Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have...
Notice Requirement
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The Supreme Court’s Decision in Amgen v. Sandoz: Clear Guidance and Open Questions for Biosimilars
By Jennifer P. Nock Comments are off
As we previously reported here, earlier this year the Supreme Court agreed to hear its first case arising under the Biosimilars Price...
Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court
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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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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 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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By Nicole DeAbrantes Comments are off
As we previously reported in this post, the Supreme Court granted certiorari in its first biosimilar case on Sandoz’s petition in Sandoz,...
Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court
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By Nicole DeAbrantes and C. Nichole Gifford Comments are off
The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and...
Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court
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