UPC Milan Accepts Jurisdiction Over Divisional Tactics in Sandoz v Novo Nordisk

By Haedar

Photo: dorofeevajana / Pixabay

Generic drug makers in Europe have long complained about what they call the "divisional game". A patentee facing a strong validity attack withdraws or surrenders the contested patent before a court can rule, while keeping one or more divisional applications alive at the European Patent Office (EPO). The challenger wins nothing it can rely on, and a near identical claim may later be granted from the divisional.

On 22 October 2026 the Milan seat of the Unified Patent Court (UPC) Central Division issued a procedural order that gives challengers new tools against that tactic. The case is Sandoz AG v Novo Nordisk A/S, UPC_CFI_2221/2026, a revocation action against European patent EP 3 689 365, which concerns a once weekly 1.0 mg dose of semaglutide for treating type 2 diabetes. The order was made on Novo Nordisk's preliminary objection under Rule 19 of the Rules of Procedure (RoP). The panel was presided over by Judge Andrea Postiglione, sitting with Judge Anna-Lena Klein and technically qualified judge Rudi Goedeweeck. Bird & Bird acted for Sandoz and Bristows for Novo Nordisk.

The three contested requests

Beyond the usual request to revoke the patent, Sandoz asked for three further forms of relief, which Novo Nordisk said the UPC had no power to grant.

Request 5 sought a declaration that the semaglutide regimen was obvious at the priority date, as a free standing finding about a composition rather than about any patent claim. Request 6 sought a determination that would bite on pending or future divisionals in the same family, so that Novo Nordisk could not use them to recreate the protection of the patent under attack. The court read this as Arrow-type relief, named after the 2007 English decision in Arrow Generics v Merck. Request 7 asked for an order barring Novo Nordisk from pulling its consent to the granted text under Article 113(2) EPC, the usual way a proprietor gets a European patent revoked at its own request, until the EPO or the UPC had ruled on validity.

What the court decided

The court upheld the objection only for Request 5. It held that the UPC has no jurisdiction to declare a composition obvious independently of a specific patent right, and found the request manifestly inadmissible as framed. It also explained why the request was not a true Arrow declaration, since courts that grant those declarations tie them to identified products or processes.

The objection failed for Requests 6 and 7. On Request 6, the court said its jurisdiction covers conduct designed to circumvent its exercise, which includes abusive use of divisional applications. The mechanism it described is Rule 360 RoP, which lets the court dispose of an action that has become devoid of purpose. If a proprietor withdraws a patent for strategic reasons tied to a divisional, the court may refuse to close the case and go on to decide whether the claims lacked inventive step. That finding would then reach a divisional claim only to the extent that it substantially corresponds to the withdrawn subject matter. The court said this gives the commercial certainty of an Arrow declaration without the vagueness that Arrow declarations are sometimes criticised for. It added that any later court would still need to decide whether the divisional had in fact been used to get around the earlier ruling.

The court rejected Sandoz's reliance on Article 24 of the UPC Agreement (UPCA) as a source of jurisdiction, noting that the article deals with the law the court applies, not the scope of its competence.

On Request 7, the court held that the Central Division has its own power to order provisional and protective measures in matters within its competence, and that this includes, where necessary, barring a proprietor from pulling its consent to the granted text. It stressed that it was answering only the abstract question of power. Sandoz's request was linked to the divisional game in general terms only, and urgency, necessity and proportionality would all have to be shown on concrete facts.

Costs were reserved to the main proceedings, and the court granted both parties leave to appeal.

Why it matters

The order is one of the clearest statements so far from a UPC panel that the court will look behind a strategic withdrawal. Before the UPC, a challenger in many national courts had little recourse when a patent disappeared mid-case. English courts developed Arrow declarations, but most continental systems have nothing comparable. If the Court of Appeal confirms the Milan approach, revocation claimants across the UPC's 18 member states would have a way to secure a merits ruling even after a patent is dropped.

The power to restrain an Article 113(2) withdrawal is more unusual. It touches the boundary between the UPC and the EPO, since the withdrawal is an act in EPO proceedings. Commentators at ip fray compared it with the anti-interference measures discussed in the Amazon and InterDigital dispute earlier this year, where UPC divisions were asked to restrain conduct in other forums. That dispute was later settled through arbitration, so no appellate guidance came out of it. The Sandoz order may now give the Court of Appeal a chance to set limits.

For proprietors, especially in pharmaceuticals where divisional families are common, the practical message is that withdrawing a patent during UPC revocation proceedings may no longer end the risk. Any withdrawal should be planned with the possibility in mind that the court continues and rules on substance. For generic and biosimilar companies, the order suggests that requests aimed at divisionals should be pleaded around specific claims and products, not as broad declarations about a technology.

A note for Indonesian readers

Indonesia is not part of the UPC, and Indonesian patent law has its own rules on divisional applications under Law No. 13 of 2016 as amended. Still, many Indonesian generic producers and licensees depend on the European status of originator patents when planning launches, and semaglutide is one of the most closely watched molecules in that pipeline.

Sources

• Unified Patent Court, Sandoz AG v Novo Nordisk A/S, UPC_CFI_2221/2026, procedural order of 22 October 2026 (decision page)
• Order text (PDF)
• ip fray, "UPC's CD Milan assumes jurisdiction over declaratory judgment concerning future divisionals and over anti-abandonment injunctions"
• Bristows, Irides weekly global patent litigation update