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Big Molecule Watch
August 15, 2024

Recent PTAB Developments for Regeneron’s Aflibercept-Dosing Patents

There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents.

On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable.  The IPRs at issue were brought by Mylan (2021-00880 and 2021-00881), Celltrion (2022-00257 and 2022-00258), and Apotex (2022-00301 and 2022-00298).   The Federal Circuit issued an order the next day dismissing the appeals.

On July 23, two PTAB panels granted adverse judgments for U.S. Patent Nos. 11,253,572 (“the ’572 patent”) and 10,888,601 (“the ’601 patent”).  The adverse judgments came as a result of Regeneron filing disclaimers with the USPTO earlier in the month for all claims of the ’572 patent and certain claims of the ’601 patent.  The IPRs of the ’572 patent were brought by Samsung Bioepis (2023-00884), Celltrion (2024-00260), and Biocon (2024-00298).  The IPRs of the ’601 patent were brought by Samsung Bioepis (2023-00739) and Biocon (2024-00201).

On August 5, Regeneron moved to voluntarily dismiss its appeal (Case Nos. 2024-1564, -1567) of two IPR final written decisions that found other claims of the ’601 patent and a related patent, U.S. Patent No. 10,130,681, to be unpatentable.  Regeneron’s motion for a voluntary dismissal of the appeal came the same day Regeneron’s opening brief was due in the matter.

Stay tuned for further updates on litigation and PTAB proceedings involving other patents listed in the Purple Book for Regeneron’s EYLEA(R).

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