On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.
The decision was delivered in a proceeding commenced by Celltrion at the end of July 2023, seeking to revoke the patent on grounds including lack of novelty, lack of inventive step and insufficiency. In September 2023, Genentech/Novartis filed a counterclaim for infringement. Celltrion admitted that it infringed the patent if it was held to be valid.
Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was approved in the UK in July 2024. It has also received approval in Europe (May 2024), South Korea (June 2024), Australia (November 2024) and Canada (December 2024). Celltrion submitted an aBLA in the US for Omlyclo® in March 2024.
The UK Court judgment follows a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent. This was based on a lack of any “concrete indications” of any “imminent infringement” of the patent by Celltrion. Although Celltrion had obtained European marketing authorisation for Omlyclo®, the Court found there was insufficient evidence of any specific timeline for price negotiations or that reimbursement applications had been made. There was also no evidence of any samples actually being provided to potential customers. In these circumstances, Novartis/Genentech’s application for provisional measures was refused.
Disputes between Novartis/Genentech and Celltrion regarding omalizumab are also ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague) and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023. In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid. The oral proceedings in the opposition are due to take place in April 2025.