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United Kingdom

England and Wales Patents Court: uniQure/CSL's Hemgenix gene therapy patent valid and infringed; Pfizer revocation fails; inventive step upheld over Stafford; secondary evidence and expert witness duties pivotal

Published on: 11 December 2024

Published by a LexisNexis IP expert
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Pfizer Inc v Uniqure Biopharma BV; Uniqure Biopharma BV and another company v CSL Behring Llc [2024] EWHC 2672 (Pat)

What are the practical implications of this case?

This decision carries practical consequences for practitioners regarding, particularly: (i) how secondary material bears on inventive step; and (ii) the significance of expert testimony and the way the judge views those experts within proceedings.

Secondary evidence

The heart of Pfizer’s case was its ‘primary evidence’: that EP 650 lacked an inventive step over prior art—Stafford, a PCT application describing non‑naturally occurring FIX polypeptide mutants with assorted substitutions at position 338—when assessed by the notional skilled team (a gene therapist and a structural biologist). On that footing, they would deem it obvious to employ a modified FIX gene bearing leucine at position 338; on Pfizer’s telling, this followed straightforwardly. The judge disagreed, placing weight on ‘secondary evidence’, namely what real‑world research teams were actually doing at material time. Accordingly, the inquiry centred on contemporaneous practice rather than hypothesis. It was considered compelling that every group working to address the defective FIX gene had not tried a leucine substitution at position 338, a point the court treated as persuasive.

Expert evidence

A Pfizer expert...

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