Mylan Files IPR on Regeneron Aflibercept Patent

Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc.  According to the petition, the claims “are drawn to monthly dosing [of aflibercept] to treat an angiogenic eye disorder.”  The Petition sets forth three anticipation grounds and four obviousness grounds for the challenged claims.

This IPR petition follows Mylan’s May 2021 petitions requesting IPR of two patents in the same family – U.S. Patent No 9.669,069 (IPR2021-00880) and U.S. Patent No. 9.254.338 (IPR2021-00881).  On November 10, 2021, both of those petitions were instituted, oral argument for both IPRs was held on August 10, 2022, and final written decisions are expected this month.  Mylan also filed petitions in July 2022 requesting IPR of two additional patents in the same family as the ‘205 patent – U.S. Patent No. 10,888,601 (IPR2022-01226) and U.S. Patent No. 10,130,681 (IPR2022-01225).  Institution decisions on those petitions are expected in January 2023.  As we previously reported, Mylan is also defending a BPCIA litigation, related to Mylan’s proposed aflibercept biosimilar, filed by Regeneron in August 2022 in the Northern District of West Virginia, a proceeding Mylan identified as a related matter in its petition.

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