UPC Report 05|25

Patent interpretation and person skilled in the art

The Court of Appeal has clarified that the construction of patent claim is a matter of law and cannot be left to a person skilled in the art, but must be done by the Court, i.e. only facts relevant to the understanding of the person skilled in the art are accessible to expert evidence (order of 30 April 2025 – UPC_CoA_768/2024 – Insulet v EOFlow). Although claim construction is based on how a person skilled in the art understands the terms used in the patent claim in light of the claim as a whole in light of the description and drawings, the Court is not bound by the expert opinion submitted by a party on how such a person understands those terms. 

The skilled person is a notional entity representing the general specialist knowledge customary in the relevant field of technology as well as average knowledge, experience and abilities in this field – as opposed to the individual knowledge of the party’s expert. It is the task of the Court to assess these circumstances as a matter of law. The opinion of an expert may then be relevant if certain facts need to be clarified. 

New nullity arguments in reply only allowed as an exception

According to the Düsseldorf Local Division, nullity arguments raised for the first time in the reply to the defence of a counterclaim for revocation are only admissible in exceptional cases (decision of 8 May 2025 – UPC_CFI_11/2024 – Grundfos v Hefei) since a new nullity argument constitutes an extension of the claim. Pursuant to Rule 263 Rules of Procedure (“RoP”), the extension of a claim is only permissible if an explanation can be provided (i) why the new argument was not included in the counterclaim for revocation, and (ii) why admission of the new nullity argument does not unreasonably hinder the other party in conducting its action.

According to the Düsseldorf Local Division, this principle applies not only if the reply to the defence of a counterclaim for revocation introduces new prior art and bases a new nullity argument on it (as previously held in Munich Local Division, decision of 13 September 2024 – UPC_CFI_390/2023 – Koninklijke Philips v Edrich) but also if the new nullity argument relies on a new combination of prior art already discussed in the counterclaim for revocation. In the case at hand, the party asserting nullity had initially argued that a specific document, Document A, lacked novelty. Document B had also been discussed by the party, but in a different context. In its reply, the party then relied in the alternative on a combination of Documents A and B. The Düsseldorf Local Division ruled that this constituted an extension of the claim, which is only permitted under the strict conditions of Rule 263 RoP.

It seems doubtful that the Court of Appeal will share this very strict view, it having already ruled that not every new argument constitutes an amendment to the case pursuant to Rule 263 RoP (decision of 21 November 2024 – UPC_CoA_456/2024 – OrthoApnea v redacted). Although changing the subject matter in the proceedings may conflict with the UPC’s “front-loaded” approach, this approach is not an end in itself but serves to promote procedural efficiency – from which perspective it is unreasonable to require the party seeking nullity to initiate a new, separate action for nullity based on an argument that was previously overlooked.

Infringement of second medical use claims

The UPC has dealt for the first time with the infringement of a patent claim concerning a second (or further) medical indication of a medicinal product (decision of 13 May 2025 – UPC_CFI_505/2024 – Sanofi v Amgen). According to the Court, a second medical use claim is, by nature, a purpose-related product claim which, due to its purpose limitation, does not confer “absolute” protection, i.e. protection regardless of (intended) use. The UPCA does not expressly address infringements of this type of patent claim.

In order for the Court to find infringement of a purpose-limited product claim, a claimant must prove that the allegedly infringing product fulfils the “use” feature(s) of the claim. An infringement will not only exist where a product is already or actually being used for the protected indication, however. It is instead sufficient for the alleged infringer to offer or place the product on the market in such way that leads or may lead to use of the product for the protected therapeutic purpose, of which the supplier of the infringing product knew or ought reasonably to have known. The package insert and the SmPC of the product may be important here.

The requirements of such behaviour cannot be defined in an abstract manner but require an analysis of all the relevant and circumstances of the individual case. These may include: (i) the extent and significance of the allegedly infringing use, (ii) the relevant market and what is customary on that market, (iii) the actions the alleged infringer has taken to influence the respective market, either (a) positively, de facto encouraging the patented use, or (b) negatively, by taking measures to prevent the product being used for the patented use. The abstract criteria formulated by the UPC give the Court much room for discretion. In the case decided, the UPC considered the off-label use alleged by the claimant to be unlikely.

Requirements for imminent infringement in the case of generic drugs

To establish sufficient grounds to consider the future marketing of a generic drug imminent patient infringement, the Lisbon Local Division has decided there must be concrete indications that the generic drug is to be launched while the patent still applies (decision of 8 May 2025 – UPC_CFI_41/2025 – Boehringer Ingelheim v Zentiva). Neither the drug’s marketing authorisation nor its eligibility for reimbursement by the Portuguese health system were sufficient indications for an imminent launch, it decided. The Lisbon Local Division’s decision aligns with the decision of the Düsseldorf Local Division that found there was no imminent patent infringement when a generics manufacturer had not participated in discount contract tenders, had not started price negotiations in a UPCA contracting member state and had not otherwise undertaken any offer negotiations (decision of 6 September 2024 – UPC_CFI_165/2024 – Novartis v Genentech, see also UPC Report 10|24).

Plea of ignorance to be disregarded

The Düsseldorf Local Division has decided that the plea of ignorance, which is admissible in German procedural law (section 138(4) Code of Civil Procedure (Zivilprozessordnung, “ZPO”)), is to be disregarded (decision of 13 May 2025 – UPC_CFI_505/2024 – Sanofi v Amgen). The EPC Rules of Procedure (Rule 171.2 RoP) did not provide for pleading ignorance, and instead require that facts are specifically contested. The local division’s view seems unnecessarily strict. Rule 171.2 RoP, on which the court relied, establishes an exemption from the duty to offer and present evidence (Rule 171.1 and Rule 172 RoP). By contrast, Rule 24(e) RoP requires that the statement of defence contains any contestation of the facts relied on by the claimant. The only requirement that can be derived from Rule 171.2 – which the UPC cites in its decision – is that such contestation must concern a specific factual allegation. If a plea of ignorance concerns a specific fact, it can be considered procedurally as (simple) contestation – which, at least for facts that are not subject to verification by the contesting party, should be regarded as a relevant contestation. It remains to be seen what position the Court of Appeal will take on the relevance of such contestation.

Admissibility of combined auxiliary requests

In a procedural order of 28 April 2025, the Hamburg Local Division broadened the leeway claimants have when defending against auxiliary requests (order of 28 April 2025 – UPC_CFI_424/2024 – Nera Innovations v Xiaomi). The Local Division clarified that the requirement under Rule 30.1(b) RoP to provide an explanation of an auxiliary request can be considered met if the claimant makes reference to earlier auxiliary requests for which sufficient explanation has already been provided. That applies in particular if the new auxiliary requests comprise a combination of requests already explained and the combination of features is comprehensibly presented. The Local Division rightly considered a structured reference – for example, a presentation of the combination of features in table form – to be sufficient.

Counterclaim for revocation always admissible against the entire patent

The Hamburg Local Division has decided that a counterclaim for revocation can incorporate patent claims that were not asserted in the infringement action (judgment of 30 April 2025 – UPC_CFI_278/2023 – AGFA v Gucci). It is therefore permissible to challenge the entire patent in dispute, even if the infringement action was for specific claims only. Counterclaims for revocation do not need to be limited to the claims underlying the infringement dispute (Article 32(1), letter (e) UPCA, Article 65(1) UPCA). Defendants in infringement proceedings are not permitted to bring isolated revocation actions before the central division while the infringement proceedings are ongoing (Article 33(4) UPCA). The comprehensive counterclaim is therefore necessary so as to ensure an effective legal defence.

Limits to considering the patent specification when interpreting patents

Hamburg Local Division has emphasised in respect of patent interpretation that the patent claim is decisive and that broader or contradictory passages of the description that go beyond the wording of the claim are irrelevant to the interpretation of the patent (judgment of 30 April 2025 – UPC_CFI_278/2023 – AGFA v Gucci). That applies in particular when a description concerns features that the applicant deliberately removed from the claim during the grant procedure, for example to distinguish it from prior art or following objections by the examining division. The description cannot be used in such cases to support the subsequent broader interpretation of the wording of the claim or to re-include a previously excluded feature in a patent’s scope of protection. The decision is in line with the Court of Appeal, which has previously decided that the description and drawings are to be used as explanatory aids to interpretation, but only insofar as they are consistent with the patent claim (see, for example UPC_CoA_335/2023 – 10X Genomics). 

Only cease-and-desist declarations with penalty clauses eliminate risk of patent infringement

The Court of Appeal has found that a prior patent infringement creates the risk that infringement will continue if the infringer does issue a cease-and-desist declaration with a penalty clause (order of 30 April 2025 – UPC_CoA_768/2024 – Insulet v EOFlow). By adopting the instrument of a cease-and-desist declaration with a penalty clause, the Court of Appeal has embraced an instrument familiar from German law – albeit without further explanation.