On 8 September 2026, the Grand Chamber of the Court of Justice of the European Union (“CJEU”) handed down its judgment in Case C-298/23 in the proceedings between Inter IKEA Systems BV (“IKEA”) and Algemeen Vlaams Belang VZW (“Vlaams Belang”), amongst others. The CJEU clarified the conditions under which freedom of expression, including political parody, may constitute a “due cause” for the unauthorised use of a well-known trademark under Article 9(2)(c) EU Trademark Regulation (EUTMR) and Article 10(2)(c) and 10(6) of the Trademark Directive (TMD). What preceded In 2022, the Belgian political party Vlaams Belang launched a campaign entitled “IKEA-plan – Immigratie Kan Echt Anders” (“Immigration Can Truly Be Different”), presenting its proposals for reform of Belgian asylum and immigration policy. The campaign made extensive use of signs and visual elements closely resembling the well-known IKEA trademarks, including the distinctive typeface, blue-and-yellow colour palette, and IKEA-style assembly-manual imagery. IKEA brought trademark infringement proceedings before the Commercial Court in Brussels. One of the parties involved is Vrijheidsfonds VZW (“Vrijheidsfonds”), a non-profit association that ran the campaign on behalf of Vlaams Belang. Vrijheidsfonds acknowledged the unauthorized use and argued that the popularity of the IKEA trademarks was deliberately exploited to amplify its political message, constituting a “due cause” under EU trademark law. The referring court stayed proceedings and submitted a preliminary reference to the CJEU. Assessment of the CJEU Two legal routes The CJEU distinguishes and confirms two applicable routes that freedom of expression, including political opinion and political parody, can in principle constitute a “due cause”: (i) use in the course of trade for goods or services under Article 9(2)(c) EUTMR / Article 10(2)(c) TMD, and (ii) use other than to distinguish goods or services under Article 10(6) TMD (implemented for Benelux trademarks in Article 2.20(2)(d) BCIP). Freedom of expression as “due cause” – high threshold  The trademark owner must first demonstrate actual infringement of its well-known trademark or at least a serious risk that such infringement will occur in the future. Once that threshold is met, a general invocation of free speech is insufficient. The third party must demonstrate that, in the specific circumstances, its interest in freedom of expression outweighs the exclusive rights of the trademark owner. The CJEU identified the key criteria for that balancing exercise: Intent and good faith: use must be genuinely motivated by the exercise of free expression in good faith, not merely to ride on the coattails of a well-known trademark or to damage it; Link to the trademark itself: the strongest justification exists where the trademark is used to express an opinion about the trademark, its owner, or its products/services, or to contribute to a debate of general interest connected to the trademark; Public interest: political speech and satire enjoy strong protection – but the debate must have a genuine connection to the trademark as such; Consequences for the trademark owner: the intensity, scale, and manner of use, the degree of similarity, and whether use creates the impression that the owner endorses the political message are all relevant. Importantly, the outcome of the balancing exercise under Article 10(6) TMD need not necessarily be the same as under Article 9(2)(c) EUTMR / Article 10(2)(c) TMD. The CJEU explained that expression outside the commercial domain may enjoy broader protection under the ECHR case law than strictly “commercial” expression. Application to IKEA/Vlaams Belang The CJEU provided clear guidance to the referring court. IKEA is an acronym coined from personal names, carrying no independent semantic meaning that could justify its use in this context. Vrijheidsfonds used the trademarks not to comment on IKEA, its products, or its practices but solely to use their reputation in a debate on immigration policy unconnected to the trademarks. The signs were very strongly similar or identical, the use was repeated, and it was disseminated online to a potentially unlimited audience. The CJEU further noted that the public might perceive IKEA as endorsing Vlaams Belang’s message contrary to IKEA’s political neutrality. The CJEU therefore concluded that Vrijheidsfonds’ interest in political expression did not appear to outweigh IKEA’s rights, subject to final verification by the referring court. Conclusion This judgment is significant for trademark owners across the EU. The CJEU makes clear that well-known trademarks enjoy robust protection even in the context of political campaigns: freedom of expression cannot be used as a blanket license to free ride on a well-known trademark. The decisive question is whether use of the specific trademark is genuinely necessary to exercise free speech, which will rarely be the case where a trademark is exploited solely for its reputational pull to amplify an unrelated message. Trademark owners confronted with unauthorized use in political or satirical contexts should document the absence of any genuine link between their trademark and the (political) debate, the extent of dissemination, and any reputational harm or false impression of endorsement. Conversely, third parties must be prepared to demonstrate concrete, good-faith reasons why use of the specific trademark was necessary to convey their message.

On 3 September 2026, the European Commission published new guidelines on how it deals with large companies that abuse their market power to sideline competitors. Following a three-year process, involving extensive consultations with businesses, academics and public authorities, clear rules are now in place. These guidelines are important for anyone doing business in the EU. The background Imagine this: a single company is so large and powerful in a particular market that competitors have hardly any fair chance to grow or even enter the market. That is what competition law seeks to prevent. European rules have long prohibited this: Article 102 of the EU Treaty stipulates that a company with a dominant position must not abuse that position to drive others out of the market. But what exactly constitutes ‘abuse’ has been a matter of dispute for years. Until now, the Commission has used a 2008 document as a guide, which no longer accurately reflected current practice involving large technology companies and digital platforms. That document is now being withdrawn and replaced by the new guidelines. What is changing? For the first time, the new guidelines explain in a coherent manner how the Commission assesses whether a company is dominant and whether it is abusing its position to squeeze out competitors. A number of points stand out. When is a company ‘dominant’? A company that controls more than half of a market is generally regarded as dominant. However, a dominant position can also exist with smaller market shares, sometimes even below forty per cent. This is the case, for example, if customers are heavily dependent on that company or if it is practically impossible for competitors to enter that market. What constitutes prohibited conduct? The guidelines describe specific forms of abuse: predatory pricing (setting prices so low that competitors go bankrupt), exclusive dealing arrangements (requiring customers to buy exclusively from the dominant firm), refusing to supply competitors, and tying. Another new feature is the explicit focus on behaviour that is, by its very nature, harmful to competition, such as the active dismantling of infrastructure on which a competitor relies, in which case the Commission is now required to prove virtually no justification at all. When is such conduct nevertheless permitted? A dominant firm may defend itself by demonstrating that its conduct is objectively necessary or that the benefits to consumers outweigh the disadvantages. The bar is set high: the greater the market power, the more convincing the evidence must be. Implications for practice The new guidelines are primarily intended to provide clarity. Any major market player operating in Europe would be well advised to assess its commercial strategy against these guidelines. Issues such as discount structures for large customers, exclusivity agreements with distributors or the refusal to grant access to proprietary infrastructure can now be assessed against a clearer framework. For smaller companies and new entrants, the publication actually provides a framework: if you suspect that a major player is forcing you out of the market, the guidelines offer tools to substantiate a complaint to the Commission or the national competition authority. National courts can also use the guidelines as a point of reference. The Commission emphasises, however, that the guidelines relate exclusively to behaviour that excludes competitors. Abuse that directly harms consumers — such as excessively high prices — falls outside the scope of the current guidelines; the Commission reserves the right to publish separate guidelines on this at a later date. Furthermore, the Court of Justice of the EU has the final say on the interpretation of the concepts set out in the new guidelines . Do you have any questions about the new guidelines, or would you like to know what they mean for your business or sector? Please contact Arnout Koeman, Monika Beck or one of our other Competition and EU specialists.

On 5 August 2026, the Provisions Judge of the District Court of The Hague (“Provisions Judge”) rendered his decision in the PI proceedings initiated by Novo Nordisk A/S (“Novo Nordisk”) against Ceban Ziekenhuisfarmacie B.V. (“Ceban”). Novo Nordisk was granted a preliminary injunction against Ceban for infringing its SPC 300936 (“SPC 936”) for semaglutide. Ceban had compounded and supplied a semaglutide-containing nasal spray under the name Semanova. According to the Provisions Judge, the pharmacy exemption under article 54c(e) of the Dutch Patent Act (ROW 1995) must be construed narrowly. It applies only where medical necessity for an individual patient is demonstrated. It does not cover structural or large-scale compounding of patented medicines. What preceded Novo Nordisk is the holder of SPC 936 for the product semaglutide, based on EP 1 863 839 (“EP 839”). EP 839 covers the active ingredient semaglutide and expired on 20 March 2026. SPC 936 is valid until 19 March 2031. Novo Nordisk markets several products containing semaglutide in the Netherlands: Ozempic® for type 2 diabetes and Wegovy® for obesity, both as once-weekly subcutaneous injections, and Rybelsus® for type 2 diabetes in tablet form. Ceban, a pharmacy, compounded a semaglutide-containing nasal spray under the name Semanova in 2025, without a marketing authorisation and without Novo Nordisk’s permission. Ceban supplied 44 nasal sprays, partly on prescription to its own patients and partly to other pharmacies. It also listed Semanova in the G-standaard, the Dutch pricelist. In total, Ceban imported 600 grams of semaglutide from a Chinese supplier, sufficient for 15,000 vials. After Novo Nordisk’s cease-and-desist letter and the writ of summons, Ceban stopped supplying the nasal spray. Shortly thereafter, a Ceban employee gave a presentation at a pharmacists’ conference in Porto entitled “Semaglutide nasal spray: a Novel Compounded Formulation”, including a slide headed “Where did we get the idea from?” Pharmacy exemption – assessment Since the validity of EP 839 and SPC 936 was not contested, the key question was whether Ceban could rely on the pharmacy exemption under article 54c(e) of the Dutch Patent Act, which was introduced into the Dutch Patent Act in February 2019. The Provisions Judge first clarified that the regulatory pharmacy exemption is not the same as the (patent-law) pharmacy exemption under article 54c(e) of the Dutch Patent Act. The regulatory exemption concerns an exception to the requirement of obtaining a marketing authorisation, which serves to protect public health and the quality, safety and efficacy of medicines, in order to safeguard the availability of necessary medicines for individual patients. The pharmacy exemption based on article 54c(e) of the Dutch Patent Act, by contrast, concerns an exception to the exclusive rights of the patentee. Therefore, even if a pharmacy preparation were to fall within the regulatory pharmacy exemption, this does not automatically entail that the requirements of the pharmacy exemption based on patent law are met. The Provisions Judge held that article 54c(e) of the Dutch Patent Act is an exception to the exclusive rights of the patentee, which must be construed narrowly. Its rationale lies in public health: it applies only where there is a medical necessity, e.g. where an individual patient requires a dosage or method of administration that is not available in the patentee’s authorised medicinal product. The exception does not allow a pharmacy to compound a patented medicine on a structural scale without the patentee’s consent. The Provisions Judge considered that supplying the nasal sprays to other pharmacies, keeping them in stock for that purpose and listing Semanova in the G-standaard fell outside the scope of the pharmacy exemption. The listing in the G-standaard was specifically considered an act of offering, reserved to the patent holder. As regards Ceban’s own patients, the Provisions Judge found that Ceban had not made sufficiently plausible that there was an unmet medical necessity. Ceban stated that the nasal spray had been developed for patients with a fear of needles, but did not explain why the individual patients concerned had such a fear or why off-label prescribing of Rybelsus®, Novo Nordisk’s semaglutide tablet, would not have been sufficient. The Provisions Judge considered that Ceban’s conduct pointed towards structural and potentially large-scale use. In particular, the Court referred to Ceban’s presentation in Portugal, the import of 600 grams of semaglutide, sufficient for 15,000 vials, the listing in the G-standaard and the use of the brand name Semanova. These circumstances were difficult to reconcile with Ceban’s position that the nasal spray was prepared only for individual patients on the basis of medical necessity. The Provisions Judge therefore held that Ceban could not rely on the pharmacy exemption and ordered Ceban to cease its infringement of SPC 936 in the Netherlands. Conclusion The decision confirms that the pharmacy exemption under article 54c(e) of the Dutch Patent Act is distinct from the regulatory pharmacy exemption. It also points out that the exemption based on the Dutch Patent Act is construed narrowly and does not cover structural or large-scale compounding without demonstrated medical necessity for individual patients.

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.