Irides: Weekly global patent litigation update

This edition features updates from: CJEU, USA, Brazil and the Unified Patent Court (UPC).

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

CJEU

Advocate General provides Opinion on whether excipients can qualify as an “active ingredient” for SPC eligibility. C‑456/24, Halozyme

On 23 April 2026, the Advocate General Emiliou (AG) handed down his Opinion in Case C‑456/24, Halozyme. The reference, made by the Czech Supreme Administrative Court, asks the CJEU how to determine whether a substance may be regarded as an “active ingredient” for the purposes of Art.1(b) of the SPC Regulation, and therefore form part of a “product” which may be eligible for an SPC. In particular, the referring Court is seeking guidance on whether the classification of the substance in the MA should be decisive.

Halozyme is the proprietor of various patents relating to recombinant human hyaluronidase PH20 (rHuPH20), an enzyme which facilitates the dispersion and absorption of co-administered medicinal products injected subcutaneously. Trastuzumab (Herceptin) is a monoclonal antibody for the treatment of breast cancer developed by Roche and first approved for intravenous administration. In 2013, the Commission granted Roche a line extension of its existing MA to cover a new subcutaneous formulation of Herceptin, combining trastuzumab with rHuPH20. In Roche’s MA documentation, trastuzumab is referred to as the active ingredient, while rHuPH20 is identified as a novel excipient. Halozyme subsequently sought SPC protection across numerous countries for trastuzumab and rHuPH20 as a “combination of active ingredients”.

Divergent national decisions emerged: SPCs were granted for the combination in some countries (including Spain, Italy and Poland), while applications were refused elsewhere (such as the UK, France and the Netherlands). Against this backdrop, the Czech Court referred questions to the CJEU focusing on whether the express designation of a substance as an “excipient” in the MA necessarily precludes it from being considered an “active ingredient” within the meaning of the SPC Regulation.

In his non-binding Opinion, the AG adopts a clear stance that a substance expressly classified as an excipient in the MA cannot be regarded as an “active ingredient”, and therefore cannot form part of a “product” eligible for SPC protection. While Halozyme argued that the decisive factor should be “actual efficacy”, the AG considers that the regulatory classification in the MA must be determinative.

The Opinion emphasises that SPCs are intended to compensate patent holders for regulatory delays specifically associated with new active ingredients, rather than regulatory delays more generally. The AG also stresses the need for simplicity, transparency and uniform application of the SPC regime across Member States. If followed by the Court, the AG's approach will reinforce the central role of the MA in defining the protected “product” for SPC purposes.
 

USA

Federal Circuit reinstates jury verdict upholding Teva’s antibody genus patents for treating headaches.

The Court of Appeals for the Federal Circuit has reinstated a $177 million jury verdict, finding that Eli Lilly infringed, and failed to prove invalid, Teva’s patents claiming a genus of humanised anti‑CGRP antibodies for the treatment of headaches. The Court reversed the District Court’s grant of Judgment as a Matter of Law (JMOL), holding that three patents – referred to collectively by the Court as “the headache patents” – satisfy the requirements of both written description and enablement.

The specification of the headache patents explained that anti-CGRP antibodies were already known in the art. However, the patents only disclosed a single example of a humanised anti-CGRP antibody falling within the scope of the claimed genus, and did not provide any sequence data. Eli Lilly therefore argued that the headache patents did not adequately disclose a representative number of species within the asserted genus.

In reversing the JMOL, the Court distinguished the case from the Supreme Court’s decision in Amgen Inc. v. Sanofi, in which claims to a functionally defined genus of antibodies were held not to be adequately enabled due to a lack of representative examples. In particular, the Court emphasised the distinction between claims directed to a genus itself and claims directed to a “known genus used as part of a different invention”. The method of use claims in the headache patents fell squarely in the latter category. Anti-CGRP antagonist antibodies (and methods of making them) were well known and humanisation was a routine process; the invention lay in their use for treating headaches.

Having drawn this distinction, the Court found that the skilled person would have understood from the specification that all humanised anti-CGRP antagonist antibodies were suitable for the limited purpose of treating headaches. Accordingly, a single example of a humanised anti-CGRP antibody was sufficiently enabling for the purposes of the claimed invention.
 

Brazil

Commercial Court grants Panasonic Preliminary Injunction against smartphone implementers in SEP dispute.

Panasonic had alleged infringement by HMD Global of Brazilian patent PI 0305710‑0, which protects technology relating a premium and optional feature of the AAC standard that enables high-quality audio playback with low battery consumption. The 6th Commercial Court of the State of Rio de Janeiro relied on the evidence of a Court appointed expert in coming to the conclusion that the patent was infringed on both a literal and equivalents basis.

Assessing HMD’s FRAND defence, the judge considered international jurisprudence including the CJEU’s decision in Huawei v ZTE, and decisions of the Munich Regional Court and the UK. In the judge’s view, the Court is unable to reach a conclusion on the price of a FRAND licence for the same reason that it is unable to determine the “fair and reasonable value of the euro”: this is a question for the market to establish. However, the Court was still able to decide whether Panasonic had made a FRAND offer on the basis that “anything that is not arbitrary or capricious will be fair and reasonable”.

In coming to the conclusion that Panasonic had made a FRAND offer to HMD, it rejected HMD’s argument that it was necessary for Panasonic to offer a bilateral licence arrangement. Panasonic had only offered a pool licence but, citing examples from Brazilian law permitting mandatory collective arrangements in other contexts, the Court recognised that pool‑only offers may satisfy FRAND obligations. The Court further found that the defendants’ conduct amounted to delaying tactics, undermining their claim to be willing licensees and defeating their FRAND defence.
 

UPC

Mannheim Local Division grants Nokia ex parte anti-suit injunction in relation to Chinese interim licence application.
[UPC_CFI_1291/2026, Nokia v Geely]

The UPC continues to provide anti-suit relief in FRAND actions where it considers its jurisdiction may be compromised by the grant of interim licence applications in other Courts. In the UPC, Nokia is pursuing SEP infringement actions against Chinese car manufacturer, Geely. In response Geely initiated rate-setting proceedings in a parallel action before the Hangzhou Court in China and applied for a worldwide “interim licence” by way of a preservation order.

The judgment notes Nokia’s submission that Geely applied to the Chinese Court for its interim licence application to be classified as confidential and, accordingly, little information on it is set out in the UPC’s judgment. However, relying on an affidavit from Nokia’s Chinese legal representatives, the Mannheim LD concluded there was a risk of a similar order being granted by the Hangzhou Court as was given in Huawei v Conversant and therefore Nokia’s ability to enforce its patents before the UPC could be severely hampered with significant monetary penalties if it breached the Order. 

The Mannheim LD held that Geely’s application for a global interim licence constituted, in substance, an anti‑suit injunction directed at preventing Nokia from exercising its right to seek and enforce injunctions before the UPC. The procedural enforceability of patent rights, including access to the UPC, was found to be an inherent element of the patent right itself, protected by Art. 47 of the Charter of Fundamental Rights of the EU, Art. 6 of the ECHR (Right to a fair trial) and the Enforcement Directive (2004/48/EC).

The Mannheim LD therefore granted an Order prohibiting Geely “from applying for an anti-suit injunction in the form of an interim licence and/or from taking any other equivalent judicial or administrative measure which would directly and/or indirectly prevent and/or is intended to prevent” Nokia from pursuing patent infringement proceedings before the UPC. It also ordered the withdrawal of the Chinese interim licence application insofar as it affected the UPC territory, and imposed significant penalty payments for non‑compliance (up to €50 million, with daily penalties of up to €500,000). The Order was made enforceable subject to provision of security of €600,000. The European Commission was notified of the decision due to potential EU competition law implications.
 

UPC

Court of Appeal clarifies limits of cross appeals under r.220.1 while granting preliminary injunction in Abbott v Sinocare. 
[UPC_CoA_901/2025]

Abbott Diabetes Care Inc. (Abbott) brought proceedings against Sinocare Inc. and A. Menarini Diagnostics s.r.l. (together the Respondents) alleging infringement of EP 3 988 471, which concerns a continuous glucose monitoring system displaying real‑time glucose data together with event information. The Hague LD refused Abbott’s application for provisional measures, finding it more likely than not that there was no infringement based on a narrow claim construction requiring event icons to be displayed on or very close to the glucose trend line. Abbott appealed. The Respondents’ cross-appealed the LD’s decision that the urgency requirements were met.

The Court of Appeal (CoA) overturned the LD’s order and granted a preliminary injunction prohibiting indirect infringement across the UPC territory, except Romania. It rejected the narrow claim construction adopted at first instance, holding that the claims did not require event icons to be displayed on or immediately next to the glucose curve. It was sufficient that the icons allowed users to correlate events with the time axis and understand their relationship to glucose changes. On that basis, the Respondents’ GlucoMen iCan system, which displays event icons below the x axis aligned with the relevant time points, was more likely than not to infringe. Infringement was indirect, as the Respondents supplied the sensors, transmitters and iCan app, which were essential means intended to put the invention into effect, despite not supplying the mobile phones required for direct infringement.

On validity, the Court rejected the added matter objection based on the use of a touchscreen to acknowledge alerts, finding that the application as filed clearly and unambiguously disclosed touch-sensitive display areas for interacting with softkey labels. The Court also upheld inventive step and made clear that confirming that a claim feature should not be excluded from the inventive step analysis merely because it is non-technical and, taken in isolation, would fall within the exclusions of Art. 52(2) EPC. A non-technical feature may still contribute to the technical character of the claimed invention as a whole through its interaction with other claim features, here by improving user–machine interaction in a safety-critical medical context. The prior art did not render the claimed real-time integrated display obvious.

As discussed further below, before reaching its decision to award the preliminary injunction, the Court also considered the requirements of urgency and necessity of provisional measures, finding that these were satisfied.

Finally, the CoA also addressed the admissibility of appeals and cross-appeals, providing important procedural guidance for UPC practice. Relying expressly on the RoP, the Court emphasised that the right to appeal is limited to parties who are adversely affected by the decision. As the Court stated, “pursuant to R. 220.1 RoP, only a party adversely affected by a decision may lodge an appeal”, and “the same applies to a cross-appeal pursuant to R. 237 RoP” a cross‑appeal, such as the one on urgency here, cannot be used to challenge reasoning where the operative outcome is favourable to the cross‑appellant, and is inadmissible if brought solely to change part of the first-instance court's reasoning. The assessment of urgency (along with necessity of provisional measures) was a necessary part of the appeal (r.211.4 RoP) and the same issue cannot form the subject of the cross-appeal, which was therefore declared inadmissible.
 

UPC

Paris Local Division revokes Michelin patent following novelty challenge based on single prior art document. [UPC_CFI_138/2025, UPC_CFI_522/2025 Michelin v Goodyear]

On 16 April 2026, the Paris LD revoked Compagnie Générale des Etablissements Michelin’s European patent EP 2 323 858 B1 (EP 858) in its entirety and dismissed Michelin’s infringement action against three Goodyear group companies. The case involved allegations that Goodyear’s Fuelmax D Endurance and Fuelmax D GEN‑2 tyres infringed claims 1, 3 and 13 of EP 858, which relates to a multi-stage tyre tread with a variable surface area. Goodyear denied infringement and counterclaimed for revocation, with the dispute turning on novelty over a single piece of prior art.

The decisive prior art was Japanese patent application JP 2001/063323, referred to as ‘Kunugi’, which was cited in the specification of EP 858 as disclosing the preamble of claim 1. The Court found that Kunugi directly and unambiguously disclosed all structural features of the claimed tyre tread, including the allegedly characterising longitudinally alternating arrangement of lateral grooves. On that basis, claim 1 was held to lack novelty.

A key aspect of the decision was the Court’s clear articulation of the limited role that technical effects can play in the novelty analysis of a product claim defined by structural features. Michelin sought to distinguish Kunugi by arguing that, although similar in appearance, the claimed tread achieved different technical effects, including improved water drainage, controlled exposure of grooves during wear, and specific stiffness characteristics. The Court rejected these arguments, emphasising that where a product claim is defined by its structural features, novelty depends on whether those features are disclosed in the prior art, not on the technical problem addressed or the effects said to result from them. Differences in purpose, optimisation, or performance were therefore irrelevant if the same structure was already made available to the skilled person.

The Court’s reasoning underscores a strict approach to novelty under the EPC framework, now applied in the UPC context. It confirms that patentees cannot rescue a structurally anticipated product claim by recharacterising the invention through the lens of technical effects, unless those effects are reflected in additional limiting structural features of the claim itself. The decision highlights the risk of relying on unclaimed effects where the prior art discloses a similar physical configuration.

In construing the claims, the Court considered issues such as the meaning of “tread element” and the correct method for measuring the spacing between lateral sipes, but concluded that, on any construction advanced by Michelin, Kunugi disclosed the same structural arrangement. The Court also confirmed that written technical statements from company employees, while lacking the value of independent expert evidence, could nevertheless be taken into account as technical information when assessing the disclosure of the prior art. Once claim 1 was found to lack novelty, all dependent claims fell with it. Michelin did not advance substantiated arguments to support the independent validity of claims 2 to 14 in the event that claim 1 was revoked, and those claims were therefore also revoked. The Court further rejected all 14 of Michelin’s conditional auxiliary requests, finding that none overcame the lack of novelty over Kunugi and that several either introduced added matter or lacked an inventive step. 

The Court dismissed the infringement action in its entirety, revoked EP 858 with effect in France, and ordered Michelin to bear the costs of the proceedings. The decision provides a clear early indication of the UPC’s willingness to dispose of cases on novelty grounds where a single prior art document discloses the claimed structure, and serves as a reminder that, for product claims, technical effects will only assist if they are translated into distinguishing structural limitations.
 

UPC

Paris Local Division addresses long-arm jurisdiction over non‑EU defendants in BYD infringement dispute. [UPC_CFI_2070/2025, BMS v BYD]

The Paris LD has decided that it has no jurisdiction over a defendant domiciled in a third country (i.e. not UPC or EU), where that defendant is not alleged to have committed any act of infringement within the territory of the EU.

BMS Innovations brought infringement proceedings against multiple BYD group entities domiciled in the Netherlands, France, Germany as well as China and the UK. The Chinese and UK defendants raised a preliminary objection under r.19 RoP, challenging the UPC’s international jurisdiction, particularly in relation to alleged infringing acts in the UK. The Court confirmed that the preliminary objection was admissible and decided, despite the Claimant’s request for one, to rule without holding an oral hearing. 

In considering jurisdiction over the Chinese defendants, the court noted that they were accused of infringing acts within the EU as well as the UK. The Court decided that the claims against them were closely connected to those against the EU‑domiciled defendants, creating a potential risk of irreconcilable judgments if proceedings were split. In those circumstances, the Court considered it appropriate and expedient to hear the claims together. However, rather than finally determining jurisdiction at this stage, it held that the question of the UPC’s international jurisdiction over these defendants for alleged UK acts should be examined by the full panel in the decision on the merits. 

The position in relation to the UK defendant was different. The only acts of infringement alleged against this defendant had occurred exclusively in the UK. The Court found that jurisdiction could not be based on Art.4 Brussels I bis (domicile), Art. 7(2) (place of harmful event), or Art. 8(1), as there was no connecting factor with the territory of the EU or the UPC creating a risk of irreconcilable judgments. The Court also rejected the defendants’ alternative request to refer questions on “long‑arm” jurisdiction to the CJEU, finding no need for a preliminary ruling. Accordingly, the Paris LD held that it had no international jurisdiction over the UK defendant and upheld the preliminary objection in relation to the UK defendant.
 

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Episode 50: GC Aesthetics succeed in r.190 application for implant samples and key technical and regulatory files.