Irides: Weekly global patent litigation update

This edition features updates from: The USA, India, the Unified Patent Court (UPC) and the European Patent Office (EPO).

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

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STOP PRESS - USA

Supreme Court reverses Federal Circuit on induced infringement standard for skinny-label generics. [Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.]

In a unanimous decision delivered on 4 June 2026, the Supreme Court reversed the Federal Circuit and held that the correct question in an induced infringement claim under 35 U.S.C. §271(b) is whether manufacturer took affirmative steps designed to encourage infringing use rather than passive actions to bring about off-label use. The Court found that Hikma's skinny label, which carved out Amarin's patented cardiovascular indication, patient information leaflet, website and press releases did not meet that threshold, with statements attributable to statutory labelling requirements, standard industry practice, omissions, or vague language falling short of the active inducement required for liability.

Our full update will be available in next week's update.
 

India

Madras High Court provides guidance on the Bolar exemption [Novartis v Venkata Narayana Active Ingredients]

On 3 June 2026, the Madras High Court handed down judgment in a long-running infringement claim brought by Novartis against Venkata Narayana Active Ingredients (Venkata) concerning Indian Patent No. 212815, relating to vildagliptin. The judgment provides helpful guidance on the Indian Bolar-type exemption under s. 107A of the (Indian) Patents Act.

Background

In an earlier infringement action brought by Novartis against Venkata in 2015, Venkata gave an undertaking to the court acknowledging the validity of the Patent and undertaking not to manufacture, sell, supply, export, import or offer for sale vildagliptin. Contrary to that undertaking, Venkata continued to export significant quantities of vildagliptin API to generic manufacturers in Egypt. Novartis therefore issued a further action against Venkata in 2018.

In the subsequent action, Venkata principally relied on the Bolar exemption (s.107A). It argued that all supplies made to the generic companies in Egypt were for the purpose of research and development only and were permitted under s.107A.

Decision

Critically, the Court held that the burden of proving reliance on s.107A lies on the party raising that defence – in this case, Venkata. In doing so, the court diverged from the approach taken by the Delhi High Court in Bayer v Union of India (Bayer) and instead treated s.107A as an exception that must be strictly established. The court held that for a API supplier to rely on the exception, two prerequisites must be satisfied: (i) regulatory requirements should be the sole purpose of making, constructing, using, selling or importing the patented product; and (ii) the use of the patented product should be reasonably related to such regulatory requirements. “Selling” in this context includes sale for the purposes of obtaining regulatory approval in India or in another country.

As to the evidence required to satisfy s.107A, the court held that a defendant must adduce documentary evidence demonstrating a genuine regulatory nexus. This includes evidence that regulatory approval was being sought and that the relevant authority had requested information such as pre-clinical or clinical trial data.

On the facts, Venkata’s evidence fell short of this threshold. The invoices and purchase orders relied upon did not indicate that the purchases were for regulatory purposes, and the certificates produced – which stated that the API was for “process validation trials” – were not corroborated by any documents from the Egyptian regulatory authorities. The Court emphasised that simply labelling supplies as for “R&D purposes” was insufficient and noted that a defendant must meet a “far heavier burden” to bring itself within the Bolar exemption. Venkata therefore failed to discharge its burden under s.107A.

The Court also provided helpful (non-exhaustive) guidance on the categories of evidence required to rely on the Bolar exemption in s.107A:

1. evidence that regulatory approval was sought in relation to the patented product in India or outside India;

2. evidence that the regulator requested product-related data such as pre-clinical or clinical trial data relating to the patented product in response to the request for approval;

3. where the person seeking regulatory approval is not the manufacturer of the API or formulation, evidence of a request for supply from the person seeking approval to the manufacturer or seller, supported by the documents referred to in (a) and (b); and

4. evidence that the impugned use of the patented product is reasonably related to the request for regulatory approval.

Whilst the court agreed with the non-exhaustive factors set out by the Delhi High Court in Bayer for evaluating whether a sale, use, import or export falls within the scope of the Bolar exemption, it recognised the lack of rule-based guidance on the issue. The Court therefore suggested that the Indian government should consider framing rules, after consulting stakeholders, specifying the documentary and other requirements for reliance on s.107A. Such guidance would help ensure that the provision is used legitimately and not abused.
 

UPC

Court of Appeal clarifies the approach to long-arm claims. [Fujifilm v Kodak UPC_CoA_312/2025 et al.]

The UPC Court of Appeal’s 2 June 2026 decision in Fujifilm v Kodak provides extensive clarifications as to how the UPC will approach long arm claims based on national designations of European patents in non-UPC territories. The decision sets out a structured framework for handling invalidity objections and comity where infringement claims are brought based on extra territorial EP designations. Our rapid reaction article summarises the framework in more detail. The court also confirmed that Art. 34 UPCA does not confine the UPC’s competence to its own territory but drew an important distinction between accepting jurisdiction and exercising it. 

This distinction lies at the heart of the judgment. The court made clear that, where jurisdiction is established under Art. 4 Brussels I bis (BR) because the defendant is domiciled in a contracting member state, that jurisdiction cannot be declined on forum conveniens type grounds, even where the dispute concerns the acts of that defendant in a non-member state. At the same time, the court emphasised that exercising that jurisdiction over non UPC designations requires the application not only of the relevant national patent law, but also principles of international law including comity. This enables the UPC to maintain a broad jurisdictional reach while tempering its practical exercise through procedural mechanisms.

The Court developed a structured framework for how such cases should be managed, distinguishing between different scenarios depending on the status of the patent in the UPC territory, focussing its guidance on issues of validity. Where a revocation claim arises in respect of non UPC designations, the UPC must decline jurisdiction over validity. Where, however, an infringement action is pursued and the patent in the UPC territory is considered invalid, the court should generally invite the patentee to withdraw extra territorial claims and, depending on the designation, may stay proceedings or dismiss them. Of particular practical importance is the situation where the patent is considered valid and infringed in the UPC territory. In that case, the court may grant relief in respect of non UPC designations on a conditional basis, subject to a subsequent finding of validity by the competent national court.

This “conditional relief” mechanism reflects an attempt to reconcile the UPC’s broad jurisdiction with the constraints of art. 24(4) BR and analogous provisions, as well as broader comity concerns. It allows the UPC to avoid undue delay in granting relief, while ensuring that its orders fall away if the competent national court subsequently finds the patent invalid.

The decision also provides helpful clarification on a number of procedural and substantive issues which are likely to be of wider application. First, the court confirmed that the UPC’s extra-territorial jurisdiction extends to allegations of joint tortfeasorship, consistent with its earlier case law, although liability must still be established under the applicable national law for the relevant acts. Secondly, the court addressed private prior use, confirming that such rights under Art. 28 UPCA are governed by national law, here German law for the German designation. Thirdly, the court gave guidance on the UPC’s front loaded procedure, holding that parties may submit additional evidence in support of an already pleaded case where earlier evidence has been challenged, without offending the procedural rules.

On the facts, the court ultimately overturned the injunction awarded at first instance in relation to the UK designation not for lack of jurisdiction, but because the infringement case failed under its view of the applicable national law on joint tortfeasance and the pleaded factual basis. outcome underlines an important practical point. Establishing UPC jurisdiction over extra territorial designations is only the first step. A patentee must still prove infringement under the relevant national law and against the correct entity, and must do so within the framework of the UPC’s case management approach to validity challenges and comity.

Finally, the decision also contains important reminders on claim construction. The court rejected the existence of any general rule that numerical ranges in claims should automatically be interpreted as including manufacturing or measurement tolerances. Whether such tolerances are incorporated remains a matter of interpretation in the specific context of the patent. This reinforces the court’s broader emphasis on a careful, context driven approach to claim interpretation, grounded in the skilled person’s understanding and the patent as a whole.

Taken together, the judgment represents a significant step in the development of UPC jurisprudence on long-arm jurisdiction. It confirms that the UPC will take a permissive approach to accepting jurisdiction over long arm claims, anchored in the BR, while developing a pragmatic and structured approach to exercising that jurisdiction.
 

UPC

Official opening of the Patent Mediation and Arbitration Centre (PMAC).

On 2 June the PMAC celebrated its official inauguration at a ceremony in Ljubljana, Slovenia. Established under Article 35 of the UPC Agreement, the PMAC has seats in Lisbon and Ljubljana and will offer expert determination and hybrid dispute resolution procedures, as well as mediation and arbitration.

Rules for mediation and arbitration both make special provision for FRAND disputes and readers may recall the Mannheim Local Division’s recent order (see Irides update here) proposing mediation at the PMAC between Samsung v ZTE in their FRAND cross-licence dispute.

While alternative means of dispute resolution may not previously have held much appeal for parties entrenched in traditional patent disputes, where injunctive relief or invalidation of the patent are the key remedies that the parties desire, the PMAC may prove to be a useful forum for disputes where a commercial resolution is possible including FRAND disputes which, at their heart, are monetary disputes relating to licence fees. Indeed following the UK Court of Appeal’s recent decision to stay Acer/ASUS v Nokia so that arbitration may take place (see here), it is possible that alternatives to formal litigation may now take a far more prominent role.
 

UPC

Court of Appeal Confirms Security for Costs Obligations Apply to SMEs [La Siddhi v Athena Pharmaceutiques, UPC_CoA_48/2026]

On 1 June 2026, the Court of Appeal confirmed that a claimant's status as a small or medium-sized enterprise does not exempt it from the obligation to provide security for costs under r. 158 RoP, dismissing an appeal by La Siddhi Consultancy Limited against a €75,000 security order made in revocation proceedings before the Milan Central Division.

The Court drew a clear distinction between the provisions of the Rules of Procedure that explicitly address SME status, such as (i) the reduced court fees regime under r. 370.8 RoP and (ii) the possibility of requesting a lower 

recoverable costs ceiling where enforcement would threaten a party's economic existence, as compared with r. 158 RoP which contains no such carve-out. The absence of an SME exception in r. 158 RoP was, the Court held, a deliberate legislative choice. The two regimes serve different purposes and operate independently.

On the facts, once Athena Pharmaceuticals had substantiated their concerns about recoverability of costs using publicly available financial information, the burden shifted to La Siddhi to provide counter-evidence. Its bare assertion that Athena’s arguments were "legally and factually unfounded" and its reliance on an SME fee-reduction declaration were insufficient. New evidence submitted on appeal was disregarded under r. 222.2 RoP as it could have been filed at first instance.

On quantum, the Court confirmed the correct methodology: start from the applicable ceiling in Annex A (“Scale of Ceilings for Recoverable Costs”) of the Administrative Committee Decision of 24 April 2023 and, where appropriate, adjust according to the circumstances of the case; the SME status of a party can be taken into account when considering any such adjustment from the ceiling. In the present case, the Central Division's reduction from €112,000 to €75,000, approximately 60% of the applicable ceiling, was upheld as a reasonable exercise of the Court’s discretion.
 

UPC

Paris Local Division Rules on Doctrine of Equivalents.
[Tiru v Valinea & Maguin, UPC_CFI_130/2025]

On 29 May 2026, the Paris Local Division (LD) handed down its decision in Tiru v Valinea Energie (UPC_CFI_130/2025). The decision concerned Tiru’s patent EP 3 178 578 (EP 578), which relates to technology implemented in a waste incineration furnace. Valinea Energie (Valinea), a company within the Veolia group, operates the accused waste treatment facility in Montbéliard, France. The second defendant, Maguin, manufactures the combustion chamber of the furnace alleged to infringe the patent.

Prior to commencing infringement proceedings, Tiru applied in December 2024 for evidence preservation measures and on-site inspections against both Valinea and Maguin. On 23 December 2024, the LD granted the applications ex parte and authorised the requested measures. In February 2025, Tiru filed infringement actions against Valinea and Maguin. Veolia, Valinea’s parent, filed a revocation action before the Paris Central Division (CD) in May 2025, and in June 2025, both defendants to the infringement action filed counterclaims for revocation of EP 578. Earlier, in May 2025, V. The LD subsequently bifurcated the revocation counterclaims, however, to the CD. In March 2026, the Paris Central Division upheld EP 578 in amended form.

Before the LD, Tiru asserted that the defendant’s waste incineration furnace infringed EP 578 either literally or by equivalents.

A significant aspect of the decision concerned the court's approach to the assessment of infringement following the CD’s validity decision. The LD emphasised that a consistent approach should be adopted between validity and infringement. Where a patentee argues during validity proceedings that a claimed feature cannot be assumed to be present in the prior art absent a clear and unambiguous disclosure, the same patentee bears the burden in infringement proceedings of proving that the feature is present in the accused product in a clear and unambiguous manner.

The Court's analysis focused in particular on the EP 578's requirement for "cooling air". EP 578 requires the presence and circulation of cooling air whose function is to cool combustion products by direct contact within the combustion chamber. Tiru argued that the accused furnace's "secondary air" system constituted the claimed cooling air. The defendants contended that the secondary air was instead used to treat carbon monoxide and did not perform the patented cooling function. The Court adopted the CD's interpretation of "cooling air" and referred to the reasoning of both the CD and earlier Board of Appeal decision. In particular, the Court noted that in these proceedings three prior-art documents had not been found to disclose the claimed cooling-air feature because such a function was not clearly and unambiguously disclosed. Applying the same logic in the infringement context, the Court held that the mere presence of secondary air in the downstream portion of the furnace did not establish that it performed the claimed cooling function. As Tiru had failed to prove that the secondary air cooled combustion products within the meaning of the patent, the Court concluded that the cooling-air features of the asserted claims were not literally reproduced.

Tiru also alleged infringement by equivalents. In assessing that argument, the court applied the four-step test previously adopted by The Hague Local Division in Plant-e v Arkyne, namely: (i) technical equivalence; (ii) fair protection for the patentee; (iii) reasonable legal certainty for third parties; and (iv) novelty and inventive step of the accused variant over the prior art. The court held that Tiru failed at the first stage. Because TIRU had not established that the accused furnace employed cooling air as required by the patent, it could not show that the accused variant performed substantially the same function or solved substantially the same technical problem as EP 578. Consequently, infringement by equivalents was not established.

As a result, the Court concluded that the claims of EP 578 were not infringed by the defendants’ product.

The decision also addresses an evidentiary challenge brought by Valinea. Valinea sought to exclude the report prepared by the independent expert who supervised the evidence preservation measures and on-site inspection. It argued that the expert's impartiality was compromised because he held a preparatory meeting with Tiru's representatives before the inspection, despite the seizure order did not expressly provide for such a meeting. Tiru argued that the challenge was inadmissible because it should have been raised before the Judge responsible for authorising the evidence preservation measures. The LD rejected that procedural objection and held that challenges concerning the execution of seizure measures and the probative value of the expert's report fall to be determined by the panel hearing the merits, rather than by the Judge who authorised the measures. On the merits, however, the court rejected Valinea's challenge. It held that preparatory discussions with the applicant were necessary to organise the practical implementation of an ex parte inspection and did not call the expert's impartiality into question.
 

EPO

New Referral to the Enlarged Board of Appeal relating to the application of claim construction principles of G 1/24 when assessing added matter [G 1/26 (“Coated steel strips”)]

Technical Board of Appeal 3.3.05 has by interlocutory decision T 873/24 referred the follow­ing questions to the Enlarged Board of Appeal (referral pending under: G 1/26 - “Coated steel strips”).

The Board considered that the case law after G 1/24 shows a real divergence on the extent to which the description and drawings may influence the meaning of a granted claim when added matter under Art. 123(2) EPC is in issue.

The questions are set out in full below, but can be summarised as follows.

Question 1 is procedural and relates to the circumstances under which a referral can be “required” under Art. 112(1) EPC.

Questions 2(a) and 2(b) ask, in essence, whether the primacy of the claims means a feature found only in the description or drawings can never be read into a granted claim, particularly where that would narrow the claim, or whether claim interpretation is instead a single process of reading the claims together with the description and drawings, with only interpretations that clearly contradict the general technical understanding of the claim language being ruled out. Questions 3(a) and 3(b) then ask how that interpretation exercise feeds into Art. 123(2) EPC. Must the amended claim be tested against every technically sensible meaning available from the claim language alone, or is it enough that the interpretation reached against the patent specification as a whole is directly and unambiguously derivable from the application as filed.

The full questions are as follows:

1. May a decision be considered to be "required" for the purposes of Article 112(1) EPC, if the referring Board demonstrates that the point of law in question arises out of the context of the case pending before it and, in the circumstances of the proceedings, it is reasonable for the Board to examine it and decide on it next?

2. (a) Does the fact that the claims are the starting point and the basis for assessing the patentability of an invention generally preclude a feature which is only disclosed in the description or the drawings of a patent from being read into the meaning of a granted claim, in particular if this leads to a restrictive reading of terms used in the claim?

2. (b) If the answer to question 2.(a) is no: is claim interpretation the result of both reading the claims and consulting the description and drawings as a unitary process and does the claim being the starting point and the basis for assessing the patentability rule out only those interpretations which can be derived from the patent as a whole but would clearly contradict the general technical understanding of the terms used in the claim?

3. (a) When assessing compliance with Article 123(2) EPC, must a term used in a claim be assessed against all interpretations that make technical sense to the skilled reader on the basis of the claim alone?

3. (b) If the answer to question 3.(a) is no: is it sufficient that only the interpretations of the subject-matter of the claim established against the background of the patent specification as a whole are directly and unambiguously derivable from the application as filed?

The Enlarged Board of Appeal will now look at the referral and questions before a decision on accepting the referral (and potential amendments to the questions) is made.