This is our second update on the litigation (you can see the prior analyses here and here, in addition to a parallel post on our companion blog concerning patent office practice) involving Janssen Biotech, Inc. (“Janssen”), Celltrion Healthcare Co. and Celltrion, Inc. (“Celltrion”), and Hospira Inc. (“Hospira”); but, judging by the course of things,
Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have been several developments, including those that occurred after the Supreme Court’s recent Amgen v. Sandoz decision.
The last major development we previously discussed was a motion for a preliminary injunction filed by Amgen seeking “to
This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”), Celltrion Healthcare Co. and Celltrion, Inc. (“Celltrion”), and Hospira Inc. (“Hospira”).
Briefly, when we last addressed this case, the litigation had already been narrowed to one patent, U.S. Patent No. 7,598,083 (“the ’083 patent”). Further, there were
Introduction and Background
The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the parties participated in the patent dance. As a result, important issues regarding the interpretation of the Biologics Price Competition and Innovation Act (the “BPCIA”) were raised, including whether a biosimilar applicant (“(k) applicant”) must give 180-days’ notice to the reference
Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and only two of those products are commercially available to patients in the United States – Sandoz’s Zarxio® (a filgrastim biosimilar to Amgen’s Neupogen®) and Celltrion and Hospira’s Inflectra® (an infliximab biosimilar to