PTAB Institutes Mylan’s Two EYLEA (aflibercept) IPRs

As we previously reported, Mylan recently filed three IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept, the active ingredient in Regeneron’s Eylea product—IPR2022-01225 (challenging U.S. Patent No. 10,130,681), IPR2022-01226 (challenging U.S. Patent No. 10,888,601), and IPR2023-00099 (challenging U.S. Patent No. 10,857,205). This week, the PTAB granted institution on two of these IPR petitions. The PTAB concluded that there is a reasonable likelihood that at least challenged claim 1 of the ’681 patent (IPR2022-01225) and at least challenged claim 34 of the ’601 patent (IPR2022-01226) are unpatentable as being anticipated by the same prior art publication. The institution decision on the ’205 patent (IPR2023-00099) is expected in April 2023.

The ’601 patent is one of six patents that Regeneron is asserting in the first phase of the BPCIA litigation between Regeneron and Mylan concerning Mylan’s aBLA for a biosimilar version of aflibercept.  In other IPRs filed by Mylan, the PTAB previously issued final written decisions invalidating the claims of two other patents related to aflibercept.  Regeneron has appealed those decisions to the Federal Circuit.