Haemophilia gene therapy patent valid and infringed (Pfizer v uniQure)
IP analysis: The Patents Court rejected Pfizer’s revocation action against uniQure’s patent EP(UK) 3,581,650 (EP 650) which protects a ‘Factor IX polypeptide mutant and a method for its production’ and forms the basis for uniQure’s haemophilia drug ‘Hemgenix’. Consequently, Pfizer may not currently launch its own haemophilia gene therapy drug ‘Beqvez’ (approved by the European Medicines Agency on 24 July 2024) in the UK, but has indicated that it intends to appeal the decision. Pfizer, while admitting infringement should EP 650 be found valid, sought to argue that EP 650 was invalid. Pfizer’s case was that the specific amino acid substitution used in EP 650 was obvious and lacked an inventive step over a single piece of prior art. In reaching its findings, the Court was strongly influenced by ‘secondary evidence’ relating to what real world research teams were doing at the relevant time and was somewhat critical of Pfizer’s experts. Written by Fergus Brown associate, solicitor and Dan Byrne partner, barrister at Venner Shipley LLP.