Bengaluru, India · Wyoming, USA+91 91132 14395contact@prasaip.comLinkedIn

UPC · EUROPE · INDIA · UK · PATENTS

The divisional game at the UPC: Sandoz v Novo Nordisk

The Unified Patent Court has said it can stop a patentee from escaping a validity ruling by withdrawing a patent and relying on divisionals. Here is what the Milan central division decided on semaglutide. We also compare how India and the UK deal with the same tactic.

A gold pen injector resting beside a row of plain wine coloured folders on a pale desk, one folder slightly pulled out.

Divisional patent applications are a lawful part of European practice. But they can also keep a patent family alive after one patent is attacked. On 22 October 2026 the Unified Patent Court said it can act when divisionals are used to avoid a validity decision.

The order was made by the Milan seat of the central division in Sandoz AG v Novo Nordisk A/S, UPC_CFI_2221/2026. It decided a preliminary objection, not the validity of the patent. But its reasoning matters to every originator and generic company litigating at the UPC.

Key points
  • Sandoz is seeking revocation of Novo Nordisk's EP 3 689 365. The patent covers once weekly semaglutide at 1.0 mg for type 2 diabetes.
  • Novo has a pending divisional, EP 4 406 593.
  • The court held that withdrawing a patent does not automatically end a revocation action under Rule 360 of the Rules of Procedure.
  • It accepted jurisdiction over an Arrow type request aimed at Novo's divisional patents.
  • It also accepted jurisdiction to restrain Novo from withdrawing its approval of the patent text at the EPO. Whether to make that order was left for later.
  • Leave to appeal was granted on the whole order.

What the "divisional game" is

Under Article 76 of the European Patent Convention, an applicant may file a divisional application while a parent is pending. The divisional keeps the parent's filing date. A patentee can therefore hold a pending divisional with claims close to a granted patent.

If the granted patent is about to be revoked, the patentee may withdraw its approval of the text. Under Article 113(2) EPC, the EPO only decides on a text approved by the proprietor. The EPO then revokes the patent without deciding on the merits. The divisional may then grant later with similar claims. Generic companies call this the divisional game. It can leave them uncertain for years.

What Sandoz asked for

Sandoz brought a revocation action on inventive step and added matter. It added three further requests aimed at the divisional game. Novo objected to these three under Rule 19 of the Rules of Procedure.

  • Request 5 sought a declaration that a semaglutide composition was obvious at the priority date, independent of any patent.
  • Request 6 sought a declaration that any claim in the family broad enough to cover claims 1 to 5 would lack inventive step.
  • Request 7 sought an order stopping Novo from withdrawing its approval of the text at the EPO until a final decision on validity.

What the court decided

No declaration about a composition in the abstract

The court upheld Novo's objection to Request 5. The request concerned a composition, not an identified patent or claim. It was not tied to a Sandoz product, so it was not a true Arrow declaration. It could also affect third parties who had not been heard. The court declared it manifestly inadmissible in its present form.

Arrow type relief against corresponding claims

The court dismissed the objection to Request 6. It treated the request as Arrow type relief limited to Novo's own divisional patents. Whether the wording is admissible remains for the main proceedings.

Withdrawal does not end the case

Rule 360 lets the court end an action that has become devoid of purpose. The court held that withdrawing the patent does not automatically mean there is nothing left to decide. Rule 360 is not a tool to end proceedings where the subject matter has simply moved to a divisional. The court may refuse to close the case and rule on validity.

Power to restrain withdrawal at the EPO

The court dismissed the objection to Request 7. It held that the central division may, where necessary, restrain a patentee from withdrawing approval of the text. The power comes from its revocation jurisdiction under Article 32(1)(d) of the UPC Agreement. The order would bind Novo, not the EPO. Urgency, necessity and proportionality were left for later. Sandoz must support the request with concrete facts.

Abuse of rights

The court said divisionals are legitimate. But using them to frustrate judicial scrutiny may be an abuse of rights. On the evidence so far, it found no misconduct by Novo.

The wider semaglutide picture

The patent also faces 18 oppositions at the EPO, which has agreed to accelerate them, according to JUVE Patent. EP 3 689 365 is itself a divisional. Its parent, EP 2 866 825, was revoked earlier by the EPO. The UPC's approach means a generic company can seek finality at the UPC even while EPO opposition runs.

How India and the UK handle similar tactics

  • India. Section 16 of the Patents Act, 1970 allows divisional applications from a pending parent. A divisional keeps the parent's priority date. Indian courts have looked closely at whether divisionals claim a distinct invention. A patentee may offer to surrender a patent under section 63, and interested persons may oppose the surrender. Revocation lies under section 64. We are not aware of any Indian court granting an Arrow declaration. Generic companies rely on pre grant and post grant opposition and on revocation.
  • United Kingdom. The Arrow declaration began in England in Arrow Generics v Merck (2007). The Court of Appeal confirmed in Fujifilm v AbbVie (2017) that such declarations can be granted where they serve a useful purpose. They are aimed at the same problem of shifting patent rights.

For Indian generic makers, the UPC order is relevant in two ways. Many sell into Europe, where these tools now apply. And Indian practice on divisionals and surrender may face similar arguments as semaglutide competition grows.

Practical steps

  • Generic companies at the UPC should plead Arrow type relief tied to their own product and to claims matching the patent in suit.
  • Map the patentee's pending divisionals early. Show how their claims track the patent under attack.
  • Keep evidence of any pattern of withdrawals or late divisional filings. Abuse needs concrete facts.
  • Originators should expect the UPC to look past withdrawal. Plan divisional filings around legitimate needs, and record those reasons.
  • In India, consider opposing a surrender under section 63 where it appears designed to avoid a ruling.

Our patent services include oppositions, revocation and freedom to operate work for pharmaceutical clients. For filing in Europe, see our international patent support. Our note on the UPC opt out after Sidel v Omnia covers another UPC strategy question.

Frequently asked questions

What is the divisional game?

It is the use of pending divisional applications to keep similar claims alive after a granted patent is attacked. Withdrawing the attacked patent can avoid a ruling on its validity.

Can the UPC stop a patentee withdrawing a patent at the EPO?

The Milan central division held that it has power to restrain withdrawal of approval of the text, where necessary to protect a revocation action. It has not yet made such an order in this case.

What is an Arrow declaration?

It is a declaration that a product or process was obvious or not new at a given date. It protects a company against later patents with similar claims.

Official source