Samsung Bioepis UK Ltd v Alexion Pharmaceuticals Inc [2025] EWHC 1240 (Pat) (20 May 2025)

Samsung Bioepis UK Ltd v Alexion Pharmaceuticals Inc [2025] EWHC 1240 (Pat) (20 May 2025)

The patent claims, on a purposive construction, require the presence of the 22 amino acid leader sequence and do not cover eculizumab as such. The Defendants' biosimilar products do not infringe the patent. Even if the claims were construed to cover eculizumab, the patent would be invalid for anticipation and obviousness over prior art, and for insufficiency. Alexion's inconsistent positions do not amount to judicial estoppel or abuse of process sufficient to revoke the patent independently.

Citation
[2025] EWHC 1240 (Pat)
Parties
Claimant: Samsung Bioepis UK Limited; Defendant (hp 2024 000020), Claimant (hp 2024 000021): Alexion Pharmaceuticals, Inc.; Claimant (hp 2024 000021): Alexion Pharma International Operations Limited; Defendant (hp 2024 000021): Amgen Limited
Jurisdiction
England and Wales
Judgment Date
20 May 2025
Procedural Posture
Patent Infringement and Revocation / Final Judgment After Expedited Trial
Outcome
Patent not infringed; patent claims invalid if construed to cover eculizumab; claim dismissed
Legal Topics
Patent Infringement, Claim Construction, Obviousness, Anticipation, Insufficiency, Judicial Estoppel, Abuse of Process
Intellectual Property Patent Law Patent Infringement Claim Construction Obviousness Anticipation Insufficiency Judicial Estoppel +1 more

Case Brief

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Parties

Samsung Bioepis UK Limited

Claimant

Alexion Pharmaceuticals, Inc.

Defendant (hp 2024 000020), Claimant (hp 2024 000021)

Alexion Pharma International Operations Limited

Claimant (hp 2024 000021)

Amgen Limited

Defendant (hp 2024 000021)

Procedural Posture

Patent Infringement and Revocation / Final Judgment After Expedited Trial

Legal Issues

  1. 1 Whether the Defendants' biosimilar products infringe European Patent (UK) No. 3 167 888 B1
  2. 2 Proper construction of the patent claims, specifically regarding the 22 amino acid leader sequence
  3. 3 Validity of the patent in light of prior art (Evans, Bowdish, Thomas, Tacken, Mueller, Hillmen 2006)

Ratio Decidendi

The patent claims, on a purposive construction, require the presence of the 22 amino acid leader sequence and do not cover eculizumab as such. The Defendants' biosimilar products do not infringe the patent. Even if the claims were construed to cover eculizumab, the patent would be invalid for anticipation and obviousness over prior art, and for insufficiency. Alexion's inconsistent positions do not amount to judicial estoppel or abuse of process sufficient to revoke the patent independently.

Court Disposition

Patent not infringed; patent claims invalid if construed to cover eculizumab; claim dismissed

Orders

  • Claim for infringement dismissed
  • Patent not revoked on grounds of judicial estoppel or abuse of process