Tandem Diabetes Care Europe v Roche Diabetes Care (CFI, 18 December 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 18 December 2024 (UPC_CFI_454/2023), the Paris Central Division dismissed Tandem Diabetes Care’s revocation action against Roche Diabetes Care’s EP 2 196 231, which concerns a system for ambulatory drug infusion, and maintained the patent as granted. Two procedural points reach beyond the case. Breach of a standstill clause requiring 90 days’ notice before any action can only give rise to contractual liability, without making the action inadmissible. A revocation claimant must also set out all its grounds and prior art in its first pleading, since later attacks amount to an amendment of the case under Rule 263. On the merits, added matter, lack of novelty and lack of inventive step were all rejected.

Facts and procedure

The parties had a standstill agreement requiring notice of any intended action 90 days before filing. Roche first raised a preliminary objection on jurisdiction, which the judge-rapporteur rejected on 10 May 2024 and which was not appealed, and then argued in its rejoinder that the action was inadmissible (paragraphs 5, 6, 9 and 14). Roche filed 26 auxiliary requests to amend, and later four more (paragraphs 7 and 10). In their reply the claimants introduced the Menot and Lieberman prior art and attacks on the dependent claims. At the interim conference of 11 September 2024 these were excluded for the assessment of claim 1 as granted and the further amendment was refused (paragraph 11). The oral hearing took place on 6 November 2024.

The applicable law

The right to effective judicial protection (Articles 6 and 13 ECHR, Article 47 of the Charter) admits only restrictions justified by an objective of general interest, which the Division extended to contractual restrictions (paragraphs 17 and 18). The front-loaded procedure requires parties to present their case in their first pleading (Rules 13 and 44, recital 7 of the preamble), any change falls under Rule 263 (paragraphs 27 to 33). On the merits, the Division applied Article 123(2) EPC and the requirements of novelty and inventive step.

Question

Does breach of a contractual standstill clause render a revocation action inadmissible, are grounds and prior art introduced in reply admissible, and is the patent valid?

Decision

Breach of a standstill clause does not necessarily deprive the breaching party of its right to sue (paragraph 16). The time limit, intended to allow a cooling-off period for negotiation, serves only a private interest and is not justified by any public interest: the action is admissible and the alleged breach is irrelevant (paragraphs 19 and 20). The new prior art may be used only to answer the defence and the application to amend, not to attack claim 1 as granted (paragraphs 35 to 38), the late attacks on the dependent claims were excluded, Roche’s parallel infringement action in Hamburg not justifying the delay (paragraph 39). The refusal of further amendments was confirmed (paragraph 40). On the merits, feature 1.5 (a partly rigid body with a flexible foil cover) is supported by the application, without any need to carry over the “tank-like” character, which is independent of that feature (paragraphs 49 to 56). No prior art discloses feature 1.3iii, under which the support structure limits the expansion of the filled container and defines its maximum volume: claim 1 is novel over Glejboel (paragraphs 59 to 63) and inventive over the combinations based on Diaz, Robertson and Glejboel (paragraphs 68 to 84). The patent was maintained as granted, with costs against the claimants (paragraphs 85, 86 and 148).

Key points for practice

• In the Division’s view, a standstill clause cannot bar access to the UPC: its breach is a matter for contract law alone (paragraphs 16 to 20).
• An objection based on such a clause does not go to jurisdiction and cannot succeed as a preliminary objection (paragraph 6).
• A revocation claimant cannot widen its attack in reply. New prior art is admitted there only in response to the defence or the application to amend (paragraphs 33 to 38).
• Practical point: all prior art and all claims attacked must be in the statement for revocation, and a later infringement action does not justify adding them late.

Provisions applied

Rules of Procedure

Rules 13, 19.1(b), 44, 48, 105, 263 and 333, recital 7 of the preamble

European Patent Convention

Art. 123(2)

Case law cited

Court of Appeal, 21 November 2024, UPC_CoA_456/2024, BITZER Electronics v Carrier, Paris Central Division, 29 July 2024, OrthoApnea, Brussels Local Division, 8 July 2024, ECJ, 16 July 2009, Mono Car Styling, C-12/08, CJEU, 18 March 2010, Alassini, C-317/08

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.