Is repeated use of Art. 10(b) Directive 2001/83 for fixed-dose combinations allowed? Preliminary questions to CJEU

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.

On 12 December 2025, the UPC Local Division Munich (“LD Munich”) handed down its decision in the parallel proceedings between Sanofi and STADA, Dr. Reddy and Zentiva and revoked Sanofi’s cabazitaxel patent EP 2 493 466 (‘‘EP 466’’) in all UPC territories in which the patent was in force and dismissed the infringement actions. In this case the UPC Court of First Instance applied for the first time the inventive step test for second medical use claims as recently determined by the UPC Court of Appeal (‘‘CoA’’) in Amgen v. Sanofi/Aventis. It was held that the patent lacked inventive step over the Phase III TROPIC (NHSC) trial document. What preceded Sanofi SA holds EP 466, which relates to a ‘’novel anti-tumoral use of cabazitaxel.’’ Sanofi markets its product containing cabazitaxel under the name JEVTANA® as a second-line treatment for prostate cancer patients. On 13 May 2024, several Sanofi entities filed infringement actions before the LD Munich against several entities of Accord, STADA, Dr. Reddy and Zentiva. Each of the defendant groups filed counterclaims for revocation based on lack of novelty and inventive step and, in some cases, added matter or lack of sufficiency of disclosure.The proceedings between Sanofi and Accord were withdrawn prior to the oral hearing, based on a confidential settlement and license agreement. On 6 September 2024, the ‘Tribunal Judiciaire de Paris’ invalidated the French part of EP 466, holding that it was obvious, considering documents describing a Phase III clinical trial with cabazitaxel and that a skilled person at the priority date would have had a reasonable expectation of success. According to the LD Munich, Sanofi appealed and settled the matter with Accord by requesting the reversal of the decision. The EPO Opposition Division (“OD”) on 15 December 2023 and Board of Appeal (“BoA”) on 3 June 2025 (T 0136/2024) rejected the oppositions filed against EP 466 and held the patent valid and not obvious. Both the OD and the BoA held that, based on the documents describing a Phase III trial with cabazitaxel, the skilled person had no reasonable expectation of success. Inventive step test – CoA The LD Munich records that the parties debated which inventive step test to apply: the problem-solution approach as applied by the EPO or the more holistic approach as formulated by the CoA, which is similar to the approach taken by the Tribunal Judiciaire de Paris. The LD Munich applies the test as formulated by the CoA in Amgen v. Sanofi-Aventis (paras 123–138). Objective (technical) problem Following the inventive step test of the CoA, the LD Munich holds that the objective problem is established by comparing the claim as a whole in the context of the description and the drawings, also considering the inventive concept underlying the invention. In order to avoid hindsight, the objective problem should not contain pointers to the claimed solution. In that regard, the LD Munich finds that the objective technical problem as formulated by the BoA contains parts of the solution and thus does not avoid hindsight. Therefore, the LD Munich reformulates the objective technical problem as the provision of a therapeutic option for treating patients suffering from castration-resistant metastatic prostate cancer who have been previously treated with a docetaxel-based regimen and have prostate cancer that progressed during or after that treatment. This includes both increased overall survival and purely palliative treatment. Reasonable expectation of success The LD Munich further assesses whether the skilled person, starting from a realistic starting point and seeking to solve the objective technical problem, would have (and not only could have) arrived at the claimed solution. Taking NHSC’s protocol of the Phase III TROPIC trial as the starting point, the LD Munich notes that it discloses all features of claim 1 in hypothesis form and records that the trial was already well advanced at the priority date. It then weighs the positive and negative pointers in the prior art. The LD Munich finds that a skilled person at the priority date would have had a reasonable expectation of success in view of the clinical Phase III trial and finds the patent invalid based on lack of inventive step. The LD Munich points out that the skilled person does not need to have certainty of success by any means. It adds that, in oncology, Phase III trials are regularly initiated without a Phase II study in the same tumour type, and holds that in this case the absence of a prostate-cancer Phase II trial did not preclude a reasonable expectation of success, No binding effect of EPO decisions Having regard to the deviating decisions of the OD and the BoA, the LD Munich considers that these decisions do not have a binding effect. It specifically emphasises that, while the UPC may, in principle, consider decisions and opinions issued by national courts and the EPO when interpreting the EPC, this does not relieve a UPC panel of its duty as an independent judicial body to interpret and apply the EPC in full. Conclusion The LD Munich revokes EP 466 in its entirety with effect in the following UPC Contracting Member States AT, BE, DE, DK, FR, IT, NL, PT and SE and dismisses the infringement actions. The decision is the first case in which the Court of First Instance applies the ‘holistic inventive step test’ formulated by the CoA. It also underlines that EPO and national decisions, althoughinfluential, have no binding effect within the UPC.

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

On 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.