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

The patent venue statue, 28 U.S.C. § 1400(b), states that “[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides or where the defendant has committed acts of infringement and has a regular and established place of business.” See 28 U.S.C. § 1400(b).  Recently, in TC Heartland LLC

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

The Amgen, Inc. and Amgen Manufacturing, Limited (“Amgen”) litigation against Hospira, Inc. (“Hospira”), filed in September 2015, was one of the earliest cases filed under the Biologics Price Competition and Innovation Act (“BPCIA”).  The case involves Hospira’s proposed biosimilar to Amgen’s Epogen®/Procrit® (epoetin alfa).  The procedural posture is somewhat complicated, as

Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson,   (“Janssen” or “Plaintiff”) filed a Complaint in the United States District Court for the District of New Jersey against Samsung Bioepis Co., Ltd. (“Samsung Bioepis” or “Defendant”),  a joint venture between Samsung Biologics and Biogen.  The patent infringement litigation relates to Samsung Bioepis’s

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

The battle over the proper forum for patent infringement litigation regarding Dupixent® (Dupilumab) appears to have been resolved.  Last week, on May 1, 2017, Sanofi, Genzyme, and Regeneron voluntarily dismissed their Declaratory Judgment Complaint in the District of Massachusetts (Civ. No. 17-cv-10465).  The dismissal, however, does not resolve the underlying patent infringement dispute, which is

The Supreme Court heard oral arguments on Wednesday in its first biosimilar case.  On a petition filed in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039, and a cross-petition filed in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195, the Court was asked to interpret two provisions of

Genentech filed suit against Amgen this past February when a dispute arose between the parties during the first step of the “patent dance” for Amgen’s bevacizumab product (ABP 215), a proposed biosimilar to Genentech’s Avastin®.  Genentech accused Amgen of violating sections (l)(2)(A) and (l)(1)(c) of the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C.