On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069. The PTAB ruled in Mylan’s favor in both IPRs, holding all challenged claims of both patents invalid as anticipated by the same prior art reference. The two patents are directed to “methods for treating angiogenic eye disorders by sequentially administering multiple doses of a vascular epithelial growth factor (‘VEGF’) antagonist to a patient.” The anticipating prior art reference disclosed, inter alia, the results of some of Regeneron’s clinical trials of aflibercept.
As we previously reported, Mylan also filed three additional IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders—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). Institution decisions on the ’681 and ’601 patents are expected in January 2023; the institution decision on the ’205 patent is expected in April 2023.
Regeneron has also filed a BPCIA case against Mylan that is pending in the Northern District of West Virginia. As we previously reported, Judge Kleeh recently issued a scheduling order setting a two-week trial in June 2023—less than a year after Regeneron filed its complaint against Mylan in August 2022—and requiring Regeneron to identify six patents from three patent families for initial proceedings. Regeneron identified the ’601 patent as one of the six patents for initial proceedings.
Stay tuned to Big Molecule Watch for further updates on these IPRs and pending litigation related to aflibercept.