Samsung Bioepis filed an IPR petition against Regeneron’s US patent no. 11,253,572directed to methods of treating an angiogenic eye disorder by intravitreal injection of aflibercept via a specified dosage regime, with a specified result.
Apotex (unsuccessfully) filed an IPR against claims 1-14 of the Patent on 10 March 2023, as the PTAB denied institution of Apotex’ petition in March 2023. Conversely, Samsung is challenging all 30 claims of the Patent. Samsung argues that a number of the claims are anticipated by press releases and a peer reviewed publication pertaining to phase III clinical trials for aflibercept. It is also arguing that various claims are invalid for obviousness in light of those disclosures.
This comes only two days after Samsung released its new phase III trial data for its aflibercept (Eylea®) biosimilar.