The Unified Patent Court (UPC) opened a two-day appeal hearing today over Sanofi’s challenge to a Munich local court decision that invalidated the company’s second medical use patent for cabazitaxel, the active compound in its cancer treatment Jevtana. This marks the final phase of a legal battle that has moved through European national courts, the European Patent Office (EPO), and now the UPC, with generics firms pushing for market entry.
The disputed patent, EP 2 493 466, protects the use of cabazitaxel-commercially known as Jevtana-when combined with prednisone or prednisolone to treat hormone-resistant metastatic prostate cancer in patients who have previously undergone docetaxel-based therapy. Second medical use patents are rarely filed by originators in Europe due to the difficulties associated with their enforcement. Nevertheless, Sanofi has fought to defend EP 466 before national courts, the EPO, and most recently the UPC.
In December 2025, Judge Matthias Zigann presided over the Munich division’s ruling, which canceled the patent’s validity in Austria, Belgium, Germany, Denmark, France, Italy, Portugal, Sweden, and the Netherlands. The court dismissed Sanofi’s infringement claims against Zentiva, Stada, and Dr. Reddy’s, aligning with earlier judgments that favored generic drugmakers. The judges adopted the reasoning of the Paris Judicial Court rather than the EPO’s stance, which had upheld the patent during opposition proceedings.
Sanofi’s appeal, filed in February 2026, targets Zentiva, betapharm, Stada, Dr. Reddy’s, and Accord, though Accord’s claims were settled before the Munich hearing. In September 2024, the Paris Judicial Court revoked the French part of the patent on the grounds of obviousness in a dispute brought by Accord, referring in particular to prior Phase I and II clinical data on cabazitaxel and an ongoing Phase III trial on the claimed indication. The French part of EP 466 was later reinstated following an agreement between the parties in appeal proceedings (case ID: 24/17193).
Generics push back at EPO
At the EPO, twelve opponents-including Glenmark, Teva, Accord Healthcare, and Ever Pharma-had contested the patent after its 2021 grant. The Opposition Division rejected the oppositions in early 2024, a decision the Boards of Appeal upheld in June 2025 (case ID: T 0136/24). Meanwhile, generic manufacturers have already introduced competing cabazitaxel products, with Accord’s version available in France since 2021.
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Sanofi’s legal strategy has evolved, shifting representation from McDermott Will & Emery to Hoyng ROKH Monegier, now led by Christine Kanz, alongside support from Carpmaels & Ransford and J A Kemp. Stada is advised by Bonabry and Hamm & Wittkopp, while Dr. Reddy’s and betapharm rely on Maiwald. Zentiva works with Pentarc, and Accord previously engaged Taylor Wessing.
Generics manufacturers have consistently argued that the patent’s claims were predictable based on existing clinical data, while Sanofi insists the combination therapy offers a meaningful improvement. The Munich court rejected that position, but the Court of Appeal will now examine whether the lower court misapplied standards for prior art and inventive step.
UPC ruling threatens Sanofi’s patent future
A failed appeal could weaken Sanofi’s ability to enforce the patent across the UPC’s jurisdiction, which spans 17 European countries. The case also tests the UPC’s alignment with national court decisions, particularly where generics have prevailed.
Legal Representation and Generic Market Activity in the Cabazitaxel Dispute
Stada continues its legal defense with Bonabry and Hamm & Wittkopp, where Daniel Hoppe and Konstantin Schallmoser lead the team. The two firms will merge at the start of 2027, combining their expertise in patent litigation. Alexander Wittkopp is providing technical advice to support the case.
