Irides: Weekly global patent litigation update

This edition features updates from: the United Kingdom, Germany 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

High Court gives its first decision on the scope of the SPC Manufacturing Waiver.

On 4 November 2025, Mr Justice Meade gave his verbal judgment in Regeneron Pharmaceuticals, Inc. v Alvotech Hf. and another, the first UK decision on the scope of EU Regulation 2019/933, as incorporated into UK law and amended (the UK SPC Waiver Regulation). Mr Justice Meade concluded that the UK SPC Waiver Regulation did not require Alvotech, as the “maker” wanting to take advantage of the export waiver, to provide the reference number of the marketing authorisation of any country of export for the notification to be effective. It is expected that the full written reasoning will be handed down soon.
 

STOP PRESS UK

Apple granted permission to appeal to the Supreme Court in FRAND dispute against Optis.

Apple has been granted permission to appeal to the Supreme Court in its ongoing dispute with Optis regarding the correct approach to determining FRAND terms for licensing SEPs. In a judgment handed down in May of this year, the Court of Appeal adopted a comparables based approach and awarded Optis a FRAND royalty of $0.15 per device, resulting in a total licence fee of $502 million plus interest. The Court also ruled that Apple must pay royalties on sales dating back to 2013, and that parallel US proceedings should serve as a “floor” for setting the global royalty rate. Apple has now been granted permission to appeal this decision to the Supreme Court.
 

UK

Warner Bros obtain an ex-parte Anti-Anti Suit Injunction against Nokia. 

On 3 November 2025, Mr Justice Mellor granted Warner Brothers Discovery (WBD) an ex parte Anti-Anti Suit Injunction (AASI) against Nokia. The global order was to restrain Nokia from seeking anti-suit relief which would have the effect of prohibiting WBD from pursuing its claim for relief in the Courts of England and Wales to declare the terms of a final RAND licence for Nokia’s Codec SEP Portfolio and any adjustable terms pending full determination of the final RAND licence. This AASI comes in light of the recent proceedings in Amazon v InterDigital where the UPC and Munich Court issued an ASI against Amazon (see our previous report here).

Mr Justice Mellor (Mellor J) accepted WBD’s submission that giving notice would defeat the purpose of the AASI relief as there was a strong possibility that a German Court or the UPC could grant an ASI following a telephone conference with Nokia’s representatives following notice of the application.

Following an analysis of the case law for (i) anti-suit injunctions (ii) AASIs (iii) anti-enforcement injunctions (iv) mandatory relief and (v) quia timet relief, the risk to WBD’s claim in the English Court was assessed. WBD put forward three factors that Mellor J stressed he was ‘sceptical’ of, including:

1. Nokia had pursued foreign injunctions for patent infringement against other implementers in multiple fora based on its Codec SEP Portfolio. It had not requested a final (F)RAND determination from these Courts, rather it had offered to engage in arbitration with an adjustable licence pending arbitration. The issue as to whether Nokia can make arbitration a contractual obligation under the ITU-T obligation is currently live pending judgment from Mellor J in multiple proceedings involving Acer, ASUS and Hisense.
2. Nokia has a history of pursing ex parte AASI’s in SEP/FRAND proceedings, including against Daimler in the Munich Regional Court in July 2019, and Sunmi in the UPC in February 2025. Although WBD acknowledged that the AASI was not directly analogous to the Anti-Interim-Licence Injunction (AILI) decision obtained by InterDigital in its dispute with Amazon.
3. The tendency of SEP holders and implementors to adopt similar strategies in (F)RAND litigations, thus the likelihood that Nokia would adopt the strategy employed by InterDigital of obtaining and AILI before WBD could issue its claim in the High Court of England and Wales.

Despite his scepticism of the aforementioned factors, Mellor J was not able to find the risk negligible or so small as to not justify the relief sought by WBD. He therefore granted the AASI on a temporary basis pending hearing from Nokia, along with permission to serve outside the jurisdiction and a confidentiality order. 
 

UK

Interim injunction ordered against Dr Reddy's Laboratories (UK) Limited in relation to empagliflozin.

On 5 November 2025, Michael Tappin KC (sitting as a Deputy Judge of the High Court) gave judgment in an interim injunction application brought by Boehringer Ingelheim International GmbH (BI DE) against Dr Reddy’s (UK) Limited (DRL). The interim injunction was granted pending the outcome of a trial scheduled for October 2026.

The application for an interim injunction was brought following DRL providing 28 days’ notice that it intended to commence sales of its empagliflozin products in the UK. Empagliflozin is an SGLT-2 inhibitor sold in the UK for the treatment of type 2 diabetes, heart failure and chronic kidney disease. As is usual in interim injunction proceedings, the Court applied the guidelines laid down in American Cyanamid v Ethicon. In summary these are: (1) is there a serious issue to be tried? (2) would damages be an adequate remedy for the claimant? (3) if the answer to (2) is no, would a cross-undertaking in damages be an adequate remedy for the defendant if it prevailed at trial? and (4) if damages are not an adequate remedy for either side, where does the balance of convenience lie?

It was common ground that there was serious issue to be tried. When it came to assessing damages, a key factor was how the empagliflozin market may change over the period until trial in October 2026. Entry of generic dapagliflozin medicines following the invalidation of AstraZeneca’s compound patent for this medicine is expected to impact the empagliflozin market with access to SGLT-2 inhibitors likely to increase. However, the extent of that increase, and the impact of any switching to generic dapagliflozin, was uncertain. This made it very hard for the Judge to assess how the market for empagliflozin will evolve over the next 14-15 months. This coupled with the risk that further generics may seek to launch their empagliflozin medicines in the UK if DRL launches, as well as some complications over calculating damages on a skinny label medicine, meant that damages were not held to be an adequate remedy for either side. In the end, the balance of convenience was held to be in maintaining the status quo. A large part of this was down to DRL’s failure to take effective steps to clear the way. The trial in the proceedings was fixed, by consent, at a time when the dapagliflozin litigation was advanced and DRL did not adapt its litigation strategy to prepare for a change in market conditions. The Deputy Judge considered DRL could not now rely on this to the detriment of the BI DE.

Two final notes, firstly, at the hearing handing down the judgment, DRL were refused permission to appeal to the Court of Appeal. It remains to be seen if they will now apply to the Court of Appeal for this permission. Secondly, the Department of Health and Social Care was an intervener in these proceedings and provided a witness statement. This statement contained helpful information on the position of the Department on matters relating to pricing/reimbursement and prescribing. The Deputy Judge made a clear point that he found the evidence an extremely valuable account of the pricing and reimbursement system operated by the DHSC and that, in his view, any Court hearing an application for an interim injunction would greatly benefit from reviewing the evidence.
 

GERMANY

Novo Nordisk successfully enforces Semaglutide patent at CPHI 2025 in Germany - 28 ex parte Preliminary Injunctions Obtained and Served. 

Last week, Novo Nordisk asserted its patent to semaglutide, EP (DE) 1 863 839, against companies offering the Active Pharmaceutical Ingredient (API) semaglutide and/or semaglutide-containing pharmaceuticals at CPHI, the leading global pharmaceutical trade fair held in Frankfurt am Main, Germany, from 28 - 30 October 2025.

26 ex parte injunctions were issued by the 4a Civil Chamber of the Düsseldorf Regional Court, 25 of which were promptly served on the infringing exhibitors directly at the trade fair and were effective immediately. In addition, the Frankfurt Regional Court (6 Civil Chamber) issued three further ex parte preliminary injunctions against exhibitors that offered finished medicinal products containing semaglutide without valid marketing authorisations, which constitutes an infringement of unfair competition law. These injunctions were likewise served on-site during the event.
 

UK 

Court of Appeal overturns Declarations of Bad Faith against ZTE.

On 31 October 2025, the Court of Appeal allowed ZTE's appeal to overturn the declarations of bad faith granted by the High Court in June this year at Samsung’s request. The unanimous decision (delivered by Lord Justice Peter Jackson, Lord Justice Arnold and Lord Justice Birss) represents the first successful interim licence appeal by a patentee before the Court of Appeal. 

The appeal arose in the context of a global FRAND determination concerning cellular SEPs (including 5G) between Samsung and ZTE, a major Chinese Standard Essential Patent (SEP) owner. Samsung first brought proceedings in the English High Court, and two working days later, ZTE commenced parallel proceedings in the Chongqing Court. The Chinese trial concluded in October 2025, while the UK trial is listed for early 2026. Both parties put forward interim licence offers, but the primary point of disagreement related to which Court should adjust the terms of the interim licence.

At first instance, Mr Justice Mellor found that ZTE had acted in bad faith by refusing to agree to the interim licence terms offered by Samsung. The proposed licence would have required ZTE to accept terms set by the English Court.

ZTE appealed the High Court’s decision on four grounds:

1. the first instance Judge erred in holding that ZTE had acted in bad faith;
2. the first instance Judge was wrong to treat the fact that the English Courts were first seised as a decisive factor;
3. the declarations granted at first instance went beyond what was necessary to remedy the mischief; and
4. the first instance Judge erred in concluding that the declarations were not contrary to comity.

The Court's decision focused on the first two grounds, which it considered together. It distinguished the case from both Panasonic v Xiaomi and Lenovo v Ericsson, in which the SEP owners were found to have acted in bad faith by seeking foreign injunctive relief in an attempt to extract higher royalties. By contrast, the Court held that a party pursuing a particular jurisdictional preference was not acting in bad faith, despite the “unattractive” nature of such conduct. The Court considered that where a party has a “legitimate and substantiated objection” to a particular forum, then an anti-suit injunction may be available, but Samsung was not found to have “seriously attempted” to advance any such objection to FRAND determination by the Chongqing Court. The Court further held that while the starting point should be whichever Court was first seised of the dispute (in this case, the English Courts), preferring another Court is not on its own a sufficient basis for a finding of bad faith (since other jurisdictions may be equally suitable for determining FRAND terms).

As to the third appeal ground, ZTE did not rely on any arguments concerning unduly extensive relief in its oral submissions and, accordingly, the issue was not addressed in the judgment. Similarly, while the Court noted that international comity was a “real concern in this case”, it did not find it necessary to determine whether the first instance judgment contravened principles of comity.

The judgment leaves open the possibility of a jurisdiction-neutral interim licence declaration, inviting further written submissions from the parties on this issue. Such a framework would provide a declaration that a willing licensor would enter into an interim licence on terms which include payment of a specified amount to the licensor (subject to a true-up mechanism), while leaving it open as to whether that true-up is to be achieved by a particular Court’s rate setting exercise or through commercial negotiations.
 

GERMANY

Munich Regional Court grant Regeneron Cross Border Preliminary Injunction Covering 22 Countries.

Following an oral hearing on 25 September 2025, the written reasons for the grant of a Preliminary Injunction (PI) covering 22 jurisdictions were published from the Munich Regional Court. It has subsequently been reported that a permanent injunction has been granted in 20 Member States although the written decision for this is pending.

Regeneron and Bayer had sued Formycon alleging that it had infringed claim 1 of EP 2364 691 (EP 691) relating to ophthalmic formulations of a VEGF antagonist for intravitreal administration on the basis of the doctrine of equivalents. This dispute is part of the ongoing worldwide litigation relating to EYLEA®, with its SPC expiring on 23 November 2025.

The Court begun by affirming its international and local jurisdiction to issue cross-border injunctions by applying BSH v Electrolux. It held that issuing a cross border PI was a procedural issue meaning it was competent to do so. The criteria for a PI are as follows: 

• whether the validity of the patent is sufficiently clear;
• if there is a clear and obviousness case of infringement; and
• whether there is an imminent threat.

Validity

The German Federal Patent Court had recently upheld EP 691 in a limited form which was said to have strong indicative value to the other European jurisdictions of its validity. It could therefore be assumed that the corresponding EPs would also be legally valid in the same form. The fact that the claims had not yet been limited in those jurisdictions was not relevant.

Infringement

The Court then considered whether EP 691 was likely infringed under the Doctrine of Equivalents. After considering the test in each of the 22 jurisdictions, it found that each jurisdiction would likely find claim 1 infringed where the variant used a histidine buffer rather than the claimed sodium phosphate buffer. It noted that expert opinions on foreign law were not required for this assessment as this would only make it more difficult for proprietors to enforce their rights. The only requirement is whether the national law of a jurisdiction modifies the requirements of the EPC in such a way that would lead to a different result. The burden to prove this lies with the party against whom the claim is made to present concrete evidence that a different decision would be made based on national law. Despite the UK not being a jurisdiction where an injunction was being sought, the fact that it had recently not found infringement by equivalence (previously reported here) was due to a different, narrower claim being asserted and different evidence before it.

Imminent threat

Finally, the Court found that there was an imminent threat of infringement to establish that a PI should be granted. In particular:

• there was a uniform marketing application which, if granted, would entitle the biosimilar to market its product in each of the 22 jurisdictions;
• there was a distribution structure in place that would enable the product to be marketing across Europe;
• Formycon had sent a letter stating it planned to launch its biosimilar following the expiry of the SPC which predated EP 691; and
• there was marketing material that indicated a global strategy with a focus on the rapid introduction of the product in Europe.

Applying a balancing exercise, the court favoured the granting of the injunction. This is because, in Germany, the interests of the plaintiff in issuing the injunction take precedence unless there are compelling reasons why that should not be the case and a claim for damages would be a sufficient remedy. Since no such reasons where substantiated, the PI was granted.
 

UPC

Court of Appeal clarifies Security of Costs for Prospective vs. Historic Legal Costs.
[UPC_CoA_8/2025]

On 30 October 2025, the Court of Appeal Issued an Order relating to security for costs. By way of background, the Appellant before the Court, Bhagat Textile Engineers (Bhagat), had been found liable for infringing a patent owned by Oerlikon Textile GmbH & Co KG (Oerlikon). Bhagat had sought to appeal the Order from the Court of First Instance on limited grounds. Following the decision at first instance, a costs award had been made against Bhagat which it had failed to pay. As part of the appeal, Oerlikon filed an application for security for costs. The application was made following the summons for the appeal hearing and requested payment of a security or a bank guarantee in favour of Oerlikon for costs in the appeal proceedings as well as the costs incurred, and not paid, from the first instance proceedings.

The Court admitted the application for security of costs, even though it was filed after the summons to the oral hearing, holding that subject to the circumstances of the case and provided it is substantiated by compelling reasons, an application for security for costs may be filed after the summons for oral hearing has been issued. Further, the Court was willing to grant the security in favour of Oerlikon in relation to costs in the appeal proceedings. However, it set the amount at half the ceiling costs, far less than requested. The Court also refused the part of the application in relation to first instance costs. This was primarily on the basis that it was a matter for enforcement of a costs decision and not security for costs.
 

UPC

Paris Local Division Rejects VIVO's Preliminary Objection in Sun Patent Trust SEP Case. 
[UPC_CFI_361/2025]

In Sun Patent Trust (SPT) against several companies in the VIVO group the Paris Local Division (LD) has rejected a preliminary objection filed by VIVO to dismiss the action brought by SPT.

Earlier this year, SPT brought a claim against VIVO in the LD for infringement of Standard Essential Patents (SEPs) relating to 4G+ technology. As part of that claim SPT asked for a finding: (i) of infringement; (2) that SPT has offered licence terms to VIVO which are FRAND or that the Court determines any adjustments to the licence terms offered to bring those terms into the FRAND range; and (3) if VIVO does not take a licence on FRAND terms, to issue an injunction.

In its preliminary objection VIVO argued that the UPC did not have jurisdiction to hear the claim (under R 19.1(a) RoP) because SPT’s claim includes a request for the determination of FRAND terms, which VIVO argued falls outside the subject matter of actions exhaustively listed in the UPCA as being within the competence of the UPC. SPT responded to the objection that it has not brought a separate claim for a FRAND determination. Rather it brought an action for patent infringement within Art. 32(1)(a) UPCA and the relief it seeks, including the injunction, is conditional on the Court resolving the factual and legal FRAND issues.

In its Order dated 30 October 2025 the LD agreed with SPT. The Court considered that the action brought by SPT is primarily an infringement action and that SPT had merely anticipated the FRAND defence that would be raised by VIVO. It was further noted that it has been decided already (in Panasonic v OPPO before the Mannheim LD) that a FRAND defence is within the jurisdiction of the UPC. The Court therefore concluded that it had jurisdiction to hear the FRAND issues and the objection was rejected. The LD noted, however, that the admissibility of the request for a FRAND determination is an issue for the main proceedings.

VIVO also raised a second objection about the jurisdiction of the LD to hear the action given none of the defendants are domiciled in France. SPT based the jurisdiction of the LD on the first criterion of Art 33.1(a), namely that a claim can be brought before a LD where actual or threatened infringement may occur. SPT had a made a purchase of an alleged infringing product offered by the VIVO group on a website dedicated to the French market. This was enough to demonstrate the concerns of alleged infringement in France and confirm the competence of the LD. This second objection was therefore also rejected. The costs of the preliminary objection were ordered to be dealt with as part of the main proceedings.
 

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

Episode 5: The UPC grants first anti-interim-license injunctions

Episode 6: Court of Appeal admits Apple’s intervention in confidentiality appeal

View all episodes here.