Novo Nordisk wins Netherlands GLP-1 compounding lawsuit
A Netherlands-based compounding pharmacy has been ordered to stop distributing a compounded nasal spray formulation of Novo Nordisk's GLP-1 agonist semaglutide in a test of the country's pharmacy exemption rules.
The preliminary injunction against Breda-based Ceban Ziekenhuisfarmacie was implemented after the District Court of The Hague ruled that Ceban's product, sold as Semanova, infringed Novo Nordisk's supplementary protection certificate (SPC) protection for semaglutide, which is sold as Ozempic and Rybelsus for diabetes and Wegovy for weight loss.
Ozempic and Wegovy are both sold as a weekly injectable in the EU, while Rybelsus is an oral formulation of semaglutide, and there are no nasal spray formulations of semaglutide approved by any regulatory authority around the world, according to Novo Nordisk.
Ceban has been ordered to "cease the infringing activities, remove product listings, disclose supply chain information, and reimburse Novo Nordisk's legal costs," said the company in a statement.
The EU compound patent on semaglutide expired earlier this year, but the drug remains under the protection of a Dutch SPC that is not due to expire until 2031, according to Germany's JUVE Patent news service, which said the case is a key test of the pharmacy exemption clause of the Dutch Patent Act.
Compounded medicines in the EU are not subject to the oversight of the EMA, and oversight and enforcement are the responsibility of authorities in member states. While they can be made in a pharmacy for an individual patient in rare cases – as detailed in the Dutch legislation – EU law nevertheless prohibits them from being bulk manufactured or marketed at scale.
Ceban, which also supplied other pharmacies with Semanova, argued in court that it should be able to make its compounded version available for up to 50 people a month under the Netherlands' rules, but did not persuade the judge.
Unlike the US, there is also no provision in the EU to allow compounding when medicines are in short supply. A big market for semaglutide and other GLP-1-acting drugs like Eli Lilly's tirzepatide sprang up in recent years, although that was largely shut down after the drugs came off the official shortages list.
"Protecting patients means protecting the integrity of the medicines they rely on," said John Kuckelman, group general counsel at Novo Nordisk.
"This decision sends a clear message that intellectual property rights protecting pharmaceutical innovation will be enforced," he added. "We will continue to take decisive legal action against those who unlawfully exploit our innovations or market unapproved semaglutide products in ways that jeopardise patient safety and undermine the regulatory framework that protects patients."
