Sandoz AG & Ors v Biogen MA Inc

Sandoz AG & Ors v Biogen MA Inc

The patent is invalid for insufficiency and excessive breadth because the skilled team cannot, without undue burden, reproduce an assay where an index value of 1.5 corresponds to the same anti-JCV antibody titre and clinical risk as in the patent, nor know if they have done so. The claim covers a class of assays, not all of which are useful for stratifying PML risk, and does not work for patients with prior immunosuppressant use. The patent is not infringed by the Sandoz Assay, as the relevant method steps are performed outside the UK and the assay does not use the >1.5 index value threshold. Arrow declaratory relief is refused as it would usurp the EPO's function. Added matter is found...

Parties
Claimant: Sandoz AG; Claimant: Sandoz Limited; Claimant: Sandoz GmbH; Claimant: Polpharma Biologics SA; Defendant: Biogen MA Inc
Jurisdiction
England and Wales
Judgment Date
14 October 2024
Procedural Posture
Patent Revocation and Infringement / Final Judgment After Expedited Trial
Outcome
Patent revoked for insufficiency and excessive breadth; claim for Arrow declaratory relief refused; no infringement by Sandoz Assay.
Legal Topics
Patent Validity, Patent Infringement, Sufficiency, Obviousness, Added Matter, Excluded Subject Matter, Territoriality, Declaratory Relief
Intellectual Property Patents Patent Validity Patent Infringement Sufficiency Obviousness Added Matter Excluded Subject Matter +2 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 / Final Judgment After Expedited Trial

Legal Issues

  1. 1 Whether EP (UK) 3 575 792 is invalid for insufficiency, uncertainty, or excessive claim breadth; whether the patent is obvious over prior art; whether the Sandoz Assay infringes the patent; whether Arrow-type declaratory relief should be granted; whether the patent contains added matter or is excluded subject matter.

Ratio Decidendi

The patent is invalid for insufficiency and excessive breadth because the skilled team cannot, without undue burden, reproduce an assay where an index value of 1.5 corresponds to the same anti-JCV antibody titre and clinical risk as in the patent, nor know if they have done so. The claim covers a class of assays, not all of which are useful for stratifying PML risk, and does not work for patients with prior immunosuppressant use. The patent is not infringed by the Sandoz Assay, as the relevant method steps are performed outside the UK and the assay does not use the >1.5 index value threshold. Arrow declaratory relief is refused as it would usurp the EPO's function. Added matter is found...

Court Disposition

Patent revoked for insufficiency and excessive breadth; claim for Arrow declaratory relief refused; no infringement by Sandoz Assay.

Orders

  • Patent EP (UK) 3 575 792 revoked.
  • Claim for Arrow-type declaratory relief dismissed.