The battle over the proper forum for patent infringement litigation regarding Dupixent® (Dupilumab) appears to have been resolved. Last...
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By C. Nichole Gifford
Over the last two weeks, Pfizer, Inc. (“Pfizer”) has filed petitions for inter partes review (“IPR”) of three additional patents...
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By C. Nichole Gifford
Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in...
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By C. Nichole Gifford
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
FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar...
Tagged with: Biogen, Celltrion, FDA, Inflectra®, Infliximab, Janssen, News, Regulatory, Remicade®, Renflexis®, Samsung Bioepsis
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By C. Nichole Gifford and Daniel McCallum
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 C. Nichole Gifford and Seth Cockrum
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
On March 31, 2017, Celltrion, Inc. (“Celltrion”) filed three new petition for inter partes review (“IPR”) of two additional patents...
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By C. Nichole Gifford
Pfizer, Inc. (“Pfizer”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on March 24, 2017, for inter partes...
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By C. Nichole Gifford and Seth Cockrum
We reported last week that Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. had filed suit in...