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…
Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals. According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration. As we…
Apotex Inc. recently filed an IPR petition, IPR2022-01524, seeking cancellation of claims 1-14 and 26-30 of U.S. Patent No. 11,253,572 assigned to Regeneron Pharmaceuticals, Inc. The challenged claims generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen of aflibercept, achieving specific visual acuity results from…
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…
As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…
As we previously reported, in IPR2016-01542, Apotex successfully challenged all 24 claims of Amgen’s U.S. Patent No. 8,952,138, directed to a protein refolding process. Apotex had filed its IPR petition in August 2016, while it was in the midst of BPCIA litigations in which Amgen was asserting the ’138 patent…
Last week, the district court in Amgen v. Apotex (No. 18-61828) (S.D. Fla.) denied Apotex’s motion to dismiss Amgen’s complaint in a follow-on suit concerning Apotex’s pegfilgrastim and filgrastim biosimilar candidates. By way of background, Amgen and Apotex have been involved in multiple patent lawsuits regarding Apotex’s pegfilgrastim and filgrastim biosimilars…
Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems. According to…
Last week, Apotex Australia, an affiliate of the Canadian-based Apotex, Inc., announced a proposed merger of their Australian and New Zealand generic pharmaceutical and over-the-counter (OTC) operations with Arrow Pharmaceutical. This combined operation aims to offer pharmacists, patients and consumers a diverse range of almost 500 products, and permit the…
As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent. Amgen’s time for filing a petition for panel rehearing or rehearing en banc of last month’s panel decision expired on…