Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) (10 April 2014)

Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) (10 April 2014)

The 115 patent is invalid for lack of inventive step because the claimed three-weekly dosing regimen for trastuzumab would have been obvious to the skilled team in light of the FDA label and common general knowledge. The 455 patent is invalid for lack of novelty and inventive step over the Andya prior art, as the relevant compositions were disclosed and enabled. Hospira is entitled to a declaration of non-infringement for its proposed trastuzumab formulations.

Citation
[2014] EWHC 1094 (Pat)
Parties
Claimant: Hospira UK Limited; Defendant: Genentech Inc.
Jurisdiction
England and Wales
Judgment Date
10 April 2014
Procedural Posture
Patent Invalidity and Non Infringement Claim / High Court (patents Court) First Instance Judgment
Outcome
Both the 115 and 455 patents are held invalid. Declaration of non-infringement granted to Hospira.
Legal Topics
Patent Validity, Obviousness, Sufficiency, Novelty, Non Infringement, Pharmaceutical Patents
Intellectual Property Law Patent Law Patent Validity Obviousness Sufficiency Novelty Non Infringement Pharmaceutical Patents

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Parties

Hospira UK Limited

Claimant

Genentech Inc.

Defendant

Procedural Posture

Patent Invalidity and Non Infringement Claim / High Court (patents Court) First Instance Judgment

Legal Issues

  1. 1 Whether EP 1 210 115 (the 115 patent) is invalid for lack of inventive step (obviousness) and/or insufficiency; whether EP 1 308 455 (the 455 patent) is invalid for lack of novelty and/or inventive step; whether Hospira is entitled to a declaration of non-infringement regarding certain trastuzumab formulations

Ratio Decidendi

The 115 patent is invalid for lack of inventive step because the claimed three-weekly dosing regimen for trastuzumab would have been obvious to the skilled team in light of the FDA label and common general knowledge. The 455 patent is invalid for lack of novelty and inventive step over the Andya prior art, as the relevant compositions were disclosed and enabled. Hospira is entitled to a declaration of non-infringement for its proposed trastuzumab formulations.

Court Disposition

Both the 115 and 455 patents are held invalid. Declaration of non-infringement granted to Hospira.

Orders

  • EP 1 210 115 patent declared invalid for lack of inventive step.
  • EP 1 308 455 patent declared invalid for lack of novelty and inventive step.