Irides: Weekly global patent litigation update

This edition features updates from: The United Kingdom (UK), China and the Unified Patent Court (UPC).

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

UK

High Court refuses MSD Mayne Pharma disclosure request. 
[MSD v Halozyme [2026] EWHC 1838 (Pat)]

On 20 July 2026, the High Court dismissed MSD’s application for further disclosure of experimental materials from Halozyme in a dispute concerning Halozyme’s patent for modified human PH20 hyaluronidase enzymes (EP 347). Halozyme alleges that EP 347 is infringed by MSD’s subcutaneous formulation of its cancer therapy Keytruda, which contains the recombinant PH20 enzyme berahyaluronidase alfa (ALT-B4).

In its Notice of Experiments, Halozyme sought to demonstrate that MSD’s ALT-B4 enzyme satisfies the functional feature of EP 347, namely that ALT-B4 exhibited at least 120% of the activity of an unmodified PH20 comparator. Halozyme’s experimental design compared MSD's enzyme with a reference enzyme sourced from the supplier Creative Biomart. Having been ordered to provide disclosure in accordance with the principles in the case law concerning work-up experiments, Halozyme also provided disclosure of work-up material relating to the experiments.

MSD contended that Halozyme’s disclosure was “manifestly deficient (being both incomplete and overly redacted)”. It argued that Halozyme should disclose additional documents relating to alternative comparator enzymes on the basis that they formed part of the work-up to the experiments relied upon and were relevant to MSD’s insufficiency case alleging undue burden in producing relevant comparator enzymes.

Applying Mayne Pharma and the later authority Magnesium Elektron v Neo Chemicals, Mr Justice Mellor (Mellor J) adopted a restrictive approach to the consequential waiver of privilege involved in the service of a notice of experiments carried out for the purposes of litigation, holding that the waiver was limited to the specific experiments relied upon in the Notice rather than extending to issues of infringement and validity more broadly. In particular, Halozyme’s evidence established that MSD’s enzyme had only been compared with one reference enzyme, the Creative Biomart product, and that no comparisons had been carried out to determine a preferred comparator. The inferences were therefore considered unsupported and MSD’s application was dismissed. 
 

UK

High Court issues contrasting decisions on expedition in STADA v Novartis [2026] EWHC 1834 (Pat) and Janssen v USA [2026] EWHC 1848 (Pat).

Mellor J has recently handed down two decisions on expedition - STADA v Novartis on 10 July 2026, and Janssen v USA on 22 July 2026.

Janssen v USA was heard first, on 6 July 2026. The USA holds a patent relevant to CAR-T technology, which is licensed to 2Seventy Bio, a company now owned by BMS. BMS markets the CAR-T therapy Abecma. Janssen markets the CAR-T therapy Carvykti. As licensee, 2Seventy Bio started infringement proceedings against Janssen at the UPC in January 2026, and the oral hearing is set for 23 March 2027.

Janssen started revocation proceedings against the USA in the UK in February 2026. The USA unsuccessfully challenged service. Once service had been resolved, the USA filed its defence and counterclaimed for infringement (along with 2Seventy Bio). The infringement claimants elected to seek financial relief in lieu of an injunction. Janssen sought expedition. Mellor J applied the four factors from Gore v Geox: i) whether there is a good reason for expedition; ii) whether expedition would interfere with the good administration of justice; iii) whether expedition would cause prejudice to either party; and iv) whether there are any other special factors. He endorsed the approach taken by Mr Justice Meade in Samsung Bioepis v Alexion, namely that the requirement for a good reason, demonstrated by real and objective urgency, is a threshold gateway. If that gateway is not satisfied, the application should fail without any balancing exercise between the remaining factors.

Janssen argued that a decision was urgently required to give it commercial certainty in advance of a NICE Health Technology Assessment of its therapy due to the threat of liability for damages/royalty payments. Carvykti is not currently available through the NHS, and Janssen must demonstrate cost-effectiveness as part of the NICE assessment to obtain a recommendation. That cost-effectiveness depends on the price offered. 2Seventy Bio and the USA argued that Janssen had started the NICE appraisal process without taking sufficient active steps to clear the way. Further, with no injunction risk, Carvykti would not be ordered off the market. Mellor J considered the issue finely balanced, but observed that, if the patent were invalid, it would be in the interests of NHS patients for it to be cleared out of the way as soon as possible in light of the NICE appraisal process. Given this, Janssen cleared the threshold gateway, but whether expedition would actually be ordered was dependent on the second to fourth Gore factors. Of interest, is that Mellor J did not expressly factor in Janssen's arguments that it was important to obtain a UK decision to persuade the UPC as part of this urgency assessment. He simply noted that the UPC is an EPC court and that any EPC judge would be interested in the decision of another EPC court.

Mellor J therefore considered the other three factors in the context of four different dates for trial: October 2026, December 2026, March 2027 (all requiring at least some degree of expedition) or from October 2027 (no expedition). October 2026 was considered to cause significant prejudice to the USA and 2Seventy Bio, given the need to instruct experts (who due to the rules on instructing experts in UK proceedings may well be different to the UPC experts) over the summer break. December 2026 would not have caused that prejudice, but there was no available slot in the Court diary. However, there was an available slot at the start of March 2027, and so trial was ordered for then.

By contrast, in STADA v Novartis, Mellor J reached the opposite conclusion on the threshold question of objective urgency.

STADA started proceedings against Novartis' combination patent and associated SPC, and indication patents protecting its Entresto product in early June 2026. The combination patent and SPC were already subject to existing proceedings brought by Accord (and Teva who had since withdrawn from the proceedings under a Tomlin Order), with the trial held at the end of June 2026. Neither Accord nor Teva had challenged the indication patents.

STADA proposed to stay its claims relating to the combination patent and SPC, agreeing to be bound by the judgment in the Accord proceedings providing it was progressed to appeal. It then sought expedition of its challenge to the indication patents for a trial in February 2027 to obtain commercial certainty. STADA argued that it had been surprised by the decision of the EPO Opposition Division to uphold one of the indication patents, and by the refusal of the Technical Board of Appeal to expedite the appeal proceedings. Therefore, any launch of STADA’s product before judgment on the indication patents would carry significant risk of being injuncted.

As in Janssen, Mellor J noted the gateway requirement for STADA to demonstrate objective urgency. Although STADA clearly had a desire for a quick decision to obtain commercial certainty, the need to rush was brought about by STADA’s own “dilatoriness” in starting proceedings. STADA had multiple opportunities to act earlier than June 2026, including after grant of EP 270, after the Opposition Division's decision in December 2025, or after the refusal to expedite the appeal proceedings. Novartis also pointed to the judgment in Aldi Stores v WSP Group, where the Court of Appeal emphasised the need for parties to "put their cards on the table when inviting the court to exercise case management powers". Relying on this Novartis argued that STADA’s conduct of starting litigation late, and seeking a conditional stay on certain patents, was frustrating efficient litigation. Mellor J found that although Aldi Stores does not apply directly to an expedition application, he accepted the underlying case management principle relied on by Novartis, namely that parties should identify disputes sufficiently early to allow the court to manage the litigation as a whole.

Putting these factors together, Mellor J concluded that there was no justification for expedition to February 2027 or May 2027, and therefore the trial should be listed in the normal window, being October 2027.
 

China

CNIPA publishes guidance to align the administrative SEP injunction standard with the Court’s FRAND test. 
[Guo Zhi Fa Bao Han Zi [2026] No. 68]

On 26 May 2026, the Chinese National Intellectual Property Administration (CNIPA) provided guidance, in an official communication, on the handling of administrative adjudication cases concerning Standard Essential Patents (SEPs). The communication was publicly released on 16 July 2026.

CNIPA observed that Art. 30, Paragraph 2 of the Order concerning "Administrative Adjudication and Mediation Measures for Patent Disputes" states that for administrative adjudication and mediation involving SEPs, where there is no specific provision in the Order, other laws and guidance may apply. CNIPA therefore turned to Art. 24, Paragraph 2 of the "Interpretation (II) of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Patent Infringement Dispute Cases" (2020 Revision) which explains that if the patentee violates the FRAND principles during negotiation, then the implementer cannot be blocked from the standard.

CNIPA concluded that the body managing the dispute should consider whether both parties fulfilled their obligations in terms of disclosure, negotiation, and proposing reasonable licensing conditions. If the patentee follows the FRAND principles and the implementer is clearly at fault for a licence not being concluded, then an injunction may be appropriate.
 

UPC

Court of Appeal confirms scope for reliance on dependent claims in revocation proceedings.
[Fujifilm v Kodak UPC_CoA_473/2025 et al]

On 13 July 2026, the Court of Appeal issued its decision in Fujifilm v Kodak concerning EP 3 476 616, relating to lithographic printing plate precursors, manufacturing methods and printing methods. The Court overturned the Mannheim Local Division’s (LD) revocation of the patent and dismissal of Fujifilm’s infringement action, holding that a patentee may rely on granted dependent claims and claim combinations already encompassed by the patent as granted without filing an auxiliary request. The Court held that r.30 applies only where the patentee seeks to maintain the patent in amended form and does not operate as a procedural prerequisite for defending dependent claims already contained within the granted patent.

The judgment provides guidance on the relationship between r.29A and 30 RoP. While patentees must clearly identify and sufficiently substantiate the dependent claims and claim combinations on which they rely, the Court rejected the LD’s approach that effectively required such claims to be included in a formal amendment application. Applying those principles, the Court concluded that Fujifilm had adequately addressed the relevant dependent claims and combinations in its first instance pleadings and that these should have been considered as part of its main defence to revocation.

The Court upheld the patent in the form resulting from EPO central limitation proceedings, dismissed Kodak’s challenges based on added matter, alleged public prior use, novelty and inventive step. In doing so, it also provided useful guidance on inventive step, emphasising that where there is no clear pointer to combine a starting point with another document, the motivation to do so cannot be derived from the contents of the document being combined.

On infringement, the Court found that Kodak’s Sonora plates infringed the German designation of the patent and rejected Kodak’s private prior use defence (applying German law). It granted injunctive relief, damages, information orders, recall and destruction measures, and awarded Fujifilm interim damages of €300,000. The Court also confirmed UPC jurisdiction over claims relating to the infringement of the UK designation following BSH v Electrolux, although it ultimately dismissed Fujifilm’s UK infringement claim on the facts.

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