Sanofi (Claimant) v. Stadapharm, Dr. Reddy’s & Zentiva(Defendants) UPC_CFI_146/2024
Order of 12 December 2025
The Munich Local Division (LD) of the Unified Patent Court (UPC) has delivered a decision in favour of the Defendants in infringement actions and counterclaims for revocation relating to Sanofi’s patent EP 2 493 466. The patent concerns prostate cancer drug cabazitaxel (Jevtana®). In May 2024,Sanofi filed infringement actions, and the defendants counterclaimed for revocation. The UPC Local Division heard validity and revocation counterclaims jointly.
Prior to this UPC decision, national courts and the EPO Technical Board of Appeal had adjudicated on the patent with differing outcomes on inventive step. Notably, the Tribunal Judiciaire de Paris invalidated the French designation on grounds of obviousness, finding that the skilled person would have had a reasonable expectation of success based on a Phase III clinical trial disclosure. Conversely, the EPO Board of Appeal upheld the patent in June 2025 (in T0136/24-3.3.04), holding that the skilled person would not have had such an expectation.
There has been much discussion amongst EPO practitioners regarding caselaw of the EPO Boards of Appeal (BoA) involving clinical trial disclosures as prior art. This caselaw has consistently shown that the outcome is highly fact specific. That said, the outcome on inventive step in such cases always tends to depend on how ambitiously the medical problem to be solved is framed and evidence regarding whether an ordinary skilled person would have a reasonable expectation of success in achieving the claimed solution. In other words, how success is defined also determines how easily one would expect to achieve success. I have a reasonable expectation of success if I am planning to climb a hill… Everest is another matter!
The inventive step assessment of the LD and divergence from the EPO BoA based on the same clinical trial disclosure also came down to how the LD defined success and went about assessing reasonable expectation of success.
The patent involved a medical use claim. The Court clarified that the feature “for use in treating prostate cancer” in the claims should be understood as a non-curative therapy, given that metastatic castration-resistant prostate cancer is incurable. Hence, treatment was to be interpreted as non-curative therapy. This includes life-extending therapy, delaying tumour recurrence or progression, or providing palliative care focused on maintaining quality of life.
In the recent Amgen v Sanofi decision, the UPC Court of Appeal stated that for medical use format claims the claimed product must be objectively suitable for the claimed use, i.e. the treatment must be meaningful. The LD’s interpretation in the current case held meaningful treatment to indicate that the claimed treatment did not require curative efficacy and palliative treatment would be enough. This interpretation is important as it led to a low threshold for success and reasonable expectation of success as part of the inventive step analysis and may well be a central issue discussed in Appeal.
The Court applied the UPC CoA approach recently set out in Amgen v. Sanofi, also related to a patent with a second medical use claim, and Meril v. Edwards. This involves identifying the objective problem from the skilled person’s perspective at the priority date, considering common general knowledge and the claims as a whole (not individual isolated claim features). The claimed solution is obvious if, at the relevant date, the skilled person would (not merely could) have arrived at it from a realistic starting point in the prior art.
Both CoA decisions mentioned above were delivered on 25 November 2025 after the oral hearing had closed in this matter but the Court considered it appropriate to apply the approach adopted by the CoA without reopening the oral hearing. The LD considered the approach similar to that taken by the Tribunal Judiciaire de Paris when deciding the revocation action against the French part of the patent in suit. Furthermore, neither the oral hearing nor the hearing of the two experts focused on a specific legal test to be applied.
Defendants argued that the position under national and EPO case law is that disclosure of phase III clinical trials relating to the claimed application gives rise to a reasonable expectation of success, unless there is evidence to the contrary. This is because these trials constitute routine tests for the person skilled in the art and are selected on the basis of experimental data, particularly when supported by previous studies.
In this case, in order to demonstrate that use of cabazitaxel to treat castration-resistant metastatic prostate cancer which progressed during or after a previous treatment with docetaxel was obvious, they argued that the disclosure of the Tropic study (Tropic documents or NHSC), a Phase III clinical trial specifically relating to that therapeutic application, corroborated by various pre-clinical and clinical data, created a reasonable expectation in the person skilled in the art that that application would be successful. Defendants relied on preclinical, phase 1 and phase II data showing certain effects of cabazitxel such as its promising activity in breast cancer patients previously treated with the same molecules, docetaxel, and having developed resistance to it. They also relied on some financial reports from Sanofi indicating that the developments of cabazitaxel continued despite the research on cabazitaxel in breast cancer being abandoned. They emphasised that the trial was progressing as planned, without interruption.
Sanofi contended that the objective technical problem is to increase the survival of the patient concerned. They also argued that castration-resistant metastatic prostate cancer is particularly difficult to treat and response rate obtained in another indication (breast cancer) is not relevant for prostate cancer. The EPO BoA had also held that the technical problem in face of the NHSC document was “to put into practice the effective treatment of prostate cancer with cabazitaxel in co administration with prednisone in patients with mCRPC who have previously been treated with a docetaxel-based regimen and who have prostate cancer that progressed during or after that treatment”. So, both the Claimant and the EPO were setting a relatively high hurdle for success.
The LD held that this formulation of the problem deviates from the approach formulated by the CoA as the formulation of the objective technical problem contains parts of the solution and thus involved hindsight. It defined the objective technical problem to be solved by the invention as providing a therapeutic option for treating castration resistant metastatic prostate cancer patients who have been previously treated with docetaxel-based regimen and have prostate cancer that progressed during or after that treatment. This includes both, increased overall survival and palliative treatment only.
Expert evidence not available to the EPO may have also swayed the LD decision. Defendants’ experts provided written reports and answered detailed questions at the validity hearing, including what a person skilled in the art would have inferred from the TROPIC study’s progress. Experts agreed that Phase III trials require a thorough review of safety, toxicity, and efficacy data from earlier trial phases, and that a reasonable expectation of meeting endpoints is necessary for trial commencement. There was some disagreement between experts regarding transferring safety and efficacy data from different tumour types and whether studies in breast cancer could be informative for prostate cancer in this scenario.
Given the objective technical problem was defined less ambitiously by the LD and success could be shown by achieving palliative care, the LD took pains to distinguish between the expectation of the trial meeting its primary endpoint and the technical problem addressed by the patent. It stated:n
However, it is important to note that the question of reasonable expectation of success of the approach disclosed in the TROPIC trial documents, in terms of assessing an inventive step, is not the same as the question of whether the TROPIC trial will meet its primary endpoint. This is because the technical problem that the patent in suit intends to solve is to provide a therapeutic option for treating patients with castration-resistant metastatic prostate cancer who have previously been treated with a docetaxel-based regimen and whose cancer has progressed during or after that treatment. This includes both increased overall survival and palliative treatment. (emphasis added)
The Court considered collective elements such as prior preclinical and clinical data, the nature of the patient group, and the lack of negative signals during the trial. The fact that the trial compared cabazitaxel to mitoxantrone (known to be ineffective and toxic) further strengthened the expectation of a favourable outcome.
In terms of the patient group referred to in the patent claim, the Court clarified that it is not limited to patients who have developed a resistance to docetaxel or do not respond to docetaxel. The patient group is simply defined as those who have previously received a docetaxel treatment. As one expert explained, it is not uncommon for patients receiving a docetaxel-based treatment to stop treatment temporarily, referred to as “treatment holiday”, and then resume it.
The Court also noted that the trial’s progress, with no interruptions, and its imminent completion at the priority date, provided strong support for a reasonable expectation of success. Hence, the crucial point in the present case is not the authorisation of the trial, it is the course of the trial without incident and the near ending of the trial, which leads to an expectation of success.
Thus, the LD concluded that the person skilled in the art would have considered that, compared to mitoxantrone plus prednisone, which he knew had only a first-line palliative effect and was not even approved for second-line use, the second-line cabazitaxel plus prednisone experiment in progress in a phase III trial for more than three years, had a reasonable chance of showing a favourable effect. The Court emphasised that certainty was not required and it is sufficient if the skilled person would have followed the teaching available in the prior art with a reasonable expectation of success.
The LD concluded that the patent lacked inventive step and diverged from the EPO BoA by defining a less ambitious objective technical problem thereby lowering the threshold for success and concurrently increasing the expectation of success from a late stage but unfinished phase III clinical trial. An appeal may be lodged at the UPC CoA within two months of the decision notification. The outcome of any appeal will be closely watched to see whether the CoA aligns with the LD and national courts, or with the EPO.