Regeneron filed an unopposed motion to terminate IPR2023-00620 after disclaiming all claims of the US process patent no 10,406,226. Celltrion filed the IPR in February 2023, and it had not yet been instituted by the PTAB. All claims of the ‘226 patent relate to a method of making a VEGF antagonist fusion protein involving expressing the fusion protein in CHO, purifying the fusion proteins such that a defined percentage is not an aggregate.
The results of Celltrion’s Ph III trials of CT-P42 were reported on 3 April 2023. CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®. On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and announced that it intends to file an ABLA in at least the US and Europe later in 2023.