On 5 August 2026, the Administrative Division of the District Court of The Hague (‘the Court’) rendered its decision in proceedings between Merck Serono S.A. (‘Merck’) and the Dutch Patent Office (Octrooicentrum Nederland, ‘OCNL’). The Court upheld OCNL’s refusal to grant an SPC for the product cladribine, marketed as Mavenclad for the treatment of multiple sclerosis. This decision confirms that, following the CJEU’s ruling in Santen, a marketing authorisation (‘MA’) for a new therapeutic indication of a previously authorised active substance cannot qualify as the first MA for the product within the meaning of Article 3(d) of Regulation 469/2009 (‘SPC Regulation’). What preceded On 22 February 2018, Merck filed an SPC application (no. 300930) for cladribine based on EP 1 827 461 (‘EP 461’), referring to the MA for Mavenclad (EU/1/17/1212, dated 24 August 2017) as the first MA. EP 461 was granted for the active ingredient cladribine and is a second medical use patent.  EP 461 covers a regimen for treating multiple sclerosis. EP 461 expired on 20 December 2025. Cladribine had previously been authorised as the active ingredient in two other medicinal products: Leustatin (1995) and Litak (2004), both for the treatment of hairy cell leukaemia. OCNL refused the SPC application as it did not meet the requirement of Article 3(d) of the SPC Regulation. Merck filed an appeal against this decision. Merck argued that OCNL should have granted the SPC. Mavenclad enables the first use of cladribine for the treatment of multiple sclerosis, which is a new therapeutic use. The earlier MAs for Leustatin and Litak related to a different therapeutic indication, namely hairy cell leukaemia. Merck further submitted that it had undergone a full de novo development programme (Phase I, II, III, and IV studies) to obtain the MA for Mavenclad. According to Merck, the CJEU’s ruling in Santen (C-673/18) is not the appropriate framework and the Court should instead follow Neurim (C-130/11). If necessary, the Court should refer preliminary questions to the CJEU. Assessment of the Court – first MA The parties agreed that the conditions of Article 3(a), (b), and (c) of the SPC Regulation were met. The disputed issue was whether Article 3(d) is satisfied: could the MA for Mavenclad be regarded as the first MA for cladribine as a medicinal product. The Court answered this question in the negative. The Court held that the text of Article 3(d) is clear: the MA on which the SPC is based must be the first MA for placing the product on the market as a medicinal product. The Court observed that an MA for a new therapeutic application (second medical indication) of a previously authorised active substance is, according to the CJEU, explicitly not to be regarded as the first MA within the meaning of Article 3(d). It was not in dispute that the MAs for Leustatin and Litak relate to the same active ingredient, namely cladribine. It follows that the MA for Mavenclad is not the first MA for placing cladribine on the market as a medicinal product, so that no SPC can be granted for that product. The Court rejected Merck’s argument that Santen does not provide the correct framework and that the Court should instead follow Neurim. The Court pointed out that the CJEU in Santen explicitly departed from its earlier decision in Neurim. The Court referred to its earlier decisions in Genmab (2023) and in Boehringer (2025), in which it had already addressed the interpretation of Article 3(d) of the SPC Regulation, and observed that ‘… those considerations are repeated and incorporated herein’. In respect of the Boehringer case, we refer to our La Gro Pharma Update of 28 May 2025. No preliminary questions to the CJEU The Court found no reason to refer the case to the CJEU for preliminary questions on the interpretation of Article 3(d). It qualified the matter as an acte éclairé. The fact that SPCs for cladribine have been granted in some other Member States does not lead to a different outcome. The same applies to the fact that the BPatG in its referral decision of 12 December 2025 in the parallel Boehringer case provisionally took a different view on certain points than this Court (and the Cour d’Appel de Paris). It referred preliminary questions to the CJEU (case C-15/26). The BPatG also acknowledged that the CJEU in Santen expressly departed from its previous case law, but doubts whether Santen’s broad interpretation also applies where the earlier MA concerns a human medicinal product and the later MA a veterinary medicinal product, i.e. the situation in the Boehringer case. According to the Court that doubt does not arise here, where both the earlier and later MAs concern human medicinal products. Conclusion The Court dismissed Merck’s appeal and upheld OCNL’s refusal to grant an SPC for cladribine. The MA for Mavenclad is not the first MA for cladribine as a medicinal product within the meaning of Article 3(d) of the SPC Regulation, as two earlier MAs had been granted for the same active ingredient. Although no SPC can be granted, Mavenclad continues to enjoy regulatory market exclusivity under Regulation (EC) No 726/2004 until August 2027.

On 28 July 2026, the Dutch Court of Appeal (“CoA”) handed down its decision in the appeal proceedings between Sandoz B.V. (“Sandoz”) and Bayer Intellectual Property GmbH (“Bayer”). The CoA overturned the District Court’s decision of 1 November 2023. The CoA held that the NL part of EP 1 845 961 B1 (“EP 961”) lacked inventive step based on newly introduced prior art comprising a patient information form and accompanying booklet for the Einstein-DVT study (“Study”), sponsored by Bayer. What preceded In our Pharma Update of 28 November 2023, we reported on the first instance decision of the District Court (“Court”), holding EP 961 inventive. The Court found, starting from the Harder Poster as the closest prior art, that the skilled person would not have had a reasonable expectation of success that rivaroxaban would be safe and effective in a once-daily (OD) dosing regimen. Sandoz appealed this decision, claiming that EP 961 is not only invalid for lack of inventive step but also for lack of novelty. Transparency request under Open Government Act On appeal, Sandoz introduced new prior art: a patient information form and accompanying booklet that was provided to patients participating in the Study. The Study was a dose finding phase II clinical study into the treatment of acute deep vein thrombosis with rivaroxaban. Sandoz received this document following a request for transparency under the Dutch Open Government Act (Wet open overheid). Assessment of the CoA – new prior art Public availability of the patient information form The CoA rejected Bayer’s argument that the patient information form was not publicly accessible prior art, as patients were implicitly bound by a duty of confidentiality due to their special relationship with the researchers and Bayer, as sponsor. Applying the EPO Guidelines, the CoA held that a document is made available to the public if members of the public could gain knowledge of its content and there was no express or tacit confidentiality obligation. Since this information was provided to at least two patients not bound by confidentiality before the priority date of EP 961, it formed part of the state of the art. Disclosure of the claim features Claim 1 of EP 961 was divided into the following features: (i) a tablet of rivaroxaban; (ii) with rapid release; (iii) for the treatment of thromboembolic diseases (TEDs), implying therapeutic efficacy and safety; (iv) in an OD dosing regimen; and (v) for at least five consecutive days. The CoA found that the key sentence in the patient information is: “A new anticoagulant has been developed for the treatment of deep venous thrombosis. This drug, BAY 59-7939, is available in tablet form, is taken once a day and works fast” (translated). The CoA held that feature (v) was undisputedly disclosed elsewhere in the patient information form. The assessment of the CoA thus focused on features (i), (ii) and (iii): The patient information form referred only to the internal Bayer code BAY 59-7939, not to rivaroxaban. However, a free-access article by Perzborn was available online before the priority date, in which BAY 59-7939 was identified by its chemical name and structural formula as rivaroxaban. The CoA held that, although the code did not form part of the common general knowledge (CGK), the skilled person, upon encountering the code, would have found the Perzborn article through a routine online search without inventive effort and identified the substance as rivaroxaban. The patient information form stated that the drug “works fast”. Bayer argued that this refers to the onset of action, not to the release from the tablet, and that rapid action can also occur with extended-release formulations. The CoA rejected these arguments, holding that a drug can only work after it has been released from the tablet, so the statement that it “works fast” necessarily implies a rapid-release tablet. The argument that it could also indicate an extended-release formulation was rejected because the patient information contained no indication that prolongation of the effect was intended. The CoA found that the patient information form disclosed that the OD dosing regimen was at least somewhat effective. The skilled person would assume that the researchers of the Study would not have set up a phase II study into the optimal OD dosing without a scientific basis for believing that an OD regimen has at least some efficacy. As to safety, the CoA found that the patient information indicated that no side effects were known. According to the information, underdosing was not considered a greater problem than with standard treatment (e.g. there were fewer and less strict check-ups). Regarding overdosing, the patient information disclosed that the risk of bleeding was comparable to that of standard anticoagulants. Combined with the known safety of rivaroxaban in a 30 mg twice-daily (BID) dosing from the phase I studies, the skilled person would have no reason to expect overdosing at the lower OD dosages. Conclusion The decision demonstrates that transparency requests can be an effective means of retrieving prior art, particularly regarding sponsor-generated clinical trial materials. It also confirms that patient-facing information may enter the state of the art in the absence of an express or tacit confidentiality obligation. In its decision the CoA rejected Sandoz’s novelty objection, but held that the disclosed patient information led to a lack of inventive step. The only step the skilled person had to take was to identify BAY 59-7939 as rivaroxaban, which could be achieved through a routine internet search without inventive effort. The features of claim 1 were disclosed to such an extent that the skilled person, would have regarded the Study as having a sound scientific basis, would have been able to predict its successful outcome and would have initiated it. The CoA revoked the NL part of EP 961, dismissing Bayer’s infringement claims.

On 17 July 2026, the Supreme Court handed down its judgment in the collective action brought by Stichting The Privacy Collective (“TPC”) against Oracle and Salesforce. The ruling is of significance to any party facing a collective action under the Mass Claims Settlement Act (“WAMCA”), and in particular regarding the question of when an interest group is sufficiently representative to claim compensation on behalf of a large group of affected parties. Background The proceedings concern the misuse of personal data belonging to ten million Dutch internet users. Among other things, TPC sought declarations of law and joint and several damages from Oracle and Salesforce totalling 5 billion euros – or 500 euros per person – on the grounds of alleged privacy breaches involving the placement of cookies and the creation of user profiles for targeted advertising. The Amsterdam District Court declared TPC’s claim inadmissible on the grounds that the representativeness requirement under Article 3:305a(2) of the Dutch Civil Code had not been met. The Amsterdam Court of Appeal quashed that judgment, declared TPC’s claim admissible after all, and referred the case back to the District Court. The parties to the proceedings lodged an appeal in cassation against this decision with the Supreme Court. The Supreme Court’s ruling The admissibility of an interest group under the WAMCA is assessed ex nunc The Supreme Court confirms that the appeal court assesses the admissibility of an interest group in WAMCA proceedings on the basis of the situation at the time of its decision, and not at the time of service of the summons. This is in line with the general principle that an appeal serves to have the case re-examined in the light of the current state of affairs. Neither the text nor the legislative history of the WAMCA provides any grounds for deviating from this principle. A ‘not negligible’ membership base is not sufficient The crux of the judgment concerns the interpretation of the representativeness requirement under Article 3:305a(2) of the Dutch Civil Code. The Court of Appeal had ruled that it is sufficient for ‘a not insignificant number of persons’ to support the action. The Supreme Court rejects that standard: the court must assess whether the collective claim has the support of ‘a sufficiently large proportion of the total group for whom the interest group represents’. The WAMCA does not specify a numerical criterion, but indicators include, amongst other things, the number of registered members or the number of people who have actively registered, and whether the registered individuals form a balanced representation of the total group. Support from other civil society organisations may, however, be taken into account when assessing whether the representativeness requirement is met. Furthermore, the Court of Appeal had failed to provide sufficient reasoning as to why anonymous ‘likes’ on TPC’s website demonstrated that the support actually came from affected individuals, whilst Oracle and Salesforce had contested this with sound reasoning. The assessment under Articles 80 and 82 of the GDPR may be deferred until the substantive assessment The Supreme Court ruled that the GDPR does not require the mandate requirement under Article 80(1) of the GDPR, in conjunction with Article 82 of the GDPR, to be assessed at the admissibility stage of WAMCA proceedings. The Court of Appeal was entitled to defer this issue, as well as the other aspects of Article 80 of the GDPR, until the substantive stage of the proceedings. There is no basis for referring questions for a preliminary ruling to the Court of Justice of the EU on this point. Exception to the prohibition on remittal to the lower court Finally, the Supreme Court accepts an exception to the main rule that, following the setting aside of a final judgment, the appeal court may not refer the case back to the court of first instance. Under the special, two-stage system of the WAMCA, where the Court of Appeal sets aside a wrongly issued declaration of inadmissibility, it may refer the case back to the District Court, because the court of first instance did not proceed to a substantive hearing on purely procedural grounds. Conclusion As the appeals concerning the representativeness test are upheld, the Supreme Court sets aside the judgments of the Amsterdam Court of Appeal of 18 June 2024 and 24 September 2024 in both cases and refers the proceedings to the Court of Appeal in The Hague for further consideration and decision. Implications for practice This judgment raises the threshold for collective actions for damages. Interest groups can no longer simply demonstrate ‘some’ support amongst their members; they will have to substantiate, with concrete evidence and figures, that a substantial proportion of the group they represent actually supports the action — particularly when damages are claimed on behalf of a very large and diffuse group. Anonymous expressions of support (such as ‘likes’) are not sufficient without further evidence that they originate from the alleged victims themselves. That said, the Supreme Court does confirm that it is permissible to take into account the support of other interest groups when assessing whether the representativeness requirement has been met. For defendants in WAMCA proceedings, the ruling provides a concrete basis for (further) challenging the representativeness of claimant interest groups, particularly in cases involving a large and generic support base and substantial sums claimed. At the same time, the Supreme Court confirms that GDPR-specific admissibility issues do not necessarily have to be resolved at the admissibility stage, which may improve procedural efficiency in complex privacy-related mass claims. Finally, the Supreme Court now explicitly offers claimants the opportunity to remedy any shortcomings regarding representativeness during the appeal proceedings: the assessment of this requirement must, in fact, take place ex nunc. Do you have any questions about the judgment discussed above or collective actions? Please contact Arnout Koeman, Lennart Hoeksema or one of our other WAMCA specialists.

Previously, I wrote about the European Commission’s revision of the SGEI Decision on 16 December 2025. The revised version of this state aid exemption came into force on 8 January 2026. The Dutch Ministry of the Interior and Kingdom Relations (BZK) has now published a guide explaining what the new state aid rules mean in practice for social and affordable housing (hereinafter: ‘the SGEI Guide’). The SGEI Guide is primarily intended for municipalities and provincial authorities, but is also useful for, for example, housing associations and developers. Recap on state aid and the SGEI exemption State aid occurs when a public authority uses state resources to grant a selective advantage to an undertaking that is not in line with market conditions and which may affect competition and trade between Member States. In principle, such aid must be notified to the European Commission, unless an exception applies. The SGEI Decision is one of these exceptions: public authorities may compensate undertakings entrusted with the provision of a service of general economic interest (SGEI) without prior notification, provided that the conditions of the SGEI Decision are met. One of these conditions is the setting out of the state aid instrument in a SGEI designation decision. The revised SGEI Decision (EU 2025/2630) has broadened the scope of the exemption. This extension includes, amongst other things, an increase in the compensation ceiling to €20 million per year, more lenient checks on overcompensation, and an additional annex relating to housing construction, under which affordable housing, in addition to social housing, may also qualify as a SGEI. You can read more about the changes introduced by the revision in my previous blog post: link. What does the SGEI Guide explain? The SGEI Guide from the Ministry of the Interior and Kingdom Relations (BZK) puts the European amendments to the SGEI Guide into Dutch practice and offers concrete guidance for municipalities, provincial authorities and housing associations. The SGEI Guide covers, amongst others, the following topics: Two SGEI categories: In addition to the social housing SGEI, there is now an affordable housing SGEI for mid-range rental and affordable owner-occupied housing. The SGEI Guide explains how these categories are defined in accordance with Dutch legislation (specifically the Act on Strengthening Regional Social Housing on the Basis of Income Thresholds, e. Wet versterking regio op de volkshuisvesting op basis van inkomensgrenzen) and what conditions apply to the provision of support for social and/or affordable housing. It also explains that, for support for affordable housing, a level playing field must be ensured, and that businesses must be eligible for state aid under the same conditions. This can be achieved, for example, through a selection procedure. Broader scope of application: the SGEI exemption for housing is not limited solely to housing construction but also covers, amongst other things, new-build projects, land acquisition, renovation, sustainability improvements and management costs. More lenient checks on overcompensation: the review period is extended from three to five years, and organisations engaged almost exclusively in SGEI activities are exempt from periodic ex-post checks. New transparency rules: from 1 January 2028, aid exceeding €1 million must be entered into a central register within 20 working days. Maintenance period: the SGEI Decision requires, in principle, that the SGEI be maintained for 20 years following the granting of the subsidy, unless a justified exception can be made. The Wet versterking regio op de volkshuisvesting op basis van inkomensgrenzen sets a longer period of 25 years for social housing; this must also be taken into account when providing social housing under the SGEI Decision. Examples of state aid instruments: the revised SGEI Decision does not prescribe any specific state aid instruments. Public authorities are free to choose the type of instrument they use to grant aid. The SGEI Guide provides four examples of aid instruments on the basis of which SGEI aid may be granted, namely a project grant, a loan guarantee, a loan facility (whether or not from a revolving fund) and a reduction in the land price. Finally, the SGEI Guide contains an example of a designation decision from the fictitious municipality of Nergenshuizen. This example illustrates how a SGEI designation for social housing, mid-range rental accommodation and combined housing schemes for senior citizens and students can be structured, including provisions on compensation, monitoring and the maintenance period. Contact Do you have any questions about the application of the SGEI Decision or other state aid-related matters? Please feel free to contact Monika Beck or one of our other state aid specialists.

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.