On April 2, 2019, Eli Lilly and Company (“Lilly”) filed a Petition for Post-Grant Review (“PGR”) of Genentech’s U.S. Patent...
Caitlin M. Wilmot
- Posts: 8
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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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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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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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Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing...
Tagged with: Abasaglar™, Biocon, Eli Lilly, FDA, Insulin glargine, Lantus®, Lusduna™, Merck, Mylan, Sanofi, Semglee™, trastuzumab
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Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir...
Tagged with: FDA, Lupin, oseltamivir phosphate, Roche, Tamiflu®
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On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation...
Tagged with: Amgen, Amgen v. Sandoz, BPCIA, FDA, Federal Circuit, filgrastim, Neupogen®, Sandoz
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On November 6, 2017, Sandoz, Inc. filed its eighth inter partes review (“IPR”) against AbbVie Biotechnology Ltd. (“AbbVie”),...
Tagged with: AbbVie, Amgen, Boehringer Ingelheim, Coherus, Humira®, IPR, Legal, PTAB, Samsung Bioepsis, Sandoz