Marleen van den Horst

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 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.

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

On 23 January 2024, the Provisions Judge of the District Court of The Hague handed down a decision in the PI proceedings initiated by Janssen Biotech Inc. (“Janssen”) against Samsung Bioepis NL B.V. (“Samsung NL”). Janssen claimed that Samsung NL infringed its Stelara SPCs granted in Italy and Denmark. The Provisions Judge denied the PI as according to his preliminary assessment Samsung NL can benefit from the SPC Manufacturing Waiver. Janssen’s SPC- Stelara Janssen holds European patent EP 1 309 692 B1 (“EP 692”) for “ANTI-IL-12 Antibodies, compositions, methods and uses“. The medicinal product of Janssen is marketed under the brand name ‘Stelara’ and contains the active ingredient ustekinumab. EP 692 was granted on 13 May 2009 in, among others, Italy and Denmark. The patent expired on 7 August 2021. After expiration, Janssen was granted a SPC in Italy, Denmark and the United Kingdom (UK – ending on 19 January 2024). Similar Stelara patents in Canada and South Korea have also expired. However, Jansen has filed patent(s) (applications) in these countries that protect the treatment regimen approved for Stelara for ulcerative colitis disease. SPC Manufacturing Waiver Samsung has developed a biosimilar of ustekinumab with Stelara as reference called SB17. Samsung NL issued a notice to the Danish and Italian authorities respectively that it intended to manufacture and stock its biosimilar in Denmark and Italy for the purpose of exporting it to the UK, Canada and South Korea based on Regulation 2019/933 regarding the SPC Manufacturing Waiver “MW Regulation”) and to market the product in the European Union after expiration of the SPC (stockpile exemption). Samsung NL mentioned that it would submit the reference numbers of its market authorisations in said countries as soon as publicly available. Samsung NL additionally undertook towards Janssen that it would not manufacture its biosimilar products for the EU-market until 24 January 2024 in order to avoid discussion on the stockpile exemption in the PI proceedings. The PI Judge’s assessment of infringement According to Janssen Samsung NL infringes its SPCs in Denmark and Italy and cannot benefit from the SPC Manufacturing Waiver because Samsung NL (i) did not specify the reference numbers of the marketing authorisations in the exporting countries, (ii) Janssen’s patent rights are in force in the countries to which Samsung NL intends to export its biosimilar, and (iii) Samsung NL is not allowed under the SPC Manufacturing Waiver to store the biosimilar products. The PI Judge finds that according to the text of MW Regulation the manufacturer is obliged to provide the reference number of market authorisation, or the equivalent of such authorisation in each exporting third country, only as soon as it is publicly available. This entails, according to the preliminary view of the Provisions Judge, that if this number is not yet publicly available, the manufacturer has the possibility to supplement the notification with the reference number of the marketing authorisation as soon as it is publicly available, as reflected in Article 5(5)(e) MW Regulation. The Provisions Judge considers that the MW Regulation is sufficiently clear on this item. It is taken into account that the nature and the content of the provisions in question were extensively debated during the revision of the earlier SPC Regulation. The Provisions Judge is therefore of the opinion that it is not necessary to raise preliminary questions to the Court of Justice of the EU on the application of the SPC Manufacturing Waiver, as suggested by Janssen. The fact that the District Court of Munich in the matter Janssen vs Formycon ruled differently on this matter does alter his view, especially because the Provisions Judge finds the reasoning of the District Court of Munich in said decision not convincing. Janssen further argued that Samsung NL may not manufacture a biosimilar under the waiver because in the countries to which Samsung NL intendeds to export its product, patent rights are existing. The Provisions Judge considers that there is no requirement under the MW Regulation that the intended exporting countries are free of patent rights and/or that the manufacturer must prove this in advance. Such requirement would be contrary to the objective of the MW Regulation of ensuring a level playing field with global competition. If EU based manufacturers were only allowed to manufacture for export to countries that are ‘free of patents’ they would be put in a serious disadvantage compared to non-EU based competitors not subject to such restrictions. In relation to the storage of the products the Provisions Judge states that it follows from the wording of Article 5(a)(a)(ii) of the MW Regulation that under the export exemption, ‘temporary storage’ is allowed. The MW Regulation does not specify a maximum period for such ‘temporary storage’ other than that it must be strictly necessary for the actual export. Conclusion The Provisions Judge is of the preliminary opinion that – contrary to the Janssen vs Formycon decision – a manufacturer of a biosimilar can rely on the SPC Manufacturing Waiver a) even if the market authorisation reference number is not yet publicly available, b) there are possible patents rights in the countries to which the product is exported and c) temporary storage of the products is possible when strictly necessary for the actual export.

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.