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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On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”)...
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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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The FDA recently proposed an amendment to its regulations defining the term “biological product.” The proposed amendment...
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On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz...
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On July 2, 2018, Genentech filed suit against Eli Lilly and Company (“Lilly”) in the Southern District of California alleging Lilly’s...
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As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents...
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Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with...
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Last week, Novartis and Amgen announced the FDA approved Aimovig™ (erenumab) for the preventive treatment of migraine in adults. The...