Samsung Files IPR Petition on Regeneron’s Aflibercept Patent

Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals.  According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration.

As we previously reported, Apotex had also filed an IPR challenging claims 1-14 of the ’572 patent.  On March 2023, the PTAB issued its Final Written Decision, denying institution of Apotex’s petition.  Samsung’s recent petition challenges all 30 claims of the ’572 patent.   Samsung argues that claims 1-5, 8-11, 15-17, 20-21, 24, and 26-30 of the ’572 patent are anticipated by press releases reporting results of Phase 3 clinical trials of aflibercept, and that claims 1-5, 8-11, and 26-30 are anticipated by a peer reviewed publication describing the Phase 3 clinical trials.  Samsung also advances six grounds of obviousness.

Stay tuned to BMW for further developments on this IPR, and check out our PTAB Tracker for information on pending and concluded IPRs on aflibercept and other biosimilar products.