No. 154 - 27 October 2026
Sandoz v Novo Nordisk – Central Division Milan, order of 22 October 2026, UPC_CFI_2221/2026
Can a patent proprietor avoid a final UPC validity decision by withdrawing its patent while continuing to pursue substantially the same subject-matter through divisional applications? And can the UPC prevent such a strategy?
The Milan Central Division has addressed these questions in a noteworthy order concerning the limits of the UPC's jurisdiction. The Court considers that it may continue revocation proceedings even after the patent has been withdrawn and, where necessary, prevent the proprietor from withdrawing approval of the patent text before the EPO.
The order adopts a far-reaching approach to the UPC's powers to safeguard the effectiveness of its proceedings. However, the Court has so far decided only a preliminary objection concerning jurisdiction. Whether the requested remedies should actually be granted remains open.
Sandoz brought a revocation action against Novo Nordisk concerning EP 3 689 365, a unitary patent directed to the treatment of type 2 diabetes using semaglutide administered once weekly at a dose of 1.0 mg.
In addition to revocation of the patent, Sandoz sought three further forms of relief intended to prevent what it described as the “divisional game”.
The concern was that a proprietor might avoid an adverse validity decision by withdrawing the patent while continuing to pursue substantially the same subject-matter through divisional applications.
Sandoz therefore requested:
Novo Nordisk challenged the UPC's jurisdiction over these additional requests by way of a preliminary objection under R. 19 RoP.
The Milan Central Division upheld the objection concerning the first request but rejected it concerning the other two.
The Court first considered whether it could declare that the relevant semaglutide composition was obvious at the priority date, independently of a specific patent right.
Sandoz relied on the concept of an Arrow declaration, known particularly from English patent litigation. Such declarations can establish that a specifically identified product or process was known or obvious at the relevant date, thereby providing commercial certainty in the face of pending patent applications.
The Court did not reject Arrow-type relief in principle.
However, Sandoz's request was not directed to a specifically identified product, process or commercial activity. Instead, it sought a broad declaration concerning technical subject-matter, potentially affecting patents and third-party rights beyond the dispute.
The Court therefore held that it lacked jurisdiction to grant the declaration in the form requested.
The Court then addressed a more fundamental question.
What happens if a proprietor withdraws approval of the patent text under Art. 113(2) EPC during pending revocation proceedings, thereby causing the patent to be revoked?
Under R. 360 RoP, the UPC may dispose of an action if it has become devoid of purpose and there is no longer any need to adjudicate.
However, the Court held that withdrawal of the patent does not automatically require termination of the revocation proceedings.
If substantially the same subject-matter continues to be pursued through divisional applications, the revocation claimant may retain a legitimate interest in obtaining a validity decision.
In such circumstances, the Court considers that it may decline to dispose of the action under R. 360 RoP and proceed to determine whether the withdrawn patent lacked inventive step.
The purpose is to prevent the proprietor from frustrating judicial scrutiny of the patent's validity while preserving substantially the same exclusionary effect through divisional applications.
The Court emphasised that such a determination would not automatically invalidate future divisional patents. Its consequences would have to be assessed in subsequent proceedings, taking account of whether the later claims substantially correspond to the subject-matter previously adjudicated.
Nevertheless, an earlier validity decision could significantly limit the practical benefit of pursuing equivalent claims through divisional applications.
The Court went one step further.
Sandoz had requested an order preventing Novo Nordisk from withdrawing approval of the patent text under Art. 113(2) EPC until a final validity decision had been issued.
The Milan Central Division held that it has jurisdiction to grant such a protective measure where necessary to safeguard pending revocation proceedings.
The Court distinguished this from a provisional injunction directed against patent infringement. Rather, the measure would serve to preserve the effectiveness of proceedings already falling within the UPC's jurisdiction.
Accordingly, the Court derived its powers from the jurisdiction over revocation actions and declarations of non-infringement under Art. 32(1)(d) and (b) UPCA, rather than from Art. 32(1)(c) UPCA concerning provisional and protective measures.
The Court thus recognised an autonomous power of the Central Division to grant protective measures safeguarding its own proceedings.
This is a particularly far-reaching aspect of the order, as the contemplated measure would restrain a proprietor from exercising a procedural right before the EPO.
However, the Court did not actually issue such an order. Whether the requirements of urgency, necessity, proportionality and the balance of interests are satisfied remains to be determined.
Underlying the decision is a broader discussion of the UPC's jurisdiction under Art. 32 UPCA.
Novo Nordisk argued that the UPC may exercise only the powers expressly conferred upon it by the UPCA.
The Milan Central Division acknowledged that Art. 32 UPCA defines and limits the Court's jurisdiction. However, it considered that the UPC must also possess the procedural powers necessary to ensure that its expressly conferred jurisdiction can be exercised effectively.
The Court referred to this as “inherent jurisdiction”.
In support, it relied on the object and purpose of the UPCA, Art. 47 of the EU Charter concerning effective judicial protection, and Art. 42 UPCA concerning proportionality, fairness and the avoidance of distortions of competition.
The Court also referred to UPC case law concerning anti-anti-suit injunctions.
Importantly, the Court clarified that inherent jurisdiction does not create an unlimited or additional jurisdiction beyond the UPCA. Rather, the relevant powers are implicit in the jurisdiction already conferred.
This reasoning provides the basis for the Court's approach to procedural strategies that might otherwise deprive UPC validity proceedings of their practical effect.
The Court expressly acknowledged that filing divisional applications is a legitimate procedural option under the EPC.
It also found that the evidence submitted by Sandoz did not establish that Novo Nordisk was pursuing an abusive divisional strategy.
In particular, a general reservation of the right to file further divisional applications was not sufficient to demonstrate misconduct.
The Court's conclusions therefore concern the powers potentially available to address such conduct, rather than a finding that an abuse had occurred in the present case.
The order is also procedural in nature. The Court has not yet determined whether the additional relief sought by Sandoz is admissible in its precise form or whether the substantive conditions for granting it are fulfilled.
The Milan Central Division granted leave to appeal the order in its entirety.
