Aflibercept IPR Updates

On July 19 and 20, 2023, the PTAB granted institution of IPR2023-00442, filed by Samsung Bioepis regarding Regeneron’s Patent No. 10,130,681 which is directed to treating angiogenic eye disorders with alibercept, and institution of IPR2023-00462, filed by Celltrion regarding Regeneron’s Patent No. 10,464,992 which is directed to formulations of VEGF antagonists including aflibercept.

As we previously reported, in February, Samsung filed challenged claims 1, 3-11, 13-14, 16-24, and 26 of the ’681 patent as obvious over certain prior art references. In instituting Samsung’s petition, the PTAB concluded that there is a reasonable likelihood that at least claim 1 of the ’681 patent is unpatentable as being obvious over the prior art references. The PTAB has also previously instituted IPRs on the ’681 patent filed by Mylan and Celltrion.

We also reported in January, Celltrion challenged claims 1-18 of the ’992 patent with one ground of anticipation and one ground of obviousness. The PTAB concluded that Celltrion “demonstrated a reasonable likelihood that at least one challenged claim of the ’992 patent is anticipated by and/or would have been obvious over the prior art of record.” The ’922 patent was previously challenged in the terminated IPR2021-00402 petition filed by Chengdu Kanghong Biotechnology and is currently involved in an ex parte reexamination (Control No. 90/014,448).

Stay tuned to Big Molecule Watch for updates on other aflibercept IPRs.