Celltrion, Inc. (“Celltrion”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on February 21, 2017 for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab). The challenged claims of the ’897 patent are directed to methods for treating patients with nonmetastatic HER2-positive
The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k) pathway for MYL-1401K, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim). According to the announcement, the BSUFA date (FDA’s target goal) for a decision on the application is October 9, 2017.
The FDA has not
Coherus Biosciences, Inc. (“Coherus”) has filed four petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of U.S. Patent No. 9,085,619 (“the ’619 patent”) related to AbbVie’s Humira® (adalimumab). The challenged claims of the ’619 patent are directed to formulations of adalimumab and closely-related antibodies. Adalimumab is a TNF
Hospira, Inc. (“Hospira”) filed two additional new petitions with the Patent Trial and Appeal Board (“PTAB”) on January 30, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 6,627,196 (“the ’196 patent”) and 7,371,379 (“the ’379 patent”) related to Genentech’s Herceptin® (trastuzumab). These filings come on the heels of three petitions Hospira filed
Hospira, Inc. (“Hospira”) filed three petitions with the Patent Trial and Appeal Board (“PTAB”) on January 20, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 7,846,441 (“the ’441 patent”) and 7,892,549 (“the ’549 patent”) related to Genentech’s Herceptin® (trastuzumab). The challenged claims of the ’441 patent are directed to a method of