Irides: Weekly global patent litigation update

This edition features updates from: the Unified Patent Court (UPC), the United States of America (USA) and Canada.

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

UPC - STOP PRESS

Paris Local Division rejects Guardant Health’s application for a Preliminary injunction on SOPHiA GENETICS’ liquid biopsy test.

In August 2025, Guardant Health (a US based cancer diagnostics company) filed an application for provisional measures based on alleged infringement of four of its patents by SOPHiA GENETICS’ liquid biopsy test.

Today, the Paris Local division has rejected Guardant’s application. This is on the basis that the patents at issue had not been demonstrated with sufficient certainty to be valid due to the existence of added matter and/or had not been demonstrated with sufficient certainty to be infringed by SOPHiA.

Bristows represented SOPHiA GENETICS before the Paris Local Division. A full write up of this decision will follow in next week’s Irides update.
 

USA

Federal Circuit Court of Appeal grant Onesta emergency stay of Preliminary Injunction.

On 22 December 2025, we reported that Judge Albright of the US District Court for the Western District of Texas (TXDC) granted BMW a Temporary Restraining Order (TRO) against Onesta, preventing it from pursuing or enforcing any injunctions from a foreign Court that would: (i) interfere with the ability of the US Court to adjudicate BMW's declaration of non-infringement claim brought before the TXDC concerning the same patents, or (ii) limit BMW's actions in relation to its products in the US on the basis of Onesta's US patents. The injunction was granted in the light of Onesta’s action against BMW in the Munich Regional Court alleging infringement of one EP and two US patents, and relying upon BMW’s establishment in the EU to confer a long-arm jurisdiction arising from the CJEU’s decision in BSH v Electrolux.

On 13 January 2026, the TXDC orally granted BMW’s request for an Anti-Suit Injunction (ASI) ordering Onesta to withdraw its claims in respect of the US patents in the Munich Court. Onesta queried whether the oral decision had to be implemented immediately and the Court clarified that it would provide an opportunity for Onesta to request an emergency stay from the Federal Circuit. Onesta filed its first motion for such a stay that evening.

The next day, however, on 14 January 2026, the Federal Circuit (FC) denied Onesta’s motion for a temporary stay without prejudice. This was followed on 15 January 2026, by the TXDC issuing a written order confirming that the oral order of 13 January was meant to take immediate effect. Given that Onesta had failed in its attempt to obtain an emergency stay, BMW issued an application for contempt of court. Meanwhile Onesta made a renewed application for an emergency stay.

On 16 January 2026, the FC granted that emergency stay. The Order also gave Onesta seven days from the date of the DC’s written decision granting the ASI to file its substantive appeal, with BMW having seven days to file its response. Given the imposition of the emergency stay, BMW withdrew its contempt application on 20 January 2026. It remains to be seen when or how the FC will consider Onesta’s expedited appeal as to the substance of Judge Albright’s decision and/or whether the German Regional Court will have anything to say about the US ASI in the meantime. 

USA

Supreme Court to hear questions on generic carve outs and induced patent infringement.

On 16 January 2026, the US Supreme Court (SC) agreed to hear an appeal concerning carve outs from generic labels and induced patent infringement. The appeal has arisen from a dispute between Amarin Pharma and Hikma Pharmaceuticals.  

Amarin's originator product Vascepa (which contains the active ingredient icosapent) is approved for two indications (i) to reduce the risk of certain cardiovascular events; and (ii) to reduce triglyceride levels in patients with Severe Hypertriglyceridemia (SH). Amarin holds a medical use patent which covers the use of icosapent in the first of these indications, namely to reduce the risk of certain cardiovascular events. In contrast, Hikma's generic icosapent product is approved for the treatment of SH only. Hikma's product therefore has a “skinny label”, as the cardiovascular risk indication (the patented indication) is carved out. Amarin alleged induced infringement of its medical use patent on the basis that Hikma had been referring to its product as a "generic version" of Vascepa and quoting Vascepa's publicly available sales figures.  

In the lower Courts, the District Court of Delaware had dismissed Amarin's infringement complaint in view of Hikma's carve out from its label, but the Federal Circuit reversed that decision. As a result, Hikma filed a petition for a writ of certiorari at the SC, asking it to consider the following questions:  

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?

2. Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use? 

Before the case was accepted by the SC, amicus curiae briefs were filed by a group referred to as "30 Scholars of Law, Economics, and Medicine", the Association for Accessible Medicines and the Solicitor General on behalf of the United States, indicating interest from various stakeholders.  Now that the SC has accepted the case, it will proceed to the merits briefs.  
 

UPC

Düsseldorf Local Division dismisses Ona Patents SL’s infringement action against Google.
[UPC_CFI_100/2024,  UPC_CFI_411/2024]

On 15 January 2026, the Düsseldorf Local Division (LD) handed down its decision dismissing Ona Patents SL’s (Ona) infringement action against Google Ireland Limited and Google Commerce Limited (together, Google) while simultaneously upholding the patent’s validity by dismissing Google’s counterclaim for revocation. The proceedings also considered the question as to the correct party to a revocation action where entitlement is in dispute and late-filed pleading amendments.

Ona filed a claim for infringement of EP 2 263 098 (EP 098), which relates to location pairing technology, commonly used to pair and locate accessories such as headphones via a smartphone or tablet. Ona alleged direct infringement of EP 098 by Google’s smartphones and tablets bearing pre-installed Android operating systems which included the location tools “Google Location Service” or “Google Location Accuracy”. After written submissions were concluded and the oral hearing had been scheduled, however, Ona sought to introduce to its claim allegations of indirect infringement based on the combination of the targeted Google devices with accessories such as headphones or controllers.

The Court, however, refused to entertain the late filed allegations. The LD made it clear that the front-loaded system of the UPC requires that all allegations must be presented in the Statement of Claim so that they can be answered by the Defendant and may only be admitted later without some justification, which was not the case in these proceedings.

Under Art. 25 UPCA, for direct infringement to be proven, it must be shown that every claimed feature is present in the alleged infringing product. The relevant claims of EP 098 require that a positioning engine, including a different means, data model and controller, is present. Without the controller, which is located on the accessory, i.e. headphones, there can be no claim for direct infringement. The infringement claim was therefore dismissed.

Although validity was ultimately not decisive in these proceedings, the LD also considered the Defendant’s counter-claim to revoke the patent, concluding it was not made out on the basis of the prior art and arguments made. The Court also considered issues of entitlement in circumstances where the chain of ownership of the patent was not straightforward and had evolved during the course of the proceedings. While the point was largely academic given the substance of the infringement and invalidity findings, the Court noted that as a starting point a claimant (or counter claimant) is entitled to take the details included on the official patent register at face value. 
 

UPC

Paris Local Division declines jurisdiction to rule on infringement of the Swiss national patent
[UPC_CFI_702/2024, UPC_CFI_369/2025]

In a decision handed down on 16 January 2026, the LD upheld IMC Creations’ (IMC) patent as valid in amended form and infringed by Mul-T-Lock’s MVP1000 padlock in the UPC territory, but not in Switzerland.

The dispute concerned IMC's European patent (which acquired unitary effect from 1 November 2023) relating to a single-sole security lock. The European patent is also in effect in the UK, Spain and Switzerland. Mul-T-Lock manufactures and markets the MPV1000 padlock, which IMC alleges infringes claims 1 and 6 of the unitary patent (as amended), and claims 1, 2 and 7 the Swiss part of its European patent as granted.

IMC argued the international jurisdiction of the LD extended to infringement proceedings relating to a national patent granted in a state bound by the Lugano Convention, as this contains similar provisions to the Brussels I Bis Regulation. It cited an earlier decision of the LD (UPC_CFI_355/2023), in which the panel did not exclude the possibility that UPC decisions may have effect beyond the territory of the UPC contracting states. Mul-T-Lock argued that infringement of a national part of a patent is governed by national law, and therefore the claim in relation to the Swiss designation must be dismissed because IMC had not pleaded infringement under Swiss law. It also argued that patent validity is a prerequisite for a finding of infringement, and the Swiss designation as granted is likely to be declared invalid because IMC had amended the claims of the unitary patent in response to an inventive step attack.

Referring to the CJEU’s decision in BSH-Electrolux, the panel held that the UPC does not have jurisdiction to assess the validity of a national patent granted by a non-UPC state. However, the UPC does have jurisdiction to hear actions for infringement of a patent granted by an EU or Lugano Convention state, unless there is a reasonable risk that the patent will be revoked nationally. In such cases the UPC must stay proceedings until the national court has ruled on validity.

On the facts, the panel agreed that the claim amendments made to the unitary patent left ‘serious doubt’ as to the validity of the Swiss patent as granted, which constituted a reasonable risk that the Swiss patent would be revoked. It was incumbent on IMC to take steps to amend the Swiss patent, where appropriate. As no national validity proceedings were pending, the panel could not stay the case. Therefore, the infringement claim relating to the Swiss designation was dismissed.

The panel upheld the unitary patent as valid in amended form and found Mul-T-Lock’s MPV1000 padlock infringed amended claims 1 and 7 on a literal interpretation. Regarding the effective date of the claim amendments, the court confirmed that under Art. 64(1) and 68 EPC, and Art. 4(1) of Regulation 1257/2012, claim amendments take effect retroactively from the date of grant. The court ordered an injunction including the delivery up and destruction of all MPV1000 products in France (the sole UPC state where the unitary patent has effect).

This decision indicates a reluctance from the UPC to rule on the infringement of national patents in non-UPC states where there is a reasonable risk the patent may be revoked. Any claim amendments sought in UPC proceedings that are not mirrored in the national designations may be indicative in assessing whether a national patent faces a reasonable risk of invalidity.

UPC

Medical Devices must align with Professional Standards to Constitute Patent Infringement.
[UPC_CFI_628/2024, UPC_CFI_125/2025]

On 13 January 2026, the Munich LD dismissed Emboline's infringement action against AorticLab with respect to its embolic protection medical device. In doing so, the LD held that, for medical devices, use of a device that differs from the manufacturer's intended operation only constitutes infringement if such use is in line with professional medical practice and the recognised rules of medical science.  

Emboline asserted EP 2 129 425 (EP 425) against AorticLab with respect to AorticLab's FLOWer embolic protection device. Such devices are used during vascular procedures to catch plaques or debris released into the bloodstream of the patient, thereby preventing downstream blockages which can lead to a stroke or a heart attack.  

The LD first addressed claim construction. EP 425 teaches that, amongst other features, the device can be retrieved from the patient after the need for it has passed. To achieve this, the claim specifies that the device is engageable by a hook on the distal end (to enable retrieval). Emboline argued that this feature only requires some type of graspable structure for a hook to engage. AorticLab contended that there must be a certain degree of intention and suitability for the component to act as a graspable structure for retrieval purposes. Given that the device is intended for use in a blood vessel, the LD held that the claim must be construed with safety and quality standards in mind; a hook simply being capable of being inserted in the device "somehow or somewhere" is not sufficient. This narrower construction also afforded suitable legal certainty to third parties in accordance with the Protocol on the Interpretation of Art. 69 EPC.  

Turning to infringement, the FLOWer device is intended to be removed from the blood vessel via its fixed rod. Emboline asserted that the FLOWer could be removed by alternative means, namely using a hook to engage a V shaped structure in the frame of the device (i.e. a graspable structure). However, if such a hook was inserted, it would pierce and damage the filter material of the device. The LD opined that patent infringement is not excluded if a non-infringing use of a device is the norm, even if the manufacturer expressly specifies a non-infringing use for its device, provided that the infringing use remains possible. However, an exception applies in the conteif such use is in line with professional practice and the recognised rules of medical science. In this case, this includes the correct removal of the device to avoid harm to the patient. Because use of a hook to engage a graspable structure in the FLOWer device for removal would damage the device, and potentially cause harm to the patient, it did not comply with medical standards and thus was held not to infringe EP 425.  

Finally, AorticLab's counterclaim for revocation had been made conditional on the LD making a finding of infringement. As the LD dismissed the infringement action, it did not need to consider the revocation claim. Consequently, the LD held that AorticLab was responsible for the unnecessary costs associated with preparing for the revocation counterclaim. In the circumstances, as Emboline had lost the infringement action and was thus responsible for those costs, the parties were ordered to bear their own costs.
 

UPC

Mannheim Local Division limits Samsungs late procedural request.
[UPC_CFI_850/2024] 

ZTE and Samsung are involved in a multi-jurisdictional FRAND dispute across the US, the UK, Germany and the UPC.

The order issued by the Mannheim LD stems from an application from Samsung triggered by ZTE referring to a rate in a licence between Samsung and a third party to justify that its offer was FRAND. Samsung argued that this submission was introduced too late into the proceedings, and asked for it to be disregarded. The Judge Rapporteur, however, declined to rule on that request at the interim stage, as it would require an in-depth analysis that can only be made at the end of the oral hearing.

In the alternative Samsung had asked for the written procedure to be extended under r. 36 RoP to enable it to file submissions in response to ZTE’s reliance upon the licence material. With the timing of the oral hearing in mind, however, the Judge Rapporteur declined that request but gave Samsung provisional permission to respond in writing during the interim procedure, with the full panel to decide on the admissibility of both parties’ submissions at the final oral hearing. The Court noted that the scope of this provisional submission should be restricted to the assessment of the third party licence, and not cover more general submissions on the FRAND conformity of Samsung or ZTE’s previous offers.

Samsung also requested an order from the Court positively requiring it to produce the third-party licence in question, subject to appropriate confidentiality protections under r. 262A RoP. The Court agreed with Samsung that the licence was highly confidential and that a confidentiality order was justified. Access was restricted to ZTE’s authorised UPC representatives and its legal representatives in the parallel German proceedings, provided they were also registered UPC representatives, three individuals at ZTE, and ZTE’s economic expert. Should it be necessary to discuss the confidential details of the licence at the oral hearing, then the hearing would be moved into private. 

Therefore, the Court granted Samsung’s request for an order against itself to produce the third-party licence. 

Canada

Canada Health publishes new draft guidance on Terms & Condition’s for all drugs.

On 12 December 2025, Canada Health published new draft guidance concerning the application of regulatory Terms and Conditions (T&Cs) under the amended Food and Drug Regulations to human and veterinary drugs, including pharmaceuticals, biologics and radiopharmaceuticals.

In particular, the draft guidance explains when T&Cs may be imposed or amended, the process for notification of an intention to impose T&Cs, how to respond to a notice of intention to impose T&Cs, compliance with T&Cs and applications to amend T&Cs. The draft guidance can be accessed here.

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

Episode 23: Court of Appeal gives guidance on language changes on the grounds of "fairness".

Episode 24: Local Division maintains Anti-Interim Licence Injunction and clarifies that final RAND relief in the UK could be in breach of the injunction. The Court of Appeal declines to suspend its effect.

View all episodes here