Semaglutide at the UPC: Milan says it can stop the "divisional game"

What was decided

The “divisional game” is the name challengers give to a familiar move. A generic company attacks a patent; the patentee, sensing it will lose, withdraws its approval of the patent text at the EPO, so the patent lapses without any court or opposition division ruling that it was invalid; and the same subject matter reappears in a divisional application from the same family, with the clock reset and the generic back where it started. For a company trying to clear the way to a European launch, the point of the attack is a ruling it can rely on, and the move takes that away.

Sandoz’s revocation action against Novo Nordisk’s unitary patent EP 3 689 365, which claims semaglutide given under the skin once a week at 1.0 mg for type 2 diabetes, asked the Milan central division for three things beyond revocation: a declaration that the dosing regimen was obvious at the priority date, whatever patent it sits in; a declaration that any claim in the same patent family broad enough to cover the patent’s claims 1 to 5 would be invalid for lack of inventive step; and an order, with a penalty, stopping Novo Nordisk from withdrawing its approval of the patent text at the EPO until the validity question is finally decided. A divisional, EP 4 406 593, is already pending. Novo Nordisk objected that none of the three is within the UPC’s jurisdiction, which is conferred by Article 32 of the UPC Agreement and nothing else.

On 22 October 2026 the panel (Postiglione, Klein and Goedeweeck) ruled on the objection alone; validity is for the main proceedings. It upheld the objection to the first request: a declaration that a composition was obvious, detached from any identified patent and from any product or activity of the claimant, is outside the court’s jurisdiction and is not an “Arrow declaration” of the kind the English courts grant, which is tied to the claimant’s own product. It dismissed the objection to the other two. The court held that its jurisdiction over revocation actions carries with it the power to make that jurisdiction effective. That includes declining to treat an action as pointless when the proprietor withdraws the patent, ruling that the patent lacked inventive step all the same, and reaching divisionals in the same family whose claims are broad enough to cover the subject matter in suit, so far as they belong to the same proprietor. It also includes an “autonomous” power to grant protective measures, among them an order restraining the proprietor from withdrawing the patent text under Article 113(2) EPC. The court was careful to say that the power exists; whether it should be used here is a separate question. Sandoz’s request was, in the court’s words, “not supported by specific factual circumstances”, and the court found no evidence yet that Novo Nordisk intends to play the game. Urgency, proportionality and the balance of interests would have to be shown on a reformulated request.

Leave to appeal was granted on the whole order, and the panel said it was not minded to stay the action while an appeal is heard. Costs were reserved.

Timeline

Date	Event
30 June 2026	Sandoz files for central revocation of EP 3 689 365 in Milan, the first UPC action on semaglutide
10 August 2026	Novo Nordisk objects to Sandoz’s three extra requests
28 September 2026	Hearing on the objection
8 October 2026	Separately, an EPO Board of Appeal revokes Novo Nordisk’s cardiovascular-use patent
22 October 2026	Milan rules: the bare obviousness declaration is out; the family-wide declaration and the no-withdrawal order are within the court’s power
2027	Merits of the revocation action; the EPO’s accelerated opposition

What it means if you are…

A generics or launch planner. This is a procedural ruling on one patent, but it reaches past semaglutide. Until now, a central revocation action at the UPC carried the risk that the patentee could make it disappear by withdrawing the patent, leaving the divisional for another day. Milan says the court will not be frustrated that way: it can rule on the withdrawn patent, it can reach the divisionals, and it can forbid the withdrawal. If the Court of Appeal agrees, a UPC revocation action becomes a more reliable way to clear a family than it was, and the divisional game loses much of its point in the seventeen UPC countries. It does not touch the UK, Spain, Switzerland or Poland, where national actions are still needed. The lesson of the lost first request is practical: tie every request to an identified patent or to your own product, and come with evidence if you allege abuse.

A parallel trader. Nothing changes on the ground. The compound protection on semaglutide, which Novo Nordisk puts at 2031 in Europe, is not in this case. The dosing patent is one layer of the secondary protection that would otherwise follow.

A wholesaler or buyer. No European supply event follows from this order. It shortens the odds that the secondary patents will be settled by a court rather than left hanging, which matters for the early 2030s, not for next year.

Status and what to watch

Whether either side appeals, and what the Court of Appeal makes of a central division asserting powers the UPC Agreement does not spell out. Sandoz’s reformulated request, if it brings one, and the evidence it needs to show. The EPO opposition to the same patent, which the Opposition Division has agreed to accelerate because of the UPC case, and the fate of the pending divisional EP 4 406 593. The merits of the revocation action follow in 2027.

This note is general information, not legal advice. The position for any product and country should be checked on the registers.