Tagged as: Genentech

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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Federal Circuit Declines to Block Sales of Amgen’s KANJINTI (trastuzumab-anns) Before Resolving Genentech’s Appeal

As we previously reported, Genentech has appealed the Delaware district court’s denial of its preliminary injunction motion that sought to bar sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar in the United States.  In conjunction with its appeal, Genentech also asked the Federal Circuit (1) to issue an injunction against Amgen pending…

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Genentech Moves for Temporary Restraining Order and Preliminary Injunction Against Amgen

Last night, Genentech filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI (trastuzumab-anns).  Genentech’s motion papers were filed under seal, and Amgen’s responsive papers on the preliminary injunction motion…

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Court Enters Preliminary Injunction Against JHL In Biosimilar Trade Secrets Case

As we previously reported, in October 2018, Genentech brought claims against Taiwan-based biosimilar developer JHL Biotech, Inc. and individual defendants for trade secret misappropriation, computer fraud, breach of contract, and other claims.  The alleged trade secrets relate to several of Genentech’s products: Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme®…

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Former Genentech Employees Accused of Stealing Biologic Manufacturing Process Trade Secrets

On October 25, 2018, the U.S. Attorney for the Northern District of California filed an indictment against four individuals (three of whom were former Genentech employees) alleging theft of trade secrets, computer fraud and abuse, and other crimes.  The indictment alleges that the defendants stole trade secrets related to Genentech’s products…

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Genentech Settles Rituximab Patent Dispute with Celltrion and Teva

On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an aBLA relating to Truxima®, Celltrion’s proposed biosimilar to Rituxan® (rituximab), infringed certain patents.  The…

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