Search Results for: "amgen v adello"

Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own…

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Filgrastim PTAB Update

As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system.  Amgen is asserting the ’878 and…

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Amneal, Amgen, and Kashiv jointly stipulate to dismiss patent in filgrastim litigation

As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…

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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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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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Kashiv Files IPRs on Amgen Process Patents

On March 7, 2019, Kashiv Biosciences filed two IPR petitions (IPR2019-00791 and IPR2019-00797) against Amgen process patents – U.S. Patent Nos. 8,940,878 and 9,643,997. The ‘878 and ‘997 patents are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system.  Kashiv asserts that claims 7-8, 11-12,…

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BPCIA Litigation Roundup (Q2 2018)

Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…

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BPCIA Litigations

The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products.  For additional details, please consult the links below or some of our prior BPCIA litigation coverage. # Litigation Accused Biosimilar [status] Reference Product Complaint Filed Status/Outcome District Court Appeal 1 Amgen v….

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