Irides: Weekly patent litigation update

This edition features updates from: Japan, the United Kingdom (UK), the Netherlands, Canada, and the Unified Patent Court (UPC).

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.
 

JAPAN

Tokyo District Court issues a rare SEP injunction against Google in relation to Pantech's LTE Standard Essential Patents.

According to reports, the Tokyo District Court has issued a landmark decision in favour of South Korean mobile manufacturer Pantech in its patent infringement case against Google, marking a rare instance where a Japanese court has granted an injunction based on a standard-essential patent (SEP).

The case centred on Pantech’s patent, which covers a method for mapping control signals in LTE network communications, and which has been declared as essential under the ETSI IPR Policy. Pantech alleged that Google’s Pixel 7 smartphones infringed this SEP and that Google failed to engage in good-faith FRAND licensing negotiations. Specifically, Pantech asserted that Google insisted on an unnecessary non-disclosure agreement, delayed negotiations, and failed to engage meaningfully with Pantech, demonstrating “hold-out” behaviour.

The Court held that while injunctions are generally unavailable for SEPs unless the implementer is unwilling to license on FRAND terms, Google’s conduct showed it was not a willing licensee. As a result, the court granted Pantech’s request for an injunction, making it provisionally enforceable if Pantech posts a ¥10 million (approximately $68,000) bond.

The ruling is significant for being one of the few SEP injunctions granted in Japan and highlights the risk faced by implementers who do not engage meaningfully in FRAND negotiations. Google has 30 days to appeal and the company has been ordered to pay litigation costs.
 

UK

Samsung wins interim licence in the UK. The Court strongly discourages the use of aggressive multi-jurisdictional injunction tactics.

In Samsung v ZTE [2025] EWHC 1432 (Pat), handed down on the 25 June 2025, Mr Justice Mellor considered Samsung’s application for interim licence declaratory relief against the backdrop of a global dispute over the terms and proper forum for the determination of a FRAND licence covering standard essential patents (SEP) in mobile technology. Ultimately, the court granted the declarations sought by Samsung, holding ZTE in breach of its good faith obligations and deeming it an unwilling licensor/licensee if it refused to enter an interim licence subject to adjustment by the English court. The ruling strongly discourages the use of aggressive, multi-jurisdictional injunction tactics to gain leverage over forum selection.

Background

Following the expiry of an earlier cross-licence, both Samsung and ZTE sought global FRAND determinations: first Samsung in the English High Court, and then ZTE in the Chongqing Intermediate People’s Court in China. After Samsung commenced English proceedings, ZTE launched infringement actions and sought injunctions in several jurisdictions, including Germany, the UPC, Brazil, and Hangzhou. Samsung responded with its own defensive and retaliatory litigation in Europe, China, and the US.

Central to Samsung’s application was the question of whether ZTE was acting as a willing licensor in good faith, as required by the ETSI IPR Policy, and whether ZTE’s conduct justified a formal declaration by the court that an interim licence should be put in place, with its terms to be finally determined by the English court. Both parties put forward interim licence offers, but their principal disagreement was over the forum to adjust the terms of the interim licence: Samsung wanted the English court; ZTE wanted Chongqing.

The Court’s Decision

Drawing on recent appellate authority, notably Panasonic v Xiaomi and Lenovo v Ericsson, the Judge identified the key issue as what a notional willing licensor in ZTE’s position would have done after Samsung commenced the English action. Mellor J held that a genuinely willing licensor would have engaged with the English proceedings and worked towards a timely FRAND trial. ZTE’s filing of multiple claims for injunctions, by contrast, was unnecessary given Samsung’s willingness to take a licence and was instead viewed as a strategy to coerce Samsung into the Chongqing forum. This amounted to bad faith conduct.

The Court rejected ZTE’s argument that such aggressive injunction-seeking was an industry norm, warning that endorsing such tactics would undermine the FRAND framework and encourage forum shopping. The Judge made an important distinction between seeking a final injunction in FRAND proceedings - where a licensee refuses to accept court-determined terms, which is legitimate - and using multi-jurisdictional injunctions to manipulate the forum or negotiation leverage, which the court disapproved.

On the question of whether granting declaratory relief would serve a useful purpose, the Court held that it would by increasing pressure on ZTE to reconsider its stance and help focus both parties on the core FRAND issues rather than peripheral tactical litigation. The Court was realistic that ZTE might persist in its strategy but found even a modest prospect of narrowing the dispute justified granting relief.

The Judge also addressed the principle of comity, considering ZTE’s objections that the English declarations would disrespect or undermine the legitimacy of foreign proceedings, particularly in China. He rejected these arguments, noting that the English proceedings were properly before the Court, that ZTE had accepted jurisdiction, and that the declarations would not interfere with other courts’ functions. In fact, such declarations could help promote international comity by potentially reducing duplicative global litigation. Mellor J also warned that siding with ZTE would set a dangerous precedent, enabling SEP licensors to force implementers into their preferred forum through litigation threats and conditional interim offers, thereby distorting the balance at the heart of the FRAND regime.

Ultimately, the Court granted Samsung’s declarations, holding ZTE in breach of its good faith obligations and deeming it an unwilling licensor/licensee if it refused to enter an interim licence subject to adjustment by the English Court. In doing so, the Court acknowledged that a possible unintended consequence of the decision is that it heightens the significance of the court first seised of a claim to determine FRAND terms, echoing concerns by Arnold LJ in Nokia v Oppo. Mellor J observed that this outcome was a product of the current legal landscape, and underscored the pressing need for ETSI and other standard-setting organisations to consider implementing clear dispute resolution mechanisms in their rules.
 

NETHERLANDS

District Court of the Hague upholds enzalutamide patent.

On 18 June 2025, the District Court of the Hague handed down its judgment in joined cases Accord Healthcare v The Regents of the University of California and Astellas Pharma; and Sandoz AG v The Regents of the University of California and Astellas Pharma. The Court found that EP 1 893 196 B2 (EP 196) was not obvious. This follows findings of validity in relation to the same patent from the German Federal Patent Court and the UK High Court (previously reported here).

EP 196 claims the compound enzalutamide for the treatment of hormone refractory prostate cancer. The Claimants in the proceedings relied on two pieces of prior art from the inventors of EP 196 in challenging the validity of the patent. This prior art disclosed a compound, RD162, which differed from the claimed compound, RD162’ (enzalutamide), in that the cyclobutyl group in the central thiahydantoin ring in RD162 is replaced with a dimethyl group in RD162’. The Claimants argued that the skilled person would, by a process of negative elimination, and without any inventive thinking, substitute the cyclobutyl group with a dimethyl group.

In assessing the Claimants’ arguments, the Court set out that these were based on hindsight. Assessing inventive step using the ‘could-would approach’ is not about whether the skilled person could have carried out the invention but whether he/she would have done so in the expectation of solving the underlying technical problem or in the expectation of some advantage.

The Court ruled that it would be clear from the prior art (due to the fact that the cyclobutyl group had remained fixed in various iterations of the compound, with changes being made at other positions in the compound) that this compound had been optimised during research into a potent androgen receptor antagonist. Therefore, the skilled person would conclude that the cyclobutyl group is optimal and see no reason to substitute a dimethyl group at the relevant position. This was particularly so given that this part of the structure of the compound is responsible for binding the androgen receptor. Further, one of the prior art compounds incorporated a dimethyl group at the relevant position and this was shown to be inferior, and the skilled person would conclude that the researchers had deliberately modified the dimethyl group to a cyclobutyl one for drug design reasons.

Overall, the Court found that the Claimants’ arguments wrongly placed focus on substituting the group at the relevant position from cyclobutyl into a dimethyl. The average skilled person would have no reason to make changes at this position in the sense that he/she ‘would’ change the fixed cyclobutyl into a dimethyl. The fact that he/she ‘could’ have changed this group was stressed not to be the relevant test.
 

CANADA

Health Canada’s consultation on biosimilar drug regulation: major changes for market access and patent litigation.

On 10 June 2025, the Canadian regulatory authority Health Canada (HC) launched a public consultation on significant revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (the guidance). If adopted, these changes would make it much quicker and less costly for companies to bring biosimilar biologic drugs (biosimilars) to market in Canada and could mean that related patent disputes happen sooner than before.

What are biosimilars?

Biosimilars are follow-on versions of complex medicines made from living cells (biologics). They offer patients a comparable option to generic drugs, but while generics are identical copies of simple chemical drugs, biosimilars are only highly similar to the original biologic. Bringing a biosimilar to market is currently more complicated and expensive than launching a typical generic drug.

What is the current process for approving biosimilars?

At present, HC generally requires manufacturers to run large “phase 3” clinical trials before approving a biosimilar. These trials can involve hundreds or even thousands of patients, comparing the biosimilar with the original drug to make sure they have comparable (i.e. highly similar) efficacy and safety. These studies are time-consuming and costly. Sometimes, if there’s a clear and measurable effect of the drug on the body (a “pharmacodynamic endpoint”), and the manufacturer can justify it, these lengthy and costly trials can be skipped but this is the exception, not the rule.

What is changing?

The new guidance proposes that, in most cases, phase 3 trials will no longer be required. Instead, companies would only need to show that the biosimilar behaves the same way in the body as the original drug. This would be done through a smaller, faster study called a comparative pharmacokinetic (PK) study. As before, safety and immune response (immunogenicity) would still be checked, and sometimes additional studies would look at specific effects on the body (pharmacodynamics). In rare cases, a larger trial may still be required, but only if HC feels it is necessary.

This move brings HC’s proposed approach into closer alignment with the direction of travel at the European Medicines Agency (EMA), which recently published a reflection paper supporting approval of biosimilars without routine clinical efficacy trials (where similar clinical efficacy and safety can be inferred without the need for comparative clinical trials).

Why does this matter for patent litigation?

Because companies could apply for approval to market their biosimilars sooner (without waiting for a lengthy phase 3 trial to conclude) if the proposals are adopted, this could also trigger any related patent disputes earlier under Canada’s Patented Medicines Notice of Compliance (PMNOC) Regulations. In Canada, applying to market a biosimilar often starts the clock for patent litigation with the originator drug company.

Other proposed changes

Other proposed changes in the guidance include:

• The draft clarifies how short protein drugs (polypeptides) will be classified, depending on how they are made. If a polypeptide is made using living cells through recombinant DNA technology, it will be considered a biologic drug and can be approved as a biosimilar. But if the same polypeptide is made by chemical synthesis in a lab (not using living cells), it will be treated as a regular pharmaceutical and can be approved as a generic drug through the simpler generic approval pathway.
• Biosimilar companies would be able to automatically receive approval for all the same medical uses (indications) as the original drug, without having to provide a separate scientific justification for each one.

HC is accepting feedback on these proposals until 8 September 2025. Anyone interested in the future of medicines and patent disputes in Canada may want to have their say.
 

UPC

Court of Appeal refuses Alexion’s request for a rehearing based on a fundamental procedural default. 
[UPC_CoA_402/2024]

Following the Court of Appeal’s rejection of Alexion’s PI applications against Samsung and Amgen, Alexion filed a request for a rehearing based on a fundamental procedural defect pursuant to Art. 81(1)(b) UPCA and r. 247(c) RoP. This was on the basis that the Court of Appeal had applied a new standard for claim interpretation without providing an opportunity for Alexion to be heard, and had based its decision on incorrect facts. The decision can be accessed here.

The Court stressed that Art. 81(1) UPCA makes clear that a rehearing may only exceptionally be granted in cases of a criminal offence or fundamental procedural defect. The procedural defect must be so fundamental that it is intolerable for the legal system, and must override the principle that proceedings which have led to a final decision (i.e. a decision of the Court of Appeal) should not be re-opened in the interest of legal certainty. Furthermore, a defect may only be considered fundamental if it can be established that without the defect the same decision would not have been taken (and the applicant has the burden to show this).

In relation to Alexion’s arguments regarding the deficiency of the Court of Appeal decision (which are not outlined in detail in the decision on the application), the Court stressed that the parties are expected to have knowledge of case law of the Technical Boards of Appeal and the Enlarged Board of Appeal of the European Patent Office relevant for the issues at hand and the arguments advanced.

Further, the right to be heard, which is reflected in Art. 76(2) UPCA, does not dictate that the parties must have had the opportunity to provide comments in writing, nor does this provision require that the Court notifies the parties in advance in the form of a preliminary opinion on any issue in dispute.

Overall, it was not considered by the Court that the order under review suffered from a fundamental procedural defect in the sense of Art. 81(1) UPCA. In essence, Alexion did not agree with the conclusions drawn by the Court. However, a mere disagreement regarding the reasoning and considerations by the Court does not constitute grounds for a rehearing. 
 

UPC

Court of Appeal rules that Claimants cannot seek security for costs at the UPC. 
[UPC_CoA_393/2025]

A decision from the Court of Appeal in AorticLab v Emboline , issued on 20 June 2025, provides important clarification on the availability of security for costs under the UPC framework.

This decision establishes a clear precedent: under the UPCA, security for costs under Art. 69(4) UPCA may only be requested by defendants. Procedural mechanisms cannot be used by a claimant to circumvent this limitation, and this limitation is unchanged by a defendant filing a counterclaim for revocation.

The Court emphasised that under the UPCA and RoP a defendant is not allowed to bring forward an invalidity defence without at the same time lodging a separate counterclaim for revocation.

The case arose from an infringement action initiated by Emboline against AorticLab concerning EP 2 129 425, relating to an embolic protection device. In the course of the proceedings, Emboline requested an order requiring AorticLab to provide security for costs, citing concerns over AorticLab’s financial stability and the risk of insolvency should an injunction be granted. AorticLab responded with a counterclaim for revocation and challenged the admissibility of the request, arguing that under Art. 69(4) UPCA, only a defendant may request such a measure.

The Munich Local Division initially granted the security request in the amount of €200,000, prompting an appeal by AorticLab. On appeal, the Court of Appeal focused on the interpretation of Art. 69(4) UPCA and r. 158 RoP. It found that the right to request security for costs is deliberately limited to defendants in Art. 69(4). Unlike earlier paragraphs of Art. 69, which refer generally to parties, paragraph 4 specifically names the defendant as the party entitled to make such a request. This limitation was deemed intentional, aligning with the underlying rationale of protecting defendants from the risk of an insolvent claimant initiating litigation without sufficient resources to cover potential costs.

Although r. 158 RoP uses broader wording by referring to “a party,” the Court stressed that the UPCA takes precedence in the event of a conflict between the two.

The Court also dismissed the suggestion that Emboline’s dual role as claimant in the infringement action and defendant in the revocation counterclaim could justify the security request. It emphasised that the counterclaim was a direct and necessary response to the infringement action and did not transform AorticLab into the initiating party in the proceedings. Since the revocation action is procedurally required for a validity challenge by way of defence under the UPCA system, allowing a claimant to seek security from a defendant in such circumstances would place an unreasonable and disproportionate burden on the defendant’s ability to mount a defence.

Accordingly, the Court set aside the Munich Local Division’s order and dismissed Emboline’s application for security for costs as inadmissible.
 

UPC

Munich Local Division confirms broad jurisdiction in multi-Defendant infringement action. 
[UPC_CFI_149/2024].

In a decision issued on 20 June 2025, the Munich Local Division ruled on jurisdictional objections raised by all 4 active defendants in a patent infringement case brought by Headwater Research LLC concerning European Patent EP 3 110 069. The defendants included 3 Motorola entities (Defendants 1 to 3): Motorola Mobility LLC, Motorola International Sales LLC, and Motorola Mobility Germany GmbH, and Flextronics International Europe B.V. (Defendant 5), which was named as a logistics partner allegedly involved in distributing the infringing devices across Europe.

Defendants 1 and 2, both US-based, objected to the jurisdiction of the Munich Local Division under r. 19.1 RoP. However, the Court dismissed their objections as inadmissible on procedural grounds. The objections were filed one day after the expiry of the one-month deadline following service of the statement of claim. The Court clarified that service rules for non-EU defendants do not allow for presumed delayed service dates and confirmed that the actual date of service, not the date displayed by the Court’s case management system, controls the deadline.

Defendant 3, based in Germany, also challenged jurisdiction, asserting that the requirements under Art. 33(1)(b) UPCA were not satisfied. The company argued that Headwater had not adequately alleged any specific acts of infringement or shown that it was meaningfully involved in the sale or distribution of the accused products. The Court rejected these arguments. It held that Defendant 3’s registered office in Germany was sufficient to establish jurisdiction under Art. 33(1)(b) sentence 1 UPCA. The Court also accepted the Claimant’s argument that there was a business relationship, within the meaning of Art. 33 1(b) sentence 2 UPCA, between Defendants 1 to 3, as Defendant 3 operated as the German distribution subsidiary and participated in the distribution of the accused Motorola devices, which was sufficient at this stage of the proceedings.

Defendant 5, based in the Netherlands, raised a more complex jurisdictional objection. It contended that it had no direct role in sales to Germany, lacked a relevant business relationship with Defendant 3, and merely operated as a holding company. The Court, however, found these arguments unpersuasive. It held that jurisdiction existed under both Art. 33(1)(a) and 33(1)(b) UPCA. Under Art. 33(1)(a), Headwater’s allegation that Flextronics delivered a sample of an infringing Motorola device into Germany was accepted as sufficient at the jurisdictional stage, even if Flextronics disputed the facts. Under Art. 33(1)(b), the Court found a qualifying business relationship between Flextronics and the Motorola defendants based on their shared commercial operations in the distribution of the accused devices, noting that the threshold for such a relationship should not be interpreted too narrowly in light of the UPC's objectives of procedural efficiency and avoiding contradictory judgments.

The Court also addressed Headwater’s procedural shift in legal argumentation. While Headwater initially relied only on Art. 33(1)(b) to establish jurisdiction, it later invoked Art. 33(1)(a) in response to the jurisdictional challenges. The Court accepted this additional legal basis, citing the principle of iura novit curia (the Court knows the law) and confirming that legal arguments can be supplemented after the filing of the statement of claim, particularly when they respond to objections and rely on the same factual foundation.

In dismissing all jurisdictional objections, the Court emphasised the importance of adjudicating the infringement claims in a single, consolidated proceeding. It noted that any attempt to exclude Flextronics or the foreign Motorola entities would fragment the case, cause procedural inefficiencies, and risk inconsistent outcomes. This decision allows the proceedings to continue on the merits against all defendants.