As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts. The current cases are listed below, in order from most-recently-filed to oldest:
Amgen v. Tanvex (19-cv-1374, S.D. Cal.)
In July 2019, Amgen brought claims against Tanvex BioPharma USA, Inc. and two related entities in connection with Tanvex’s TX-01 biosimilar of Amgen’s Neupogen (filgrastim). Tanvex’s proposed biosimilar has not been approved by the FDA. The case is currently pending in the Southern District of California; Tanvex has answered the complaint.
Immunex v. Samsung Bioepis (19-cv-11755, D.N.J.)
In April 2019, Immunex, Amgen, and Hoffman-LaRoche brought claims against Samsung Bioepis in connection with Eticovo (etanercept-ykro), a biosimilar of Enbrel (etancercept). Eticovo has been approved by the FDA. The case is currently pending in the District of New Jersey; Samsung Bioepis has answered the complaint.
Amgen v. Hospira (18-cv-1064, D. Del.)
In July 2018, Amgen brought claims against Hospira and its corporate parent, Pfizer, in connection with Nivestym (filgrastim-aafi), a biosimilar of Amgen’s Neupogen (filgrastim). Nivestym has been approved by the FDA and has launched commercially in the United States. The case is currently pending in the District of Delaware; defendants have answered the complaint.
Genentech v. Amgen (18-cv-924, D. Del.)
In June 2018, Genentech brought claims against Amgen in connection with Kanjinti (trastuzumab-anns), a biosimilar of Genentech’s Herceptin (trastuzumab). Kanjinti has been approved by the FDA and has launched commercially in the United States. The case is currently pending in both the District of Delaware and at the Federal Circuit. In July 2019, the district court denied Genentech’s motion for a preliminary injunction. Genentech has taken an interlocutory appeal of that decision to the Federal Circuit, which declined to enjoin sales of Kanjinti during the pendency of the appeal.
Genentech v. Immunex (17-cv-1407 and 19-cv-602, C.D. Cal. and D. Del.)
In October 2017, Genentech brought claims against Immunex and Amgen in connection with Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s Avastin (bevacizumab). Mvasi has been approved by the FDA and has launched commercially in the United States. Related cases are currently pending in the Central District of California, the District of Delaware, and the Federal Circuit. In July 2019, the district court denied Genentech’s motion for a preliminary injunction. Genentech has taken an interlocutory appeal of that decision to the Federal Circuit, which declined to enjoin sales of Mvasi during the pendency of the appeal.
Janssen v. Celltrion (17-cv-11008, D. Mass.)
In May 2017—refiling claims that had initially been asserted in March 2015—Janssen Biotech brought claims against Celltrion and Hospira in connection with Inflectra (infliximab-dyyb), a biosimilar of Janssen’s Remicade. Inflectra has been approved by the FDA and has launched commercially in the United States. In July 2018, the district court granted Celltrion’s motion for summary judgment and Janssen has appealed to the Federal Circuit. Patterson Belknap represents Janssen in this action.
Immunex v. Sandoz (16-cv-1118, D.N.J.)
In February 2016, Immunex, Amgen, and Hoffman-LaRoche brought claims against Sandoz in connection with Erelzi (etanercept-szzs), a biosimilar of Enbrel (etanercept). Erelzi has been approved by the FDA. The case is currently on appeal to the Federal Circuit. A ten-day bench trial was held in September 2018. In October 2019, the district court found in favor of plaintiffs, upholding the validity of two patents related to Enbrel and entering a permanent injunction against Sandoz. Sandoz has appealed to the Federal Circuit.
Amgen v. Hospira (15-cv-839, D. Del.)
In September 2015, Amgen brought claims against Hospira and its corporate parent, Pfizer, in connection with Retacrit (epoetin alfa-epbx), a biosimilar of Hospira’s Epogen and Johnson and Johnson’s Procrit (epoetin alfa). Retacrit has been approved by the FDA and has launched commercially in the United States. In September 2017, a jury found in favor of Amgen and awarded $70 million in damages, which were upheld in post-trial motions. Hospira has appealed to the Federal Circuit.
