In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
Amgen
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By Nicole DeAbrantes Comments are off
On May 20, 2019, the PTAB denied a request for rehearing in Apotex Inc. v. Amgen Inc., Case IPR2016-01542 (Paper 67), but modified its...
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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 Nicole DeAbrantes Comments are off
Recently, in Adello Biologics LLC v. Amgen Inc., Case PGR2019-00001 (Paper No. 13) (PTAB Apr. 19, 2019), the PTAB instituted...
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By Benjamin R. Holt Comments are off
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for...
Tagged with: Amgen, FDA, Federal Circuit, Praluent®, Regeneron, Repatha®, Sanofi, Supreme Court
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By Seth Cockrum Comments are off
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”)...
Tagged with: Amgen, District Court, filgrastim, News, pegfilgrastim, Sandoz
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By Caitlin M. Wilmot Comments are off
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No....
Tagged with: Amgen, Apotex, BPCIA, filgrastim, Litigation, Neulasta®, Neupogen®, pegfilgrastim
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By Andrew Storaska Comments are off
Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was...
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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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