Novo Nordisk A/S v. Ceban Ziekenhuisfarmacie B.V., The Hague District Court, PI Judge, 5 August 2026, Case no. ECLI:NL:RBDHA:2026:21938
Regulatory Pharmacy exemption v. Pharmacy exemption under Patent Law
In preliminary injunction proceedings before the District Court of The Hague, Novo Nordisk successfully enforced its Dutch SPC for semaglutide against Ceban (short for: Centrale Bereidingsapotheek Nederland), a company that operates a retail pharmacy.
In 2025, Ceban prepared a nasal spray containing semaglutide (“Semanova”) without a marketing authorisation and without Novo Nordisk’s consent.
Ceban did not contest validity of Novo Nordisk’s SPC but relied on the patent law pharmacy exemption of Art. 54c(e) of the Dutch Patent Act 1995.
The PI Judge ruled that there is a clear disctinction between the regulatory pharmacy exemption under the Medicines Act and the pharmacy exemption under the Dutch Patent Act:
“The (regulatory) pharmacy exemption under the Medicines Act is, in principle, irrelevant to the interpretation of the pharmacy exemption under patent law. The regulatory pharmacy exemption constitutes an exception to the mandatory marketing authorisation (required in connection with the protection of public health and the control of the quality, safety, and efficacy of medicinal products) in order to ensure the availability of necessary medicinal products for individual patients. This is distinct from patent law protection and the exception thereto in the case of a legitimate invocation of the pharmacy exemption under patent law. If Ceban can successfully invoke the regulatory pharmacy exemption, it does not automatically follow that it is also entitled to successfully invoke the pharmacy exemption under patent law. The judge in preliminary relief proceedings therefore does not need to rule on the regulatory pharmacy exemption or on the patient safety of the Semanova nasal spray.
“Contrary to what Ceban has repeatedly argued, there is no basis for assuming that, under the patent law pharmacy exemption, small scale compounding (for up to 50 individual patients per month) would be permitted without further qualification. The fact that such small scale compounding by pharmacists would be permitted under the regulatory pharmacy exemption is irrelevant in this context. As already discussed above, the regulatory pharmacy exemption (as an exception to the requirement for a marketing authorization) simply has a different basis than the pharmacy exemption under patent law. It is therefore possible that the compounding of patent protected medicinal products by a pharmacy falls under the regulatory pharmacy exemption but not under the patent law pharmacy exemption. In and of itself, it is true that the regulatory pharmacy exemption is, in that case, “an empty shell”, but that does not provide grounds for a broader interpretation of the pharmacy exemption under patent law. In this regard, Novo Nordisk has argued, without contradiction, that the vast majority of medicinal products dispensed by a pharmacy are not (or are no longer) protected by patent law.”
The Court found that the circumstances pointed toward structural and potentially large scale use falling clearly outside the patent law pharmacy exemption. At the hearing, when asked, Ceban was unable to explain what the incentive was for providing an alternative dosage form. In particular, it is unclear whether there was an actual need on the part of prescribing general practitioners or patients, or whether it was more of a business idea on Ceban’s part. It had imported 600 grams of semaglutide which is enough, according to Novo Nordisk’s uncontradicted assertion, for some 15,000 vials. And it had registered the product in the G-Standard under its own brand name.
On the other hand, not every supply of the Semanova nasal spray according to the PI judge categorically constitutes an infringement. Whether, and, if so, which, supplies constitute an infringement can, if necessary, be determined in proceedings on the merits.
An injunction and additional measures were granted.
A copy of the judgment (in Dutch) can be read here.
An English translation of the judgment (provided by Koen Bijvank (Brinkhof) who represented Novo Nordisk in this matter) can be read here.
