Irides: Weekly global patent litigation update

This edition features updates from: The CJEU, India, the Unified Patent Court (UPC) and Australia.

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

CJEU

Danish Court refers new questions to CJEU on interpretation of SPC Regulation. 
[Case C-262/26 Genmab v Danish Board of Appeal]

The Danish Maritime and Commercial Court (DMCC) has referred two questions to the CJEU on Art. 1(b) and 3(b) of the SPC Regulation: whether a “loose combination” of active ingredients (i.e. when the active ingredients are not formulated in a single pharmaceutical form but administered separately) can be considered a “product” under Art. 1(b) of the SPC Regulation and whether a type II variation to an existing marketing authorisation (MA) to encompass the “loose combination” can be considered a valid MA under Art. 3(b) of the SPC Regulation. 

The referral is a result of Genmab’s application for an SPC for "daratumumab, bortezomib, thalidomide and dexamethasone" based on its MA for Darzalex (daratumumab). Darzalex was first approved as a monotherapy, but in 2020 a type II variation added an indication for its use in combination with bortezomib, thalidomide and dexamethasone for a specific patient group. Each of the four active ingredients is administered separately under different dosage regimens. Both the Danish Patent and Trade Mark Office and its Board of Appeal refused the application.

As there was “reasonable doubt” as to the interpretation of the relevant provisions, the DMCC referred the following questions to the CJEU: 

1. Must Art. 1(b) and Art. 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 be interpreted as meaning that a Supplementary Protection Certificate can be granted for a product consisting of a new combination of active ingredients which has been granted a MA in combination, notwithstanding the fact that the combination of active ingredients is not contained in the same physical pharmaceutical form, but instead constitutes a loose combination of active ingredients to be administered separately?

2. If the answer to the first question is in the affirmative, can a variation of type II, within the meaning of Commission Regulation (EC) No 1234/2008 of 24 November 2008, to a MA pursuant to Directive 2001/83/ EC of a new combination of active ingredients which are not contained in the same physical pharmaceutical form, but instead constitute a loose combination of active ingredients to be administered separately, satisfy the condition laid down in Art. 3(b)?
    

India

High Court awards interim security to InterDigital in SEP Infringement against Transsion. 
[InterDigital v Shezhen Transsion]

On 1 July 2026, the High Court of Delhi granted InterDigital’s applications for pro tem security against Transsion in its SEP infringement actions, holding that an interim monetary deposit balanced the parties’ positions in light of the implementer’s asymmetric advantage pending determination of FRAND terms and liability.

The Court noted that it was relevant to consider the merits of the case but that these need not be examined as deeply as may be required when considering an application for an interim injunction. As the balance of equities between the parties is the paramount concern, only a prima facie understanding of whether the patents are valid, essential and infringed should be considered. In considering whether this has been made out in the current case, the Court’s treatment of foreign judgments is notable. Although the Court confirmed that decisions from other countries are not binding, it considered rulings from various jurisdictions on the validity and essentiality of the patents in suit supported a prima facie finding that they were valid and essential. When considering infringement the Court also considered standard conformance testing results. Here it was noted that, although the probative value of the testing results had not been established and it was open to the defendants to challenge them in the course of the case, they were sufficient for the level of examination needed at this stage. The Court also considered it to be a relevant factor that a significant number of players in the market, including those with a better bargaining position than the defendant, had taken licences and were paying royalties for the portfolio in question.

The Court emphasised that the ultimate consideration for a deposit of pro tem security was to balance equities and ensure security to the patentee and, in doing so the financial condition of the defendant was one factor, but not the only factor, to consider. Having stated that it was in a robust financial condition, the Court commented that the defendant should have “no qualms” paying a deposit at this stage. The Court noted that it could not be “fathomed” that a defendant to sell its products, continue with negotiations and technical evaluations, not provide any security, not show it was using alternative non-infringing technology and still insist that no order should be granted for pro tem security. 

The patentee had not provided any third party licence agreements but the Court confirmed that there was no mandatory requirement to do so, especially at the pro tem security stage. In the absence of any comparable licences, the Court took a practical approach to setting the amount for the security payment and used the defendant’s own counteroffer as a benchmark. It was ordered that the defendants had to provide either a cash deposit or an unconditional bank guarantee to the Court within 8 weeks.
 

UPC

Court of Appeal rejects Guardant Health’s preliminary injunction application due to unreasonable delay.
[Guardant Health, Inc.v Sophia Genetics UPC-CoA-19/2026]

In a decision dated 2 July 2026, the Court of Appeal (CoA) provided guidance on the steps a patentee should take to comply with the urgency requirement in the preliminary injunction proceedings brought by Guardant Health (Guardant) against SOPHiA Genetics’ (SOPHiA) liquid biopsy test. Bristows represented SOPHiA in these proceedings. The Paris Local Division (LD) first decision was previously reported here. 

The Court reiterated the position in Mammut v Ortovox that the decisive point in time for assessing urgency is when the applicant has, or should have had, after exercising due diligence, the necessary facts and evidence within the meaning of r.206.2(d) RoP. 

At first instance, Guardant had asserted four different patents against SOPHiA, but had only appealed in respect of one. The CoA held that the relevant question was when Guardant became aware of infringement of the patent claims subject to the appeal proceedings, not when Guardant acquired the necessary knowledge regarding the other patents asserted at first instance. The Court noted that a patent holder is not obliged to assert all patents in one application for provisional measures. If a patent holder has the necessary information for filing an application regarding some, but not all patents, delaying filing may be regarded as an unreasonable delay. Further, filing separate applications, even with very similar parties, facts and legal grounds, would be compatible with procedural efficiency and the UPC’s frontloaded system. In contrast, asserting multiple patents in a single application carries the risk that a prompt decision cannot be expected, while an application for provisional measures is characterised by the fact that a decision is required urgently.

The CoA reiterated that as a general rule a patentee is not obliged to monitor the market for infringement. However, if the patentee becomes aware of specific circumstances that suggest infringement, the patentee is expected to act with due diligence so it can take action against all alleged infringers as quickly as possible. A long-standing infringement may therefore be an indication that the patentee has turned a blind eye to the infringement. The relevant awareness needs to be somebody who by virtue of their position in the legal entity is capable of pursuing infringement proceedings or reporting it to the relevant person. This excludes employees who were not involved in evaluating intellectual property claims or who did not have an obligation to provide information to the relevant person.

In this case, the fact that Guardant had brought UK proceedings for parallel patents to those asserted in the UPC did not create a presumption that it was ready to start proceedings in the UPC. However, it was relevant that Guardant had relied on evidence of infringement in a warning letter sent in the UK on 27 May 2025, which indicated that it had been in possession of relevant information well before it started its claim in the UPC at the end of August. The Court also explained that as a general rule, a patent holder may wait a reasonable time for a response to a warning letter before drafting and lodging an application for provisional measures. However, on the facts of this case waiting for a response was not warranted given the patents the notice letter referred to were not in issue before the CoA.

Guardant had the burden of proof of showing when it became aware of infringement of the patent in suit but had only indicated in a witness statement that it was not aware before “May 2025” of technical infringement or SOPHiA’s commercial activities. Due to this, and the fact that it was clear Guardant had access to the relevant user guide in May 2025, the Court assumed Guardant was aware of technical infringement from 1 May 2025. Since the further evidence relied upon by Guardant was in the public domain, the Court held that a diligent patent holder, on the facts of this case, would have had knowledge of SOPHiA’s commercial activities by 15 May 2025 and would have been able to issue infringement proceedings shortly thereafter (as opposed to at the end of August). The appeal was therefore dismissed for lack of urgency.
 

UPC

Court of Appeal further address third party access to document.
[Huawei v Quinn. UPC‑CoA‑53/2026]

The CoA has provided helpful clarification on both the procedural route for challenging decisions on access to documents and the substantive approach to granting such access. The appeal arose from an application by Quinn Emanuel for access to pleadings in concluded infringement proceedings between Huawei and MediaTek. The Judge Rapporteur had granted access subject to redactions, a decision upheld by the Munich Local Chamber (LC). Huawei sought to challenge that outcome, arguing both that the application should not have been granted and that the procedural route adopted was incorrect.

On procedure, the CoA addressed the uncertain position under the RoP on how decisions of a Judge Rapporteur under r.262.1(b) RoP should be reviewed. It held that such decisions fall within the category of procedural decisions and are therefore subject to panel review under r.333, followed by the possibility of appeal under r.220.2-220.4. In doing so, the CoA rejected the approach taken by the Munich LC that the application for review was inadmissible, and also clarified that a direct appeal route under r.220.1 is generally inappropriate given the hybrid administrative and judicial character of access to file proceedings (starting as an administrative process but containing adversarial elements, including participation of the underlying parties).

On the merits, the CoA reaffirmed that, once proceedings have concluded, the balance will generally favour granting access to the case file. The public interest in transparency and understanding how the UPC operates will ordinarily outweigh concerns about the integrity of proceedings, which no longer arise once the case has ended.

The Court confirmed that a law firm can qualify as a member of the public for the purposes of r.262.1(b), and that general interests in professional development and improving client advice are capable of constituting a legitimate interest justifying access.

Overall, the decision confirms a relatively liberal approach to post‑termination access and reinforces the importance of transparency within the UPC system, while preserving safeguards through redaction of confidential material.
 

UPC

Court of Appeal provides guidance on orders for the production of evidence under R.190 RoP.

On 29 June 2026, the CoA handed down a decision providing guidance on the production of evidence under R.190 RoP in Polytechnik Luft- und Feuerungstechnik v Dall Energy [UPC-COA-57/2026].

The CoA considered the underlying principles under EU law and noted that the UPC’s power to order the production of evidence was “not unlimited and is subject to cumulative constraints”: 

• Firstly, such measures may only be granted on the basis of “specific and substantiated allegations and cannot serve exploratory or speculative purposes”. “Fishing expeditions” are not permitted; there must be a “concrete link” between the requested measure and the facts relied upon by the requesting party. 

• Secondly, the evidence must be strictly necessary/relevant to the issues in dispute. The Court must ensure that the measures ordered are genuinely necessary of the resolution of the dispute.

• Thirdly, the measures must be proportionate. This requires that the evidence cannot be reasonably obtained by the requesting party through less burdensome means and the burden imposed on the responding party be justified in light of the interests at stake.

• Finally, the Court must strike a fair balance between competing rights, including the protection of confidential information, trade secrets and personal data. On this point, the CoA also confirmed that strict confidentiality measures do not replace the requirement that disclosure is limited to what is strictly necessary and proportionate in scope.
   

Australia

IP Australia update Patent Manual of Practice and Procedure Process restating patentability of computer implemented inventions.

IP Australia has updated its Patent Manual to reflect the Full Federal Court's decision in Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2025] FCAFC 131 and the subsequent Public Consultation. New guidance is given on the assessment of computer-implemented inventions, which must be assessed as a whole to determine whether they provide a genuine technical contribution, rather than merely implementing an abstract idea on a computer.

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