Tagged as: 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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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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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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BPCIA Litigation Updates: Amgen v. Apotex, Immunex v. Sandoz, Janssen v. Celltrion

A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday.  With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July  opinion in the case must now be…

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