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In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
By Andrew Storaska Comments are off
In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
Tagged with: aBLA, Amgen, Amgen v. Sandoz, doctrine of equivalents, FDA, Featured, Federal Circuit, Sandoz
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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 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 Seth Cockrum Comments are off
On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz...
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By Nicole DeAbrantes Comments are off
The Patent Trial and Appeal Board (“PTAB”) recently denied Sandoz’s petition for inter partes review (“IPR”) of claims 1-30 of...
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By Caitlin M. Wilmot Comments are off
Earlier this month, the Patent Trial and Appeal Board (“PTAB” or “the Board”) denied institution of Sandoz’s petition for inter...
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By Seth Cockrum Comments are off
Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab. In the announcement,...
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By Seth Cockrum Comments are off
On the same day that the PTAB instituted review of an AbbVie Biotechnology Ltd. (“AbbVie”) patent covering a method of using adalimumab...
Tagged with: AbbVie, adalimumab, News, PTAB, Sandoz
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By Seth Cockrum Comments are off
At the urging of Sandoz Inc. (“Sandoz”), the PTAB instituted review of claims 1, 2, and 5-7 of U.S. Patent No. 9,067,992 (“the ʼ992...
Tagged with: AbbVie, adalimumab, News, PTAB, Sandoz
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