
This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”),...
By Daniel McCallum Comments are off
This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”),...
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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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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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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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