uniQure successfully defends haemophilia gene therapy patent against Pfizer

uniQure has prevailed in a dispute with Pfizer. uniQure is active in the field of gene therapy and owner of EP 3 581 650. The patent protects a “Factor IX polypeptide mutant and a method for its production” for treating haemophilia. It forms the basis of uniQure’s drug Hemgenix.

Pfizer has developed a product called Beqvez (formerly known as Durveqtix), a gene therapy indicated for treating adults with moderate to severe haemophilia B. The European Medicines Agency approved the drug on 24 July 2024. The company has not yet launched the product on the UK market.

Pfizer challenges patent

Pfizer attacked EP 650 for lack of inventive step over the prior art, but simultaneously admitted to infringing it in case of validity. The pharma innovator argues that the specific protein the EP 650 uses is obvious.

In a recent ruling, UK High Court judge Richard Hacon rejected the revocation claim and found uniQure’s patent to be valid and infringed (case ID: HP-2022-000035). According to a report by Law360, Pfizer has indicated that it will appeal the UK judgment.

In the opposition proceedings at the EPO, initiated by Pfizer, the Opposition Division recently issued its preliminary opinion, indicating the validity of EP 650. The oral hearing is scheduled for early October 2025.

In the parallel proceedings in the Netherlands, a ruling is expected on 27 November.

British-Dutch teams

uniQure and their distribution partner CSL instructed a pan-European team from Simmons & Simmons for the UK and Dutch proceedings. London-based partner Scott Parker led the proceedings at the UK High Court. Associates Amy Crouch and Alexander Kritharidis assisted. Barristers in the UK for uniQure/CSL were Andrew Waugh KC and Katherine Moggridge of Three New Square.

In the Netherlands, the team around partners Bas Berghuis van Woortman and Oscar Lamme also included associate Bouke Algie as well as patent attorney Johan Renes. The latter joined the Amsterdam office in spring 2021 as a partner and had previously worked at DLA Piper, as well as in-house for genetic engineering company uniQure part-time.

The international team worked very closely with Ellen Broug, vice president IP at uniQure, as well as the executive director global IP Hans-Peter Hauser, and chief IP officer Galit Gonen-Cohen at uniQure’s marketing partner CSL. In the EPO opposition, patent attorneys Natalia Wegner and Daniel Wise from Carpmaels & Ransford are representing the biotechnology company.

Pfizer relied on an equally international team from Taylor Wessing. In the UK a team around Michael Washbrook including associate Sarah Nesbitt represented the pharma company. Barristers Andrew Lykiardopoulos KC, Henry Ward, and Thomas Jones of 8 New Square assisted.

In the Dutch proceedings, Eindhoven-based partner Charlotte Garnitsch represented Pfizer, together with Geert Theuws, Margot van Gerwen, and Yolandi Coetzee. Patent attorney Ellen Crabbe from Brantsandpatents provided support in technical matters.