Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s Epogen®/Procrit® for approval across all indications after a public meeting held on May 25, 2017. The meeting materials are available from the FDA’s website here.
The history of this application is interesting. The original biologics application
Partner Nikki Gifford gave a presentation entitled “Intellectual Property – Recent Developments and Implications,” at the World Biosimilar Congress in San Diego, California, on Wednesday, May 24, 2017. The 30-minute session covered: (1) the BPCIA’s “patent dance”; (2) what’s at stake in Sandoz v. Amgen, and the potential outcomes and practical implications of the
Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”) related to Genentech’s Herceptin® (trastuzumab). Celltrion has announced that it plans to submit an application for a trastuzumab biosimilar product to the FDA this year (possibly as early as next month), as reported
Baxalta Incorporated and Baxalta GmbH (collectively “Baxalta” or “Plaintiffs”) filed a Complaint in the United States District Court for the District of Delaware on May 4, 2017, against Genentech, Inc. (“Genentech”) and Chugai Pharmaceutical Co. Ltd., (“Chugai,” and collectively with Genentech “Defendants”) alleging that Defendants’ bispecific monoclonal antibody emicizumab infringes claims 1, 4, 15, 17
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
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
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