Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and...
BiosimilarsIP.com Legal provides analysis of legal decisions from federal courts and from the PTAB related to biologics and biosimilars.
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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 C. Nichole Gifford and Seth Cockrum Comments are off
As we previously reported, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. filed a Declaratory Judgment...
Tagged with: Amgen, District Court, dupilumab, Dupixent®, Immunex, Legal, Litigation, Regeneron, Sanofi
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By C. Nichole Gifford and Seth Cockrum Comments are off
Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. (collectively “Plaintiffs”) filed a Complaint in the...
Tagged with: Amgen, District Court, dupilumab, Dupixent®, Immunex, Legal, Litigation, Regeneron, Sanofi
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By Daniel McCallum and C. Nichole Gifford Comments are off
Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint...
Tagged with: Amgen, Avastin®, bevacizumab, BPCIA, District Court, Genentech, Genentech v. Amgen, Legal, Litigation, Patent Dance
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By C. Nichole Gifford Comments are off
Inter partes review (“IPR”) is one of several post-grant procedures created by the Leahy Smith America Invents Act (“AIA”). An...
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By C. Nichole Gifford Comments are off
On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act...
Tagged with: Avastin®, bevacizumab, BPCIA, District Court, Genentech v. Amgen, Legal, Litigation, Patent Dance
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