
On April 2, 2019, Eli Lilly and Company (“Lilly”) filed a Petition for Post-Grant Review (“PGR”) of Genentech’s U.S. Patent...
On April 2, 2019, Eli Lilly and Company (“Lilly”) filed a Petition for Post-Grant Review (“PGR”) of Genentech’s U.S. Patent...
Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics...
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
Earlier this month, the Patent Trial and Appeal Board (“PTAB” or “the Board”) denied institution of Sandoz’s petition for inter...
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
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®
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
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