Intellectueel Eigendom & Technologie

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.

Ondernemers die merkproducten verhuren of via een poolsysteem beschikbaar stellen, behouden ook nadat die producten bij een klant in gebruik zijn genomen de volledige eigendom over hun merkproducten. Het Gerechtshof Den Haag bevestigt dit in een recent tussenarrest[1] waarin La Gro optreedt namens Container Centralen A/S (CC).  In dit artikel bespreken we de praktische relevantie van het arrest voor merkhouders die een circulair (verdien)model exploiteren, dat steunt op terugkerende inkomsten, zoals huur en servicefees. De feiten CC exploiteert een Europees poolsysteem voor transportcontainers in de sierteeltsector. In de pool rouleren circa 3,5 miljoen containers. Deelnemers van deze pool kunnen containers huren of eigen containers inbrengen, in ruil voor een jaarlijkse vergoeding. Om zichtbaar te maken dat containers bij de pool horen, zijn zij voorzien van een zogenoemde CC-tag, een model en merkenrechtelijk beschermd identificatielabel. Overdracht of doorverkoop van containers met tags en losse tags aan derden is contractueel uitdrukkelijk verboden. In deze zaak hield één van de deelnemers zich daar niet aan. Hij verkocht honderden containers en losse tags aan derden buiten het systeem om. Zijn verweer luidde dat CC haar merkrechten al had ‘uitgeput’ door de containers en tags aan hem beschikbaar te stellen. De uitputtingsleer: wanneer verliest een merkhouder zijn grip? De uitputtingsleer houdt in dat een merkhouder zich niet langer kan verzetten tegen verdere verhandeling van zijn product, zodra hij dat product zelf of met zijn toestemming in de Europese Economische Ruimte in de handel heeft gebracht. De achterliggende gedachte is dat de merkhouder zijn economische beloning heeft ontvangen en de vrije handel daarna niet mag blokkeren. Het hof hanteert daarbij twee cumulatieve vereisten, ontleend aan de jurisprudentie van het Hof van Justitie van de EU: er is pas sprake van in de handel brengen indien de handeling (a) derden het recht verleent over de waren te beschikken, en (b) de merkhouder in staat stelt de economische waarde van zijn merk te realiseren. Het oordeel: geen uitputting bij een duurovereenkomst Het hof oordeelt dat aan beide vereisten niet is voldaan. Pooldeelnemers verkrijgen uitsluitend het recht de containers met tags en de losse tags binnen de contractuele voorwaarden te gebruiken en mogen deze nooit aan derden overdragen. Dat betekent dat de deelnemers niet vrijelijk over de containers met tags en/of losse tags kunnen beschikken. Bovendien kwalificeert het hof het verdienmodel van CC als een duurovereenkomst: het draait niet om een eenmalige verkoopopbrengst, maar om het over een langere periode innen van huur en fees. Juist omdat die tarieven bewust laag zijn gehouden als tegenprestatie voor een duurzame relatie, heeft CC bij de initiële terbeschikkingstelling van de containers de economische waarde van haar merk nog niet verzilverd. In die omstandigheden is er volgens het hof geen sprake van in de handel brengen en dus ook niet van uitputting. Waarom is dit arrest van belang? De uitspraak biedt merkhouders met verhuur- en poolmodellen een stevige juridische basis. Het hof benadrukt dat de uitputtingsleer niet automatisch van toepassing is zodra een merkhouder zijn producten beschikbaar stelt in een poolsysteem. Zolang het verdienmodel is gebaseerd op langdurige inkomsten en deelnemers geen vrij beschikkingsrecht over de producten verkrijgen, houdt de merkhouder grip op de merkproducten, ook wanneer die producten feitelijk bij klanten in gebruik zijn. De voorwaarde is wel dat dit contractueel deugdelijk is verankerd: duidelijke bepalingen die overdracht en doorverkoop uitsluiten zijn essentieel. Voor merkhouders met een circulair of op terugkerende inkomsten gebaseerd (verdien)model is dit een welkome bevestiging van hun rechtspositie. Wilt u weten of uw contracten en verdienmodel voldoende bescherming bieden aan uw merkrechten? Onze specialisten op het gebied van intellectueel eigendomsrecht adviseren u graag. Neem contact met ons op voor een vrijblijvend gesprek. [1] Hof Den haag, 31 maart 2026, C/09/621316 / HA ZA 21-1039

On 1 November 2023, the District Court of The Hague handed down a decision in the invalidity proceedings instituted by Sandoz B.V. (“Sandoz’’) against Bayer Intellectual Property GmbH. (“Bayer’’). The Court held the once-daily dosing regimen of rivaroxaban, claimed in EP 1 845 961 B1 (“EP 961”), inventive. The use of rivaroxaban and the anticipated launch of Sandoz’s generic product Rivaroxaban is used as an anticoagulant for the treatment of thromboembolic disorders (TEDs). Bayer markets its rivaroxaban product under the name Xeralto. Bayer was the owner of EP 1 261 606 B1 that protects the active ingredient rivaroxaban. Based on said patent, Bayer was granted SPC no. 300370 that will expire on 1 April 2024. Sandoz is planning to launch a generic product containing rivaroxaban in the Netherlands after expiration of the SPC. Sandoz started invalidity proceedings claiming that EP 961 is invalid due to lack of inventive step. Bayer instituted a counterclaim requesting: 1) an injunction against Sandoz for (likely) future infringement of the NL part of EP 961 and 2) a declaration that any offering or placing on the market of Sandoz’ product (e.g. listing the product in the ‘G-Standaard’), or importing or storing the product for those purposes, is an infringing act. What preceded EP 961 was granted on 22 April 2015. Opposition was filed by fifteen parties. In 2018 the Opposition Division revoked EP 961 for lack of inventive step. In appeal, the Technical Board of Appeal (“TBA’’) maintained the patent as granted. Since then, multiple national suits have been filed to invalidate EP 961 e.g. in Germany, Norway and in the United Kingdom. In its decision of 9 June 2023 the Court of Oslo concluded that the patent was inventive. Difference between the TBA and NL proceedings The main difference is that the TBA found EP 961 inventive based on Kubitza I & II and the Harder Abstract, whereas in the Dutch (and Norwegian) proceedings Sandoz introduced the ‘’Harder Poster’’ as new prior art, which was not introduced in the opposition. The Harder Poster reveals parameters in the pharmaco-dynamics that suggest suitability for a once-daily dosing. After summarising the reasoning of the TBA, the District Court of The Hague discusses the Norwegian decision in the parallel proceedings, where the Harder Poster has been taken into account in assessing inventive step. The District Court’s assessment of inventive step Following the parties, the District Court applies the PSA and takes the Harder Poster as the closest prior art. The difference between the Harder Poster and the claimed invention is that the latter concerns the medical use of rivaroxaban in the claimed dosage regimen. Harder is a phase I study on the pharmacodynamic effects of rivaroxaban on eight healthy subjects, but not a study on what the effects and therapeutic efficacy are in patients. The technical effect of the distinguishing feature is that rivaroxaban in the dosage regimen (once daily for at least five days with a rapid release dosage form) is effective and safe in TED patients. According to the Court the objective technical problem is: “finding an oral dosage regimen of rivaroxaban that is safe and effective against TEDs”. This is almost the same as defined by the TBA, albeit that the Court does not concur with the TBA’s (additional) objective of finding a ‘convenient’ dosage regimen as part of the problem to be solved. To assess inventive step, it must be assessed whether, based on the technical problem, the invention was obvious for the average skilled person on the priority date. According to the Court an inventive step is lacking if the person skilled in the art, based on the relevant state of the art, would have solved the problem as claimed in the patent. As the invention is the result of further research, the invention is not only obvious if the skilled person had carried out that research and the results are clearly predictable, but also if there is an incentive in the state of the art that there is a reasonable expectation of success. This means that the skilled person is able to predict a reasonable successful outcome of the research project within an acceptable time period. The hope to succeed is insufficient. The Court points out that the Harder Poster does not provide a reasonable prediction that rivaroxaban would be safe and effective in patients in a once-daily dose. It does not provide convincing results to support this, as the study was conducted in only eight healthy subjects, lacks data on half-life time, whereas the type of tests used were of an experimental nature. Moreover, the skilled person would not have a reasonable expectation of success, because of numerous negative pointers, like 1) the high (and life-threatening) risk of over- and under-dosing patients in anticoagulant research would make him cautious to extrapolate results in phase I studies to a phase II study, 2) Harder does not provide half-time data, which is an important indicator for determining dosing frequency, 3) the negative research experience with a comparable Xa inhibitor, razaxaban, leading to severe bleeding in patients and 4) some medical-ethics committees rejected Bayer’s proposal to test once daily dosing of rivaroxaban in clinical trials. The District Court also assesses Sandoz’ argument that the skilled person, starting to test two- or three-day doses in a phase II study would, through routine steps, ultimately end up with a once-daily dosing regimen. But the Court rejects this view as Sandoz failed to describe how the skilled person would have overcome the negative pointers and would endeavor to also try a once-daily doses with a reasonable expectation of success. Conclusion Based on its own assessment and with reference to the Norwegian judgment and the TBA decision, the District Court rejects Sandoz’ claim for invalidity and holds EP 961 inventive. Both counterclaims of Bayer are granted.

On 3 October 2023, the Provisions Judge of the District Court of The Hague rendered its decision in the PI proceedings between Grünenthal GmbH. et al. (“Grünenthal’’) and Teva B.V. et al. (“Teva’’). The Provisions Judge (“PI Judge”) is of the preliminary opinion that EP 1 457 208 B9 (“EP 208”) makes the technical effect plausible and is inventive. The likelihood of EP 208 being held valid in final relief proceedings is high and therefore a PI against Teva is granted. Making this case particularly interesting is that in parallel final relief proceedings, courts in Germany and the United Kingdom have found EP 208 invalid. The PI Judge (who is also a Judge in the Dutch local division of the UPC) is of the preliminary opinion that the plausibility standard in the Netherlands is different from that in the UK, referring to the recent PI decision of the Court of Appeal in the Apixaban case. Grünenthal is since July 2022 the owner of the Dutch part of EP 208 that is in force in the Netherlands until 14 March 2024. It markets the patented drug, which is a long-acting testosterone drug, under the name ‘Nebido’. What preceded  After Teva received a Dutch marketing authorisation for its generic product called ‘Testosterone Teva’ in December 2022, Grünenthal sent warning letters to Teva in February and April 2023, Teva did not respond until 24 August 2023 when it notified Grünenthal that it planned to enter its generic product in the G-Standaard of October 2023. Grünenthal initiated PI proceedings against Teva before the District Court of The Hague, accusing Teva of infringing EP 208. The interim claim in the PI proceedings  A first, interim hearing was held on 12 September 2023 dealing with the incidental (provisional) claim of Grünenthal, requesting the PI Judge to order Teva to withdraw the listing of its generic product from the October G-standard in order to avoid it being published.  The PI Judge handed down its interim decision on 13 September 2023, ordering Teva to withdraw its product from the October 2023 G-Standaard. According to the PI Judge, Grünenthal has a profound interest in maintaining the status quo as Teva is not yet on the market (nor any other generic) nor listed in the G-Standard, so no price erosion has taken place yet. The fact that Teva chose to ignore the warning letters is explicitly taken into account in the ultimate balance of interest in favour of Grünenthal. The main claims in the PI proceedings  On 26 September, the second oral hearing on the main claims was held. Grünenthal claimed that EP 208 is (about to be) infringed and is seeking a PI prohibiting manufacturing and distributing the generic product and an injunction against unlawful conduct.  The PI Judge rendered its decision on the main claims on 3 October 2023, finding the Dutch part of EP 208 provisionally valid and infringed. According to the PI Judge the Dutch part of EP 208 and the Dutch PI proceedings differ from the German and English final relief proceedings because: i) the claims of Dutch part of EP 208 have been substantially limited by Grünenthal during the Dutch PI proceedings, ii) the statements presented, the expert evidence and substantive debate were not identical and iii) the Dutch plausibility standard in the light of inventive step, after G2/21, differs from the plausibility standard in the UK. In formulating the Dutch plausibility standard, the PI judge refers to the G2/21 decision and to the recent decision of the Court of Appeal in the Apixaban case (section 4.35-4.43). which we have discussed in our Pharma Update of 25 August. The PI judge mentions that the plausibility criterion formulated by the Enlarged Board of Appeal in G2/21 is an abstract criterion. It must be filled in based on the specific circumstances of the case. This leads the PI Judge in section 4.41 to consider: “In applying the G2/21 test when assessing the inventive step of a claim in which the technical effect is not included as a feature, unlike the referral from Teva to the TBA case Agrevo, it is not necessary for the patentee to provide proof, or make it plausible in PI proceedings, that the technical effect works with at least the majority of the claimed compositions.”  The PI Judge observes that the outcome could have been different if Teva had made it plausible that the person skilled in the art, based on the application, could not derive, or has reasons to question that the technical effect would occur over the full breadth of claim 1 as limited in the Dutch part of EP 208.

On 15 August 2023, the Court of Appeal of The Hague (”CoA”) rendered its decision in the PI proceedings between Bristol-Myers Squibb Holdings Ireland Unlimited Company (“BMS’’) and Sandoz B.V. (“Sandoz’’), Centrafarm B.V. et al. (“Centrafarm”) & Teva B.V. et al. (“Teva’’). The CoA is of the preliminary opinion that EP 1 427 415 B1 (“EP 415”) makes the technical effect plausible, allowing post-published evidence to be taken into account. The CoA comes to its finding after the Enlarged Board of Appeal (“EBA’’) handed down its decision in G2/21. The likelihood of EP 415 being held valid in the pending final relief proceedings is high and therefore a PI against the generic companies is granted. Making this case of particular interest is that two out of the three CoA Judges are also Appeal Judges in the UPC. This case may show the position the UPC may take on plausibility. BMS is the owner of EP 415 and of SPC no. 300500 based on this patent (“SPC”). EP 415 was in force in the Netherlands until 16 September 2022. The SPC relates to apixaban or pharmaceutically acceptable salt forms thereof (marketed by BMS as Eliquis®) and is in effect from 17 September 2022 until 19 May 2026. What preceded  The first apixaban case in the Netherlands was the PI proceedings between BMS and Sandoz. The Provisions Judge of the District Court of The Hague (“PI Judge” rendered his decision on 10 May 2022. According to the PI Judge, there is no inventive step due to lack of plausibility and therefore a good chance that the patent (and the SPC) will be held invalid in final relief proceedings. A PI against the sale of generic apixaban by Sandoz was denied. No appeal was filed. On 23 March 2023 the EBA decided case G2/21 on plausibility. It considered three questions about the circumstances in which it is permissible to rely on post-published evidence of a technical effect in support of inventive step. The EBA provides guidelines on whether or not to consider post-filed evidence. The new PI proceedings After the EBA ruling, BMS filed another interim relief proceedings against Sandoz and against Centrafarm. BMS requested the PI Judge to grant a PI against both generic companies, alleging infringement of the NL part of EP 415 and the related SPC. The key question was whether the G2/21 decision changed the position taken in the earlier preliminary judgement given on 10 May 2022 and what the standard of plausibility should be in the Netherlands for taking into account post-published evidence. According to the Provisions Judge, the G2/21 decision does not change the application of the concept of plausibility, as the EBA embraces the consistent line of case law of the Technical Boards of Appeal. Therefore, the PI request of BMS is dismissed. BMS also filed interim relief proceedings against Teva before the same Provisions Judge, requesting a PI against Teva. In this case the Parties agreed that a judgement should be rendered identical to the judgment of 17 May 2023, so that all cases could subsequently be heard in the same appeal proceedings. The Provisions Judge rejected the PI against Teva on the same grounds as expressed in his  decision of 17 May 2023. The main considerations of the CoA The key question in the interim relief appeal proceedings is which criteria should be applied in order to decide whether or not post-published evidence can be accepted to hold a patent claim inventive (ab initio plausibility or ab initio implausibility) in light of the decision of the EBA in G2/21. Unlike the Provisions Judge, the CoA holds the patent inventive. It finds that the post-published evidence can be taken into account. According to the CoA, the sole criterion in G2/21 for taking into account a technical effect when applying the PSA is if for the skilled person, having the common general knowledge in mind, and based on the application as originally filed, said technical effect is derivable as being encompassed by the technical teaching and embodied by the same originally disclosed invention. This entails that it is not obliged that the patent application always needs to provide ‘’proof’’ or needs to make plausible that the technical claimed effect actually occurs. This needs to be filled in on a case-by-case basis. The CoA refers to par. 77 of G2/21 to stress that the admission of post-published evidence is different in assessing inventive step when compared to assessing sufficiency of disclosure. The circumstances of the apixaban case imply that on the priority date the average person skilled in the art could derive from the application, WO 652, that apixaban has the most advantageous effect as an fXa inhibitor. Therefore, the criterion as described in G2/21 has been met. The patent application disclosed more than a mere verbal statement of the technical effect so there is no reason for the skilled person in the art to doubt that the function of apixaban (an improved fXa inhibitor) could not be achieved (ab initio implausibility). There is no requirement that any evidence to that effect should be included in the application. The CoA stated that in the final relief proceedings in France and Norway, the Courts came to a similar conclusion based on the same reasoning. It is remarkable that the CoA explicitly considers the decisions of these countries as highly persuasive to the detriment of the UK High Court and Appeal Court decisions, which it distinguishes as being made on the basis of assessing sufficiency of disclosure. The CoA points out (sections 3.21-3.24) that in many countries invalidity proceedings have been instituted, some of which have been decided, others are pending, two of which in NL.