UPC Can Curb Divisional Games in Semaglutide Patent Case

The Milan seat of the Unified Patent Court's Central Division ruled on 22 October in Sandoz v Novo Nordisk (UPC_CFI_2221/2026) that, if a patentee withdraws a patent during revocation proceedings while pursuing substantially the same protection through a divisional application, the court may refuse to close the case and still decide whether the patent lacked inventive step. Where necessary, it may also order the patentee not to withdraw its approval of the patent text at the EPO.

The patent at issue is Novo Nordisk's unitary patent EP 3 689 365, covering a semaglutide composition for preventing or treating type 2 diabetes, given parenterally once a week at 1.0 mg.

Sandoz's three extra requests

Sandoz seeks revocation of the whole patent for lack of inventive step and added matter, and made three further requests which, it told the court, are meant to stop the "divisional game". Novo Nordisk filed a preliminary objection on 10 August against those three requests only, without challenging the revocation action itself; the parties were heard in Milan on 28 September. The court ruled as follows:

• Request 5, a declaration that the composition was obvious at the priority date: it is not tied to a specific patent or product, so it is an abstract declaration outside UPC jurisdiction and manifestly inadmissible as drafted.
• Request 6, a declaration that any claim in the same family broad enough to cover the subject-matter of claims 1 to 5 lacks inventive step: within jurisdiction, and close to an English-law Arrow declaration; whether and how far it is granted is left to the main proceedings.
• Request 7, an order stopping Novo Nordisk from withdrawing its approval of the patent text under Article 113(2) EPC: the Central Division has power to grant such interim measures, but the request is linked only in general terms to the divisional game and must be supported by concrete facts; urgency, proportionality and any penalty have not been assessed.

Withdrawal need not end the case

The key is Rule 360 of the Rules of Procedure. Withdrawing a patent would ordinarily leave a revocation action without purpose, but the court held that this is not automatic: if the same subject-matter can still be pursued through a divisional, the claimant may keep an interest in a ruling, and the court can decline to dispose of the action and decide on validity. Such a finding would affect a later divisional patent only where its claims substantially correspond to what was adjudicated; it is not a ruling on patents not yet granted. A patentee later seeking provisional measures would have to disclose it to the court.

What the court has not found

The court did not find that Novo Nordisk is playing a divisional game. Sandoz pointed to the pending family application EP 4 406 593 and to a statement in which Novo Nordisk reserved the right to file divisionals during EPO prosecution; the court saw this as a general reservation of procedural rights, not evidence of misconduct. Validity, and whether Requests 6 and 7 are granted, will be decided in the main proceedings. The court gave both parties leave to appeal the whole order and reserved costs.

J&C notes that generic and biosimilar companies bringing revocation actions at the UPC can frame additional requests around an identified patent family and specific claims, rather than an abstract declaration about a composition, and should support any interim request with evidence of the patentee's actual conduct. For patentees, withdrawing a patent mid-revocation and switching to a divisional may not stop the UPC from ruling.

Source: www.unifiedpatentcourt.org