Pfizer Inc v Uniqure Biopharma BV

Pfizer Inc v Uniqure Biopharma BV

The skilled team would not have perceived Stafford's identification of R338L-FIX as a scientifically meaningful instruction, but rather as patent drafting. There was no reasonable expectation of success in substituting leucine at position 338 for gene therapy in haemophilia B. Secondary evidence shows no team tried R338L-FIX for over a decade, and the Padua variant was a surprising breakthrough. The patent involves an inventive step over Stafford and is valid.

Parties
Claimant: Pfizer Inc.; Defendant: Uniqure Biopharma B.V.; Part 20 Claimant: Uniqure Biopharma B.V.; Part 20 Claimant: CSL Behring LLC; Part 20 Defendant: Pfizer Inc.; Part 20 Defendant: Pfizer Limited
Jurisdiction
England and Wales
Judgment Date
25 October 2024
Procedural Posture
Patent Validity and Infringement / Final Judgment After Trial
Outcome
Patent is valid and infringed.
Legal Topics
Inventive Step, Obviousness, Gene Therapy, Biotechnology, Patent Infringement, Secondary Evidence
Intellectual Property Patent Law Inventive Step Obviousness Gene Therapy Biotechnology Patent Infringement Secondary Evidence

Case Brief

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Parties

Pfizer Inc.

Claimant

Uniqure Biopharma B.V.

Defendant

Uniqure Biopharma B.V.

Part 20 Claimant

CSL Behring LLC

Part 20 Claimant

Pfizer Inc.

Part 20 Defendant

Pfizer Limited

Part 20 Defendant

Procedural Posture

Patent Validity and Infringement / Final Judgment After Trial

Legal Issues

  1. 1 Whether European Patent (UK) 3 581 650 lacks inventive step over prior art Stafford
  2. 2 Whether the patent is invalid for insufficiency
  3. 3 Whether the patent is infringed by admitted acts if valid

Ratio Decidendi

The skilled team would not have perceived Stafford's identification of R338L-FIX as a scientifically meaningful instruction, but rather as patent drafting. There was no reasonable expectation of success in substituting leucine at position 338 for gene therapy in haemophilia B. Secondary evidence shows no team tried R338L-FIX for over a decade, and the Padua variant was a surprising breakthrough. The patent involves an inventive step over Stafford and is valid.

Court Disposition

Patent is valid and infringed.

Orders

  • Patent upheld as valid.
  • Infringement established against admitted acts.