In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
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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PTAB Institutes Review of AbbVie Patent Directed to Treatment of Chronic Plaque Psoriasis
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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