Pfizer Inc v UniQure Biopharma BV [2024] EWHC 2672 (Pat) (25 October 2024)

Pfizer Inc v UniQure Biopharma BV [2024] EWHC 2672 (Pat) (25 October 2024)

The patent is invalid for lack of inventive step. The prior art Stafford clearly and unambiguously disclosed the R338L-FIX variant, and the skilled team, motivated to solve the Manno problem, would have considered and tested the leucine substitution as routine. The difference at position 148 was not inventive. The patent is therefore obvious and invalid. Insufficiency was not separately determinative. Infringement was admitted if the patent was valid, but as the patent is invalid, the infringement claim fails.

Citation
[2024] EWHC 2672 (Pat)
Parties
Claimant / Part 20 Defendant: PFIZER INC.; Defendant / Part 20 Claimant: UNIQURE BIOPHARMA B. V.; Part 20 Claimant: CSL BEHRING LLC; Part 20 Defendant: PFIZER LIMITED
Jurisdiction
England and Wales
Judgment Date
25 October 2024
Procedural Posture
Patent Validity and Infringement / First Instance Trial Judgment
Outcome
Patent revoked for lack of inventive step; infringement claim dismissed.
Legal Topics
Patent Validity, Inventive Step, Obviousness, Insufficiency, Patent Infringement
Intellectual Property Patents Patent Validity Inventive Step Obviousness Insufficiency Patent Infringement

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Parties

PFIZER INC.

Claimant / Part 20 Defendant

UNIQURE BIOPHARMA B. V.

Defendant / Part 20 Claimant

CSL BEHRING LLC

Part 20 Claimant

PFIZER LIMITED

Part 20 Defendant

Procedural Posture

Patent Validity and Infringement / First Instance Trial Judgment

Legal Issues

  1. 1 Whether European Patent (UK) 3 581 650 is invalid for lack of inventive step over prior art Stafford (WO 99/0496)
  2. 2 Whether the patent is insufficient
  3. 3 Whether the patent is infringed if valid

Ratio Decidendi

The patent is invalid for lack of inventive step. The prior art Stafford clearly and unambiguously disclosed the R338L-FIX variant, and the skilled team, motivated to solve the Manno problem, would have considered and tested the leucine substitution as routine. The difference at position 148 was not inventive. The patent is therefore obvious and invalid. Insufficiency was not separately determinative. Infringement was admitted if the patent was valid, but as the patent is invalid, the infringement claim fails.

Court Disposition

Patent revoked for lack of inventive step; infringement claim dismissed.

Orders

  • European Patent (UK) 3 581 650 is revoked.
  • Infringement claim by Uniqure and CSL Behring is dismissed.