Sandoz v Novo Nordisk (CFI, UPC_CFI_2221/2026, 22 October 2026)

Dhenne Avocats · 29 October 2026

Our analysis

Summary

By order of 22 October 2026, the Milan section of the Central Division rules on Novo Nordisk A/S’s preliminary objection to three ancillary requests in the revocation action brought by Sandoz AG against unitary patent EP 3 689 365, on once-weekly semaglutide. The panel declines jurisdiction over an abstract declaration that a composition was obvious, but holds that it has jurisdiction to counter the abusive use of divisional applications: it may refuse to dispose of the action under Rule 360 RoP where the proprietor withdraws the patent, and may find a lack of inventive step whose reach extends to claims in the same family that substantially correspond to the subject-matter adjudicated. It also holds that the Central Division may, as a protective measure, restrain the proprietor from withdrawing its approval of the text of the patent before the EPO. Leave to appeal is granted.

Facts and procedure

Sandoz AG brought an action before the Milan section of the Central Division for revocation in its entirety of Novo Nordisk A/S’s European patent with unitary effect EP 3 689 365, which claims a composition of semaglutide for use in the prevention or treatment of type 2 diabetes, administered once weekly at a dose of 1.0 mg by parenteral administration. It relies mainly on lack of inventive step and added matter. Besides the usual requests for revocation and costs (Requests 1 to 4), it made three further requests. Request 5 sought a declaration that a composition of semaglutide administered once weekly at 1.0 mg by subcutaneous administration was obvious at the priority date. Request 6 sought a declaration that any claim of a patent in the same family within the Court’s competence, broad enough to cover the subject-matter of claims 1 to 5 of the patent, would lack inventive step. Request 7 sought an order, under penalty, preventing the proprietor from withdrawing its approval of the text of the patent at the EPO (Art. 113(2) EPC) until a final decision on validity. On 10 August 2026, Novo Nordisk filed a preliminary objection under Rule 19 RoP directed only at those three requests. At the oral hearing of 28 September 2026, Sandoz explained that they were meant to prevent the “divisional game”, an application in the same family (EP 4 406 593) being pending before the EPO (paragraph 6). The panel comprised Andrea Postiglione (presiding judge and judge-rapporteur), Anna-Lena Klein and Rudi Goedeweeck (technically qualified judge).

The applicable law

Art. 32(1) UPCA lists the Court’s exclusive competences, including actions for declarations of non-infringement (point b), provisional and protective measures (point c) and revocation actions (point d). Following the Court of Appeal in XSYS v Esko, the panel construes it under Art. 31 of the Vienna Convention on the Law of Treaties, in the light of the object and purpose of the Agreement (paragraphs 11 and 12), the right to an effective remedy and the protection of intellectual property under Arts 47 and 17 of the Charter of Fundamental Rights (paragraph 9), and Art. 42(2) UPCA, which requires the Court to ensure that procedures and remedies do not distort competition (paragraph 14). Rule 360 RoP allows the Court to dispose of an action that has become devoid of purpose. Art. 76(1) and Rule 36(1) EPC govern divisional applications (paragraph 4), and Art. 113(2) EPC makes the maintenance of the patent conditional on the proprietor’s approval of the text. Art. 47(6) UPCA gives standing to bring a revocation action to any person concerned by the patent.

Question

In a revocation action, may the Court rule on the obviousness of a composition independently of any patent, rule on the validity of equivalent claims within the same family, and restrain the proprietor from withdrawing its approval of the text of the patent at the EPO in order to escape a validity ruling?

Decision

The panel upholds the preliminary objection only as regards Request 5, declared manifestly inadmissible in its present form. Directed to “a composition” rather than an identified patent, claim or product, it does not specify the remedy sought within the meaning of Rule 13.1(k) RoP and is not an Arrow-type declaration, which concerns a defined product, process or activity of the claimant (paragraphs 16 and 17). Its reach would also risk affecting third parties who have not been heard (paragraph 18). The panel holds, however, that it has an “inherent” jurisdiction, which it regards as part of the conferred jurisdiction, to secure the effectiveness of judicial protection, including against the abusive use of divisional applications, treated as a possible abuse of rights (paragraphs 7, 12 and 15). It draws on the anti-anti-suit injunction case law (Huawei v Netgear) and on Omnia v Sidel (paragraphs 13 and 22). Request 6 therefore falls within its jurisdiction, its admissibility being left to the main proceedings (paragraph 24). Withdrawal of the patent by its proprietor does not automatically render the action devoid of purpose: where the withdrawal forms part of a divisional strategy, the panel may refuse to dispose of the action under Rule 360 RoP and rule on inventive step, with effect limited to claims that substantially correspond to the subject-matter adjudicated (paragraphs 27 to 32). The panel adds that this power does not, strictly speaking, stem from inherent jurisdiction but from Art. 47 UPCA combined with Rule 360 RoP (paragraph 33), and that any effect on a granted divisional would not be automatic (paragraph 34). Art. 24 UPCA, which concerns the applicable law, is not an autonomous source of jurisdiction (paragraph 25). As to Request 7, the Central Division has its own protective power, rooted in Art. 32(1)(b) and (d) UPCA and distinct from the provisional measures against infringement that Directive 2004/48 organises around the infringement of a right (paragraphs 36 to 39). The conditions for granting it, including urgency and proportionality, remain to be assessed on specific facts (paragraph 35). Costs are reserved. Leave to appeal is granted, and the panel is not minded to stay the proceedings if the Court of Appeal does not rule promptly (paragraph 43).

Key points for practice

• The UPC confronts the “divisional game” head-on for the first time, classifying it as a possible abuse of rights, without finding any abuse here, since a general reservation of rights made before the EPO was held insufficient (paragraphs 6 and 7).
• Withdrawing the patent during the proceedings no longer guarantees the proprietor that the revocation action will end, as Rule 360 RoP leaves the Court to assess the claimant’s continuing interest (paragraphs 27 to 30).
• A request for a declaration must target an identified patent, claim or product, since abstract wording invites inadmissibility (paragraphs 16 to 18).
• A proprietor later seeking provisional measures on a divisional would have to disclose, under Rule 206 RoP, that a corresponding claim has been held invalid (paragraph 34).
• The reasoning moves between an expressly affirmed inherent jurisdiction (paragraph 12) and a mere exercise of conferred powers (paragraph 33). The Court of Appeal, if seised, will have to clarify that basis.
• Practical point: a generic company facing a divisional strategy should document the pending applications in the family and file, with supporting facts, a protective request against withdrawal of the text of the patent.

Provisions applied

UPC Agreement

Arts 1, 3, 24, 32(1)(b), (c) and (d), 42 and 47(6) UPCA

Rules of Procedure

Rules 13.1(k), 19, 20, 21, 206, 220, 316 and 360 RoP

EPC

Arts 76(1) and 113(2) EPC, Rule 36(1) EPC

Charter of Fundamental Rights of the European Union

Arts 17 and 47

Directive 2004/48/EC

Arts 2, 4, 9 and 23

Regulation (EU) No 1257/2012

Recital 4

Related decisions

• XSYS Italia v Esko-Graphics Imaging, Court of Appeal, 2 June 2025, cited for the method of interpreting Art. 32(1) UPCA.
• Huawei v Netgear, Munich Local Division, 11 December 2024, anti-anti-suit injunction relied on in support of the Court’s inherent powers.
• Omnia, Central Division, 7 May 2026, and Sidel Participations v Omnia, Court of Appeal, 21 September 2026, action for a declaration of non-infringement admissible before grant was completed.
• Pari Pharma v Koninklijke Philips, Central Division, 27 November 2025, and LS9 v bellissa HAAS, Central Division, 19 August 2026, on who is a person concerned under Art. 47(6) UPCA.

Prepared by Dhenne Avocats from the official decision, consulted on 29 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.