Sanofi Loses Key Patent Protection for Cancer Drug Cabazitaxel at European Court
核心洞察
The Unified Patent Court revoked Sanofi's patent EP 2 493 466 protecting the anti-tumor use of cabazitaxel in combination with prednisone or prednisolone for treating hormone-refractory metastatic prostate cancer (搜索).
Multiple generic companies including Accord Healthcare, Zentiva, Stada (搜索), and Dr. Reddy's successfully challenged the patent through counterclaims for revocation at the Munich local division.
The court's decision follows similar rulings in France and earlier favorable decisions for generics in the UK and Germany, allowing generic versions of the chemotherapy drug Jevtana to enter European markets.
The Unified Patent Court (UPC) has revoked Sanofi's key patent protecting the cancer drug cabazitaxel, dealing a significant blow to the pharmaceutical giant's intellectual property strategy and opening European markets to generic competition. The Munich local division ruled against Sanofi's EP 2 493 466 patent, which protected the novel anti-tumor use of cabazitaxel in combination with prednisone or prednisolone.
The patent formed the foundation for Sanofi's chemotherapy drug Jevtana, used to treat hormone-refractory metastatic prostate cancer (搜索) in patients previously treated with docetaxel-based chemotherapy. Healthcare professionals rely on this treatment option for patients with advanced prostate cancer (搜索) who have exhausted other therapeutic approaches.
Court Dismisses Sanofi's Infringement Claims
In one of the first major originator-generics disputes at the UPC, Sanofi filed infringement claims against multiple generic manufacturers including Accord Healthcare, Zentiva, Stada (搜索), and Dr. Reddy's at the Munich local division in May 2024. The generic companies responded with counterclaims for patent revocation.
During the hearing in mid-October, the three-judge panel under presiding judge Matthias Zigann indicated they would likely revoke the patent after extensive discussions about its validity. The court chose not to discuss patent infringement in detail due to their validity concerns.
The panel, which included judges Alima Zana, Tobias Pichlmaier, and technically qualified judge Carola Wagner, ultimately revoked the patent for UPC countries including Austria, Belgium, Germany, Denmark, France, Italy, Portugal, Sweden, and the Netherlands. Judge Zigann emphasized that the court followed the decision of the Paris court rather than the European Patent Office (EPO).
Pattern of Generic Success Across Europe
The UPC decision continues a trend of favorable rulings for generic manufacturers across European jurisdictions. Generic companies had already received positive decisions from UK courts in 2018 and German courts in 2019. In September 2024, the Judicial Court Paris revoked the patent on grounds including obviousness in a dispute against Accord Healthcare.
Multiple generic companies are now active in various European countries with their own versions of cabazitaxel following these court victories. The EPO had granted the use patent in February 2021, but twelve opponents immediately challenged the decision, including major generic manufacturers Glenmark, Teva (搜索), Accord Healthcare, and Ever Pharma (搜索).
Second Medical Use Patent Challenges
EP 2 493 466 represents a second medical use patent, a category that originators in Europe seldom submit due to practical enforcement difficulties. After the Opposition Division rejected the opposition in early 2024, an appeal was lodged, which the Boards of Appeal dismissed in September this year.
The patent specifically protected the combination therapy approach using cabazitaxel with prednisone or prednisolone, representing a targeted treatment strategy for patients with hormone-refractory metastatic prostate cancer (搜索) who had progressed on docetaxel-based chemotherapy.
Legal Representation and Settlement
McDermott Will & Emery represented Sanofi throughout the proceedings, with partner Frédéric Chevallier leading the team alongside associate Emie Paganon. Chevallier had previously represented the pharmaceutical company at Herbert Smith Freehills during the French proceedings.
The generic manufacturers employed various legal teams, with Stada (搜索) relying on Bonabry lawyers and Hamm & Wittkopp patent attorneys. Maiwald assisted Dr. Reddy's and betapharm, while Zentiva worked with Pentarc and df-mp patent attorneys.
Shortly before the hearing, Sanofi and Accord Healthcare entered into a confidential settlement agreement, with both parties withdrawing their respective claims in that specific case.
Sanofi retains the right to appeal the UPC ruling, though the consistent pattern of decisions favoring generic manufacturers across multiple European jurisdictions suggests significant challenges ahead for maintaining patent protection for this important cancer treatment.