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
The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end of September 2017. Under BsUFA, the U.S. Food and Drug Administration (“FDA”) is authorized to collect fees directly from biosimilar drug product applicants, and the fees are dedicated to expediting the approval
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
Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s Epogen®/Procrit® for approval across all indications after a public meeting held on May 25, 2017. The meeting materials are available from the FDA’s website here.
The history of this application is interesting. The original biologics application
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
Partner Nikki Gifford gave a presentation entitled “Intellectual Property – Recent Developments and Implications,” at the World Biosimilar Congress in San Diego, California, on Wednesday, May 24, 2017. The 30-minute session covered: (1) the BPCIA’s “patent dance”; (2) what’s at stake in Sandoz v. Amgen, and the potential outcomes and practical implications of the
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 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.