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On 10 April 2026, the Supreme Court handed down a judgment of significance to investment companies and conglomerates with multiple subsidiaries. The central question was whether a parent company fined by the Netherlands Authority for Consumers and Markets (“ACM”) for a cartel infringement committed by its subsidiary can recover the fine paid from that subsidiary. The Supreme Court’s answer is clear, but contains a nuance that is important in practice. The case Between 2004 and 2011, the investment firm Bencis held an indirect stake in Meneba, a Dutch flour manufacturer. From 2001 to 2007, Meneba participated in a cartel of flour manufacturers, in breach of article 6 of the Competition Act and article 101 of the Treaty on the Functioning of the European Union. The Dutch Competition Authority (the legal predecessor of the ACM) therefore imposed a fine of €9 million on Meneba in 2010. On 17 July 2014, the ACM also decided to impose a fine on Bencis. This fine followed Bencis’s sale of its shares in Meneba in 2011. The basis for this fine was that Bencis, as the parent company, was able to exercise decisive influence over Meneba’s commercial policy, meaning that, for the purposes of competition law, it formed a single undertaking with its subsidiary Meneba. The fine imposed on Bencis amounted to over €1.27 million. Although Bencis contested the fine, it was upheld by both the Administrative Court and the Trade and Industry Appeals Tribunal (“CBb”). Bencis considered it unfair that it had to pay a fine for the conduct of its former subsidiary and brought the matter before the civil court. It claimed compensation from Dossche (the party that had acquired Meneba in 2018) for the fine imposed on it. Both the District Court and the Court of Appeal dismissed the claims. As set out in further detail below, the cassation appeal lodged against this decision was also dismissed by the Supreme Court. The Supreme Court’s ruling The Supreme Court held, first and foremost, that the allocation of liability for a competition fine within a single undertaking is governed by national law, subject to the EU law principles of effectiveness and equivalence. Insofar as Bencis based its claim on a tort (Article 6:162 of the Civil Code), the Supreme Court ruled that a breach of competition law by a subsidiary is not automatically unlawful vis-à-vis the parent company. Additional circumstances are required for this, for example that the subsidiary deliberately misled the parent company or kept it unaware of the infringement. As Bencis failed to establish such additional circumstances, the claim for tortious liability was dismissed. The Supreme Court did not assess the substance of Bencis’s argument that Meneba had been unjustly enriched at Bencis’s expense, on the grounds that Meneba had paid a lower fine than would have been the case had it been the sole party fined. However, the Court of Appeal had already ruled that there was no unjust enrichment, a ruling which was upheld on appeal. Conclusion and practical implications This judgment could have far-reaching consequences for investment companies and other conglomerates. Where a parent company exercises decisive influence over a subsidiary, it runs the risk of being held personally liable for that subsidiary’s competition law infringements, even if it was unaware of them. As this judgment emphasises, recouping a fine imposed on the subsidiary from the parent company is only possible if the parent company can demonstrate additional circumstances from which it follows that the subsidiary acted unlawfully, for example through deception or the deliberate withholding of information. The lesson is clear. Investment firms and conglomerates would be well advised to invest in ongoing compliance within their portfolio companies. Neither conducting due diligence prior to an acquisition nor carrying out annual checks on whether any legal violations have been committed is, in itself, sufficient to avoid liability for fines or to recover any such fine from a subsidiary. Organisations that have not yet taken sufficient action in this area would benefit from offering their staff and directors targeted training and education in competition law. A well-structured compliance programme not only reduces the risk of breaching the cartel prohibition, but also strengthens the organisation’s position in any enforcement proceedings. Are you interested in compliance training courses, or do you have any questions on this subject or any other questions regarding competition law? Please do not hesitate to contact Arnout Koeman, Noa van den Brink, or one of our other competition law specialists.

The Dutch healthcare sector is facing radical changes. Rising healthcare costs, staff shortages and the call for a future-proof healthcare landscape are forcing hospitals, healthcare providers and health insurers to work more closely together and redistribute care. However, cooperation in healthcare quickly touches on competition law: when healthcare institutions make agreements amongst themselves about who provides which care, this can easily qualify as a prohibited market-sharing agreement. The Netherlands Authority for Consumers and Markets (“ACM”) recently published a letter on this subject, addressed to the parties participating in the ‘Round Table on a Future-Proof Healthcare Landscape through Concentration and Distribution’. This is an important signal for all healthcare providers and insurers active in regional partnerships. Description of the letter The ACM notes that healthcare markets are undergoing significant change. Healthcare stakeholders — including patient organisations, healthcare providers, hospitals and health insurers — are working together to create a regionally balanced healthcare landscape for the future. The Round Table, led by the Dutch Healthcare Institute, is the platform where this collaboration takes shape. ACM recognises the social importance of these developments and wishes to contribute constructively. At the same time, the regulator emphasises that agreements on the redistribution of healthcare between healthcare institutions must be assessed against competition rules. Such agreements may amount to market-sharing agreements — one of the most serious categories of competition infringements under Article 6 of the Dutch Competition Act and Article 101 TFEU. To provide legal certainty to the parties, the ACM has indicated that it will not initiate an investigation on its own initiative into regional healthcare collaborations that may restrict competition, provided the following conditions are met: All relevant parties from the healthcare triangle comprising healthcare providers (including medical specialists and nurses), health insurers and patients are involved. Which patient representatives must be involved depends on the agreements made. Depending on the specific case, patient representatives with specific knowledge of the condition in question may sometimes be required. Concrete, measurable and identifiable objectives have been set regarding affordable, accessible and high-quality care, and all relevant parties support these agreements . The ACM thereby sets enforcement priorities: it indicates where its enforcement focus does not lie, without the legal prohibition ceasing to apply. The information letter serves as a guide for parties to organise their cooperation in such a way that it remains within the bounds of competition law. What does this mean for your healthcare organisation? For healthcare institutions, health insurers and other healthcare parties, this notice has concrete implications: The obligation to assess compliance remains. The announcement that the ACM will not conduct proactive investigations does not relieve parties of the obligation to assess their cooperation agreements themselves against the competition rules. The prohibition on market-sharing agreements remains in full force. Document your cooperation carefully. Record the objectives underlying the cooperation, the alternatives considered and the intended benefits for patients. A thorough file is essential in the event of a retrospective review. Seek legal advice at an early stage. Particularly in the case of regional reallocation agreements — where hospitals or healthcare providers agree on who will provide certain types of care — the line between such arrangements and prohibited market-sharing agreements is fine. Seeking legal advice early on prevents costly mistakes. Engage with the ACM as a discussion partner. The ACM explicitly states its willingness to contribute ideas regarding potential collaborations. Informal consultation with the regulator — or a formal request for an opinion — can provide valuable clarity before agreements are implemented. Keep an eye on European dimensions. In the case of collaborations that may affect trade between EU Member States, Article 101 TFEU also applies. This is particularly relevant for border regions or where foreign healthcare providers are involved. In short: the ACM allows for cooperation in the healthcare sector, but sets clear boundaries. A proactive and legally sound approach is essential for any healthcare party involved in regional redistribution agreements. Contact Do you have any questions on this subject? Or do you have other competition law queries? Please feel free to contact Arnout Koeman or Monika Beck or one of our other competition law specialists.

La Gro provided legal assistance to Pruis Orthopedie in connection with the sale of shares to Ortho Dev Nederland, a subsidiary of Eqwal. The La Gro team supported Pruis Orthopedie throughout the entire process. Founded in 1932, Pruis Orthopedie is a long-established name in the region and specialises in the production of high-quality insoles, adaptations to regular footwear and (semi-)orthopaedic shoes. The company is known for its craftsmanship, quality and personal service. The Eqwal Group and offers a broad range of orthopaedic solutions. Through the transaction, the Eqwal Group further strengthens and expands its presence in the Stedendriehoek region (Apeldoorn, Deventer and Zutphen). Pruis Orthopedie will, for the time being, continue to operate under its own name. Contact The La Gro team advising the shareholder of Pruis Orthopedie comprised Pieter van den Oord, Patrycja Chelmiak and Fardau Talsma. For assistance or questions, you can contact them or one of our specialist from the mergers and acquisitions team.

It has been a topic of considerable debate in employment law circles for quite some time: does an employee accrue holiday entitlement during a so-called dormant employment contract? Conflicting frameworks: Dutch law and European law Dutch law links the accrual of holiday entitlement to the payment of salary. The accrual of holiday days therefore stops when the 104-week waiting period during illness comes to an end. European law applies a different standard and links holiday entitlement to work, including periods of incapacity for work, and not the payment of salary. On the basis of the European legislation, sick employees would be entitled to full accrual of holiday days even after the 104 week waiting period. The fact that these different frameworks lead to uncertainty is evident from the conflicting rulings on the accrual of holiday days after the end of the waiting period. No accrual of holiday days after the end of the waiting period In the rulings in which the court rules that the employee does not accrue holiday days after the end of the waiting period, reference is made, among other things, to the recuperative function of holidays. After the expiry of the waiting period, the employee would no longer have any (reintegration) obligations, and as a result, holidays would lose its function of recovery and rest. In these rulings, courts also point to the fact that employees with a dormant employment contract receive social benefits (WIA or WW), under which they are entitled to holidays with continued payment of benefits. If the employee were also to accrue paid holiday days with the employer during the same period, that would amount to double entitlement. Accrual of holiday days after the end of the waiting period In an earlier blog, we highlighted the ruling of the District Court of Gelderland, in which the judge ruled that Dutch national law is incompatible with Article 31(2) of the Charter of Fundamental Rights of the European Union, which determines that every worker has the right to annual leave with pay. The court ruled that Article 7:634 of the Dutch Civil Code must therefore be excluded from application. The employer ended up being ordered to pay the holiday days accrued during the dormant employment contract. Preliminary question to the Supreme Court – awaiting an answer On 2 March 2026, the District Court of Rotterdam acknowledged the above-mentioned inconsistent case law and uncertainty. The court considered that proceedings will continue to yield inconsistent outcomes in the future without a definitive answer from the Supreme Court on the question of whether holiday days are accrued during a dormant employment contract. The court therefore intends to refer a preliminary question to the Supreme Court on this subject. Although it will take a little longer, employers can look forward to clarity on the accrual of holiday days after the end of the waiting period. Contact Do you have questions about leave and long-term illness, or would you like to exchange views? Please contact Annemiek Varkevisser, Rose Horstman or one of our other employment law specialists.

The long-term engagement of temporary agency workers is not unusual in many organisations. Temporary agency work is used to create flexibility and to absorb fluctuations in staffing levels. But how “temporary” is such work if the same agency worker has been working for the same hirer for many years? In a recent judgment, the Supreme Court made it clear that temporary agency work must genuinely be of a temporary nature.  Case: agency worker working for the same hirer for 13 years In a recent case before the Supreme Court an agency worker had worked almost continuously for nearly thirteen years at the same factory, first at Unilever and later at Upfield. He worked via various temporary employment agencies and successively performed the roles of production worker and dispatch worker. Formally, he was an agency worker. In practice, he performed the same structural work for many years for the same hirer. When Upfield closed the factory, permanent employees were able to invoke the Social Plan. This did not apply to agency workers. The agency worker argued that, due to the long duration of his assignment and the nature of his duties, he was entitled to the same protection as permanent employees. He relied on the Temporary Agency Work Directive (Uitzendrichtlijn) and the Dutch Allocation of Labour by Intermediaries Act (Waadi). In his view, there was no longer any question of temporary agency work with a temporary character, but of structural work. The subdistrict court and the court of appeal ruled in favour of Upfield. In their view, the need for a flexible staffing buffer justified the long-term use of temporary agency work. Upfield pointed to fluctuating workload, seasonal influences and the need to cover staffing gaps. Upfield had also taken other agency workers into permanent employment and had offered the agency worker concerned a one‑year contract. The court of appeal considered it relevant that Upfield therefore did not rely exclusively on temporary agency work. Supreme Court judgment: temporary agency work is by definition temporary The Supreme Court corrected the approach of the lower courts. According to the Supreme Court, temporary agency work must, by definition, be temporary. This follows from the Temporary Agency Work Directive. That Directive permits prolonged or successive engagement of an agency worker only if the temporary nature of the work is safeguarded and there is an objective justification. A general reliance on flexibility is not sufficient for this purpose. Precisely where an agency worker has been working for the same hirer for many years, almost without interruption, this is a strong indication that the work is structural in nature, according to the Supreme Court. The Supreme Court further held that long-term temporary agency work with the same hirer is an indication of possible abuse of successive agency contracts. In such a situation, the court must assess whether the agency structure is not being used to circumvent rules on the protection of employees, such as protection against dismissal, continued payment of wages and access to a permanent position with the hirer. According to the Supreme Court, the court of appeal applied the wrong test. The court of appeal accepted the need for a flexible staffing buffer too readily as an objective justification for thirteen years of temporary agency work. Nor does the fact that other agency workers were taken on as permanent employees and that the agency worker concerned was offered a one‑year contract alter this. In the Supreme Court’s view, the actual deployment of the same agency worker for thirteen years exceeds the boundary of what can still be regarded as temporary. The Supreme Court therefore quashed the judgment and referred the case to the Amsterdam Court of Appeal. Implications for practice: scrutinising temporary agency work The judgment marks a shift as regards the length of time for which an agency worker may be engaged by the same hirer. The key point is that temporary agency work must be temporary. Temporary agency work is intended to cover peaks, sickness, replacement or clearly defined projects, and not to fill structural positions for many years. Points of attention for employers that work with agency workers include the duration of the engagement and whether agency workers are deployed for a temporary project, a peak season or, for example, demonstrably fluctuating production. In addition, this judgment is also relevant in the context of Social Plans and collective labour agreement arrangements. Agency workers are still regularly excluded from such schemes. If temporary agency work in fact no longer has a temporary character, an agency worker may argue that he or she is entitled to protection comparable to that of a permanent employee of the hirer. Employers should be aware of this. Contact If you have any questions about the temporary nature of temporary agency work or would like to discuss this further, please contact Rose Horstman or one of our other Employment Law specialists

On 27 January, the Amsterdam Court of Appeal handed down a judgment in the long-running proceedings between trade union FNV and Uber concerning the legal classification of the working relationship between Uber and its drivers. At the heart of the dispute was whether Uber drivers should be classified as employees (in which case the Taxi CAO – the collective labour agreement for the taxi sector – would apply to them) or as self‑employed contractors. FNV argued that Uber drivers in practice operate in a relationship of authority and subordination vis‑à‑vis Uber and are therefore employees. Uber – supported by a number of drivers who participated in the proceedings – argued, by contrast, that the drivers operate as independent entrepreneurs. What happened before the Court of Appeal’s judgment? In first instance, the Amsterdam District Court ruled that Uber drivers are employees. Uber appealed that judgement. In an interlocutory judgment, the Court of Appeal applied the Deliveroo criteria developed by the Dutch Supreme Court, but encountered the question of how one of those criteria – entrepreneurship – should be applied. The Court of Appeal therefore referred a number of preliminary questions to the Supreme Court. The Supreme Court answered those questions on 21 February 2025 and ruled that, when determining the classification question, there is no hierarchy among the various Deliveroo criteria. The entrepreneurship criterion must therefore be taken fully into account when assessing whether an employment contract exists. This made clear that other criteria do not automatically carry greater weight. Following that decision, the proceedings before the Amsterdam Court of Appeal were resumed. What did the Court of Appeal decide? The Court of Appeal ruled that the Uber drivers in question display a strong degree of entrepreneurship and concluded that there was no employment contract. In doing so, the Court of Appeal attached particular weight to, among other things: the scale of the drivers’ investments, including purchasing and choosing their own car; the freedom to determine their own working hours; the freedom and strategy involved in accepting or declining rides; and bearing entrepreneurial risks, such as liability and incapacity for work. The Court of Appeal further noted that, while the drivers concerned do work many hours per week, they also use multiple platforms at the same time. Uber drivers are often logged into several apps simultaneously, which the Court of Appeal considered an indication of entrepreneurship. Finally, the Court of Appeal expressly observed that the assessment may turn out differently if  the specific circumstances of an individual driver warrant it. It is therefore entirely possible that certain Uber drivers would qualify as employees. The classification of working relationships is not “one-size-fits-all”. What does this mean in practice? Once again, this judgment confirms that classifying a working relationship is not a standard, tick‑the-box exercise. Whether there is an employment contract or genuine self‑employment depends on an overall assessment of all the circumstances of the case. The individual circumstances are decisive. There is no uniform classification for everyone, not even within a single platform or organisation. A tailored, case‑by‑case approach is, and remains, necessary. The new coalition parties say little of substance in their coalition agreement about policy on the self‑employed (zzp’ers). The focus appears limited to tackling bogus false self‑employment and continuing work on the Self‑Employed Act. Hopefully, the legislative process will be taken up promptly and that the new legislation will provide concrete guidance that can be used in practice.  If you have any questions about the classification of working relationships, or about the implications of this judgment for your organisation, please contact Lisa van Baarsel or one of our other employment law specialists.

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 18 December 2026 the Provisions Judge of the District Court of The Hague (“Provisions Judge”) rendered his decision in the PI proceedings initiated by Newron Pharmaceuticals S.p.A. (“Newron”) & Zambon S.p.A (“Zambon”) against Vivanta Generics S.R.O. (“Vivanta”). According to the preliminary opinion of the Provisions Judge, the Dutch SPC for safinamide, based on EP 1 613 296 (“EP 296”), meets the requirement of Art. 3(a) of Regulation 469/2009 (“SPC Reg.”). A preliminary injunction (“PI”) is granted. What preceded Newron was the proprietor of EP 296 entitled “Methods for treatment of Parkinson’s disease.” It claimed the use of safinamide in combination with levodopa/PDI for treating Parkinson’s disease by way of Swiss-type claim. The patent expired on 8 April 2024. The Dutch Patent Office granted SPC no. 300752 (“SPC”), which will expire on 7 April 2029. Newron’s medicinal product is marketed under the brand name ‘Xadago’. Zambon is Newron’s exclusive licensee in the Netherlands. On 7 April 2025, Vivanta obtained two marketing authorisations (‘‘MAs’’) in the Netherlands for its generic safinamide products (“the Products”). The Products were listed in the pricelist (”G-Standaard”) for November 2025, published on 27 October 2025. On 3 November 2025 Newron c.s. initiated PI proceedings, the oral hearing was held on 6 November 2025. Article 3(a) SPC Reg. – product protected by patent. The dispute focused on the requirement of Art. 3(a) of the SPC Reg. Parties agreed that Newron’s SPC meets the criteria of Art. 3(b-d) SPC Reg. Vivanta argued that EP 296 does not protect safinamide as such, but only the combined administration of safinamide with levodopa/PDI. Since the SPC has been granted for the single active ingredient safinamide, the SPC product falls outside the invention. In support of this, Vivanta in par. 4.16 referred to CJEU case law (Medeva and Yeda), where the Court of Justice held that Art. 3(a) precludes grant of an SPC for ingredient A when the basic patent claims only a combination A+B. In paras 4.18-19 the Provisions Judge rejects this argument. He applies the two-step test developed by the CJEU in Teva/Gilead (confirmed in Teva/MSD and MSD/Clonmel). A product is protected by a basic patent under Art. 3(a) of the SPC Reg. if two cumulative criteria are met: (i) from the perspective of the person skilled in the art and in light of the description and drawings, the product necessarily falls under the invention for which the patent was granted, and (ii) the product is either expressly mentioned in the claims or can be specifically identified by the skilled person based on all information disclosed in the patent in combination with the state of the art at the filing or priority date. As to the first step, the Provisions Judge holds that, correctly construed, claim 1 of EP 296 does not claim a combination product comprising both safinamide and levodopa/PDI, but a further medical use of safinamide as an add-on therapy in patients already on a stable levodopa/PDI regimen. Claim 1 is drafted as a Swiss-type claim, which entails that it is claiming a second or further medical application/use of a known medical product. For the second step, the Provisions Judge holds that safinamide is expressly identified in claim 1 and throughout EP 296 the focus is on the active safinamide. The product underlying the SPC is safinamide, which is also the sole active ingredient in Xadago according to the MA. Levodopa/PDI are not active ingredients of the Xadago product itself. Discussing the arguments of Vivanta, the Provisions Judge considers in par. 4.22 that while Santen overruled the Neurim approach to Art. 3, it reaffirmed that the SPC Reg. is not limited to entirely new active ingredients and that a new method of obtaining a product or a new application of a product may also be protected by a certificate, provided that the product has not previously been the subject of an MA as a medicinal product. As is the case here. The Provisions Judge rejects Vivanta’s argument based on Medeva and Yeda, as the situation in these cases was very different. In both cases, the independent claims related to combination products (A+B), whereas in the present case claim 1 concerns only one component (A). The Provisions Judge finds that both steps of the Teva/Gilead test are met and that safinamide is protected by EP 296 for the purposes of Article 3(a) SPC Reg. Therefore, the Provisions Judge holds the present SPC preliminary valid. Other jurisdictions According to the Provisions Judge (par. 4.24), the SPC applications relating to safinamide have been refused in the UK, Finland and Sweden. These cases concerned SPC applications that were defined as a combination of safinamide and levodopa/PDI, creating a discussion on Art. 3(b) instead of Art. 3(a). In Germany the SPC is also refused on the basis of Art. 3(a) (appeal pending). Conclusion As the Provisions Judge holds the SPC valid, the inclusion of Vivanta’s Products in the G-Standaard constitutes infringement within the meaning of Art. 53 Dutch Patent Act. Therefore, a PI is granted.

On Friday, January 9, 2026, the European Commission published the guidelines associated with the Foreign Subsidies Regulation (“FSR”). In these guidelines, the European Commission clarifies various concepts in the FSR and explains the application of the FSR. This publication marks another step in making the FSR review process transparent.  Foreign Subsidies Regulation – how was it again? On July 12, 2023, the FSR became applicable. The FSR allows the European Commission to address distortions caused by foreign subsidies. The aim is to create a level-playing-field between all (EU and non-EU) companies operating within the EU. In a nutshell, the FSR contains three procedures: A reporting requirement for transactions involving subsidies given by third countries. This notification requirement applies if the target company, one of the merging parties or the joint venture has an EU turnover of at least EUR 500 million and these companies have received subsidies from third countries totaling more than EUR 50 million in the three years prior to the conclusion of the purchase agreement; A notification requirement for procurement involving subsidies from third countries. This notification requirement applies if the estimated contract value is at least EUR 250 million and the tenderer has received more than EUR 4 million in subsidies from third countries in the three years prior to the notification; and An ex-officio procedure by the European Commission, in which the European Commission launches an investigation on its own initiative. Since coming into force, the European Commission has launched a few investigations and has completed very few investigations as well as published decisions. As such, these guidelines, which the European Commission needed to draft according to the FSR, are also timely. They give (foreign) parties more legal certainty about their legal position under the FSR.    On what issues do the FSR guidelines provide more clarity? The comprehensive guidelines (48 pages) explain many parts of the FSR. A few points to highlight are the following: The assessment of market distortions caused by subsidies from third countries. The guidelines clarify that when the European Commission has concluded that a company has benefited from a foreign subsidy, the European Commission determines whether market distortion has occurred in two steps. First, the Commission examines whether the foreign subsidy strengthens the firm’s position in the EU market. Second, the European Commission examines the impact of the subsidy on competition in the market. In doing so, the European Commission analyzes whether the subsidy is responsible for a change in the company’s behavior and market dynamics to the detriment of other market parties. Assessment in tenders. The European Commission also provided further clarification on how it will assess market distortions caused by subsidies in tenders. In doing so, the European Commission will first examine whether the company adjusted the tender as a result of the subsidy. If so, the European Commission will assess whether the tender is unduly advantageous by comparing it with other comparable tenders and assessing the tender by comparing the conditions with the contracting authority’s own estimates. The balancing test. The balancing test can be applied by the European Commission on a grant-by-grant basis and takes into account the specific circumstances of the case. The guidelines explain how to weigh positive effects of a subsidy versus negative effects of a subsidy. In doing so, the European Commission will include only the positive effects that are specific to the subsidy. The test will also include the severity of the market distortion and the positive effects without the market distortion. An ex-officio investigation. The European Commission has provided more clarity in the guidelines on when it will initiate an ex-officio investigation. In doing so, the guidelines provide so-called safe harbor thresholds: for procurement procedures with a low value, subsidies under EUR 4 million and subsidies aimed at special circumstances (such as natural disasters), the European Commission will not start an investigation. What does this mean for your company? With the publication of these FSR Guidelines, the European Commission is taking the next step in the development of the FSR. These guidelines give companies and contracting authorities more clarity on how the European Commission assesses notifications. Importantly, the European Commission is also introducing safe harbor thresholds that will allow companies and contracting authorities to be more certain that the European Commission will not start an investigation. This will increase legal certainty. Do you have questions about the FSR or the guidelines discussed above? Please contact Arnout Koeman or Monika Beck or one of our other FSR and procurement law specialists.

La Gro provided legal assistance to Prodeba in the acquisition of the youth care activities of Stichting Maatwerk Autisme (MAG) in Maassluis. As of 1 January 2026, Prodeba will be responsible for the care of young people in Maassluis. This transaction will enable the specialist support for children and young people with autism in the region to continue uninterrupted. Stichting Maatwerk Autisme will continue to operate as a care provider for both young and adult clients. As part of the reorganisation of care in Maassluis, support for adult clients will be transferred to Wmo Maatwerk, part of Ipse de Bruggen. Prodeba and Wmo Maatwerk will continue to work closely together to further strengthen healthcare provision in Maassluis and to make the transition as smooth as possible for clients. A large proportion of the employees involved in youth care in Maassluis will be transferring to Prodeba. This will ensure that knowledge, experience and familiar faces are retained for clients and their families, contributing to continuity and stability in care. The importance of a careful transition and appropriate care for children and young people is central to this transaction. As Prodeba itself puts it: ‘We are proud that this step will enable us to continue to support children, young people and families in Maassluis with care that is tailored to their development and offers them prospects for the future.’ The legal advice, negotiations and recording of the agreements in the contract documentation were carried out on behalf of Prodeba by Pieter van den Oord and Reinoud van Ginkel. Contact If you have any further questions, please contact Pieter van den Oord, Reinoud van Ginkel, or one of our other specialists from the mergers & acquisitions team. They will be happy to assist you.

On 16 December 2025, the European Commission adopted the revised version of the Exemption Decision for state aid for services of general economic interest (“SGEI Decision”). The SGEI Decision makes it possible to grant aid for services that cannot usually be provided profitably on the market without the need to notify the aid to the European Commission. This SGEI Decision has now been updated by the European Commission, partly with the aim of stimulating housing construction and combating the housing crisis. What exactly has changed? And what consequences does this have for you? You can read all about it in the blog below! What is state aid? State aid law aims to protect competition by preventing governments from unfairly favouring certain companies. This is achieved through the prohibition of state aid in Article 107 of the Treaty on the Functioning of the European Union (TFEU). Under Article 107(1) TFEU, state aid is deemed to exist if the following five cumulative conditions are met: The aid is granted to an undertaking engaged in an economic activity; The aid is financed from state resources; The aid confers on the undertaking an economic advantage that it would not have obtained under normal market conditions (non-market conformity); The aid is selective: it applies to one or more specific undertakings or a specific sector/region; The aid may distort competition and adversely affect trade between Member States of the European Union. If all of the above conditions are met, the aid is prohibited unless it is approved by the European Commission or a successful appeal can be made on the basis of an exception. One of these exceptions is aid for services of general economic interest (“SGEI“). Services of general economic interest SGEIs are economic activities that serve the general interest but cannot usually be offered profitably on the market. State aid is therefore required to be able to offer these services to citizens on the market under the desired conditions or quality. This may concern, for example, social housing or the operation of economically inefficient bus services. Public authorities have a certain degree of discretion in determining which services they qualify as SGEIs. The SGEI Decision The European Commission has developed a number of instruments on the basis of which SGEI aid can be lawfully granted to undertakings. One of these instruments is the SGEI Decision. On the basis of the SGEI Decision, public authorities may compensate undertakings entrusted with the operation of a SGEI for the provision of the SGEI in question, provided that the following conditions are met: The service qualifies as an SGEI; The compensation does not exceed €20 million per year or falls within the other categories of SGEIs covered by the scope of the SGEI Decision in accordance with Article 2(1) of the SGEI Decision; The period for which the undertaking is charged with the SGEI does not exceed 10 years; The amount of compensation does not exceed what is necessary to cover the net costs of implementing the SGEI, including a reasonable profit, i.e., there must be no overcompensation; The undertaking that will perform the SGEI is entrusted with the performance of the SGEI in an entrustment decision setting out the SGEI, the compensation mechanism and other relevant aspects as prescribed in the SGEI Decision; The administrative conditions (control of overcompensation, transparency) are met.   Why revise? The European Commission has conducted an evaluation of (the application of) the ‘old’ SGEI Decision in practice. This has led to the conclusion that the current state aid rules do not provide sufficient guidance for Member States to tackle the housing crisis that the entire European Union is facing. The ‘old’ SGEI Decision was also in need of updating, clarification and simplification of the administrative conditions in certain areas. For these reasons, the European Commission has adopted a revised version of the SGEI Decision, which incorporates experiences from the old decision, economic changes (including the housing crisis) and market developments. The revision is part of the European Commission’s ‘European Plan for Affordable Housing’. SGEI Decision: new vs. old The European Commission has made the following changes to the revised SGEI Decision with regard to the following topics: Increase in compensation ceiling In view of inflation since the entry into force of the ‘old’ SGEI Decision in 2012, the Commission has raised the general compensation ceiling. Based on the revised SGEI Decision, it is possible to grant up to €20 million per year in aid under the general compensation ceiling. Under the “old” SGEI Decision, this ceiling was €15 million. Social and affordable housing as SGEI In order to combat the housing crisis in Europe, the European Commission has further elaborated/relaxed the frameworks for SGEI aid for social housing. It has also added affordable housing as a category of aid. SGEI aid for social and affordable housing is not subject to the general compensation ceiling and may therefore exceed €20 million per year, provided that this does not lead to overcompensation. The European Commission has set out the main definitions and conditions for housing aid in the annex to the revised SGEI Decision. An SGEI in the field of social housing is defined as a service for disadvantaged households or socially disadvantaged groups, including the homeless. SGEIs for affordable housing mainly concern households that are not disadvantaged but which, due to market developments, in particular market failure, do not have access to housing on affordable terms. Examples include first-time buyers, the elderly or single parents. In the annex to the revised SGEI Decision, the Commission sets out, among other things, the following conditions (in addition to the general conditions of the SGEI Decision) that must be met when granting aid for social and/or affordable housing: Quality, environmental and accessibility requirements: social and affordable housing must be of adequate quality and accessibility, comply with environmental standards and be adapted to the needs of households. Duration: in principle, social and affordable housing must be used for that purpose for at least 20 years to prevent subsidised housing from being sold quickly on the commercial market. Eligible costs: the annex contains a broad list of costs that are eligible for coverage by SGEI aid. With regard to affordable housing, requirements are also imposed on the prices charged that can be charged. These must be set in a transparent manner and remain below market prices, but not lower than necessary to achieve the objective pursued. The dwellings in question must also actually be used as affordable housing (and not, for example, as second homes) and the allocation of dwellings must be based on open systems. New/amended aid categories Critical medicines have been added as a possible aid category in the revised DAEB Exemption Decision. The frameworks for airports, air connections, maritime connections with islands and ports have also been amended. Control of overcompensation The European Commission has relaxed the regime with regard to the control of overcompensation. Under the ‘old’ SGEI Decision, control of overcompensation had to take place every three years and at the end of the SGEI. In the revised SGEI Decision, this frequency has been reduced to once every five years. Furthermore, ex post monitoring is no longer required if the beneficiary does not carry out any activities other than the SGEI and is legally obliged to reinvest all profits in the SGEI. Reporting and transparency obligations Under the ‘old’ SGEI Decision, Member States were subject to a biennial reporting obligation. This obligation will be abolished in 2026. Transparency will be ensured from 2028 onwards by means of a registration obligation. From 1 January 2028, all state aid under the SGEI Decision exceeding €1 million per undertaking will have to be registered in a central register within 20 working days of the aid being granted. Entry into force The above changes will enter into force on the twentieth day following the publication of the revised SGEI Decision in the Official Journal of the European Union. Practical impact Although the revised version of the SGEI Decision introduces a large number of changes at first glance, the essence of the decision remains largely the same in practice. The basic principles, such as the requirement for an allocation decision and the prohibition of overcompensation, remain in full force. These basic principles are supplemented by concrete guidelines that public authorities can use to tackle the housing shortage in a more flexible and efficient manner. The practical implications are currently limited to incorporating the new frameworks for social and affordable housing when granting support to this type of SGEI. Governments will be relieved of the biennial reporting obligation and will need to check for overcompensation less frequently. As of 1 January 2028, aid providers will be required to register aid grants exceeding €1 million per undertaking per SGEI in a central register. The extent to which these changes will solve the housing crisis remains to be seen in practice. Contact Do you have any questions about this topic? Or do you have other questions about state aid law? Please feel free to contact Monika Beck or one of our other state aid specialists.