Sanofi v Reddy Pharma (CFI, 12 December 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

The Munich Local Division revokes Sanofi’s European patent EP 2 493 466 in its entirety. The patent covers cabazitaxel in combination with prednisone or prednisolone for treating metastatic castration-resistant prostate cancer previously treated with a docetaxel-based regimen. The infringement actions against the generic manufacturers Stada, Dr Reddy’s and Zentiva are dismissed as a result. This note concerns the action against Dr Reddy’s (UPC_CFI_147/2024) and the related counterclaim for revocation (UPC_CFI_374/2024), the decision is common to all three sets of proceedings. It matters to pharmaceutical practitioners for two reasons: the Division applies the inventive step test laid down by the Court of Appeal in Amgen v Sanofi on 25 November 2025, and it openly departs from the EPO decisions that had upheld the patent, siding instead with the Paris Tribunal judiciaire.

Facts and procedure

On 13 May 2024, Sanofi SA, as successor of Sanofi Mature IP, and ten group companies sued Accord, Stada, Dr Reddy’s and Zentiva, which market generic versions of JEVTANA. The defendants, here Reddy Pharma SAS, betapharm Arzneimittel GmbH and Dr Reddy’s Srl, counterclaimed for revocation for lack of novelty and inventive step, adding in some cases added matter or insufficiency. Following a settlement, the action and counterclaim involving Accord were withdrawn before the hearing. The patent had survived opposition (Opposition Division, 15 December 2023, Board of Appeal, 3 June 2025, T 0136/2024), whereas the Paris Tribunal judiciaire had invalidated the French designation on 6 September 2024, a decision under appeal. The oral hearing took place on 14 and 15 October 2025, the decision was given on 12 December 2025 in the joined proceedings UPC_CFI_146/2024 and 496/2024, 147/2024 and 374/2024, 148/2024 and 503/2024.

The applicable law

Claim 1 is treated as a purpose-limited product claim under Art. 54(5) EPC, achievement of the therapeutic effect being a functional feature. Inventive step is assessed under Art. 56 EPC and the Court of Appeal’s test: a reasonable expectation of success implies that the skilled person can predict the outcome rationally. The Division adopts that test although the Court of Appeal ruled after the oral hearing had closed, and sees no need to reopen the hearing.

Question

Does a published Phase III trial protocol, presenting the claimed combination and indication merely as a hypothesis to be tested, deprive a medical use claim to that result of inventive step?

Decision

The Division starts from document D2 (NHSC), which describes the TROPIC trial protocol and discloses every feature of claim 1 except feature group B, presented as a hypothesis. It reformulates the objective technical problem (providing a therapeutic option for these patients, whether by prolonging survival or by palliative treatment) and rejects the Board of Appeal’s formulation as containing elements of the solution. In the light of the available indicators (Phase I data, Phase II results in breast cancer, low P-gp affinity, absence of a standard treatment, acceptable toxicity at 25 mg/m², a trial running for three years without interruption), the skilled team of an oncologist, a chemist and a pharmacologist had a reasonable expectation of success. Certainty is not required. Discontinued trials of other taxanes and statistical success rates do not alter that conclusion. EPO and national decisions are to be taken into account but do not bind the UPC. As Sanofi did not argue the dependent claims separately and filed no application to amend under Rule 30 RoP, the patent is revoked for Austria, Belgium, Germany, Denmark, France, Italy, the Netherlands, Portugal and Sweden. The infringement actions are dismissed. Sanofi SA bears the costs of the counterclaims and all Sanofi claimants those of the infringement actions. All other requests, including the preliminary objections, are set aside without consideration.

Key points for practice

• A published protocol of an advanced Phase III trial may suffice to found a reasonable expectation of success against a second medical use claim.
• The Division applies the Court of Appeal’s test handed down after the hearing closed, without reopening it, as the file was sufficient.
• An EPO decision upholding the patent does not bind the UPC, which may reach a different view on inventive step.
• Practical point: a proprietor who advances no separate case for the dependent claims and files no application to amend (Rule 30 RoP) risks losing the whole patent on a single ground.

Provisions applied

Agreement on a Unified Patent Court

Arts 54 and 65

Rules of Procedure

Rules 25, 30 and 334

European Patent Convention

Art. 52, Art. 54(5), Art. 56, Art. 69, Art. 83, Art. 138(1)

Case law cited

Amgen v Sanofi-Aventis, Court of Appeal, 25 November 2025, Meril v Edwards, Court of Appeal, 25 November 2025, XSYS v Esko, Court of Appeal, 2 June 2025.

Related decisions

• Sanofi v Stada, 12 December 2025, the same joint decision issued in action UPC_CFI_146/2024 and counterclaim UPC_CFI_496/2024.
• Sanofi v Zentiva, 12 December 2025, the same joint decision issued in action UPC_CFI_148/2024 and counterclaim UPC_CFI_503/2024.

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.