The Unified Patent Court (UPC) Court of Appeal has issued a significant decision on 19 June 2025 in cases filed by Alexion Pharmaceuticals, Inc. in two high-profile pharmaceutical patent disputes (App_8340/2025). The decision, delivered on June 19, 2025, establishes important precedents for fundamental procedural defects under Article 81(1)(b) UPCA and Rule 247(c) RoP, while underscoring the increasingly vital relationship between European Patent Office (EPO) case law and UPC proceedings.
For practitioners, the reference by the Court of Appeal to EPO case law is significant and it underlines the importance of understanding practice before the EPO.
Case background
The decision stems from Alexion's unsuccessful attempts to secure preliminary injunctions against Samsung Bioepis and Amgen regarding their eculizumab biosimilars (Epysqli® and Bekemv® respectively) in the European market. The UPC Court of Appeal had previously denied Alexion preliminary injunctions on December 20, 2024, upholding earlier decisions of the Hamburg Local Division delivered on June 26, 2024.
Alexion's rehearing applications, based on claims of fundamental procedural defects, were systematically rejected by the Court of Appeal, which found that the pharmaceutical company had failed to establish sufficient grounds under the strict procedural standards required for such applications.
Procedural significance
The Court of Appeal's decision provides crucial guidance on the interpretation of fundamental procedural defects, setting out general principles that will govern future rehearing requests. The ruling clarifies the high threshold required for establishing violations of Article 76 UPCA and reinforces the Court's commitment to maintaining procedural integrity in patent disputes.
The growing importance of EPO case law in UPC proceedings
This decision also arrives at a critical juncture in the evolution of European patent law, where the relationship between EPO case law and UPC proceedings has become increasingly significant. Recent developments show that UPC judges have demonstrated respect for EPO proceedings while remaining unafraid to decide validity independently on the record before them.
The harmonization of patent interpretation standards between the EPO and UPC represents a fundamental shift in European patent litigation strategy. The Enlarged Board of Appeal has recently brought the EPO's case law in line with the UPC through recent decisions on claim interpretation. This convergence is creating a more unified approach to patent validity and infringement assessments across European jurisdictions.
Strategic implications for patent holders
The Alexion decision has immediate practical consequences for pharmaceutical companies and patent holders operating in the European market. With both Samsung Bioepis and Amgen now free to continue selling their eculizumab biosimilars in the EU, the decision demonstrates the UPC's rigorous approach to preliminary injunction standards in pharmaceutical disputes.
The parallel nature of EPO opposition proceedings and UPC litigation has become a critical consideration for patent strategy. The UPC maintains discretion to stay its proceedings where a decision in EPO opposition proceedings is expected rapidly, highlighting the interconnected nature of these proceedings and the importance of coordinated legal strategies.
This decision provides further evidence of the UPC's maturation as a sophisticated patent court capable of handling complex pharmaceutical disputes. The decision's emphasis on procedural integrity while maintaining flexibility in substantive patent law interpretation suggests the court is finding its institutional voice in the European patent landscape.
The pharmaceutical industry will no doubt be closely monitoring these developments, as companies seek to establish important precedents for biosimilar competition and patent enforcement strategies across EU member states.
About the Unified Patent Court
The Unified Patent Court serves as a single patent court for participating European Union member states, providing unified jurisdiction over European patents and Unitary Patents. Since its establishment, the court has handled numerous high-profile patent disputes while developing a sophisticated body of case law that increasingly references and builds upon EPO precedents.
For any questions about UPC practice, please contact Nick Bassil or your usual Kilburn & Strode advisor.