
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
By Benjamin R. Holt Comments are off
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
Tagged with: aBLA, Amgen, BPCIA, Enbrel®, etanercept, Eticovo, FDA, Featured, Patent Dance, Regulatory, Samsung Bioepis, Sandoz
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By Spencer Johnson Comments are off
We previously wrote about Genentech’s U.S. Patent No. 6,407,213 (“the ’213 patent”) to Carter, first in October 2017, and more...
Tagged with: Boehringer Ingelheim, Celltrion, District Court, Featured, Genentech, IPR, Mylan, Patent Dance, Pfizer, Samsung Bioepsis
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By Seth Cockrum Comments are off
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents...
Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab
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By Rachel M. Echols Comments are off
On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging...
Tagged with: Adello Biologics, Amgen, Featured, filgrastim, Legal, Neupogen®, Patent Dance, Sandoz v. Amgen
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By Seth Cockrum Comments are off
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents...
Tagged with: BLA, BPCIA, Celltrion, District Court, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab
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By Seth Cockrum Comments are off
On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International...
Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, IPR, News, Patent Dance, Roche, Teva, trastuzumab
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By Daniel McCallum Comments are off
Several of the Federal Circuit’s initial decisions involving the Biologics Price Competition and Innovation Act (the “BPCIA”) focused...
Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Federal Circuit, Legal, Litigation, Patent Dance
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By Nicole DeAbrantes Comments are off
On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of...
Tagged with: 351(k) pathway, 505(b)(2), BLA, District Court, Guidance, Merck, NDA, Patent Dance, Sanofi
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By C. Nichole Gifford Comments are off
Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States...
Tagged with: AbbVie, adalimumab, Boehringer Ingelheim, BPCIA, District Court, Humira®, Legal, Litigation, Patent Dance
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