Irides: Weekly patent litigation update

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

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

UK

UK High Court grants Amazon an ex-parte AASI injunction against InterDigital.

On 21 October, Mr Justice Meade granted an ex parte interim Anti-Anti-Suit Injunction (AASI) in the Amazon v InterDigital proceedings, until a further hearing (the return date) when both parties will be heard, which will take place by 30 October 2025. The AASI prevents InterDigital, temporarily at least, from seeking any measures restraining Amazon from pursuing final relief in the UK proceedings, including from interfering with Amazon’s request for a declaration as to what reasonable licence terms for InterDigital’s patent portfolio would be.

The application was brought by Amazon against the backdrop of the recent Anti-Interim Licence Injunctions (ASIs) granted by the German Regional Court and UPC (previously reported here). Following the grant of that ASI relief, Amazon made clear that it is no longer seeking any interim licence relief in the UK. However, the Court considered that subsequent evidence put forward by InterDigital appeared to imply that pursuit of final relief in the UK proceedings would undermine the German and UPC proceedings, which in turn could indicate that it might make further ex parte applications to the foreign courts to restrain that final relief.

The Judge considered it was seriously arguable that a further anti-suit injunction if brought by InterDigital, would block the heart of the UK proceedings (determination of RAND terms of a final RAND licence, whether Amazon is entitled to such a licence and the availability of specific performance) and so undermine the Court’s jurisdiction, particularly in circumstances where there are currently no other proceedings where these issues could be determined. He further considered InterDigital’s behaviour might arguably be said to be vexatious or oppressive in that having previously stated to the UK Court that final RAND relief was not blocked by the current German and UPC ASIs,  it subsequently adduced evidence in the context of Amazon’s expedition application for the main proceedings which implied that expedited final UK relief might interfere with the foreign proceedings in which the ASIs had been granted.

The Judge made it clear though that: (i) the AASI relief in the UK is not intended to criticise or impact upon the ASIs previously granted by the German and UPC Courts (the interim licence aspects of the UK claim having been explicitly carved out of the ambit of its AASI Order); (ii) “absolutely nothing arising from any order [made] should be understood as hostile to the UPC or Munich court”; and (iii) the order is such that “it provides no interference at all with proceedings in the UPC or in the German national courts”. Rather, the AASI is granted for the short period until the inter partes return date and is directed specifically at InterDigital, rather than the foreign courts, to “preserve the position from what … would be an exceptionally disruptive application by InterDigital”.
 

NETHERLANDS 

District Court of The Hague upholds ruling of Dutch IPO to refuse an Supplementary Protection Certificate for durvalumab.

On 15 October 2025, the Administrative Division of the District Court of The Hague issued a ruling upholding the Dutch IPO’s decision not to grant an Supplementary Protection Certificate (SPC) for durvalumab on the basis of lack of compliance with Art. 3(a) of the SPC Regulation.  

Dana Farber Cancer Institute (DFCI) was the owner of EP 1 210 428 (EP 428) which, very broadly speaking, is to the use of PD-L1 antibodies to modulate the immune response and methods for making such antibodies.   As is well known, several PD-L1 antibodies have been approved for the use of immunotherapy as a treatment for certain types of cancer.  One such antibody is durvalumab sold as the active ingredient in Imfinzi® by AstraZeneca and used to treat certain cancers including non-small cell lung cancer and small cell lung cancer.  DFCI sought an SPC for durvalumab based on the 428 patent and the MA for Imfinzi which enabled durvalumab to be marketed as a medicinal product.  The 428 patent only includes functionally defined claims and teaches how to generate anti-PD-L1 antibodies generally, but durvalumab is not disclosed anywhere in the specification.  The Dutch IPO held that durvalumab was not “protected by a basic patent in force” for the purposes of Art. 3(a) of the SPC Regulation and the Court of The Hague agreed.  The Court took as its basis for interpreting Art. 3(a) the relatively recent rulings of the CJEU in Teva v Gilead (C-121/17); Royalty Pharma (C-650/17) and Teva v Clonmel (C-119/22 and C-149/22).   From these cases, the Court derived a two-stage test for the examination of Art. 3(a): (i) does the product fall under the invention of the basic patent? and (ii) is the product either expressly mentioned in the claims of the patent or is it specifically identifiable?   The Court further opined, relying on Royalty Pharma,  that if a product is the subject of a later patent which has involved an independent inventive step, this indicates lack of compliance with Art. 3(a).

Notwithstanding that a corresponding SPC had been granted in the UK, Ireland, Austria, Cyprus, Italy, Denmark, Luxembourg  Germany, Hungary and Poland, the Dutch Court held that durvalumab was not specifically identifiable in EP 428 and that the development of durvalumab had involved an independent inventive step resulting in a patent to a third party which was applied for almost a decade after EP 428.  The Court noted that there were no pointers to producing durvalumab in the specification, which meant that if the skilled person used the disclosed techniques to generate antibodies, they could arrive at other anti-PD-L1 antibodies with different properties (e.g. atezolizumab, avelumab).   Moreover, the Court seemed to be particularly influenced by the fact that it took researchers at AstraZeneca several years to invent durvalumab and that skill and judgement had to be exercised by the AZ team along the way.  

The above decision is one of several decisions on third party SPCs for PD-L1 antibodies from national courts within the European Union which show the ongoing uncertainty surrounding the interpretation of Art. 3(a).   The current draft of the revised SPC Regulation prohibits the granting of SPCs to patentees based on third party MAs without the consent of the MA holder.  This would go a long way to resolving the current issues on Art. 3(a).  However the revised SPC Regulation appears, for the moment at least, to be stuck in the legislative organs of the EU and there is not much clarity on the timing of its implementation or its ultimate content.
 

UPC

UPC grants permanent long arm injunction 
(UPC_CFI_386/2024).

On 10 October 2025, the Local Division of the Hague upheld the validity of HL Display AB's patent for shelf dividers and found Black Sheep Retail Products B.V. (BSRP) had directly and indirectly infringed the patent.

Validity and infringement

Noting that the description and drawings do not generally limit the subject-matter of the claimed invention, the Court held that BSRP had not shown any special circumstances to add features to the claim wording from the description and drawings. Along with its arguments for a narrow claim construction, BSRP's added matter attack (that certain features omitted from the claim were inextricably linked to other features within the claim) also failed.

Following the lead of both parties, the Court applied the problem solution approach to considering inventive step. On that basis, as the prior art did not disclose a system for preventing the rear end of a shelving accessory from being accidentally disengaged, the patent was found to inventively solve the problem of providing a shelving system in which an accessory is more securely fixed to a shelf, whilst also allowing for simple release and repositioning.

BSRP's non-infringement arguments were also dismissed. When its shelf accessory and rear securing device were sold together, it was held to constitute direct infringement despite not being sold in an assembled state, as the system claimed by the patent was being sold. When each component was sold separately, this was indirect infringement as each were found to be means relating to essential elements of the invention.

Counterclaim for non-infringement

BSRP had developed a second product consisting of the rear securing device sold with a new accessory (or the new accessory alone). However, their counterclaim for a declaration of non-infringement for this revised product was held to be inadmissible - there was no assertion by the patentee of infringement prior to BSRP instituting the counterclaim, nor had the defendant applied in writing to the proprietor for an acknowledgement to the effect of the declaration claimed under R. 61.1 RoP. The Court did not infer any assertion of infringement from the mere fact that the patent had been asserted against BSRP's un-modified product. In terms of substance, however, the Court did not include BSRP's second product within the scope of its injunction (see below).

Jurisdiction and scope of the decision

There were no prior or pending proceedings relating to the patent before the UPC or any national court or authority, and the defendant was domiciled in the Netherlands. Following BSH v Electrolux, the Court applied long arm jurisdiction to countries outside the UPC Territory where the patent was in force: Liechtenstein, Ireland, Norway, Poland, Switzerland and the United Kingdom.

The defendant's counterclaim for revocation only pertained to the Contracting Member States (CMS), and was asserted as a defence for the non-CMS. For the EU member states in which the patent was in force that were Lugano member states but were not UPC CMS, the Court found there was no serious, non-negligible chance that the patent would be revoked by the competent national court. Therefore, for both these states, and the non-CMS that were not Lugano member states where the patent was in force, the Court held inter partes that the patent is valid. As infringement was found, the Court ordered a final injunction in all territories where the patent was in force.
 

UPC

Paris Central Division finds further Edwards patent valid and infringed in ongoing dispute with Meril 
(UPC_CFI_189/2024).

The Paris Central Division has dismissed a revocation action brought by Meril Life Sciences against EP 4 141 181 (the Patent) owned by Edwards Lifesciences Corporation, but upheld Edwards’ counterclaim that the Patent was infringed by Meril’s ‘Octacor’ and ‘Octapro’ systems. This is part of a long running dispute between the companies; a related patent was upheld by the Paris central division on 19 July 2024, which on 15 November 2024, the Munich local division found was infringed by Meril (previously reported here).

When considering validity the Court found that the claims as granted added matter and Auxiliary Request 1 was not novel, but upheld the Patent on the basis of Auxiliary Request 2.  Of note is that when assessing inventive step, the Court took the approach of: (1) identifying the objective problem underlying the claimed invention; (2) identifying the state of the art at the time of the invention; and (3) considering whether it would have been obvious to the person skilled in the art to arrive at the claimed solution. The Court held that when assessing inventive step, the Court should take a “holistic approach” rather than just focussing upon isolated distinguishing features.

On infringement, the Court found that Meril’s ‘Octacor’ and ‘Octapro’ systems literally infringed several claims of Auxiliary Request 2. When considering the Court’s discretion to grant an injunction, the Court recognised there was a public interest in excluding from the injunction Meril’s XL-size valves (over 30 mm) for which no alternative products were available on the market.

In contrast to the earlier parallel dispute before the Munich Local Division noted above, the exclusion from the injunction was not subject to clinicians applying for an exemption from Edwards via Edwards’ Medical Request Portal. The Court commented that such pre-authorisation made utilisation by doctors more cumbersome and gave Edwards an inappropriate power of scrutiny over the evaluations by physicians. Instead, the Court held that the public interest is satisfied by the free production and commercialisation of the XL-size valves.
 

UPC

Occlutech obtains preliminary injunction against Lepu 
(UPC_CFI_553/2025). 

On 21 October 2025, the Hamburg Local Division granted a Preliminary Injunction (PI) in Occlutech v Lepu on the basis of Occlutech's patent for a braided occlusion device, EP 2 387 951. Of particular interest are the Court’s findings on imminent infringement, urgency and the balance of interests between the parties.

Imminent Infringement

The Court noted that in Boehringer/Zentiva the Court of Appeal held that whether there is an imminent infringement must be decided on a case-by-case basis considering whether the potential infringer has “set the stage” for the infringement to occur (previously reported here).

In Boehringer the grant of a marketing authorisation to a generics company alone was held not amount to an imminent infringement. However, completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement.

The Court noted that it was relevant that a medical device may be placed on the market anywhere in the EU as soon as it has obtained its CE-mark. This is in contrast to generic drugs which require certain national procedures to be completed after a marketing authorisation is granted before such drugs can be placed on the market. Therefore, the combination of Lepu obtaining CE-mark approval for its products, its announcement that it would showcase its products at a trade fair and its active and constant presence at key medical conferences was sufficient to “set the stage” to market its products and therefore establish the threat of imminent infringement.

Urgency

The Court held that when assessing whether the applicant has acted with sufficient speed, the relevant point in time is when the threat of infringement was imminent. In this case, this was when the CE-mark was obtained for Lepu’s products as prior to this Lepu’s product could not be sold in the European Union. The argument that Occlutech could have potentially assessed product features based on a product catalogue before the CE-mark was obtained was considered irrelevant.

Weighing of interests

When considering the balance of interests of the parties, the Court found that there was a reasonable potential for significant harm to Occlutech, justifying the PI. As a result of the parties being direct competitors in the field of occlusion devices, the Court considered that it was likely that the introduction of Lepu’s device would adversely affect Occlutech’s sales opportunities. Further, Occlutech had argued that Lepu would likely offer its product at a significantly lower price leading to price erosion, which Lepu had not sufficiently substantiated was incorrect. 
 

UPC

Court of Appeal Clarifies Penalty Rule in Kodak v. Fujifilm
(UPC_CoA_699/2025).

On  14 October 2025, the UPC Court of Appeal addressed an appeal by Kodak against penalty orders issued by the Mannheim Local Division in an infringement action brought by Fujifilm concerning EP 3 511 174.

In its decision the Court gave extensive guidance on the system of penalties under R. 354 RoP. Of note were:

• Penalty orders may be issued separately after the main decision (even if they had previously not been requested or had been refused) and do not require an appeal against the original decision.
• The amount of any penalty must be set by the Court at an amount which is sufficiently deterrent to be coercive, but also proportionate, considering the importance of the order in question.
• The Court should generally specify when and under what conditions the penalty is due. In the extraordinary situation when a compliance period is not provided for in the penalty order, the claimant must set one. At this point the defendant can object and, if the parties cannot agree, it will be decided by the Court.
• An order to pay any penalty sum under R. 354.4 RoP must be based on a prior penalty order from the Court. Thus a claimant alleging a defendant has not complied (or not complied in a timely manner) with an order from the Court must request the Court who made such order, to make a further order for the defendant to pay the penalty sum.
• The burden of proof for compliance with any penalty order lies with the defendant, and evidence requirements may include verification by independent professionals.
   

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