Sandoz AG & Ors v Biogen MA Inc [2024] EWHC 2567 (Pat) (11 October 2024)

Sandoz AG & Ors v Biogen MA Inc [2024] EWHC 2567 (Pat) (11 October 2024)

The patent is invalid for insufficiency: the skilled team could not perform the invention across the breadth of claim 1 without undue burden, particularly in relation to the cut-off calibrator and splitting seropositives. The patent is also invalid for lack of inventive step over Gorelik and WO369. There is no infringement as the Sandoz assay is performed outside the UK and does not fall within the claim scope. Declaratory (Arrow-type) relief is granted to Sandoz to provide commercial certainty.

Citation
[2024] EWHC 2567 (Pat)
Parties
Claimant: Sandoz AG; Claimant: Sandoz Limited; Claimant: Sandoz GmbH; Claimant: Polpharma Biologics SA; Defendant: Biogen MA Inc
Jurisdiction
England and Wales
Judgment Date
11 October 2024
Procedural Posture
Patent Revocation and Infringement / First Instance Judgment After Expedited Trial
Outcome
Patent revoked; no infringement; Arrow declaration granted
Legal Topics
Patent Validity, Patent Infringement, Biosimilars, Declaratory Relief, Insufficiency, Inventive Step, Added Matter, Territorial Scope, Arrow Relief
Intellectual Property Patents Patent Validity Patent Infringement Biosimilars Declaratory Relief Insufficiency Inventive Step +3 more

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Parties

Sandoz AG

Claimant

Sandoz Limited

Claimant

Sandoz GmbH

Claimant

Polpharma Biologics SA

Claimant

Biogen MA Inc

Defendant

Procedural Posture

Patent Revocation and Infringement / First Instance Judgment After Expedited Trial

Legal Issues

  1. 1 Whether EP(UK) 3 575 792 is invalid for insufficiency, lack of inventive step, added matter, or excluded subject matter
  2. 2 Whether Sandoz's assay infringes the patent (directly or by equivalence)
  3. 3 Whether declaratory (Arrow-type) relief should be granted to Sandoz

Ratio Decidendi

The patent is invalid for insufficiency: the skilled team could not perform the invention across the breadth of claim 1 without undue burden, particularly in relation to the cut-off calibrator and splitting seropositives. The patent is also invalid for lack of inventive step over Gorelik and WO369. There is no infringement as the Sandoz assay is performed outside the UK and does not fall within the claim scope. Declaratory (Arrow-type) relief is granted to Sandoz to provide commercial certainty.

Court Disposition

Patent revoked; no infringement; Arrow declaration granted

Orders

  • EP(UK) 3 575 792 is revoked for insufficiency and lack of inventive step
  • Biogen's counterclaim for infringement is dismissed