The Patents Court of the High Court has handed down judgment upholding the validity of EP(UK) 3,581,650, the patent which protects the UK’s first licensed gene therapy product called Hemgenix®. The patent is owned by uniQure and exclusively licensed to CSL Behring. As a consequence the patent is infringed by Pfizer; the judgment is to be found here.
Hemgenix is a gene therapy that reduces the rate of abnormal bleeding in those with haemophilia B by enabling the body continuously to produce factor IX, the deficient protein in haemophilia B. It uses AAV5, a non-infectious viral vector derived from the adeno-associated virus (AAV). The AAV5 vector carries the Padua gene variant of Factor IX (FIX-Padua) to the target cells in the liver, causing the production of Factor IX proteins that are 5 to 8 times more active than normal.
Andrew Waugh KC and Katherine Moggridge of 3 New Square instructed by Simmons & Simmons acted for uniQure/CSL.
Image of Factor IX courtesy of the European Bioinformatics Institute http://www.ebi.ac.uk/