On March 2, 2017, the PTAB issued a decision denying Celltrion, Inc.’s (“Celltrion”) request for inter partes review (“IPR”) of claims 1-14 of U.S. Patent No. 7,976,838 related to Genentech’s Rituxan® (rituximab). This denial comes less than a week after the PTAB instituted IPR of U.S. Patent No. 7,820,161, related to the same product,
Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint without prejudice on March 1, 2017 for lack of subject matter jurisdiction in light of Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). As discussed in our earlier post (which raised the
Inter partes review (“IPR”) is one of several post-grant procedures created by the Leahy Smith America Invents Act (“AIA”). An IPR provides a mechanism for challenging the patentability of one or more claims of an issued patent through an administrative “trial” conducted by three Administrative Patent Judges from the United States Patent and Trademark Office’s
Celltrion, Inc. (“Celltrion”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on August 15, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,820,161 (“the ’161 patent”) related to Genentech’s Rituxan® (rituximab). On February 24, 2017, the PTAB issued a decision instituting review of claims 1–3, 5–7, and 9–11 of
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
On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262. A dispute arose between the parties during the first step of the “patent dance” for Amgen’s bevacizumab product (ABP 215), a proposed biosimilar to Genentech’s Avastin®.
Amgen announced in November 2016, that
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
The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”). On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039 and on Amgen’s conditional cross-petition for certiorari
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