In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
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BiosimilarsIP.com Legal provides analysis of legal decisions from federal courts and from the PTAB related to biologics and biosimilars.
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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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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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On February 14, 2019, the PTAB issued final written decisions in two separate IPRs filed by Sanofi-Aventis, Genzyme Corp., and Regeneron...
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The PTAB recently denied institution of two IPRs filed by CSL Behring LLC, CSL Behring GMBH, and CSL Behring Recombinant Facility AG...
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The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for...
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Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics...
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