Publications

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.

On Tuesday, 2 December 2025, the Court of Justice of the European Union (”CJEU”) ruled in the case of Stichting Right to Consumer Justice and Stichting App Store Claims v. Apple. In this case, the plaintiffs claim that Apple abused its dominant position by retaining a 30% commission on purchases made through the App Store. According to the plaintiffs, this caused damage to users. The plaintiffs brought a case before the Amsterdam District Court on behalf of all affected users of the Dutch App Store under the Dutch Mass Claims Settlements Act (“WAMCA”). However, this case raised an important question: does the Amsterdam District Court have jurisdiction to hear such a dispute, given that the affected users are spread across Amsterdam and the rest of the Netherlands? Background Pursuant to Article 7(2) of Regulation 1215/2012, a court has jurisdiction to hear a dispute if the harmful event occurred within its jurisdiction or if the damage occurred there. The Amsterdam District Court ruled that it had international jurisdiction to hear the dispute between the plaintiffs and Apple. The court determined that Apple’s abusive practices took place on Dutch territory because the App Store is specifically designed for the Dutch market and is offered in Dutch. Moreover, the damage occurred in the Netherlands: the increased prices were paid there by users with a Dutch bank account. However, the court had doubts about its territorial jurisdiction. Therefore, the court referred questions to the CJEU for a preliminary ruling. After all, there are eleven districts in the Netherlands within which different courts have jurisdiction. If Article 7(2) of Regulation 1215/2012 is strictly applied, users who suffer damage in the Netherlands because of Apple’s actions can only bring a claim before the court in the district where their damage occurred (i.e. often where they live). Such a strict approach would require the plaintiffs to file their collective claims with eleven different Dutch courts. The ruling  The CJEU stated that the NL App Store and certain apps offered there are specifically designed for the Dutch market. In addition, the language used in the Dutch App Store is Dutch. This means that the Dutch App Store constitutes a “virtual space” that can be equated with the entire territory of the Netherlands. The damage resulting from purchases made in this virtual space therefore occurred throughout the entire territory of the Netherlands, regardless of where the users concerned were located at the time of purchase. Any Dutch court that has jurisdiction to hear the dispute based on article 7(2) of Regulation 1215/2012 therefore also has territorial jurisdiction to assess the entire dispute for all users. Such centralisation of jurisdiction in a single court is in line with the objectives of Regulation 1215/2012, specifically to improve access to justice and to prevent parallel proceedings on the same dispute. Implications of the Apple ruling for collective claims This ruling facilitates access to the courts for representative entities with exclusive standing, acting on behalf of large groups of individuals. When a representative entity initiates a collective action on behalf of a sufficiently defined group that has made purchases in a “virtual space”, any court in the country in which that space is offered has jurisdiction over the entire collective claim.  Do you have any questions about the ruling discussed above or collective actions? Please contact Arnout Koeman or one of our WAMCA specialists.

KS Energy Systems has acquired MORRENsystems and MORRENsolar. With this strategic move, KS Energy Systems adds a renowned specialist in solar carports to its organization. By combining expertise, designs, and production facilities, KS Energy Systems can offer clients in the Netherlands and abroad an even more comprehensive range of solar carport solutions. La Gro provided legal support to KS Energy Systems during this transaction. KS Energy Systems, founded in 2024 and based in Alphen aan den Rijn, specializes in the design, construction, production, and installation of solar carport structures. Through the acquisition, KS Energy Systems strengthens its position as a manufacturer of solar carport constructions and reinforces its market presence in sustainable canopies and solar carports. Strengthening the position within the solar carport market In recent years, MORRENsystems and MORRENsolar have developed into well-established names in the solar carport market. Their expertise, designs, and design rights will be integrated into KS Energy Systems’ product portfolio. Ongoing projects will continue, and customers will remain supported in the manner they are accustomed to. At the same time, the collaboration enables greater scale, increased production capacity, shorter lead times, and further professionalization. The acquisition comes at a time of rapidly growing demand for solar carports. Increasingly, companies and institutions are seeking sustainable alternatives when rooftops are full or unsuitable for solar panels. By joining forces, a stronger platform is created that can serve customers both nationally and internationally with innovative and scalable solar carport solutions. The legal advice, negotiations, and documentation of agreements were carried out on behalf of KS Energy Systems by Pieter van den Oord, Reinoud van Ginkel, and Tahir Bodha. Contact For further questions, please contact Pieter van den Oord, Reinoud van Ginkel, or any of our other specialists from the mergers & acquisitions team. They will be happy to assist you.

As of 1 January 2026, the administrative regime for granting regular de minimis aid and de minimis aid for services of general economic interest (SGEI) will change. The key point is that the administrative obligation will largely shift from the beneficiary to the aid provider. From 1 January 2026, public authorities will have to register regular and SGEI de minimis aid in a central register (on national or EU level) and check in advance that the relevant de minimis threshold is not exceeded. This is in contrast to the current system, which allows a de minimis declaration requested from the aid beneficiary. Curious about what this will mean for you? We explain it in the blog below. What is state aid? State aid law aims to protect competition on the internal market 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 on the market (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 (interstate effect). If all of the five 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 de minimis aid. De minimis aid The de minimis regulations allow governments to grant limited amounts of aid without having to notify the Commission. These amounts are considered too low to affect the internal market. There are four types of de minimis aid, each with its own threshold. Each company may receive a maximum of this ceiling amount of de minimis aid over a period of three calendar years. The thresholds apply per undertaking and per Member State. A Dutch private limited company can therefore receive a maximum of the relevant threshold for de minimis aid from all Dutch authorities combined over a period of three calendar years. Administrative obligation: old vs. new The thresholds for regular and SGEI de minimis aid have been increased as of 1 January 2024. This increase also modernised the administrative regime. This modernisation requires a more active approach from the aid provider compared to the current system and will take effect on 1 January 2026. Current system Under the current system, de minimis aid may be granted after 1) the beneficiary has been informed in writing or electronically by the aid provider of the amount of the aid and its de minimis nature, with direct reference to the applicable de minimis regulation, and 2) the beneficiary has submitted a statement of all de minimis aid received by that beneficiary over a period of three years. In short, a fairly undemanding administrative obligation with no deadlines attached. System as of 1 January 2026 As of 1 January 2026, information on de minimis aid granted (SGEI and regular) will have to be registered in a central register (the eAid register). The information must be registered within 20 working days of the aid being granted and must be stored in the register for at least 10 years after the aid has been granted. Authorities may only grant new de minimis aid after checking in the register that the applicable threshold amount has not been exceeded. The following data regarding the grant of the aid must be registered: Identification of the beneficiary; The amount of aid; The date of granting; The granting authority; The aid instrument; and The sector concerned based on the NACE classification. For three years after the introduction of the register, the ‘old’ administrative obligation will continue to apply in addition to the obligation to register aid. During that period, in addition to registration, authorities will also have to notify the beneficiary in writing or electronically of the amount of aid and its de minimis nature, with reference to the applicable regulation, and request a de minimis declaration. Regular and SGEI de minimis aid granted before 1 January 2026 is subject to the ‘old’ administrative obligation and therefore does not need to be registered. No registration requirement has yet been announced for de minimis aid for the fisheries and aquaculture sector. De minimis aid for the agricultural sector will be subject to the above registration requirement from 1 January 2027. Practical impact for public authorities From 1 January 2026, public authorities will be responsible for the registration requirement for regular and SGEI de minimis aid. Within 20 working days of granting the aid, public authorities will have to register the aid and the necessary related data in the eAid register. Prior to granting new de minimis aid, the register must also be checked to ensure that the applicable threshold amount is not exceeded. For three years after the introduction of the register, the current administrative obligation will also continue to apply, i.e. in addition to registration, the aid provider will also have to request a de minimis declaration and inform the beneficiary of the amount of aid and its de minimis nature, with reference to the applicable regulation. Contact Do you have any questions on this subject? Or do you have other questions about state aid law? Please feel free to contact Monika Beck or one of our other competition & state aid specialists.

Since June 28, 2025, new rules have been in force in the Netherlands regarding the digital accessibility of products and online services. With the introduction of the European Accessibility Act, commercial organizations such as banks, e-commerce companies, transport companies, and communication companies are now also required to make their digital products and services accessible in accordance with the Web Content Accessibility Guidelines (WCAG). As a result, many more companies will have to adapt their websites and apps to offer an inclusive user experience that can be used independently, without the help of third parties. Previously, this obligation only applied to government institutions under the Temporary Digital Accessibility Decree. Commercial organizations were previously exempt, but this has changed with the introduction of the European Accessibility Act. The Netherlands has incorporated the directive into the Accessible Products and Services Bill. Recently, questions about the Accessibility Directive were recently asked in the Dutch House of Representatives. Scope of application The directive has a broad scope and applies to various products and services provided by private parties, including those of financial institutions. Examples include payment terminals, ATMs, consumer banking services such as internet banking, and e-commerce services such as opening a savings account or taking out insurance online. Banks and other service providers must design their products and services in such a way that everyone can use them. This means that information must be available through multiple senses, for example, both in written text and as spoken explanations. Websites and apps must be easy to use with screen readers and speech recognition. Payment terminals must be accessible to people with visual impairments, for example, through speech support. Consumers must also be able to conduct their banking affairs offline, by telephone or in person at the counter. All information must also be understandable and written at a maximum language level of B2. Transition period and exceptions A transition period until 2030 applies to existing products and services. Small businesses with fewer than ten employees and an annual turnover of up to two million euros are exempt from the obligations. Exceptions are possible if adaptation would impose a disproportionate burden or fundamentally change the nature of the product, provided this is properly substantiated. The directive does not apply to services between businesses. Supervision and enforcement The Netherlands Authority for the Financial Markets (Autoriteit Financiële Markten) specifically supervises financial companies, such as banks, insurers, investment institutions, asset managers, and lenders. This means that the AFM ensures that these services are accessible to all consumers, including the more than two million people with disabilities in the Netherlands. The basic principle is that consumers must be able to purchase these financial services independently and without the help of third parties. This is in line with the message of the AFM during Accessibility Week (October 6-12, 2025), which emphasizes that financial products and services must be accessible to everyone. In the Netherlands, the Netherlands Authority for Consumers and Markets (Autoriteit Consument en Markt), the National Inspectorate for Digital Infrastructure (RDI), the Dutch Media Authority (Commissariaat voor de Media), and the Human Environment and Transport Inspectorate (Inspectie Leefomgeving en Transport) are also involved in supervising other sectors. If the supervisory authority discovers that a product or service does not comply with the rules set out in the directive, the company must take appropriate corrective measures without delay. The supervisory authority determines the timeframe within which this must be done, depending on the severity of the problem. If a company fails to take the appropriate measures in time to resolve a problem with a product or service, a supervisory authority may intervene. It may then take appropriate provisional measures, such as imposing a fine, banning or restricting the product in question, or even withdrawing it from the market altogether. Contact Do you have questions about this topic or would you like to discuss the European Accessibility Act? Please contact Donald Volleberg, Jiahui Plomp or our Insolvency, Restructurering & Finance, Securities law team. We are happy to assist you.

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

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

On July 23rd, 2025, the International Court of Justice issued a groundbreaking advisory opinion on the obligations of states under international law with regard to climate change and climate agreements. In this article, we discuss the essence of the advisory opinion and its potential impact on Dutch and international case law concerning the climate liability of companies and states. Reason: Vanuatu’s appeal The initiative for these proceedings came from the island nation of Vanuatu, which is threatened by rising sea levels and extreme weather conditions. On March 29, 2023, the United Nations General Assembly adopted Resolution 77/276, requesting the International Court of Justice to issue an advisory opinion on (in short) the following questions: What are the obligations of states under international law with regard to human-induced climate change? What are the legal consequences for states whose actions have caused significant damage to the climate and the environment, resulting in effects that will be felt by certain states and future generations? What is the contents of the opinion about climate agreements? The International Court of Justice confirms that states are obliged to protect the climate. These obligations arise from the UN Charter, the UN Climate Convention, the Paris Agreement, the rights recognized in the Universal Declaration of Human Rights, international customary law, and general principles of law. The International Court of Justice qualifies these obligations as erga omnes. This means that these obligations apply to every state. Even states that are not party to the climate treaties may therefore be required to take effective measures to limit climate change. In addition, there is an obligation for states to cooperate and support each other. The ruling on liability is striking: states that fail to meet their climate obligations and thereby cause damage may be required to compensate for that damage in full. A state that takes insufficient measures to reduce its CO2 emissions could therefore, in theory, be liable to another state that suffers damage as a result. However, a complex causality threshold applies here. Legal significance: not binding, but influential Although the advisory opinion is not binding, its legal and political impact could potentially be significant. Thousands of lawsuits relating to climate change are currently pending worldwide, including a number in the Netherlands. Examples include the proceedings brought by Dutch enviromental defense organisation ‘Milieudefensie’ against the ING bank and the ongoing appeal in cassation in the case of Milieudefensie against Royal Dutch Shell. The opinion of the International Court of Justice implies that non-compliance with international climate agreements must have concrete consequences. This is in line with a trend in Dutch case law, in which international climate agreements end up entailing concrete obligations for companies and the State. For example, in the Shell case, the Court of Appeal in The Hague ruled that international climate agreements contribute to an obligation for companies such as Shell to reduce their CO2 emissions. The reduction obligation imposed on the State by the Dutch Supreme Court in 2019’s Urgenda ruling was also based in part on international climate agreements. In the proceedings against ING, which have not yet been heard on their merits, Milieudefensie also invokes such agreements in its summons. It is therefore not inconceivable that the non-binding ruling of the International Court of Justice will play a role in future climate cases against banks, other companies, and governments, both in the Netherlands and abroad. Want to know more? Do you have questions about this topic or would you like to discuss the consequences of the Court’s ruling? Please contact La Gro’s Energy team or Climate Litigation team. We are happy to assist you.

On 13 August 2025, the UPC Court of Appeal (‘CoA’) granted a PI in proceedings between Boehringer Ingelheim International GmbH (‘Boehringer’) and Zentiva Portugal LDA (‘Zentiva’). The CoA has set the standard for imminent infringement in relation to the launch of a generic medicine and the launch preparations. The CoA overturns the order of the Local Division Lisbon, granting Boehringer a PI against Zentiva for all UPC territories in which the patent has effect. What preceded Boehringer holds EP 1 830 843, which protects indolidone derivatives for the treatment or prevention of fibrotic diseases. Boehringer markets its product containing nintedanib as esilate in Portugal under the name Ofev® for the treatment of idiopathic pulmonary fibrosis. Zentiva obtained two Portuguese Marketing Authorisations (‘MA’) for its generic medicines (‘generics’) on 30 August 2024. It subsequently secured pricing and reimbursement approval in the process of completing the Prior Evaluation Procedure (‘PEP’) on 6 December 2024. Boehringer initiated PI proceedings against Zentiva, arguing that by completing all the necessary regulatory steps, Zentiva had positioned itself to launch at any time, thereby creating a real and immediate risk of infringement. On 8 May 2025, the Local Division Lisbon dismissed the requested PI, holding that the MA and PEP completion were administrative steps which, in themselves, did not establish a risk of imminent infringement. Boehringer appealed the decision. Assessment of the CoA – imminent infringement Under Article 62(1) and (4) UPCA, the UPC Court may grant a PI against an alleged infringer, intended to prevent an imminent infringement. According to the CoA, the legal test for imminent infringement (i.e. when the infringement has not yet occurred) is: whether the potential infringer has already set the stage for it to occur. In such cases, the infringement is only a matter of initiating the act, as all necessary preparations have been fully completed. This must be assessed on a case-by-case basis. The standard of proof is whether there is a sufficient degree of certainty, on the balance of probabilities, that it is more likely than not that a patent infringement is imminent. The risk of permanent price erosion is an important factor in determining whether a PI is necessary (CoA, order of 3 March 2025, UPC_CoA_523/2024, APL_51115/2024, Sumi vs Syngenta). According to the CoA merely obtaining a MA does not amount to imminent infringement. However, completing all national regulatory procedures like covering health technology assessment, pricing, and reimbursement can constitute imminent infringement if the generic manufacturer is in a position to make offers or supply the product. The CoA considers that this assessment depends on the applicable national legal framework. In the Portuguese legal context, the CoA ruled that, although it is customary to apply for a PEP before a patent expires, this had been done prematurely, namely ≥1 year before the patent expired. The CoA found that no further administrative approval was required for Zentiva to offer its generics on the market after the MA and the PEP approval were granted, because: the pre-notification to INFARMED (the National Authority for Medicines and Health Products) is just a formality that can be fulfilled by the supplier with relative ease and at short notice; the classification of Portuguese public procurement procedures as “pre-contractual” under national law does not limit the meaning of “offering” under Article 25 UPCA. Taking part in public procurement procedures with generic products while the patent is still in force will generally constitutes an infringing offer; while medicines are generally procured through public procurement procedures in Portugal, it is also possible for public hospitals, under certain conditions, to acquire nintedanib products outside of such procedures, in which Zentiva could participate with the approved PEP, and there are no other mechanisms that keep Zentiva from participating in public procurement proceedings and offering its generics, except that any restraint would be purely voluntary rather than imposed by law. Conclusion This decision offers significant clarification for both innovators and generic companies regarding the concept of imminent infringement. The key question is whether the generic company is in a position to offer and supply its generic products without further administrative hurdles. If so, imminent infringement exists – even if no sales have yet occurred. By contrast, merely obtaining a MA does not in itself amount to imminent infringement. Completing all regulatory steps well before patent expiry, without legal or regulatory barriers to offering, may therefore justify the grant of a PI. The Court makes clear that voluntary self-restraint is no substitute for enforceable legal restrictions.