UPC Weekly - The UPC view on the "divisionals game"

Aled Richards-Jones

3 min read

UPC Weekly brings you timely, thoughtful and joined-up insight into the evolving landscape of patent litigation at the Unified Patent Court.

2026 Week 43

In its order of 22 October 2026 in Sandoz v. Novo Nordisk (UPC_CFI_2221/2026), the Central Division Milan broadly agreed with Sandoz that the UPC has some concrete tools to address what might be considered to be abusive use of divisional applications. They are:

  • Continuing ongoing validity proceedings to a merits determination, despite the proprietor’s abandonment of the patent.

  • Granting “anti-abandonment injunctions” to restrain a party from voluntarily revoking the patent which is the subject of pending revocation proceedings.

  • Granting “Arrow-type” declarations which state that a specific patent, product or process was old or lacked an inventive step at a given priority date. However, the CD was clear that the UPC has no jurisdiction to consider requests for broader declarations that “that a composition, independently of a specific patent right, was obvious at a given priority date.”

Divisionals are a legitimate and important part of the EPC system. They allow an applicant to pursue distinct inventions disclosed in an earlier application, when unity objections arise and also provide a mechanism for continuing to pursue subject matter which was disclosed in the original application, but which is not protected by the parent case.

However, in recent years, European courts have had to consider divisional strategies which would-be market entrants say are abusive. This is particularly prevalent in the pharmaceutical sector, where generics and biosimilars complain about “the divisionals game”, an umbrella term for a strategy where a proprietor abandons a patent or patent application before an adverse validity decision is issued by the EPO or the courts, only to then pursue the subject-matter through a newly filed divisional. Such strategies are said to shield a proprietor’s patent portfolio from judicial scrutiny while maintaining the threat of infringement proceedings brought on future granted divisionals, prolonging the commercial uncertainty facing would-be market entrants.

What the CD Milan was asked to consider – Sandoz’s Requests 5-7

Sandoz brought revocation proceedings against Novo Nordisk in relation to EP 3689365 B1, which concerns a composition comprising semaglutide for use in the prevention or treatment of type 2 diabetes, administered once weekly at a dose of 1.0 mg by parenteral administration.

Sandoz sought revocation of the patent in its entirety, relying principally on lack of inventive step and added matter. In addition to the ordinary revocation relief (Requests 1 to 3) and costs (Request 4), Sandoz formulated three further requests. The wording is important, so we set them out in full here:

Request 5: "that pursuant to its inherent jurisdiction, the Court declares that at the priority date of the patent in suit a composition comprising semaglutide for use in the prevention or treatment of type 2 diabetes, wherein semaglutide is administered once weekly in an amount of 1.0 mg, and wherein semaglutide is administered by subcutaneous administration, was obvious to the skilled person in the art having regard to the common general knowledge and/or the prior art relied upon in the present proceedings"

Request 6: "that the Court, for all patents it has competence under Art. 32.1 UPCA pursuant to its inherent jurisdiction, declares any claim of a Unitary Patent or respective European Patent granted for the Contracting Member States, entitled to claim the priority date of any application within the patent family of EP 3 689 365 broad enough to cover the subject matter of claims 1 to 5 of the patent in suit, would be invalid on the grounds of lack of inventive step"

Request 7: "to safeguard the Claimant’s legitimate interest in legal certainty on the validity of the claimed subject matter that the Court issues an order - under penalty to be further specified by the Court - that prevents the Proprietor from withdrawing the approval of the text of the Patent at the EPO (Art. 113(2) EPC) until the EPO opposition division, the Board of Appeal, or the UPC issues a final decision on the validity of the Patent"

Novo Nordisk filed a preliminary objection under Rule 19 RoP directed only at Requests 5 to 7, arguing that these exceeded the UPC’s jurisdiction. Sandoz stated that Requests 5 to 7 were purposely directed at preventing Novo Nordisk from playing the "divisional game", pointing to a pending family member, EP 4406593.

In its order, the CD Milan considered the issues as a matter of principle, without determining whether these requests should be granted in this specific case.

The Arrow background

Many readers will be aware of the Arrow Generics line of authority from the English courts which allow a party facing a real commercial threat from pending divisional applications to obtain an ‘Arrow declaration’ that its own product was old or obvious at the relevant priority date, thereby clearing the way without revoking a patent that does not yet exist.

Sandoz argued that its three requests were ancillary to and necessary for the effectiveness of the revocation action, relying on (amongst other provisions) the UPC's exclusive jurisdiction over unitary patents, a purposive reading of Art. 32(1) UPCA (the types of action for which the UPC has competence) and Art. 47 of the EU Charter of Fundamental Rights (the right to an effective remedy).

UPC has jurisdiction to consider Requests 6 and 7, but not Request 5

The CD dismissed Request 5. It held that the request, framed around “a composition” rather than an identified patent, claim, application or product, sought an impermissibly abstract declaration of obviousness untethered from any concrete right before the Court, contrary to the requirement under Rule 13.1(k) RoP that relief be clearly identified.

Holding that Request 5 was not a genuine Arrow declaration, the CD noted that Arrow-type relief must be anchored to a defined claimant product, process or proposed activity. Sandoz itself described Request 5 as directed at “patentability of subject matter, not product characteristics”, intended to “bind future divisionals” generally. The CD further noted that, as framed, the declaration risked affecting the rights of third parties not before the Court.

By contrast, the CD held that it did have jurisdiction to consider Request 6, properly construed. It read Request 6 as genuine Arrow-type relief: a defined, concrete request for a ruling on obviousness capable of giving Sandoz commercial certainty against future enforcement of claims having at least the same scope pursued through the same patent family. However, this came with an important caveat that such a declaration would only bind the present parties to the proceedings. If proprietorship of the divisionals changed before any future litigation, then the new proprietor’s right to be heard would be engaged.  

On Request 7, the CD likewise found jurisdiction. The CD held that the UPC Central Division seized of a revocation action has an autonomous jurisdiction to grant provisional and protective measures necessary to preserve the effectiveness of that action, grounded in Art. 32(1)(b) and (d) UPCA (declarations of non-infringement and revocation actions) reserved to Central Divisions, rather than in the injunctive jurisdiction under Art. 32(1)(c) UPCA (actions for provisional and protective measures and injunctions) which is reserved to Local Divisions. The Court reserved for later determination whether the conditions for actually granting such an interim measure (urgency, proportionality, risk of harm, balance of interests and precise scope) are met on the facts.

Although not requested by Sandoz, the CD used the occasion to outline a further measure available to the UPC. Addressing the mechanism under Rule 360 RoP, by which the Court may dispose of an action that has become “devoid of purpose” (which may arise, for example, where a patentee withdraws its approval of the patent text under Art. 113(2) EPC, causing the patent to be treated as never having existed), the CD held that such withdrawal does not automatically deprive it of jurisdiction or automatically render the action devoid of purpose. Rather, it is for the Court to “find” that the action has become devoid of purpose. Where a withdrawal is used to shift the real subject-matter of the dispute to a divisional application rather than to genuinely extinguish it, the Court may decline to dispose of the action and may proceed to determine that the patent lacked inventive step notwithstanding its withdrawal.

A big development – and not the last word on jurisdiction

The order is significant for the biopharmaceutical industry, making it clear that the UPC is prepared in principle to embrace a flexible approach to protect its jurisdiction for considering the validity of claimed subject matter. This continues a line of cases in which the UPC takes an expansive view of its jurisdiction, although subject to some practical constraints, as we have seen in case law on long-arm jurisdiction.

Considering the list of actions for which the UPC has competence, in Art. 32(1) UPCA, the CD noted that it must have powers that are implicit in the effective administration of these actions, but that this is not unlimited:

A court entrusted with exclusive jurisdiction over revocation actions, declarations of non-infringement, actions for damages derived from provisional protection, prior use, and provisional and protective measures must have the procedural powers necessary to ensure that those heads of competence are effective. This is not a licence to create an unlimited jurisdiction.

The CD explained that its approach here was grounded in protecting the effectiveness of proceedings before the CD against external procedural steps capable of frustrating the exercise of patent rights or access to the Court.

Yet it is likely that this will not be the last word on these matters – the order grants the parties leave to appeal. Appeals against orders on preliminary objections are usually heard quickly and so we may have further news within the next couple of months.

 

 

News, insights, and features

Stay up to date with our latest thinking.