Conflicting Validity Standards: The Munich Local Division on Clinical Trial Obviousness
The Munich Local Division revoked a Sanofi prostate cancer patent, favouring a French national court's obviousness finding over an EPO Board of Appeal decision. The panel independently assessed the expectation of success.
Litigating a blockbuster pharmaceutical patent across Europe often forces a patent proprietor to navigate conflicting standards of obviousness between different venues. When an EPO Board of Appeal upholds a patent against a specific prior art attack but a national court strikes it down on those exact same documents, practitioners naturally wonder which approach the Unified Patent Court will adopt. In UPC_CFI_503/2024, the Munich Local Division faced precisely this scenario regarding Sanofi's prostate cancer drug Jevtana, requiring the panel to weigh an EPO Board of Appeal finding against a contrary French national judgment.
How did the Munich Local Division resolve the conflicting validity findings?
The dispute centred on EP 2 493 466, which claims the anti-tumoral use of cabazitaxel in combination with prednisone or prednisolone. The defendants filed counterclaims for revocation based on a lack of inventive step over documents describing a Phase III clinical trial known as the TROPIC study.
The panel was presented with two divergent prior assessments. The Tribunal Judiciaire de Paris had previously revoked the French designation of the patent, concluding that a skilled person would have had a reasonable expectation of success based on the clinical trial documents. Conversely, the EPO Board of Appeal upheld the patent in T 0136/24, finding that the skilled person would only have had a mere hope of success.
The Munich Local Division chose to conduct its own rigorous assessment. During the oral hearing, the panel questioned expert witnesses specifically on what information a person working in the industry at the priority date would have derived from the Phase III TROPIC study and the time that had passed since it started. Following this testimony, the panel aligned with the French national court. The operative finding was clear: the patent in question is invalid and shall be revoked in its entirety.
How did the panel construe the therapeutic effect in the purpose-limited product claim?
Before assessing validity, the division established the correct interpretation of the claims under Article 69 EPC. Claim 1 was drafted as a purpose-limited product claim in the format governed by Article 54(5) EPC. The panel confirmed that for such claims, attaining the claimed therapeutic effect is regarded as a functional technical feature.
The claim specifies the use of cabazitaxel for treating castration-resistant metastatic prostate cancer in patients previously treated with a docetaxel-based regimen. The panel construed this treatment as a non-curative therapy, noting that metastatic castration-resistant prostate cancer is an incurable condition. The therapeutic effect was therefore understood as the absence of progression or death when the disease had previously progressed.
Why did the preliminary objections regarding temporal jurisdiction fail?
The defendants raised preliminary objections arguing that the Unified Patent Court lacked jurisdiction over claims arising before the entry into force of the Unified Patent Court Agreement. This objection was dismissed under Rule 20 RoP. The panel noted that the court possesses jurisdiction over prior infringing acts.
Additionally, the defendants argued a lack of jurisdiction for countries that are not yet Contracting Member States. Because Sanofi explicitly limited the infringement actions to the relevant territories where the patent was in force and the court had competence, the panel dismissed these territorial objections.
What must practitioners anticipate when relying on EPO validity findings after this decision?
This decision demonstrates that the Unified Patent Court will not automatically defer to the EPO Boards of Appeal on substantive questions of validity. Even when a Board of Appeal has recently upheld a patent against the exact same prior art attack, the local divisions may independently evaluate the evidence.
When defending a patent based on clinical trial publications, patent proprietors must be prepared for the court to scrutinise whether the skilled person had a reasonable expectation of success or merely a hope that the trial would work. The procedural efficiency of the court also requires careful preparation: the Munich Local Division actively interrogated expert witnesses on the clinical data during the oral hearing and announced its inclination to revoke the patent by the second day. Practitioners managing parallel proceedings must therefore build their validity defence on the technical merits of the evidence itself, rather than relying on the persuasive weight of a favourable EPO Board of Appeal decision.