Search Results for: "genentech v amgen"

Federal Circuit Will Not Halt Sales of Amgen’s MVASI (bevacizumab-awws) Before It Resolves Genentech’s Appeal

As we previously reported, after Amgen obtained FDA-approval for MVASI (bevacizumab-awws), a biosimilar of Genentech’s AVASTIN, Amgen submitted—and the FDA approved—a number of supplements that revised, among other things, manufacturing and labeling information for the product. Genentech subsequently filed a motion in the district court, arguing that the FDA’s approval…

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Genentech appeals district court’s refusal to block Amgen’s trastuzumab and bevacizumab biosimilars

As we previously reported, Amgen commercially launched two biosimilars in the United States earlier this month: KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin®; and MVASI® (bevacizumab-awwb), a biosimilar to Avastin®.  Amgen’s launch announcement on July 18, 2019 came shortly after a Delaware federal district court denied Genentech’s requests for a temporary…

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Biosimilar Litigation Updates

Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…

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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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Genentech Seeks to Dismiss and Strike Amgen's Counterclaims and Certain Defenses in Bevacizumab Biosimilar Litigation

As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses.  On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated…

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Court Grants Amgen’s Motion To Dismiss Genentech’s Declaratory Judgment Counts in Mvasi™ Litigation, and Sets June 2020 Trial Date

We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product.  In particular, Genentech had sought a judgment that Amgen could not market its product…

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