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Litigation on Amgen’s Biosimilar to Avastin Settles on Heels of Amgen Procedural Victory at Federal Circuit

We have previously covered various aspects of a legal battle between Genentech and Amgen regarding Amgen’s efforts to market Mvasi, a biosimilar to Genentech’s bevacizumab product, Avastin.  These aspects include Genentech’s quickly-dismissed February 2017 action contending Amgen was in violation of the Biologics Price Competition and Innovation Act (“BPCIA”) (covered here and here), and Amgen’s declaratory judgment action for non-infringement, invalidity, and unenforceability filed in the Central District of California, which was subsequently dismissed in favor of infringement actions brought by Genentech in the District of Delaware (covered here).

With the Delaware cases ongoing, Genentech filed a second patent infringement action in March 2019 spurred on by two Supplemental Biologics License Application (“sBLA”) filed by Amgen that updated certain information related to changes in the manufacturing facility and drug label of its bevacizumab biosimilar.  Genentech then moved to prevent a pending launch of Mvasi under the argument that the sBLA required Amgen to give a new notice of marketing, which would have required Amgen to wait an additional 180 days to launch its biosimilar.  The court denied those motions in July 2019, and Amgen promptly launched its Mvasi product.

Genentech quickly filed an appeal that was accompanied by an emergency motion requesting Amgen be enjoined from selling Mvasi during the appeal.  The emergency motion was denied in August 2019, and the Federal Circuit heard the appeal in June 2020. On July 6, 2020, the Federal Circuit affirmed the lower court’s decision that Amgen’s sBLAs were not new applications that required new notices because the notice statute of the BPCIA requires notice of commercially marketing the biological product, which was not changed in any of Amgen’s supplements.

At this point, Amgen, had essentially overcome all procedural hurdles to marketing Mvasi, and had been marketing the product for nearly a year, while the Delaware infringement cases were pending.

On July 7, 2020, a stipulation of dismissal was filed in the pending Delaware infringement cases, stating that the parties “have entered into a Bevacizumab Settlement Agreement,” voluntarily dismissing all claims with prejudice. A notice of settlement was also provided to the Federal Circuit, indicating that Genentech would not be pursuing further appeal.

While the terms of the settlement are not public, a Q1 2020 earnings presentation by Genentech’s parent company Roche noted “biosimilar erosion in US and Japan” for Avastin. Roche also disclosed efforts to gain approval for Avastin as part of a combination therapy with Genentech’s Tecentriq product for various indications, suggesting that Roche may plan to focus its resources on other therapies rather than continuing to incur legal costs in litigation against Amgen.  Amgen, meanwhile, has reported more than $200 million in U.S. net sales of Mvasi from launch through Q1 2020.