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ARTICLE · 01 AUGUST 2025

A Leading Case – Beware Sequence Errors In Patent Claims

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The UK Patents Court has held that Samsung Bioepis' and Amgen's eculizumab biosimilars for treating PNH did not infringe Alexion's EP3167888, as the claims covered...

United KingdomIntellectual Property
Alex Bruce
Alex Bruce
Sian Hope
Sian Hope
Rachel Fetches
Rachel Fetches
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Samsung Bioepis UK Ltd v Alexion Pharmaceuticals Inc [2025] EWHC 1240 (Pat) – Mr Justice Meade – 20 May 2025

The UK Patents Court has held that Samsung Bioepis' and Amgen's eculizumab biosimilars for treating PNH did not infringe Alexion's EP3167888, as the claims covered the amino acid sequence of eculizumab including the leader sequence (which is in fact cleaved off during production of the biopharmaceutical product). Importantly, the Defendants' biosimilars of eculizumab did not comprise this leader sequence. These proceedings are a reminder that incorrect amino acid claims can be fatal in infringement proceedings – even when the commercial product is a blockbuster drug.

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