This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”),...
BPCIA
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By Spencer Johnson Comments are off
Introduction The Amgen, Inc. and Amgen Manufacturing, Limited (“Amgen”) litigation against Hospira, Inc. (“Hospira”), filed in...
Tagged with: Amgen, Amgen v. Hospira, BPCIA, District Court, epoetin alfa, Epogen®, Erythropoietin, Featured, Federal Circuit, Hospira, Janssen, Legal, Litigation, Notice Requirement, Patent Dance, Pfizer, Procrit®, Retacrit®, Supreme Court
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By C. Nichole Gifford Comments are off
Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s...
Tagged with: Amgen, Amgen v. Hospira, BPCIA, epoetin alfa, Epogen®, FDA, Hospira, Janssen, News, Pfizer, Procrit®, Regulatory, Retacrit®
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Janssen Files BPCIA Patent Infringement Suit Against Samsung Bioepis’s Renflexis® (infliximab-abda)
By C. Nichole Gifford Comments are off
Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson, (“Janssen” or “Plaintiff”) filed a Complaint in...
Tagged with: BPCIA, District Court, Inflectra®, Infliximab, Janssen, Legal, Litigation, Patent Dance, Remicade®, Renflexis®, Samsung Bioepsis
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By C. Nichole Gifford Comments are off
Partner Nikki Gifford gave a presentation entitled “Intellectual Property – Recent Developments and Implications,” at the World...
Tagged with: BPCIA, IPR, Litigation, Patent Dance, Sandoz v. Amgen, Supreme Court
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Litigation Spotlight: The Apotex Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) Litigation
By Rachel M. Echols Comments are off
Introduction and Background The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the...
Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Featured, Federal Circuit, filgrastim, Legal, Litigation, Litigation Spotlight, Neulasta®, Neupogen®, Notice, Notice Requirement, Patent Dance, pegfilgrastim
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By C. Nichole Gifford Comments are off
The Supreme Court heard oral arguments on Wednesday in its first biosimilar case. On a petition filed in Sandoz, Inc. v. Amgen, Inc., et...
Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court
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By C. Nichole Gifford and Daniel McCallum Comments are off
Genentech filed suit against Amgen this past February when a dispute arose between the parties during the first step of the “patent...
Tagged with: Amgen, Avastin®, bevacizumab, BPCIA, District Court, Genentech, Genentech v. Amgen, Legal, Litigation, Patent Dance
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By Daniel McCallum Comments are off
Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and...
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