Publications

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 12 May 2026, the House of Representatives (Tweede Kamer) approved the legislative proposal More Certainty for Flexible Workers. This brings the introduction of new rules for on-call workers, temporary employees, and agency workers one step closer. In addition, the House of Representatives made a number of significant amendments to the proposal. The legislative proposal More Certainty for Flexible Workers aims to provide employees on flexible contracts with greater certainty regarding their income and working hours. Flexible contracts include, for example, on-call contracts, agency work contracts, and fixed-term contracts. In the Netherlands, nearly three in ten employees work on a flexible contract, making the Netherlands the front-runner in flexible working for the EU. Zero-hours contracts to be abolished, except for under-18s, pupils, students, and those entitled to the state pension One of the most widely discussed aspects of the legislative proposal is the replacement of zero-hours contracts with bandwidth contracts. A bandwidth contract closely resembles the current minimum/maximum contract, but the minimum number of contracted hours may no longer be zero, and the maximum may not exceed 130% of the minimum. An exception is made for young people under the age of 18, those that still go to school, students, and those entitled to the state pension (AOW) insofar as they work no more than 16 hours per week. This group may continue to work on a zero-hours contract. The rationale behind this is that workers in these categories still have a legitimate need for flexibility. The successive contracts rule is only broken after 36 months A fixed-term contract can, by operation of law, convert into a permanent contract. This is known as the ‘successive contracts rule’ (ketenregeling). The rule is triggered when a chain of contracts has exceeded a period of 36 months, or when a fourth contract is concluded, as long as the chain was not interrupted for a sufficiently long period at some earlier point. Currently, a gap of six months between two contracts breaks the chain. Under the legislative proposal, this interruption period will increase to 36 months. Only for pupils and students working no more than 16 hours per week will the interruption period remain at six months. This amendment is designed to prevent abuse: after the change, merely waiting before offering an employee a new contract is substantially less practical. The rules set out in the paragraph will apply to contracts concluded after 1 January 2028. Contracts concluded before that date will continue to be governed by the current rules. Improved legal position of agency workers Finally, the legislative proposal strengthens the position of agency workers. Phase A of an agency arrangement will be reduced from 78 weeks to 52 weeks. Phase B will change from a maximum of six contracts over four years to six contracts over two years. After Phase B, an agency worker must be offered a permanent employment contract. The House of Representatives has added to the legislative proposal that an agency clause (uitzendbeding) may not be invoked during any period in which an agency worker is incapacitated for work due to illness. As a result, an agency worker can no longer lose their job and income simply because they have fallen ill. Furthermore, the House of Representatives has tightened the rules on the terms and conditions of employment applicable to agency workers. The legislative proposal already establishes the principle that agency workers are entitled to at least equivalent terms and conditions of employment as employees who are directly employed by the client. For specific employment conditions, such as pay, allowances, holiday pay, bonuses, end-of-year payments, and leave arrangements, derogation will no longer be possible at all. What does this mean in practice? The legislative proposal is now before the Senate (Eerste Kamer). It is expected to be adopted, although further amendments may be made before it passes. Do you have questions about the effect the legislative proposal More Certainty for Flexible Workers will have on your organization? Feel free to contact Rose Horstman or any of our other specialists.

In the case between the trade unions FNV and CNV and the Temper platform, the Court of Appeal ruled that workers carrying out work via the Temper platform qualify as agency workers. Temper therefore qualifies as a temporary employment agency. This marks another milestone in the series of court rulings on platform work and sends a clear signal to (temporary) employers who make use of platform workers. Temper is an online platform where workers and clients can connect and agree on the work to be carried out. Temper presents itself as a neutral intermediary: a digital marketplace where self-employed people (freelancers) can secure assignments from companies that need extra help on a temporary basis. FNV and CNV took the following position. In their opinion there is a temporary employment contract between Temper and the Temper workers as referred to in Article 7:690 of the Dutch Civil Code. The workers were not ‘genuine entrepreneurs’, but agency workers, with all the legal consequences that entails. What is the court’s ruling? Contrary to the ruling of the Amsterdam District Court, the Court of Appeal has concluded that a temporary employment contract exists between Temper and a worker, as a result of which Temper qualifies as a temporary employment agency. The Court of Appeal reaches this conclusion by applying the criteria set out in the Supreme Court’s Deliveroo judgment. In doing so, the Court of Appeal considers that Temper is closely involved in the establishment of the contractual triangular relationship between Temper, the worker and the client. Temper is also closely involved in how remuneration is determined, how it is paid out and the amount of the remuneration. Given this degree of involvement, Temper – according to the Court of Appeal – cannot be characterised as a mere intermediary platform. The Court of Appeal also ruled that the workers run no (substantial) commercial risk with regard to the question of whether the workers act as entrepreneurs in the course of economic activity. The Court of Appeal considers that there is no evidence to suggest that a significant number of workers have made ‘substantial investments’, given that the list of Temper’s top 25 clients shows that these roles involve work for which no investment is required. The number of workers who are not registered with the Chamber of Commerce, and the fact that entrepreneurship – which is aimed at making a profit – is incompatible with an average hourly rate of €20.78, mean that Temper’s defence does not hold up with regard to these Deliveroo criteria either. All in all, the working relationship is characterised predominantly by factors relating to employment agreement and not – or at least to a much lesser extent – by factors indicative of genuine entrepreneurship. What does this mean in practice? The Temper ruling is the latest in a series of platform rulings following those on Deliveroo and Uber, and once again demonstrates that the actual working situation is of decisive importance. This applies not only to the traditional employer-employee relationship, but also to triangular arrangements such as this one. For Temper and similar platforms, being classified as a temporary employment agency has far-reaching consequences under employment law. As a temporary employment agency, Temper must comply with the Waadi and the collective agreement for temporary workers, as well as ensure pension accrual via StiPP. Contact Do you have any questions about the classification of your employment relationships with platform workers or about the implications of the Temper ruling for your organisation? If so, please contact Lisa van Baarsel, Dunia Caillette or one of our other employment law specialists.

On 16 April 2026, the Court of Justice of the European Union (“CJEU”) delivered an important judgment on the question of when victims in cartel damage cases may sue multiple group companies before a single court. The judgment is relevant for companies operating within international group structures, but also for parties seeking to recover damages following a competition infringement. Central to the case is the so-called ‘anchor defendant’: a defendant established in the Netherlands who is used to bring foreign co-defendants before the Dutch courts. The background The ruling stems from two Dutch proceedings before the Amsterdam Court of Appeal. The first case concerned claims for damages arising from the power cables cartel. The second case concerned claims for damages arising from an Italian cartel in the market for cardboard and packaging materials. In both proceedings, not only were companies summoned that were directly named in a cartel decision, but also other group companies. Some of these were established in the Netherlands and acted as anchor defendants. The claimants sought to bring all defendants jointly before the Dutch courts on the basis of Article 8(1) of the Brussels I bis Regulation. That provision allows multiple defendants to be summoned before the court of the domicile of one of them, provided there is such a close connection between the claims that joint proceedings are desirable. The aim of this is to prevent different courts from issuing conflicting decisions. The judgment of the CJEU The CJEU has ruled that a close connection may also exist where the anchor defendant is not itself designated as a liable party in the cartel decision. The decisive factor is whether there are serious indications that the anchor defendant belongs to the same ‘undertaking’ within the meaning of competition law as the entities to which the infringement has been attributed. The concept of ‘undertaking’ in EU competition law is broader than that of a separate legal entity. Different companies within a group may together form a single economic unit. In such a case, liability for a cartel infringement may, under certain circumstances, extend throughout the group. The CJEU does emphasize, however, that Article 8(1) must not be used artificially. A claimant may therefore not sue a Dutch company with no genuine connection to the dispute solely to bring foreign parties to the Netherlands. However, when determining jurisdiction, the court does not need to assess in full whether the claim against the anchor defendant will succeed on its merits. This may only be relevant if that claim is manifestly unfounded or artificial. Finally, the CJEU confirms that Article 8(1) not only designates international jurisdiction but also the court with relative jurisdiction within the Member State: the court of the domicile of the defendant against whom the action is brought. A national referral to another competent court within the same Member State remains possible, provided that this does not undermine the effectiveness of the Regulation. Implications for practice This judgment strengthens the position of claimants in cartel damages cases. They are given greater scope to concentrate related claims against various group companies before a single court, even if the anchor defendant is not itself named in the cartel decision. For international groups, this means that group structures must be scrutinized. Even companies that are not themselves the addressees of a fine decision may be involved in civil proceedings if they form part of the same economic unit. The judgment thus once again underlines the importance of effective competition law compliance across the entire group. Do you have any questions regarding international jurisdiction or actions for damages? Please contact Arnout Koeman, Lennart Hoeksema or one of our other Competition and EU or Commercial Litigation specialists.

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.