On 6 September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of EP3805248 relating to an omalizumab formulation.
The UPC proceedings (case Numbers: ACT_18492/2024 and ACT_18551/2024) were commenced on 9 April 2024, and heard on 31 July 2024. They relate to Celltrion’s Omlyclo® (CT-P39), biosimilar to Novartis/Genentech’s Xolair® (omalizumab).
In this week’s decision, four judges held that there were no “concrete indications” of any “imminent infringement” of the patent by Celltrion. According to the UPC, in order for an infringement to be imminent in this case, all pre-launch preparations must have been completed in such a way that an offer for supply could be made at any time. Although Celltrion had obtained European marketing authorisation for Omlyclo® in May 2024, 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.
As set out in the UPC decision, disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the UK, 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 EP3805248 is valid. The oral proceedings in the opposition are due to take place in April 2025.
Celltrion’s Omlyclo® has been approved in Europe (May 2024), the UK (July 2024) and South Korea (June 2024). Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023. Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.