness attacks under stricter “improvement-over-prior-art” tests in some national jurisdictions. Patentees in those areas now have an explicit doctrinal hook for arguing inventive step even where their patent claims a parallel rather than superior solution.
For UPC litigators, the consolidated docket pattern in this case is also notable: eight separate appeal numbers were collapsed into a single Court of Appeal decision. The Court of Appeal will continue to consolidate where infringement and validity proceedings raise the same underlying patent issues, reducing duplicative briefing.
For multinational corporate groups facing UPC litigation, the “same parties” doctrine has immediate practical implications: setting up a separate corporate vehicle to insulate against res-judicata effects of UPC judgments against an affiliate is unlikely to work where the entities share interests. Counsel structuring corporate-group operations should assume UPC judgments may bind the broader group.
Your browser cannot display this PDF inline.