Alexion v Amgen & Samsung Bioepis (UPC_CFI_124/2024)
Decision date:
26 June 2024
Osborne Clarke summary
- Alexion asserted its European patent (EP 888) against Samsung Bioepis and Amgen, seeking provisional measures to prevent the marketing and launch of their respective biosimilar products to eculizumab (Soliris).
- The asserted claim (claim 2) covers a pharmaceutical composition comprising an anti C5 antibody with a heavy chain consisting of SEQ ID NO:2 and a light chain consisting of SEQ ID NO:4. SEQ ID NO:4 is disclosed in the patent as including a 22 amino acid N-terminal signal peptide sequence.
- Applying Article 69 EPC and the Protocol, the court interpreted the claim from the skilled person’s perspective, taking the claim’s purpose into account (to provide a therapeutic that binds C5). The Hamburg LD concluded that although SEQ ID NO:4 in the specification includes an N terminal signal peptide, the skilled person would construe the claim as referring to the mature light chain without the first 22 amino acids, using common general knowledge (and readily available tools/databases) to recognise and locate the signal peptide.
- On that construction, Samsung's and Amgen's product were held to more likely than not to infringe claim 2.
- Notwithstanding the infringement analysis, under Article 62(4) UPCA and Rule 211.2 RoP, the court must also be sufficiently convinced of the patent’s validity. Crucially, where an EPO opposition is pending, a decision on provisional measures cannot rest solely on the court’s own validity view, if an opposition is pending at the EPO the court must also factor in the likelihood of invalidation by the EPO (citing previous Court of Appeal guidance, including Rule 209(2) RoP).
- The EPO Board of Appeal had allowed grant only on a claim set that literally included SEQ ID NO:4 with the signal peptide, and had previously rejected attempts to “correct” SEQ ID NO:4 under Rule 139 EPC across the family. In the UPC proceedings, Alexion accepted that an antibody including the signal peptide would be non functional and not a usable pharmaceutical. On that understanding, the court found it reasonably likely that the EPO would find the granted claim insufficiently disclosed under Article 83 EPC and revoke the patent.
- The court therefore dismissed Alexion's application for provisional measures, finding that the validity of the patent was not sufficiently certain due to potential revocation by the EPO.
- The decision for Samsung Bioepis is available in full here.
Issue
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