Sanofi’s recent infringement lawsuits at the Unified Patent Court (UPC) mark a pivotal moment for pharmaceutical patent litigation.
Background: Sanofi’s Jevtana (cabazitaxel), used for treating metastatic castration-resistant prostate cancer (mCRPC), has faced competition from generics since its regulatory exclusivity expired in March 2021. Sanofi’s market exclusivity now hinges on its medical use patent (EP 2,493,466), upheld by the EPO but currently under appeal.
Recent Developments:
On May 13, 2024, Sanofi filed infringement lawsuits against Accord, Stada, Dr. Reddy’s/betapharm, and Zentiva in the Munich Local Division of the UPC.
This is notably the first small-molecule case at the UPC, whereas previous cases have involved biologicals.
If the UPC upholds the ’466 patent, generics may face injunctions and damages across UPC countries. If revoked, generics will avoid these penalties.
A hearing is expected in March 2025, with decisions by mid- to late-2025. Appeals can be made to the UPC Court of Appeal in Luxembourg.
The EPO’s Technical Board of Appeal will finalize the validity of the ’466 patent between 2026-2028, or earlier if expedited (late 2025 to 2026).
There are no significant barriers to generic competition in non-UPC countries (e.g., the UK).
Pharma Patent Litigation at the UPC:
Pharmaceutical companies were initially cautious about the UPC system, fearing the central revocation of valuable patents.
Recent cases signal growing confidence in the UPC.
The UPC’s upcoming decisions on validity and infringement will set crucial precedents, potentially attracting more pharma patentees.
Industry Impact:
The increase in pharma disputes (Cabazitaxel, Eculizumab, Omalizumab, ASP7317 (Retinal Pigment Epithelium Cells) and anti-PCSK9 antibodies (evolocumab and alirocumab)) indicate a significant shift.
Pharma companies may increasingly use the UPC alongside national courts for comprehensive litigation strategies.
With upcoming decisions likely to shape future strategies, the UPC’s role in resolving high-stakes pharmaceutical disputes is set to grow.
