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 patent”) on April 3, 2018.  The ʼ992 patent is entitled “Use of TNFα Inhibitor for Treatment of Psoriatic Arthritis,” and is assigned to AbbVie Biotechnology Ltd. (“AbbVie”).  The claims of the

Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing approval from both the European Commission (which applies to all 28 European Union member states) and the European Economic Area member states of Norway, Iceland, and Liechtenstein.[1] Additionally, the Therapeutic Goods Administration approved the biosimilar for use

Sandoz’s request for inter partes review (“IPR”) of U.S. Patent Numbers 9,512,216 (“the ’216 patent”) and 8,802,100 (“the ’100 patent”) was denied by the Patent Trial and Appeal Board (“the Board”) on the grounds that Sandoz did not show that the patents were likely unpatentable.  The decisions not to institute an IPR of either patent

Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir phosphate), one of the most popular antivirals prescribed for relief from the influenza virus. The active ingredient is indicated for the treatment of acute, uncomplicated influenza A and B in patients two weeks of age or older who have

We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, or unenforceable.  That same day, Celltrion and Teva also filed a suit seeking declaratory

On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit against Genentech, Inc., Hoffmann-La Roche Inc., and City of Hope seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, and/or unforceable. According to Celltrion and Teva, a

In October, a Federal Circuit panel vacated a permanent injunction against Sanofi and Regeneron’s Praluent® and remanded the proceeding to the district court for a new trial on the defendants’ written description and enablement defenses.[i] The panel had held that the district court erred by (i) excluding the defendants’ evidence of written description and

Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European Medicines Agency (“EMA”).  According to Sandoz, “[t]he comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms

Samsung Bioepis (“Bioepis”) has joined a growing list of challengers to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) issued to Carter, et al. by filing two new petitions for inter partes review (“IPR”).  The ʼ213 patent, entitled “Method for Making Humanized Antibodies,” is generally directed to antibodies with humanized variable domains comprising non-human complementarity