Irides: Weekly global patent litigation update

This edition features updates from: The United Kingdom (UK), Belgium, Germany and The Unified Patent Court (UPC).

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

UK

Patents Court gives its first decision on the scope of the SPC Manufacturing Waiver. 

Following verbal judgment on 4 November 2025 (previously reported here), on 24 November 2025 Mr Justice Meade handed down the full written reasons in the first UK decision relating to the “SPC manufacturing waiver”. The EU SPC manufacturing waiver is set out in Art. 5 of Regulation (EC) No 469/2009 (the EU SPC Regulation), which was introduced by Regulation (EC) No 2019/933 (the Amendment Regulation). The EU SPC Regulation as amended is assimilated into UK law in the Assimilated SPC Regulation.

Alvotech intended to manufacture aflibercept, the active ingredient in Regeneron’s Eylea® (used to treat wet macular degeneration), in the UK, where Eylea® was protected by an SPC until its expiry on 22 November 2025. Alvotech did not dispute the validity of the SPC or that its actions would infringe the SPC if it could not avail itself of the SPC manufacturing waiver. Alvotech notified Regeneron of its intention to manufacture under Art. 5 of the Assimilated SPC Regulation on 30 April 2025, followed by a further notification on 12 August 2025 (due to alleged shortcomings in the first notification). Regeneron argued both notifications were invalid as they did not provide an MA number for the intended territory of export and sought an injunction before SPC expiry. Alvotech’s defence was, essentially, that Art. 5 requires that the MA number only needs to be provided “as soon as it is publicly available”. No MA number was publicly available at the date of either notification, therefore the MA number did not need to be included in the notifications in order for them to be valid.

Following an analysis of the articles, recitals and travaux préparatoires of the Amendment Regulation, and European decisions relating to Art. 5 of the EU SPC Regulation (the relevant parts of which are identical to Art. 5 of the Assimilated SPC Regulation), Mr Justice Meade found in favour of Alvotech and refused to grant the injunction. The Judge confirmed that the requirement to provide the MA number in the notification “as soon as it is publicly available” means that a notification which does not contain an MA number can still be valid and, therefore, three months after that notification, the maker may begin manufacturing. Mr Justice Meade considered that this was supported by an ordinary reading of Art. 5(5). In addition, Recital 17 to the Amendment Regulation clarifies that a notification can be updated once the reference number is available, which implies that the notification is valid when given, but may then be updated. The Judge considered this interpretation to be consistent with the legislative purpose, i.e. levelling the playing field between generic/biosimilar manufacturers based in the EU/UK versus those based elsewhere.

Mr Justice Meade also confirmed that Art. 5 does not require the intended country of export to be completely free of IP rights in order for a SPC manufacturing waiver notification to be valid. In particular, waivers are not precluded for export countries where protection is open to serious challenge, or is obviously invalid, or does not cover the maker’s product. In order to police compliance with the waiver conditions in the Assimilated SPC Regulation, the SPC holder is entitled to request information from the maker and this may include confidential information.
 

BELGIUM

Brussels Enterprise Court considers the SPC Manufacturing Waiver.

The French-speaking Brussels Enterprise Court has also addressed the requirements of the SPC manufacturing waiver in proceedings between Regeneron and Sandoz. Consistent with the decision in the UK (and an earlier Dutch-speaking Brussels Enterprise Court decision, previously reported here), the Court found that a valid notification under Art. 5 of the EU SPC Regulation does not require a maker to have obtained an MA in the country of export before providing its notification. The Court further confirmed that (i) the maker does not have provide the SPC holder with the intended country or countries of export; and (ii) it is not a requirement of Art. 5 of the EU SPC Regulation that the intended country or countries of export must be completely free of IP rights.
 

Germany

Dolby wins Europe’s first-ever Preliminary Injunction based on a Standard Essential Patent.

It has been reported that Dolby has been granted a Preliminary Injunction (PI) on the basis of a Standard Essential Patent (SEP) relating to the HEVC standard in the Regional Court of Munich on 19 November 2025 against implementer Roku. This may be the first time that there has been a PI on the basis of an SEP. The written decision is still pending but reports indicate that the PI was granted on the basis that Roku was considered not to be a willing licensee, and so not entitled to rely upon any FRAND defence, on the basis that it had sought what the Court regarded as interim licence or anti-suit relief in parallel proceedings in the US.
 

UPC

Court of Appeal sets guidance assessing inventive step. 
[UPC_CoA_528/2024,  UPC_CoA_529/2024] 

On 25 November, the Court of Appeal (CoA) handed down its decision in Amgen v Sanofi and Regeneron, reversing the decision of the Central Division in Munich (CD) to revoke Amgen’s patent EP 3 666 797 (EP 797). The claims of EP 797 relate to antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9 (PCSK9). By targeting PCSK9, it reduces binding to low density lipoprotein receptor (LDLR), which is important in lowering cholesterol levels. The CD had found that EP 797 lacked inventive step, using the problem-solution of the EPO.

In contrast, the CoA did not adopt the EPO’s problem-solution approach, instead opting to set guidance broadly aligned with the approach the Paris CD previously coined the ‘holistic’ approach, which is derived from the CoA’s guidance in the Nanostring/10X Genomics PI case. The Court acknowledged that National Courts have adopted various tests to assess inventive step, including the problem-solution-approach used by the EPO, and the “holistic” approaches used in the UK and Germany. The Court commented that, when properly applied, these approaches should and generally do lead to the same conclusion. However, the guidance is clear - the holistic approach is preferred by the UPC and the headnotes set out clear steps in the analysis which should be followed.  The approach shares a degree of commonality with the EPO, but there are some marked differences, discussed below.

The Court also set guidance on claim construction, addressing medical use claims and the effect of dependent claims.

Claim Interpretation

Independent claim 1 was drafted as a medical-use claim. Consequently, the claimed invention must result in a lowering that brings about a therapeutic effect. The fact that the skilled person does not derive any minimum effect from the claim or description does not alter this conclusion, as the therapeutic effect derives from the use of the medical-use claim format, not the claim language.

The CoA also stated that the question as to whether conclusions can be drawn from the subject-matter of dependent claims will depend on the circumstances of the individual case. If the dependent claim is adding additional features, then it argues against drawing conclusions in relation to how the main claim is interpreted. In this case, dependent claims 6 and 7, which claimed the administration of the antibodies with another medicament that lowers cholesterol, did not support an interpretation that the antibody is not therapeutically effective on its own.

Inventive Step

The CoA’s guidance for assessing inventive step can be broadly summarised as comprising three steps:

1. Framing the ‘objective problem’ of the invention, which is to be done by reference to the underlying technical teaching of the patent rather than isolated differences over the prior art, and should avoid hindsight or pointers to the claimed solution;
2. the selection of one or more realistic starting points in the prior art; and
3. whether the claimed solution would be obvious in light of the objective problem, specifically whether the skilled person would be motivated to implement it as the “next step” (i.e. would, not only could).

What is the objective problem?

This is assessed from the perspective of the skilled person with their common general knowledge at the priority date. As outlined above, the objective problem should not contain pointers to the solution (e.g. using PCSK9 inhibitors to lower cholesterol). Further, this is to be based on the claim as a whole in context of the description and the drawings and must be based on the technical effect that the skilled person on the basis of the application understands is achieved with the claimed invention. This is a distinct difference compared to the EPO, where the problem is instead framed with reference to distinctions over the prior art.

The CoA began by setting out that the underlying problem the invention purports to solve was in providing a therapeutically effective treatment of  hypercholesterolemia or atherosclerotic disease or other conditions related to elevated serum cholesterol levels. It noted that the use of PCSK9 inhibitors to target LDLR levels should not be within the problem, as it already points to the solution and introduces hindsight into the inventive step assessment.

What is a realistic starting point?

A starting point is realistic if it would have been of interest to the skilled person who wishes to solve the problem. This may be the case if the relevant piece of prior art already discloses several features similar to those relevant to the invention as claimed and/or addresses the same or a similar underlying problem as that of the claimed invention. There can be more than one starting point and inventive step must be assessed from each.

The relevant field of technology is not just the field relevant to the objective problem, but also fields where the same or a similar problem has arisen of which the skilled person must be expected to be aware.

Would (not only could) the skilled person, starting from a realistic starting point in the state of the art in the relevant field of technology, wishing to solve the objective problem, arrive at the claimed solution? (i.e. would they have been motivated to arrive at the claimed solution?)

The CoA stressed that the skilled person is uninventive, and there must be a pointer/motivation from the starting point to implement the next step. A solution is obvious where the skilled person would take the ‘next step’ indicated by the pointer or as a matter of routine.

Reasonable expectations of success are relevant in this regard and the burden to prove the expected success lies with the party asserting invalidity of the patent. A reasonable expectation of success implies that whilst the skilled person may perform some routine experimentation, they must have been able to rationally predict, based on the known facts, the successful conclusion of that work.

This question will always depend on the circumstances of the case. The more unexplored the technical field, the lower the expectation of success. Practical and technical difficulties as well as the costs involved in testing whether the desired result will be obtained are also relevant factors. However, generally, the stronger the pointer to the claimed solution, the lower the threshold for a reasonable expectation of success. The fact that multiple teams are working contemporaneously on the project does not necessarily imply there was a reasonable expectation of success.

Finally, where the patentee submits evidence that there were uncertainties or practical/technical difficulties, the burden of showing that this will not prevent the skilled person from having a reasonable expectation of success falls on the party alleging obviousness.

Applying the above assessment to the facts in this case, the CoA ultimately found that despite there being a pointer in the prior art that would provide the skilled person with a strong incentive to block PCSK9 activity to reduce LDL levels in order to be able to treat hypercholesterolemia and similar diseases, they would not have a reasonable expectation of success. This is because the prior art only contained data on the extracellular activity. At the priority date it was not known whether the contribution of the PCSK9 inhibitors were intracellular and extracellular, and without in vivo data, the skilled person could not reasonably predict whether the antibody route would lead to a therapeutically effective treatment of hypercholesterolemia and similar diseases.

Sufficiency

The CoA also offered guidance on the application of the sufficiency test to functional features. The test is whether the skilled person is able to reproduce the claimed subject-matter on the basis of the patent without any inventive effort and without undue burden.

Commenting specifically on functional features, the CoA said that a patentee is not required to disclose how every embodiment within the functional definition should be obtained. Therefore, the non-availability of some embodiments is immaterial to sufficiency for a functionally defined claim. The only requirement is for the skilled person to be able to obtain suitable embodiments within the scope of the claim.

EP 797 was held to be sufficiently disclosed. The respondents were unable to show that, based on the teachings to measure the binding of the antibodies and the common general knowledge, the skilled person would be unable to obtain further antibodies with the claimed functional properties, i.e. “to the catalytic domain of a PCSK9 protein of the amino acid sequence of SEQ ID NO: 1”. No evidence was submitted showing that the screening methods disclosed would be unsuitable to enable the skilled person to identify whether an antibody binds to the catalytic domain without undue burden.

The CD’s decision was reversed, and the respondents ordered to pay the costs of the proceedings.

*We note that the first panel of Court of Appeal also handed down its judgment in Meril v Edwards on Wednesday, 26 November 2025 that, despite being from a different panel, replicates the inventive step wording, thus affirming the holistic approach. We will report further on this case in next week’s newsletter.
 

UPC

Administrative Committee announces amendments to Court Fees. 

As published earlier this week, on 4 November 2025, the Administrative Committee of UPC adopted amendments to the Table of Court Fees, as well as the relevant provisions of the Rules of Procedure and the Guidelines on the determination of Court fees. The stated aim of the changes is to modernise the fee structure and ensure fairness while maintaining accessibility for Small and Medium-Sized Enterprises (SMEs). The amendments will take effect from 1 January 2026.

The key features of the amendments include:

• Inflation Adjustment. The court fees have been updated to reflect inflation since the original fee schedule was established in 2016 and ensure that the fee structure remains economically aligned with current conditions.
• Increase in Value-Based Fees for Appeals. The amendment allows for a 10% increase to value-based fees before the Court of Appeal to reflect the complexity and resource demands of appellate proceedings.
• Introduction of Value-Based Fees for Provisional Measures and Other Applications. Previously, provisional measures were subject to fixed fees. The new system introduces value-based fees for these applications, aligning costs with the financial stakes involved.
• Adaptation of Reimbursement Scheme. Following several orders and decisions on this topic, the reimbursement framework for court fees has been revised to provide clearer guidelines and improved fairness. This includes adjustments to refund conditions in cases of withdrawal or settlement.
• SME Protection Measures. Recognising the potential impact of fee increases on smaller entities, the amendments incorporate measures to mitigate these effects for SMEs, which may include reduced fees or special provisions to maintain access to justice.

In addition to fee adjustments, corresponding provisions in the Rules of Procedure and the Guidelines on fee determination have been amended to ensure consistency and clarity. More information on the fees can be found here.
 

UPC

Paris Local Division rejects first SPC Preliminary Injunction based on lack of urgency.
[UPC_CFI_697/2025]

The UPC has issued its first decision involving an SPC, setting an important precedent for the assessment of urgency in the context of generic product launches. At the Paris LD, Merz sought a Preliminary Injunction (PI) against Viatris for alleged infringement of French SPC No. FR13C0033, based on EP 2377536 and protecting fampridine (FAMPYRA®) until July 2026. Viatris launched its generic, FAMPRIDINE VIATRIS LP 10 mg, in France in June 2025.

Viatris opposed the application, challenging urgency, patent validity and SPC validity, citing prior marketing in Bulgaria and Poland.

The Court rejected the application for unreasonable delay under r. 211.4 RoP, stressing that urgency is a decisive threshold. A key conclusion was that imminent infringement and actual infringement are alternative triggers for provisional measures, not sequential stages. Having the necessary evidence for either of these situations puts the patentee in a position where a PI action can be initiated. Therefore, if there is an existing case for imminent infringement, the clock for assessing urgency cannot be restarted once actual infringement begins. Regulatory steps performed by Viatris (pricing and reimbursement, which had been completed by November 2024) made entry of the generic product foreseeable, and the Court therefore considered that Merz should have had the necessary knowledge of imminent infringement at an earlier stage. Even taking account of the fact that Merz only regained direct exploitation rights from its licensee on 2 January 2025, the delay until 31 July 2025 to file the application resulted in a lack of urgency. The Court also stressed that Merz should have exercised due diligence when reacquiring the rights and that in doing so would have gained knowledge of the imminent infringement by Viatris.

The application was therefore denied, and Merz was ordered to pay €56,000 in costs. In light of the lack of urgency the Court declined to comment on SPC validity and infringement, so these remain open issues for future proceedings. The decision underscores that originators must act promptly when regulatory milestones signal generic entry.
 

UPC

The Hague Local Division dismisses infringement claim against Molecular Instruments’ HCR Products. 
[UPC_CFI_187/2024, UPC_CFI_507/2024]

On 18 November 2025, The Hague Local Division (LD) held that two European patents owned by Advanced Cell Diagnostics, Inc. (ACD) were valid but not infringed by the defendant, Molecular Instruments, Inc.   ACD’s patents (EP 1 910 572 (EP 572) and EP 2 500 439 (EP 439) related to assays for the detection of RNA molecules using RNA in situ hybridization (ISH) technology, marketed as RNAscope. ACD brought an infringement action against the defendant in relation to its kits of probes that detect RNA in the cell using ISH techniques (the HCR Products). The defendant counterclaimed for the revocation of both patents.

Validity

For assessing validity, the parties had agreed that the assessment for inventive step should follow the more holistic approach set out in Amgen v. Regeneron/Sanofi decision (UPC_1/2023 of 16 July 2024) citing the explanation that “a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated to consider the claimed solution and to implement it as a next step in developing the prior art.” The Court noted that, in practice, the parties appeared to apply the problem-solution but explained that the “result does not depend on the specific test and as the cited sentence seems to apply to both, the Court will apply principles that are common to both tools for assessing inventive step”.

The Court considered the three pieces of prior art, noting that the skilled person would have knowledge of in vitro and in situ assay methods for detecting RNA. However, none of the prior art documents would lead the skilled person to the invention as there was no teaching at priority date that use of the required “cruciform” DNA probes in an in situ assay would work.

The defendant also raised an insufficiency/inventive step squeeze and added matter arguments that were rejected by the Court.

Infringement

ACD alleged that the HCR Products infringed the method claims of EP 572 and kit/sample claims of EP 439. For the purposes of claim construction, the Court focussed on the interpretation of Claim 1 of EP 572. In considering the knowledge of the skilled person, the Court took into account the CGK agreed by the parties in the parallel UK proceedings, where ACD’s patents were found to be invalid. It was also agreed that the product description from the UK proceedings could be used for the infringement assessment.

The defendant’s product was found not to infringe on a literal interpretation as the label probes were overlapping, while the wording of claim 1 of EP 572 specifically stated that there were “non-overlapping regions”. It was noted that “non-overlapping” is a word known in the art and would be given its literal meaning by the skilled person and there was nothing in the patent specification to suggest otherwise.

On infringement by equivalence, the defendant objected to the late introduction of equivalence arguments by the claimant in the reply to the statement of defence on the basis that the claimant had run an equivalence case in the UK from 2022 and could have included such arguments in its Statement of Case dated 22 April 2024. The Court rejected this objection explaining that the defendant was not prejudiced by the arguments as it had the opportunity to respond in writing in its statement of rejoinder and orally at the oral hearing in the main proceedings.

The Court held that there was no infringement by equivalence on the basis that it was necessary for legal certainty (it would be impossible to construe how much overlap would be considered equivalent) and the invention was not so significant (given all the ingredients of the invention were already known, just not the combination) that a finding of equivalence was necessary for fair protection of the patentee. The Court also accepted the defendant’s argument that the overlap used was necessary for the different way that the result is achieved in the HCR Products, which arguably lead to an improvement over the claimed inventions, and was not just a work around of the claims.
 

UPC

Milan Local Division issues default Judgment granting a pan-UPC Injunction. 
[UPC CFI No. 802/202]

On 19 November 2025, the Milan Local Division (LD) issued a default judgment under Art. 37 UPCA, finding and declaring that the defendants’ Pizza Former machine infringed EP 3 691 454 B1 (EP 454), a unitary patent. The patent protects a method for shaping pizza dough and a machine for implementing that method.

The defendants, Gastroteam and Salvatore Marciuliano, formerly exclusive distributor of Morello’s Pizzarella machine in Sweden, ceased their commercial relationship with Morello in 2018 and subsequently began manufacturing and marketing the Pizza Former across Europe. Neither defendant filed a defence to the Statement of Claim served earlier this year by Morello, which asserted that the Pizza Former infringed EP 454. This prompted the claimants’ request for judgment in default.

The Court confirmed proper service and that the defendants had failed to comply with the imposed procedural deadlines before assessing whether the claim met the evidentiary threshold required under Art. 54 UPCA and r. 355.2 RoP. It emphasized that default does not equate to automatic success; the claimant must still prove the facts on which its claim is based. The Court found that the claimants had satisfied this standard of proof and the facts presented justified the measures requested.

Technical analysis presented by the claimants demonstrated that the Pizza Former machine infringed nearly all of the patent claims; the Pizza Former was deemed to literally reproduce all but two of the claims of EP 454. Documentary evidence also satisfied the Court that the defendants were manufacturing, offering for sale, and distributing the infringing product throughout UPC Contracting Member States.

Upon finding the defendants liable for patent infringement, the Court found that the infringement was sufficiently serious to justify a pan-UPC injunction prohibiting the continuation of the infringement. Given that the Pizza Former was a direct replacement for the Pizzarella, each infringing product sold was deemed to be directly taking a sale from the claimants and eroding their market share, justifying the need for an injunction. This injunction takes immediate effect in all UPC Contracting Member States.

The Court also ordered the withdrawal and destruction of all infringing products within 30 days, disclosure of commercial documentation relating to the infringing products, and publication of the decision. Quantum of damages is to be determined at a subsequent hearing.
 

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Episode 12: The Hague Local Division issues Decision by Default Judgment granting Amycel a Permanent Injunction

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