The battle over the proper forum for patent infringement litigation regarding Dupixent® (Dupilumab) appears to have been resolved. Last week, on May 1, 2017, Sanofi, Genzyme, and Regeneron voluntarily dismissed their Declaratory Judgment Complaint in the District of Massachusetts (Civ. No. 17-cv-10465). The dismissal, however, does not resolve the underlying patent infringement dispute, which is
Over the last two weeks, Pfizer, Inc. (“Pfizer”) has filed petitions for inter partes review (“IPR”) of three additional patents related to Biogen and Genentech’s Rituxan® (rituximab) at the Patent Trial and Appeal Board (“PTAB”). The proceedings are: IPR2017-01166, filed on April 21, 2017, regarding U.S. Patent No. 8,329,172 (“the ’172 patent”); IPR2017-1167, filed on
Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in Japan. Trastuzumab is a monoclonal antibody indicated for the treatment of patients with metastactic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens. Celltrion’s Herzuma (trastuzumab) is
The Supreme Court heard oral arguments on Wednesday in its first biosimilar case. On a petition filed in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039, and a cross-petition filed in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195, the Court was asked to interpret two provisions of
FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar approved by the FDA and the second infliximab biosimilar to Janssen’s Remicade®. Infliximab is an Anti-Tumor Necrosis Factor (Anti-TNF) monoclonal antibody approved in the U.S. for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and
Genentech filed suit against Amgen this past February when 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®. Genentech accused Amgen of violating sections (l)(2)(A) and (l)(1)(c) of the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C.
As we previously reported, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. filed a Declaratory Judgment Complaint against Amgen, Inc. and Immunex Corporation in the United States District Court for the District of Massachusetts on March 20, 2017, preemptively seeking a determination that Sanofi and Regeneron’s Dupixent® (dupilumab) product does not infringe U.S.
On March 31, 2017, Celltrion, Inc. (“Celltrion”) filed three new petition for inter partes review (“IPR”) of two additional patents related to Genentech and Biogen’s Rituxan® (rituximab). Two of the petitions challenge claims of U.S. Patent No. 7,682,612 (“the ’612 patent”) and the other seeks review of all nine claims of U.S. Patent No.8,206,711 (“the
Pfizer, Inc. (“Pfizer”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on March 24, 2017, for inter partes review (“IPR”) of U.S. Patent No. 7,820,161 (“the ’161 patent”) related to Biogen’s and Genentech’s Rituxan® (rituximab). The challenged claims of the ’161 patent are directed to a method for treating rheumatoid arthritis
We reported last week that Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. had filed suit in Massachusetts seeking a declaratory judgment that their Dupixent® (dupilumab) product does not infringe Amgen’s U.S. Patent No. 8,679,487 (“the ’487 patent”). The litigation was filed on March 20, 2017. In a one-two punch combination, Sanofi and Regeneron