Irides: Weekly global patent litigation update

This edition features updates from: The UK, Switzerland, Indonesia and the Unified Patent Court (UPC).

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world.
 

STOP PRESS: UK

Patents Court turn their attention to how to identify an active ingredient. [Aristo v Takeda [2026] EWHC 2414 (Pat)]

On 24 September 2026, His Honour Judge Hacon (HHJ Hacon) handed down a decision upholding the validity of Takeda’s SPC for lisdexamfetamine (LDX), which is based on the approval of its ADHD medicine Elvanse®. Elvanse contains LDX, which is lysine covalently bonded to dexamfetamine (DEX). DEX was first approved as a medicine many years ago. LDX is a prodrug. It is pharmacologically inactive but upon ingestion it is metabolised to provide the active drug – DEX.

The LDX SPC has been the subject of conflicting decisions in Europe (upheld in Sweden, and Denmark and Switzerland (reported below) and rejected in Germany and Czechia) and is currently the subject of a pending referral to the CJEU from the Danish Court of Appeal (C-794/25). The validity of the SPC turns on whether the active ingredient (“product” in SPC terms) is DEX or LDX. If the former, the SPC is invalid under Art. 3(d) SPC Regulation given earlier approvals of DEX.

SPCs are granted for “products”. Products are defined as active ingredients or combinations of active ingredients (Art. 1(b) SPC Regulation). But what constitutes an active ingredient? The CJEU and English Courts have a long history of ruling on this question and have consistently adopted a narrow approach to Art. 1(b) such that polymers facilitating sustained release (MIT, C-431/04), adjuvants (GSK, C-210/13), and carrier proteins which have a pharmacological effect when covalently bonded to other active ingredients (Forsgren, C-631/13) have not been considered active ingredients.

Furthermore, reformulation of a previously approved drug as albumin-coated nanoparticles has been held not to lead to a distinct active ingredient from the previously approved drug (Abraxis, C-443/17).

Despite extensive case law, the criteria for determining whether a substance constitutes an active ingredient remains under consideration. The issue is currently before the CJEU in Halozyme (C-456/24), which concerns an SPC application relating to trastuzumab and recombinant human hyaluronidase.

In Halozyme, Advocate-General Emiliou (AG) recently opined that the classification of substances set out in the MA is determinative for the purposes of SPC applications. The so-called Forsgren test, i.e. whether the substance in issue has a pharmacological, immunological or metabolic action of its own, comes into play only where there is ambiguity in the MA, a situation which is unlikely to occur frequently.

In the case at hand, HHJ Hacon considered the AG’s approach to have force, particularly on the basis that it would facilitate the simple SPC assessment process which was envisaged by the legislature (see para 16 Explanatory Memorandum), and that has been endorsed by the English Courts (Newron [2024] EWCA Civ 128). HHJ Hacon considered that much of the divergence in outcomes in this area results from attempts to apply the Forsgren test outside of the “exceptional circumstances” in which the AG considers it to be confined.

Applying the AG’s approach to the LDX SPC application, HHJ Hacon concluded that the reasonable reader of the SmPC and EPAR would consider LDX (and not DEX) to be the active ingredient in Elvanse®, notwithstanding that LDX is pharmacologically inactive. HHJ Hacon went on to consider the properties of LDX and DEX and concluded that, in any event, LDX has an immunological and/or metabolic action (of its own) due to its PK profile when compared with that of DEX.

The question which is at the heart of this case is likely to receive further judicial treatment in the coming months and years. If Aristo or Stada appeal the decision, we might expect a decision from the Court of Appeal in early 2027. Furthermore, we are likely to see a decision from the CJEU in the Halozyme case in late 2026 or early 2027 and in the LDX case in late 2027 or early 2028.
 

Switzerland

Federal Court confirms validity of Tadeka's Lisdexamfetamine SPC and grants final injunction.
[Takeda v Spirig Healthcare O2025_005]

Consistent with HHJ Hacon’s decision in the UK (reported above), on 5 August 2026, the Swiss Federal Patent Court also upheld the validity and infringement of Takeda’s LDX SPC. The Court rejected Spirig HealthCare challenge, which questioned whether a prodrug can constitute a distinct SPC product where it is metabolised into an active ingredient that was previously authorised.

The basic patent, EP 1 644 019, claims LDX, including in the form of its mesylate salt which contains LDX in the form of a dimethyl sulphate salt and is authorised for the treatment of ADHD. DEX has been authorised in Switzerland since the 1970s but was only authorised (in its sulphate salt form) for the treatment of ADHD in 2020.

Spirig HealthCare argued that, because LDX is only active following cleavage of the lysine, the relevant active ingredient for the purpose of the SPC is DEX. According to Spirig HealthCare, this meant that that the Elvanse® authorisation could not qualify as the first authorisation of the product for SPC purposes.

The Court disagreed, placing significant weight on the regulatory classification adopted by Swissmedic and the UK MHRA. It noted that lisdexamfetamine dimesylate had been authorised as a new active substance and held that, given the close relationship between SPC law and medicines regulation, the assessment of the relevant active ingredient should align with the approach taken by the competent regulatory authority. The judgment notes that this mirrors the view expressed by the recent opinion of AG Emiliou in ECJ Case C-456/24 – ‘Halozyme’.

The Swiss Court therefore concluded that LDX, rather than DEX, was the relevant product and that the Elvanse® authorisation was the first authorisation of that product. A final injunction was granted together with orders for disclosure and accounting. The decision contrasts with the rulings in parallel German proceedings and may prove influential while related questions remain pending before the CJEU following a referral arising out of the Danish proceedings.
 

Indonesia

Constitutional Court restores exclusion of second medical use patents in public health ruling. 
[255/PUU-XXIII/2025]

Indonesia’s Constitutional Court has reinstated Art. 4(f) of the Patent Law, reversing the 2024 reforms that had permitted patent protection for second medical use inventions.

In a decision effective from 28 August 2026, the Court held that the removal of the provision was unconstitutional and restored the exclusion of patents directed to new uses of known products and new forms of known compounds that do not deliver a significant increase in efficacy. The Court considered the exclusion an important safeguard against pharmaceutical patent evergreening and a measure supporting access to affordable medicines and the domestic generic medicines industry.
 

UPC

The Court of Appeal distinguishes jurisdiction from admissibility in pre-grant declaration of non-infringement dispute.
[Sidel v Omnia UPC-CoA-90/2026]

On 21 September 2026, the Court of Appeal (CoA) dismissed Sidel’s appeal and confirmed that the UPC has competence to grant a Declaration of Non-Infringement (DNI) in respect of patents which had not yet granted at the time the action was commenced. Holding that Omnia’s action effectively related to a DNI of the patents at issue, the Court upheld the Paris Central Division’s (CD’s) finding that the UPC has competence under Art. 32(1)(b) UPC. The Court considered that the question of whether an action for a DNI can be commenced before formal grant of a patent was one of admissibility rather than competence.

Omnia had commenced proceedings seeking a DNI in respect of two patents which had not yet granted at the time of filing the claim but which were granted shortly thereafter. At first instance and on appeal, Sidel argued that the UPC lacked competence because Art. 32(1)(b) UPCA refers to patents, not patent applications.

The Court considered that Omnia was aiming to obtain a DNI with respect to the patents following their grant and that the reference to patent applications in the Statement of Claim was merely a description of their status at the moment of filing the action. The Court therefore agreed that the action concerned a request for a DNI of patents which is covered by Art. 32(1)(b) UPCA.

The key question was, according to the Court, not one of competence but one of admissibility. In circumstances where admissibility is not one of the permissible objections that can be raised as a preliminary objection under r. 19 RoP, the Court considered that the question of whether an action for a DNI of the patents in issue is inadmissible (for example, because r. 61 RoP and r. 63 RoP may require the patent to have been granted) remained to be determined in the further proceedings.

In circumstances where the action was lodged by Omnia before Sidel filed its applications to opt the patents out from the exclusive competence of the UPC, the Court agreed with the Paris CD and ruled that the applications to opt out EP 194 and EP 351 were ineffective pursuant to Art. 83(3) UPCA and r. 5(6) RoP.
 

UPC

Court of Appeal clarifies res judicata, prior use rights and rule 171.2 challenges.
[Heraeus v Vibrantz UPC-CoA-919/2025 et al]

On 16 September 2026, the CoA dismissed both parties' appeals from the Munich Local Division's (LD) decision in Heraeus Electronics v Vibrantz. The decision addresses a number of important procedural and substantive issues, including the effect of national validity judgments before the UPC, the scope of r. 362 RoP, the evidential consequences of a pleading made "on the grounds of lack of knowledge" under r. 171.2 RoP, the relationship between Art. 28 UPCA and national prior user rights, and the circumstances in which infringing conduct in one Contracting Member State can support relief in others.

The patent concerned a metal sintering composition used for joining electronic components. Before the UPC proceedings, the German part of the patent had been challenged before the German Federal Patent Court (FPC) by Vibrantz. The FPC upheld the patent in amended form and Vibrantz later withdrew its appeal. In the UPC, Heraeus brought an infringement action and defended the patent only in the form upheld by the German Court.

The CoA agreed with the LD that the FPC's judgment barred further attacks on the German designation of the patent based on lack of patentability. The key question was whether the extent of the res judicata effect of the national judgment was governed by national law. The Court held that it was, whether through Art. 36(1) of the Brussels Ia Regulation, treating the UPC as a common Court of a Member State, or through Art. 24(1)(e) UPCA. Applying German law, lack of patentability under Art. 138(1)(a) EPC constituted a single ground of action encompassing both novelty and inventive step. As a result, those attacks could not be relitigated before the UPC. The Court further held that res judicata constituted an absolute bar to proceedings under r. 362 RoP. Although r. 362 provides that the court "may" rule that proceedings cannot continue, the Court held that there is no discretion where an absolute procedural bar exists.

The CoA rejected submissions that this approach was inconsistent with the objective of uniform patent protection. During the transitional period, the UPC and national Courts operated within a system of concurrent jurisdiction. The UPC was not a "super-appeal body" for national Courts and reconsidering issues already determined by a national Court would increase, rather than reduce, the risk of inconsistent outcomes.

On validity, the CoA held that the amended claim was sufficiently disclosed and that the amendment did not give rise to a clarity objection. It also upheld the LD’s findings that the French, Italian and Romanian designations were novel and inventive.

The Court also confirmed that Art. 28 UPCA does not create a harmonised European prior use right. Instead, it expressly refers to national law. Applying s.12 of the German Patent Act, the Court concluded that Vibrantz had established a German prior use right. In doing so, it clarified the operation of r.171.2 RoP. Where an alleged fact lies outside a party's sphere of knowledge and responsibility, that party may plead lack of knowledge without providing a substantive response. The fact is therefore not deemed admitted but must be proved.

The Court was satisfied that Vibrantz had proved, through witness evidence and testing of retained samples from batches actually used before the priority date, that it possessed the invention before the priority date. Importantly, it held that subjective possession of the invention did not require any appreciation of the technical significance of the claimed parameter. Nor was the invention realised merely by chance. The resulting prior use right was not confined either to the specific batches tested or to the measured values themselves.

Finally, the CoA refused relief in France, Italy and Romania. Heraeus accepted that it could not identify any actual infringing acts in those states and instead relied on Vibrantz's activities in Germany, its international business structure and the existence of the EU single market. The Court held that only established unlawful use can support a presumption that a defendant will continue or extend its activities into other Contracting Member States. Since Vibrantz's proven activities in Germany were lawful by virtue of its prior use right, those activities could not give rise to an inference of infringement elsewhere. Nor had Heraeus established any imminent infringement. The Court therefore had no need to decide whether Vibrantz also enjoyed prior use rights in France, Italy or Romania.

The decision provides significant guidance on the interaction between UPC proceedings and national judgments during the transitional period. It confirms that the scope of any res judicata effect is determined by national law and clarifies that the UPC cannot be used to relitigate matters already finally determined by a national Court between the same parties. The decision also holds that a risk of infringement requires a finding of unlawful use, so that use which is lawful in one Contracting Member State by virtue of a right of prior use cannot give rise to a risk of infringement in another.
 

New episodes: You, Me and the UPC: Case by case

Episode 91: Munich Central Division clarifies limits of entitlement based revocation under Art. 138(1)(e) EPC

Episode 92: Abbott secures UPC-wide Preliminary Injunction over Continuous Glucose Monitoring patent