Dutch pharmacy exemption defence fails in Novo Nordisk semaglutide case

Novo Nordisk continues its efforts to defend the market exclusivity of its blockbuster semaglutide products in Europe. In a judgment handed down yesterday, the District Court The Hague granted the Danish pharmaceutical company a preliminary injunction against Ceban Ziekenhuisfarmacie, a Breda-based pharmacy that had begun compounding a semaglutide-containing nasal spray under the name Semanova (case ID: C/09/704955 / KG ZA 26-494).

The compound patent EP 1 863 839 protecting semaglutide expired in March this year. However, Novo Nordisk still holds Dutch SPC 300936, which remains in force until 19 March 2031. Novo Nordisk markets semaglutide under the brand names Ozempic (for type 2 diabetes) and Wegovy (for obesity) as once-weekly subcutaneous injections, as well as in tablet form as Rybelsus.

Ceban (Centrale Bereidingsapotheek Nederland) operates as a central compounding pharmacy within a group of eight companies across the Netherlands, Belgium, and Spain. The retail pharmacy had prepared the nasal spray in 2025, dispensed it to its own patients and supplied it to other pharmacies. It also had the product listed in the Dutch G-Standard drug database and included in electronic prescribing systems used by general practitioners.

Scope of the pharmacy exemption

The central legal question concerned the scope of the pharmacy exemption under Article 54c(e) of the Dutch Patent Act. This provision, which only entered into force in February 2019, exempts from patent infringement the preparation of medicinal products for immediate use in individual cases pursuant to a medical prescription.

Ceban argued that its activities fell within both the regulatory and patent law pharmacy exemptions, contending that small-scale compounding for up to 50 individual patients per month should be permitted. Novo Nordisk countered that Ceban was preparing semaglutide on a systematic scale, thereby undermining the patent holder’s rights.

Preliminary relief judge J.Th. van Walderveen sided with Novo Nordisk on the key points. The court found that the resale of nasal sprays to other pharmacies, the stocking of products for that purpose and the registration in the G-Standard fell outside the pharmacy exemption. The judge also expressed doubts as to whether the individual dispensations to Ceban’s own patients could be justified, noting that Ceban had imported 600 grams of semaglutide — enough to manufacture 15,000 vials — and had given the product a brand name. The court concluded this pointed towards “structural and potentially large-scale use”.

Regulatory and patent law separated

The court explicitly distinguished between the regulatory pharmacy exemption under the Medicines Act and the patent law exemption. According to the ruling, the two exemptions have different bases: the regulatory exemption serves to ensure availability of necessary medicines for individual patients, while the patent law exemption must be interpreted narrowly to avoid undermining the patent holder’s exclusive rights.

The court observed that Ceban had failed to sufficiently explain the medical need for the nasal spray formulation. When asked at the hearing, Ceban’s attorney stated the product had been developed to help patients with a fear of injections but did not deny the financial motivation. A presentation given by a Ceban employee in Porto in April 2026, headed “Where did we get the idea from?”, further supported the impression that the compounding was driven by commercial rather than medical considerations.

The court did, however, reject Novo Nordisk’s request for an injunction against the Porto presentation as an alleged incitement to infringement, finding that such a presentation could not be regarded as an offer of a patented product.

Injunction and disclosure

The court ordered Ceban to cease all distribution of semaglutide-containing nasal sprays in the Netherlands, to remove the product from the G-Standard, prescribing systems and its website, and to recall products supplied to other pharmacies. Ceban must also disclose the identities of its Chinese semaglutide supplier and its professional customers within four weeks. The judge imposed penalty payments of up to €500,000.

Novo Nordisk had also filed a request for enforcement with the Dutch Health and Youth Inspectorate in February 2026, based on alleged violations of the Medicines Act. The regulator extended the decision period until October 2026. The preliminary relief judge noted that the regulatory question was separate from the patent infringement proceedings.

The parties clashed over litigation costs. Novo Nordisk initially submitted a bill of €143,188.77 under Article 1019h of the Dutch Code of Civil Procedure but limited its claim to €45,400 for attorneys’ fees during the hearing, corresponding to the maximum indicative rate for standard PI proceedings in patent cases. Ceban objected, arguing the proceedings did not concern the technical substance of the patent but rather the legal limitations of the right. The court awarded €50,053.77 in total costs.

An appeal against the decision is possible.

Ex parte PIs in Germany

The proceedings form part of a broader European campaign in which Novo Nordisk has been defending its semaglutide portfolio against generic and biosimilar competitors. In parallel proceedings at the European Patent Office, the company recently succeeded in defending EP 3 746 111 B1, which protects a formulation improving bioavailability of oral semaglutide. However, the EPO Boards of Appeal revoked several other Novo Nordisk patents relating to semaglutide in tablet form, including EP 2 827 845, EP 2 827 885 and EP 2 866 825.

In Germany, the 4a Civil Chamber of the Regional Court Düsseldorf had awarded Novo Nordisk an ex parte PI against several companies in late autumn. They had been offering products containing semaglutide at the global pharmaceutical trade fair CPHI in Frankfurt from 28 to 30 October 2025. The Danish patent holder also saw EP 839 infringed by these products and applied for preliminary injunctions, which were served on the infringing exhibitors directly at the trade fair. Furthermore, the 6th Civil Chamber of the Frankfurt Regional Court issued three further ex parte PIs against exhibitors that offered finished medicinal products containing Semaglutide without valid marketing authorization, which constitutes an infringement of unfair competition law. These injunctions were likewise enforced on-site during the event.

Bijvank and Mooij for Novo Nordisk

Patent litigators Koen Bijvank and Barbara Mooij of renowned Dutch law firm Brinkhof represented Novo Nordisk. The team boasts extensive experience in pharma litigation, representing generic drug and biosimilar manufacturers such as Sandoz in various disputes.

Bijvank has a long-standing relationship with the client. The double qualified litigator and patent attorney is equally active in EPO proceedings, for example concerning CRISPR-Cas technology. Thus patent holders and innovators in the pharma and biotech sectors such as The Broad Institute, Amgen, and Novartis also trust in the firm. In the EPO opposition over semaglutide patents, patent attorneys from British firm D Young & Co represented the Danish pharma company.

Koen Bijvank

In the proceedings at the District Court of The Hague, the Brinkhof litigators cooperated with Raquel Frisardi, associate general counsel at Novo Nordisk.

In the PI proceedings in Düsseldorf and Frankfurt, a team of Hoyng ROKH Monegier acted for the Danish patent holder. The team was led by partner Christine Kanz and included partner Mathis Breuer, counsels Sandra Stolzenburg-Wiemer, Valentin Wagner as well as associates Max von Leitner and Ling-Ling Dorsch and Karsten Müller. Counsel and patent attorney Claudia Hertzsch provided support in technical matters.

Ceban relied on Macro & Versteeg advocaten, a boutique law firm specialising in regulated markets, based in Heemstede. Arnold Versteeg has a particular focus on the regulated market for healthcare. He is a trial lawyer, with experience in administrative and civil law cases.