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…
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…
As we previously reported, last week the U.S. District Court for the District of Delaware denied Genentech’s motion for a preliminary injunction against Amgen in the BPCIA litigation concerning Amgen’s Kanjinti (trastuzumab-anns). A redacted version of the court’s opinion has now been posted to the public docket. As set forth…
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…
On April 5, 2019, Genentech filed patent infringement and declaratory judgment complaint against Pfizer in the District of Delaware in response to Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab). In the complaint, Genentech alleges infringement of 22 patents, out of a total…
We previously reported on the biosimilar trade secrets case, Genentech v. JHL. Genentech asserted claims including trade secret misappropriation under state and federal law, breach of contract, and breach of state and federal computer fraud and abuse acts. On March 20, the district court entered a case management order ,…
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®…
As we have reported, over the course of the past thirteen months Plaintiffs Genentech, Inc. and City of Hope sued each of Pfizer, Celltrion and Teva, Amgen and Samsung Bioepis in the District of Delaware for patent infringement under the BPCIA based on their submissions of aBLAs seeking FDA approval…
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…
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…