On October 3, 2017, Pfizer, Inc. (“Pfizer”) filed a petition for inter partes review (“IPR”) against U.S. Patent No. 7,846,441...
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By C. Nichole Gifford Comments are off
Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to...
Tagged with: Allergan, Amgen, Biocon, Celltrion, FDA, Genentech, Herceptin®, Hospira, Mylan, News, Pfizer, Regulatory, Teva, trastuzumab
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By C. Nichole Gifford Comments are off
Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017,...
Tagged with: adalimumab, Humira®, Invalidity, IPR, News, PTAB, Sandoz, USPTO, Validity
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By C. Nichole Gifford Comments are off
On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. ...
Tagged with: Infliximab, Janssen, Merck, News, Remicade®, Renflexis®, Samsung Bioepsis
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By C. Nichole Gifford Comments are off
Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection...
Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi
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By C. Nichole Gifford Comments are off
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab
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By C. Nichole Gifford Comments are off
Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two...
Tagged with: AbbVie, adalimumab, Amgen, Boehinger Ingleheim, Coherus, Humira®, Legal, News, PTAB
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By C. Nichole Gifford Comments are off
On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897...
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By Nicole DeAbrantes Comments are off
The patent venue statue, 28 U.S.C. § 1400(b), states that “ny civil action for patent infringement may be brought in the judicial...
Tagged with: BPCIA, District Court, Federal Court, Legal, Litigation, News, Supreme Court, Venue
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