Sandoz asks European patent court to revoke Novo Nordisk semaglutide patent
A Sandoz challenge to a Novo Nordisk semaglutide patent in Europe could change competition for the 1 mg diabetes dose there, but it does not alter US approvals.
Sandoz has asked the Unified Patent Court to revoke a Novo Nordisk patent covering the 1 mg dose of semaglutide for diabetes. The revocation action was filed in the court's Milan Central Division on 30 June 2026 and targets Novo Nordisk unitary patent 3 689 365, which covers that dose in 18 European Union countries.
Semaglutide is the active ingredient in Novo Nordisk's Ozempic, Wegovy and Rybelsus [1]. Ozempic and Rybelsus are diabetes medicines, while Wegovy is approved for weight loss. The patent at issue covers the 1 mg diabetes dose rather than the higher strengths used in obesity treatment.
The Unified Patent Court handles patent disputes for a group of EU countries in a single proceeding instead of separate national lawsuits. A ruling revoking a unitary patent would remove that patent's protection across the countries it covers.
Novo Nordisk's half-year financial report shows how much the semaglutide franchise contributes to the company. Adjusted Ozempic sales were DKK 31,375 million in the second quarter of 2026, up 5% at constant exchange rates, and sales of the Ozempic pill, also sold as Rybelsus, were DKK 5,228 million, down 4% at those rates [1]. Novo Nordisk reported total second-quarter net sales of DKK 78,488 million, up 3% at constant exchange rates, and adjusted operating profit of DKK 33,389 million, up 11% [1]. The company raised its full-year outlook and now expects adjusted sales growth of 0% to -6% and adjusted operating profit growth of 0% to -6% at constant exchange rates, citing increased expectations for GLP-1 product sales [1].
No hearing date in the Sandoz case has been reported, and the court has not published a decision timetable. Sandoz has not disclosed whether it intends to sell a semaglutide product, and no response from Novo Nordisk to the filing has been reported.
Why it matters for patients
The case concerns European patent rights, not US approvals. It does not change the FDA-approved status of Ozempic, Wegovy or Rybelsus, and it does not by itself put a competing or generic version of semaglutide on the US market. Whether any generic version of semaglutide is approved for sale in the United States has not been reported.
In Europe, the outcome could matter in the 18 countries covered by the patent. If the patent is revoked, other manufacturers could seek to market the 1 mg diabetes dose in those countries, which could affect price and supply there. If the patent is upheld, Novo Nordisk keeps exclusive rights to that dose in those markets until the patent expires. The expiry date has not been reported.
For patients who take semaglutide, this filing does not change what is dispensed at a US pharmacy. Whether a European ruling would eventually affect US prices or supply is not known and would depend on separate patent and regulatory decisions. The filing also provides no new information about how well semaglutide works or what its risks are.
What happens next
The Sandoz case continues at the Unified Patent Court's Milan Central Division. No hearing date, decision date or settlement talks have been reported. Novo Nordisk has not said publicly how it will respond to the action, and no timetable for the court's ruling has been published.
Sources
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