Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting infringement of 37 US aflibercept patents. The heavily redacted Complaint does not disclose any information about Samsung’s abbreviated Biologics Drug Application (aBLA) for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions. However, the Complaint states on information and belief that between 2 July 2019 and 8 June 2023 Samsung entities imported or directed the importation into the US of 36 shipments of SB15.
Samsung has filed IPR petitions against a number of Regeneron aflibercept patents: US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 in April 2023, US10,888,601 in April 2023 and US10,130,681 in January 2023.