Search Results for: "amgen v apotex"

Accord BioPharma substituted for Apotex as party in filgrastim/pegfilgrastim biosimilar litigation

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…

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PTAB Institutes PGR of Protein Refolding Patent at Issue in Filgrastim and Pegfilgrastim Litigations

U.S. Patent No. 9,856,287, which is directed to a protein refolding method, is one of the patents-in-suit in the pending Amgen v. Adello (filgrastim) BPCIA litigation and the sole patent-in-suit in the pending Amgen v. Apotex (filgrastim and pegfilgrastim) BPCIA litigation. As we previously reported, in November 2018, Adello and…

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District Court Denies Apotex’s Motion to Dismiss Amgen’s Complaint in Second Lawsuit

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…

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Biosimilar-Related Patent Litigation Updates

Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…

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New BPCIA Complaint: Amgen Sues Apotex, Again, over Proposed 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…

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