Tagged as: Amgen

Court Denies TRO/PI in Genentech v. Amgen; Amgen Announces Launch

As we previously reported, on July 10, 2019, Genentech filed  motions for a temporary restraining order and preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI™ (trastuzumab-anns).  Yesterday, the District Court denied Genentech’s motions and lifted the standstill order given during the…

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Amgen petitions for rehearing en banc following Federal Circuit decision

On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate.  As we previously reported, on May 8, 2019, a Federal…

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Fresenius Kabi Files a Petition For Inter Partes Review of Amgen’s Pegfilgrastim Patent

On June 8, 2019, Fresenius Kabi filed a petition for inter partes review challenging the validity of U.S. Patent No. 9,643,997, entitled “Capture purification processes for proteins expressed in a non-mammalian system.”  The challenged claims in the patent, owned by Amgen Inc., relate to processes for purifying recombinant proteins expressed in a…

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BREAKING NEWS: Federal Circuit Affirms Sandoz’s Victory Over Amgen in Filgrastim and Pegfilgrastim Biosimilar Patent Litigation

This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar.  As we previously reported, in December 2017 the Northern California district court granted summary…

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Amgen Answers Coherus’s Adalimumab Complaint

As we previously reported, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging that Amgen’s adalimumab product for sale in Europe, Amgevita™, infringes three Coherus formulation patents related to adalimumab because Amgen allegedly manufactures its European product in the United States.  As we also reported, Coherus amended its…

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Update on the Amgen v. Adello Filgrastim Litigation

On April 15, 2019, the parties filed their opening claim construction briefs (Amgen’s Brief; Adello’s Brief) in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim).  The patents at issue are U.S. Patent Nos. 8,940,878; 9,643,997; 8,952,138; and 9,856,287, each generally directed to the production of proteins in…

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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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