UPC_CFI_2221/2026 – Sandoz v Novo Nordisk

Expert Commentary

Arrow declaration Facts 1. Sandoz filed a revocation action with respect to Unitary Patent 3 689 365 for 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, with parenteral administration. 2. Sandoz field three other requests: “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; 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; and 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.” 3. Novo Nordisk filed a preliminary objection against the requests under 5-7 above arguing that the Court is not competent to hear these requests. 4. An oral hearing took place focusing only on the preliminary objection. The Court 1. The Court describes arrow declaration: to make sure that whatever patent (f.i. based on divisionals) is granted on the basis of the original application, is not infringed by the product of Sandoz because at the priority date of the patent that product was not new or inventive over the prior art existing at the priority date. 2. The Court sees what is requested under 7 as trying to avoid the so-called divisional game: one withdraws the application just before a refusal by the EPO and files in the meantime a new patent application for similar subject matter. 3. The Court does not think that there is enough evidence that Novo Nordisk is going to play the divisional game. 4. The Court qualifies the divisional game as an abuse of rights: “an abuse of rights arises where a legal entitlement is exercised in apparent compliance with its conditions, but in a manner that departs from the purpose for which the right was conferred. The right to file a divisional application is conferred to organise and protect disclosed subject-matter within the patent grant system; it is not conferred to circumvent, neutralise, or indefinitely postpone effective judicial determination of patent validity. In that sense, the allegation of a “divisional game” is not merely a criticism of prosecution strategy. It raises a question of whether procedural rights are being exercised in a way that undermines the balance between exclusive protection and legal certainty on which the patent system rests.” 5. The Court addresses the Unitary Patent package and Art. 47 of the Charter and sates that all these provisions are to be read together: “10. All these provisions must be read together. The protection of patent rights cannot be detached from the procedural mechanisms by which their validity, scope and enforceability are contested. Nor can an exclusive and unified court system be interpreted in a manner that deprives parties of any effective tribunal for a patent-related dispute that falls within the field for which that system was established.” 6. The Court concludes that its jurisdiction goes further than the strict literal interpretation of Art. 32(1) UPCA and referred to anti-antisuit injunctions as an example. 7. The Court states that, under the UPCA, it has jurisdiction for measures necessary for an effective judicial protection of rights arising under the patent system. 8. The Court has no jurisdiction for measures which have no relation to the patent but request 6 is allowable as it is directed to divisional patents. 9. In fact, request 6 seeks an arrow declaration and the Court of Appeal has already shown a certain openness with respect to competence questions. 10. The Court refers to R. 361 RoP which gives the possibility to consider an action devoid of purpose and dismiss it. 11. Request 7 is ancillary to the revocation action and is therefore allowable. 12. The Court refuses request 5 but considers requests 6 and 7 not manifestly inadmissible. Comment 1. The Court uses a lot of wording to justify the allowability of requests 6 and 7. 2. In the practice, it is important that the Court holds that it can issue an arrow declaration. 3. We have to await a decision of the Court of Appeal, of course, but I cannot see why the Court of Appeal would not allow an arrow declaration.

Key Holdings

• The UPC's jurisdiction extends beyond a strict literal interpretation of Art. 32(1) UPCA to include measures necessary for the effective judicial protection of rights arising under the patent system.
• A request seeking an Arrow-style declaration directed to existing or future divisional patents within a patent family is within the Court's competence and not manifestly inadmissible.
• Engaging in a 'divisional game' to withdraw applications before EPO refusal to circumvent, neutralise, or indefinitely postpone judicial validity determinations constitutes an abuse of rights.
• An order restraining a patent proprietor from withdrawing approval of the text at the EPO under Art. 113(2) EPC is ancillary to a revocation action and allowable to protect legal certainty.

Tags

• Arrow declaration
• Preliminary objection
• Competence
• Abuse of rights
• Divisional game
• Revocation