Sandoz AG v. Novo Nordisk A/S, UPC Central Division, Seat Milan, 22 October 2026, Case no. UPC_CFI_2221/2026
Arrow declaration, divisional game
Headnotes
1. The UPC has no jurisdiction to entertain a claim seeking a declaration that a composition, independently of a specific patent right, was obvious at a given priority date.
2. The UPC has jurisdiction to ensure the effectiveness of the judicial protection entrusted to it. That jurisdiction extends to conduct designed to circumvent its exercise, including the abusive use of divisional applications. In revocation proceedings or actions for a declaration of non-infringement, that jurisdiction may be exercised, in particular, by declining to dispose of the action under Rule 360 RoP and by determining that a patent lack(ed) inventive step, notwithstanding its withdrawal at the proprietor’s initiative.
3. The UPC Central Division has an autonomous jurisdiction to grant provisional and protective measures in matters entrusted to it by the UPCA which includes the power, where necessary, to preserve the effectiveness of pending revocation proceedings, to restrain a party from withdrawing its approval of the text of the patent under Art. 113(2) EPC.
Summary
Sandoz AG brought revocation proceedings against Novo Nordisk A/S with the Milan Central Division in relation to Unitary Patent EP 3 689 365, concerning a composition comprising semaglutide for use in the prevention or treatment of type 2 diabetes.
In its Statement of Claim, Sandoz seeks revocation of the patent in its entirety, relying principally on lack of inventive step and added matter. In addition to the ordinary revocation relief (1, 2 and 3) and costs (4), Sandoz formulates three further requests:
5) that pursuant to its inherent jurisdiction, the Court declares that at the priority date of the patent in suit a composition comprising semaglutide for use in the prevention or treatment of type 2 diabetes, wherein semaglutide is administered once weekly in an amount of 1.0 mg, and wherein semaglutide is administered by subcutaneous administration, was obvious to the skilled person in the art having regard to the common general knowledge and/or the prior art relied upon in the present proceedings;
6) that the Court, for all patents it has competence under Art. 32.1 UPCA pursuant to its inherent jurisdiction, declares any claim of a Unitary Patent or respective European Patent granted for the Contracting Member States, entitled to claim the priority date of any application within the patent family of EP 3 689 365 broad enough to cover the subject matter of claims 1 to 5 of the patent in suit, would be invalid on the grounds of lack of inventive step; and
7) to safeguard the Claimant’s legitimate interest in legal certainty on the validity of the claimed subject matter that the Court issues an order – under penalty to be further specified by the Court – that prevents the Proprietor from withdrawing the approval of the text of the Patent at the EPO (Art. 113(2) EPC) until the EPO opposition division, the Board of Appeal, or the UPC issues a final decision on the validity of the Patent.
Novo Nordisk filed a preliminary objection pursuant to Rule 19 RoP directed only against Requests 5, 6 and 7. At the oral hearing, which exclusively addressed the preliminary Objection, Sandoz clarified that Requests 5, 6 and 7 are purposely directed to preventing the Defendant from using what Sandoz describes as the “divisional game”.
The Court explains divisionals and the ‘divisional game’. In the Court’s view, there is no unequivocal evidence that Novo Nordisk is presently preparing to implement the alleged ‘divisional game’, since it’s actions may also be understood as a sheer general reservation of procedural rights within the pending EPO proceedings. The Court therefore adopts a purely systematic approach.
The Court qualifies the divisional game as an abuse of rights as follows:
“In general terms, an abuse of rights arises where a legal entitlement is exercised in apparent compliance with its conditions, but in a manner that departs from the purpose for which the right was conferred. The right to file a divisional application is conferred to organise and protect disclosed subject-matter within the patent grant system; it is not conferred to circumvent, neutralise, or indefinitely postpone effective judicial determination of patent validity. In that sense, the allegation of a “divisional game” is not merely a criticism of prosecution strategy. It raises a question of whether procedural rights are being exercised in a way that undermines the balance between exclusive protection and legal certainty on which the patent system rests.”
The Court discusses the Unitary Patent Package and Art. 47 of the Charter, and stresses that:
“All these provisions must be read together. The protection of patent rights cannot be detached from the procedural mechanisms by which their validity, scope and enforceability are contested. Nor can an exclusive and unified court system be interpreted in a manner that deprives parties of any effective tribunal for a patent-related dispute that falls within the field for which that system was established.”
Against that background, the Court maintains that its jurisdiction encompasses such measures and determinations as are necessary to ensure the effective judicial protection of rights arising under the patent system. This includes the right related to clearing the way of potentially invalid patents.
The Court’s view is that Request 5 is not allowable in the broad and unspecified (non Arrow declaration) form in which it is framed, and the Court does not have jurisdiction to decide on this request.
After lengthy considerations, the Court deems Request 6 and 7 within the jurisdiction and the competence of the Court. It concludes:
“For these reasons, the Court considers that Novo Nordisk’s Preliminary Objection is well-founded only in relation to Request 5 as presently formulated. Requests 6 and 7 are not manifestly inadmissible and fall within the Court’s jurisdiction in the limited terms set out above. Their ultimate merits, scope and any appropriate relief are reserved for further determination in the main proceedings.”
A copy of the Order can be read here.
