NL Provisions Judge grants PI and finds that Newron's SPC for Xadago (safinamide) complies with Article 3(a) SPC Regulation

On 2 July, the Court of Appeal of the UPC (“CoA”) handed down its decision in the PI proceedings between Guardant Health, Inc. (“Guardant”) and Sophia Genetics SA et al. (“Sophia”). Both parties appealed the decision of the Local Division Paris (“LD Paris”) of 23 January 2026. Although Guardant successfully objected to the finding that the patent was likely invalid for added matter, the CoA held that the urgency requirement was not met and therefore no PI was granted. What preceded Guardant is the proprietor of EP 3 443 066 (“EP 066”), which claims a method for detecting the presence or absence of colorectal, ovarian, lung or pancreatic cancer. EP 066 was granted on 2 October 2024 and claims priority of 14 and 18 April 2016. No opposition was filed. In addition to its UPC designation, EP 066 is in force in CH, ES and the UK. Sophia offers the MSK-DDM test in the UPC territories, CH, ES and NO. On 27 May 2025, Guardant sent a warning letter to Sophia arguing that the MSK-DDM test falls within the scope of several patents, but not mentioning EP 066. Sophia replied on 20 June 2025. On 14 July 2025, Guardant started litigation in the UK for infringement of the UK parts of several patents, including EP 066. It lodged its reasons on 18 August 2025. On 29 August 2025, Guardant applied for a PI before the LD Paris for the alleged infringement of several patents, including EP 066. The LD Paris held that the urgency requirement was met, but that EP 066 was likely to be invalid for reasons of added matter and therefore rejected a PI. Guardant appealed the order regarding EP 066 and costs; Sophia lodged a cross-appeal. Assessment of the CoA – urgency The CoA held that the assessment of unreasonable delay depends on the circumstances of the individual case. The decisive point in time is when the applicant has, or should have had, after exercising due diligence, the necessary facts and evidence. The burden of proof rests on the applicant. The CoA found that Guardant acted with unreasonable delay based on the following five principles: 1) A patent holder is not obliged to assert all patents in one application for a PI. If a patent holder has the necessary information for some, but not all patents, delaying the filing until it has information regarding all patents may constitute unreasonable delay. The CoA considers it compatible with procedural efficiency and the frontloaded system to file multiple separate applications weeks apart before the same division, since asserting multiple patents in a single application carries the risk that a prompt decision cannot be expected. 2) If a patent holder is aware, on the basis of a certain document, that one or more of its patents have been infringed, it must not turn a blind eye to the fact that the document also indicates the infringement of its other patents. The fact that the warning letter did not concern EP 066 does not justify the conclusion that Guardant was unaware of the infringement of EP 066. 3) While a patentee is generally not obliged to monitor the market, it must investigate the market with due diligence once it becomes aware of specific circumstances suggesting infringement. As soon as Guardant was aware of infringing activities in the UK, it was expected to investigate whether infringement occurred in the UPC territory, CH and ES. 4) For legal entities, the decisive factor is when the authorised representative body or an individual capable of pursuing the infringement internally becomes aware of the possible infringement (e.g. an employee of the legal department or a senior member of the sales department). The fact that other employees attended Sophia’s online seminars is insufficient, as they were not involved in evaluating potential patent infringement claims and had no obligation to forward information to decision makers. 5) 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 a PI. However, since the warning letter did not concern EP 066, there was no reason for Guardant to wait for Sophia’s response before drafting an application regarding EP 066. Based on a certain document, the CoA concludes that Guardant (should have) had knowledge of the alleged infringement of the MSK-DDM test by 1 May. All information Guardant further relied upon was publicly available, requiring no substantial investigative measures. A diligent patentee could have completed this inquiry within two weeks, making 15 May 2025 the latest date on which Guardant should have been aware of the infringement in the UPC territory, CH and ES. Therefore, leaving a three-months’ gap from 15 May 2025 until 29 August 2025 for submitting the PI application, while Guardant stated it needed two weeks for drafting, is unreasonable. The patent’s complexity, technical tests and expert consultation do not justify the delay: Guardant failed to specify when the analyses began, for which patents they were essential, their duration or why the delay was reasonable. Even assuming the tests took a month, a two-months delay remained unaccounted for. Conclusion This decision provides a comprehensive guidance on urgency required for PIs in the UPC. The CoA establishes that a patentee: 1) need not assert all patents in one application and must not delay filing once it has sufficient information for some; 2) must not ignore infringement of other patents indicated in a document it has reviewed; 3) must investigate infringement in other designated territories once aware of infringement in one; 4) is deemed aware only when the authorised representative body or an individual capable of pursuing the infringement internally becomes aware of it and 5) may wait for a response to a warning letter, but not if that letter did not concern the patent at issue. As Guardant failed to meet these principles, no PI was granted.

On 24 December 2025, the Council of State (the highest administrative body in NL, hereafter: “Council”) issued its judgment in the administrative appeal proceedings between the Dutch Medicines Evaluation Board (‘‘CBG’’) and several generic companies incl. Laboratorios Cinfa S.A. (‘‘Cinfa’’) against Organon N.V. (‘‘Organon’’). The case concerns fixed-dose combination (“FDC”) products containing ezetimibe and atorvastatin and the use of the simplified procedure for obtaining a marketing authorisation (“MA”) based on Art. 10(b) of Directive 2001/83 (the “Directive”). In the NL version of the Directive, Art. 10(b) is article is referred to as Art. 10ter). The Council stayed the proceedings and referred two preliminary questions to the Court of Justice of the European Union (“CJEU”). The answers to these questions are particularly important, as they may determine whether Art. 10(b) of the Directive can be relied on more than once for the same FDC, allowing subsequent applicants to obtain an MA without submitting a full dossier on the mono products and instead to provide new data only on the FDC itself. What preceded Cinfa applied in NL for several MAs for FDC products containing ezetimibe and atorvastatin. The CBG granted these MAs under the simplified requirements of Art. 10(b) of the Directive. For the same combination, the CBG had already granted an MA to Organon for its product Atozet. This MA was also based on the Art. 10(b) procedure. Both Organon and Cinfa submitted their own dossier for the FDC, relying on the existing mono product dossiers for the respective individual active substances, which were no longer protected by data/market exclusivity. Furthermore, the indications do not fully overlap. Cinfa’s products are indicated as a substitution therapy. Organon objected to the MAs granted to Cinfa. The CBG dismissed Organon’s objections. Organon therefore appealed to Administrative Division of the District Court of Noord Holland (the “Court”). The Court held that the MAs for Cinfa’s FDC could not lawfully be granted using the Art. 10(b) procedure. In the Court’s view, ezetimibe and atorvastatin had already been combined “for therapeutic purposes” in Atozet. On a literal reading, Art. 10(b) only applies where the active substances “have not hitherto been used in combination for therapeutic purposes”. Once an FDC has been authorised under Art. 10(b), thesame combination can therefore no longer benefit fromthat simplified route. Both the CBG and Cinfa appealed to the Council. Interpretation of Article 10 (b) Directive 2001/83 The Council notes that Art. 10(b) offers a simplified route for FDCs where each active substance is already authorised as a mono product and its data exclusivity has expired. The applicant may rely on the existing mono product dossiers and only has to provide new preclinical and/or clinical data for the combination product itself. The Council states that the primary objective of the Directive is the protection of public health, while it also aims to avoid unnecessary repetition of animal/human testing, but also to create an environment that does not unduly hinder pharmaceutical innovation and competition. The Council points out that the phrase “have not hitherto been used in combination for therapeutic purposes” could be read as implying that only the first FDC of particular active substances may rely on Art. 10(b). Thus, once an MA has been granted under Art. 10(b) for a given combination, subsequent applicants for the same combination would be excluded from using this provision. However, the Council observes that this textual reading does not fully align with the objectives and structure of the Directive. In regulatory practice, a substantial majority of Member States allow multiple Art. 10(b) MAs for the same combination, provided each applicant submits its own dossier for the FDC and does not rely on data still under protection. The CMDh has endorsed this approach, and the European Commission has, in several opinions and a 2022 letter, taken the position that multiple Art. 10(b) applications for the same combination are not excluded as long as regulatory data protection is respected. The Council also refers to the decision of the Spanish ‘Tribunal Supremo’, which held that neither national nor EU law precludes repeated use of Art. 10(b) for the same combination, and notes that similar litigation is pending in France. In view of the divergent national case law and administrative practice, the Council concludes that the interpretation of Art. 10(b) is not an acte clair and that there is a risk of inconsistent application across the EU. The preliminary questions to the CJEU To ensure a uniform interpretation of Art. 10(b), the Council refers two questions to the CJEU: 1. Whether Art. 10(b) of the Directive must be  nterpreted as allowing a subsequent MA for the same FDC of active substances to be granted under that provision, even where an earlier MA for that combination has already been granted using Art. 10(b)? 2. Whether, when answering the first question, it is relevant that the subsequent combination product is applied for with a different therapeutic indication from that of the earlier combination product – i.e. whether a different indication implies a different “therapeutic purpose” within the meaning of Art. 10(b)? Conclusion The forthcoming CJEU judgment will clarify whether Art. 10(b) can be relied on more than once for the same FDC and whether differences in therapeutic indications are relevant for that assessment. The outcome will clarify the way to go forward with MA applications for FDC products by using the Art 10(b) route, a full-dossier application or a belated generic application.

On 12 December 2025, the UPC Local Division Munich (“LD Munich”) handed down its decision in the parallel proceedings between Sanofi and STADA, Dr. Reddy and Zentiva and revoked Sanofi’s cabazitaxel patent EP 2 493 466 (‘‘EP 466’’) in all UPC territories in which the patent was in force and dismissed the infringement actions. In this case the UPC Court of First Instance applied for the first time the inventive step test for second medical use claims as recently determined by the UPC Court of Appeal (‘‘CoA’’) in Amgen v. Sanofi/Aventis. It was held that the patent lacked inventive step over the Phase III TROPIC (NHSC) trial document. What preceded Sanofi SA holds EP 466, which relates to a ‘’novel anti-tumoral use of cabazitaxel.’’ Sanofi markets its product containing cabazitaxel under the name JEVTANA® as a second-line treatment for prostate cancer patients. On 13 May 2024, several Sanofi entities filed infringement actions before the LD Munich against several entities of Accord, STADA, Dr. Reddy and Zentiva. Each of the defendant groups filed counterclaims for revocation based on lack of novelty and inventive step and, in some cases, added matter or lack of sufficiency of disclosure.The proceedings between Sanofi and Accord were withdrawn prior to the oral hearing, based on a confidential settlement and license agreement. On 6 September 2024, the ‘Tribunal Judiciaire de Paris’ invalidated the French part of EP 466, holding that it was obvious, considering documents describing a Phase III clinical trial with cabazitaxel and that a skilled person at the priority date would have had a reasonable expectation of success. According to the LD Munich, Sanofi appealed and settled the matter with Accord by requesting the reversal of the decision. The EPO Opposition Division (“OD”) on 15 December 2023 and Board of Appeal (“BoA”) on 3 June 2025 (T 0136/2024) rejected the oppositions filed against EP 466 and held the patent valid and not obvious. Both the OD and the BoA held that, based on the documents describing a Phase III trial with cabazitaxel, the skilled person had no reasonable expectation of success. Inventive step test – CoA The LD Munich records that the parties debated which inventive step test to apply: the problem-solution approach as applied by the EPO or the more holistic approach as formulated by the CoA, which is similar to the approach taken by the Tribunal Judiciaire de Paris. The LD Munich applies the test as formulated by the CoA in Amgen v. Sanofi-Aventis (paras 123–138). Objective (technical) problem Following the inventive step test of the CoA, the LD Munich holds that the objective problem is established by comparing the claim as a whole in the context of the description and the drawings, also considering the inventive concept underlying the invention. In order to avoid hindsight, the objective problem should not contain pointers to the claimed solution. In that regard, the LD Munich finds that the objective technical problem as formulated by the BoA contains parts of the solution and thus does not avoid hindsight. Therefore, the LD Munich reformulates the objective technical problem as the provision of a therapeutic option for treating patients suffering from castration-resistant metastatic prostate cancer who have been previously treated with a docetaxel-based regimen and have prostate cancer that progressed during or after that treatment. This includes both increased overall survival and purely palliative treatment. Reasonable expectation of success The LD Munich further assesses whether the skilled person, starting from a realistic starting point and seeking to solve the objective technical problem, would have (and not only could have) arrived at the claimed solution. Taking NHSC’s protocol of the Phase III TROPIC trial as the starting point, the LD Munich notes that it discloses all features of claim 1 in hypothesis form and records that the trial was already well advanced at the priority date. It then weighs the positive and negative pointers in the prior art. The LD Munich finds that a skilled person at the priority date would have had a reasonable expectation of success in view of the clinical Phase III trial and finds the patent invalid based on lack of inventive step. The LD Munich points out that the skilled person does not need to have certainty of success by any means. It adds that, in oncology, Phase III trials are regularly initiated without a Phase II study in the same tumour type, and holds that in this case the absence of a prostate-cancer Phase II trial did not preclude a reasonable expectation of success, No binding effect of EPO decisions Having regard to the deviating decisions of the OD and the BoA, the LD Munich considers that these decisions do not have a binding effect. It specifically emphasises that, while the UPC may, in principle, consider decisions and opinions issued by national courts and the EPO when interpreting the EPC, this does not relieve a UPC panel of its duty as an independent judicial body to interpret and apply the EPC in full. Conclusion The LD Munich revokes EP 466 in its entirety with effect in the following UPC Contracting Member States AT, BE, DE, DK, FR, IT, NL, PT and SE and dismisses the infringement actions. The decision is the first case in which the Court of First Instance applies the ‘holistic inventive step test’ formulated by the CoA. It also underlines that EPO and national decisions, althoughinfluential, have no binding effect within the UPC.

On 1 October 2025, the District Court of The Hague (“Court”) handed down its decision in the accelerated final relief proceedings between Samsung Bioepis NL B.V. (“SB”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”). The Court dismissed SB’s revocation action against the NL part of EP 2 364 691 (“EP 691”) and the NL part of EP 2 944 306 (“EP 306”) and denied the requested Arrow declarations. The Court held that SB’s aflibercept biosimilar (Opuviz) infringes EP 691. It maintained EP 306 in amended form. What preceded Regeneron holds EP 691 and EP 306, which are divisionals of EP 2 209 103. Both patents are entitled: “VEGF antagonist formulations suitable for intravitreal administration”. The medicinal product of Regeneron is marketed under the brand name ‘Eylea’. Eylea is used in the treatment of, amongst others, wet Age-related Macular Degeneration (wAMD). On 13 January 2025, the Opposition Division of the EPO invalidated EP 306, holding that EP 306 was not entitled to priority and contained added matter. Regeneron appealed. In the appeal proceedings Regeneron relied, in its Main Request, on one single claim. No opposition was filed against EP 691. SB started two revocation actions before the Court claiming that both patents are invalid due to added matter, lack of novelty and lack of inventive step based on several prior art documents. It also contested that the patents can claim priority based on US 484. In each case, SB also requested an Arrow declaration. Regeneron filed a counterclaim for infringement of the NL part of EP 691. Moreover, it requested the Court to grant an injunction in all designated states of EP 691 (excluding UK and DE) based on the alleged threat of unlawful acts performed by SB. The decision Added matter and priority In the combined proceedings, the Court rejected SB’s arguments and held that, based on common general knowledge, both US 484 and the applications for EP 691 and EP 306 provide a clear and direct basis for combining aflibercept with the excipients in the claimed amounts or ranges. The formulations were disclosed directly and unambiguously in US 484 and in the applications, including those claims or parts referring to the mature sequence (‘’consisting of”), the sodium phosphate buffer, and the pre-filled syringe. Novelty The Court notes that the skilled person would understand that intravitreal use requires an isotonic formulation. In contrast, the prior art (WO 852 and Fraser) only disclose hypertone formulations, whereas WO 650 does not disclose intravitreal use. Thus, none of these documents discloses directly and unambiguously claims 1 and 6 of EP 691. Therefore, the Court finds EP 691 novel. Inventive step The Court rejects SB’s invalidity arguments regarding inventive step. Based on the common general knowledge a skilled person could have arrived at the formulation claimed in EP 691 on the basis of US 234. However, SB has not sufficiently demonstrated that he would have done so without inventive labour, because he had a reasonable expectation of success. The Court states that there is no try-and-see situation applicable under these circumstances. Infringement of claim 6 The Court finds that claim 6 of EP 691 is infringed. In reaching this conclusion, the Court relies on Regeneron’s expert evidence, including the CEPTER report, which demonstrates that SB’s product corresponds to the claimed aflibercept composition. SB did not submit any experimental data nor did it provide samples to contradict these findings. Unlawful acts of SB Regeneron also requested an injunction in all designated states of EP 691 (excluding UK and DE) as it considers it likely that SB will grant third parties in all designated states the right to use SB’s marketing authorisation (“MA”) for Opuviz. The Court finds it has jurisdiction to hear such claim under article 4 of the Brussels I bis Regulation, but dismisses the request as Regeneron insufficiently substantiated which third parties threaten to make use of the MA of SB in which countries. Other jurisdictions The Court notes that there are ongoing proceedings relating to these (or related) patents in: DE, UK, SK and the US. The proceedings in DE focused on the validity of EP 691. Shortly after the Court handed down its decision on 1 October, the UK High Court rendered its judgement on 8 October in the parallel revocation action filed by Formycon and SB UK. The High Court held that EP 306 was not entitled to priority and thus invalid for added matter. EP 691 was maintained but in an amended form. Contrary to the NL decision, the High Court found that there was no infringement. The UK decision also mentions that there are parallel proceedings in FR, IT, BE and CA. Conclusion The Court holds the NL part of EP 691 valid and infringed. Furthermore, the Court maintained the NL part of EP 306 in amended form.

On 10 September 2025, the District Court of The Hague (“Court”) rendered its decision in the accelerated final relief proceedings between Samsung Bioepis UK Ltd. (“SB”) and Janssen Biotech Inc. (“Janssen”). The Court dismissed SB’s revocation action and upheld the NL part of EP 3 883 606 (“EP 606”) containing a second medical use of the active ingredient ustekinumab (marketed as Stelara). What preceded This case follows earlier litigation in the Netherlands regarding the basic patent EP 1 309 692 (‘’EP 692”) and its SPC related to ustekinumab. In January 2024, the Provisions Judge of the District Court, denied Janssen a PI against SB. SB could benefit from the SPC Manufacturing Waiver for the production and stockpiling for export of its biosimilar products. This decision was confirmed by the Court of Appeal in February 2025 (see our Pharma Updates of 31 January 2024 and 19 February 2025). Both EP 692 and its SPC are now expired and the current dispute focuses only on EP 606. Janssen markets ustekinumab under the brand name ‘Stelara’ for various immune-mediated inflammatory diseases, including psoriasis, psoriatic arthritis, Crohn’s disease, and, since 2019, ulcerative colitis (“UC”). Janssen obtained EP 606 as a second medical use patent for the treatment of UC. SB started a revocation action claiming EP 606 is invalid due to lack of novelty, lack of inventive step and insufficiency of disclosure. Furthermore, SB argued that, with regard to claim feature 2.5, Janssen cannot claim priority on the basis of priority documents (P1, P2, P3). In the proceedings Janssen solely relies on priority documents P2 and P3. The decision Priority documents P2 and P3 – claim interpretation The Court held that Janssen can rely on the priority document P2 because “week 0” in claim feature 2.5 must be understood as the start of the maintenance phase of the UNIFI study, and that CSFCR (corticosteroid-free clinical remission) must be achieved at week 44, and not merely before week 44, as SB contended. The Court also clarified that based on the interpretation by the person skilled in the art, claim feature 2.5 does not require a specific level of statistical significance. It further notes that parties no longer disagree that claim feature 2.5 is not limited to patients who were on corticosteroids at the start of the study. Novelty SB further argued that EP 606 lacked novelty based on the UNIFI Protocol, the Ochsenkühn Abstract and Poster, and the Sands Abstract and Slides, or alternatively due to public prior use. The Court does not follow SB’s reasoning and rejects the arguments. None of the cited documents directly and unambiguously discloses claim feature 2.5; inherent disclosure is insufficient for novelty. Inventive step SB presented numerous inventive step attacks. It argued lack of inventive step based on the UNIFI Protocol (or in combination with the common general knowledge), the Ochsenkühn Abstract and Poster, and the Sands Abstract and Slides. The Court applied the PSA regarding inventive step. The Court emphasised that inventive step is only lacking if the skilled person in the art, starting from the prior art, would have had a reasonable expectation of success in solving the problem; a mere hope to succeed or the fact that a trial/study was “obvious to try” is insufficient. The threshold for a reasonable expectation of success depends on: i) the complexity and duration of the research and ii) the complexity of the technical problem to be solved. The Court also addressed SB’s reliance on a recent TBA decision (T1941/21). From that decision follows that clinical trials are usually initiated on the basis of encouraging results from preclinical experiments. Thus, the announcement of a Phase II trial may provide a skilled person with a reasonable expectation of success. According to the Court this needs to be assessed on a case-by-case basis. In assessing the specific circumstances of this case, the Court held that the prior art did not provide a reasonable expectation of success. In this case the threshold is high because of the: high endpoint of the UNIFI study, difficult patient population, and inconsistencies and limitations in the available data. Therefore, the Court held EP 606 inventive. Sufficiency of disclosure SB argued that EP 606 was not sufficiently disclosed. The Court held that these arguments were unfounded. Other jurisdictions The Court notes that there are ongoing proceedings regarding the validity of EP 606 in the UK, Italy and Denmark. On 30 July 2024 the High Court of the UK, rendered its decision in final relief proceedings and found the UK part of EP 606 invalid for lack of inventive step based on the ‘Sands Abstract’ and the ‘Sands Slides’. The Court further points out that in the US parties reached a settlement regarding the market entry of SB. Conclusion Based on its own assessment, the Court holds the NL part of EP 606 valid and dismisses SB’s revocation action.