The UPC has issued a landmark order signalling it may bar patent proprietors from using divisional applications to escape judicial scrutiny of validity. The decision emerged from a dispute over the GLP-1 drug semaglutide.
Court asserts jurisdiction over divisional withdrawals
The case centres on EP 3 689 365, which claims a composition containing semaglutide for weekly treatment of type-2 diabetes at a 1.0 mg dose. The compound is the active ingredient in Novo Nordisk’s products Ozempic, Wegovy and Rybelsus. Sandoz lodged a revocation action in Milan, alleging lack of inventive step and added matter.
Beyond a standard revocation, Sandoz asked the court to grant three additional declarations aimed at curbing what it calls the “divisional game.” That practice involves pulling a patent application shortly before an adverse decision while preserving equivalent subject matter in pending divisionals, such as EP 4 406 593, which remains under examination.
The panel addressed the reach of the UPC’s authority under Article 32 UPCA. It held that the court possesses “inherent jurisdiction” to ensure the effective exercise of powers expressly granted by the agreement. The power is not an extra layer but an implicit element needed to secure the system’s operation.
Presiding judge Andrea Postiglione led a panel that also included legally qualified judge Anna-Lena Klein and technically qualified judge Rudi Goedeweck. They noted that strategic use of divisionals can create uncertainty for competitors and delay generic entry, which may amount to an abuse of rights under Article 76 EPC and Rule 36 EPC.
Abuse of Patent Rights
In the broader context of European patent practice, this approach mirrors earlier decisions that limited tactics designed to prolong monopoly protection.
Sandoz’s first extra request sought a sweeping declaration that any composition comprising semaglutide was obvious at the priority date, irrespective of a specific patent. The panel deemed the request manifestly inadmissible, finding it overly broad and likely to affect uninvolved parties. It distinguished the claim from an “Arrow declaration,” which targets a defined product or process.
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The second request, however, was accepted. It asks for a declaration that any claim of a unitary or European patent entitled to the priority of an application within the EP 365 family-covering claims 1 to 5-would be invalid for lack of inventive step. The court interpreted this request as seeking Arrow-type relief aimed at preventing the re-emergence of the same protective perimeter through a divisional application.
The panel noted that, should Novo Nordisk withdraw its approval of the text of the patent under Article 113(2) EPC during the proceedings, the court may decline to dispose of the action under Rule 360 of the Rules of Procedure. According to the order, the Milan division may still rule on validity despite the withdrawal, with consequential effects on divisional patents whose claims substantially correspond to the adjudicated subject matter.
Court Affirms Jurisdiction
On the third request, which seeks an order preventing Novo Nordisk from withdrawing its approval of the patent text at the EPO until a final validity decision, the court likewise affirmed its jurisdiction. The panel grounded this power in Article 32(1)(b) and (d) UPCA on revocation and declarations of non-infringement, holding that central divisions must be able to protect the effectiveness of their own proceedings. The panel clarified that this measure differs from infringement injunctions governed by Directive 2004/48/EC, which fall to national courts.
The panel granted the parties leave to appeal the order in its entirety but indicated it is not currently inclined to stay the first-instance proceedings pending any appeal. It is not yet known whether any of the parties will make use of the option to appeal.
Opposition proceedings and related patent environment
Additional semaglutide-related patents owned by Novo Nordisk have already faced revocation at the EPO. The parent patent EP 2 866 825 and earlier filings were cancelled in 2024, illustrating a broader pattern of challenge to the company’s portfolio.
Legal representation and procedural context
Bird & Bird leads Sandoz’s efforts, with Milan partner Giovanni Galimberti heading the team, supported by German colleagues Oliver Jüngst and Jan van Dieck, and associate Nelly-Isabel Kerb.
