Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”) of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”). The ’865 patent issued on August 10, 2021 and is…
The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs) and Post Grant Reviews (PGRs) by 25% “to improve cost recovery.” Additionally, the PTO is proposing to allow IPR and PGR petitions to exceed the current…
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen…
Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc. According to the Petition, the challenged claims of the ’992 patent “encompass a formulation comprising the VEGF inhibitor protein, aflibercept, which Regeneron markets…
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, and at the PTAB. Below is our recap of…
The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion’s motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc. As we previously reported, this is one of two…
Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and 26 of U.S. Patent No. 10,130,681, and IPR2022-01226 challenging claims 1-9, 34-39, 41-43, and 45 of U.S. Patent No….
On June 3, 2022, the PTAB instituted inter partes review of U.S. Patent No. 9,750,752 (“the ’752 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of claims 1-16 of the ‘752 patent, directed to methods of treating giant cell arteritis by subcutaneously administering tocilizumab. …
On April 14, 2022, the U.S. Court of Appeals for the Federal Circuit reversed the PTAB’s determination in IPR2016-01542 that claims of Amgen’s U.S. Patent No. 8,952,138 are obvious. The ’138 patent claims are directed to methods of refolding proteins by “contacting the protein with a refolding buffer comprising a…
On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent. The ’231 patent has claims directed to formulations of aflibercept, the active ingredient…