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
As previously reported, earlier this year Celltrion, Inc. (“Celltrion”) filed petitions seeking inter partes review (“IPR”) of certain Genentech patents covering Herceptin® (trastuzumab). In particular, Celltrion challenged the patentability of certain claims of U.S. Patent Nos. 7,846,441 (“the ʼ441 patent”); 7,892,549 (“the ʼ549 patent”); 6,626,196 (“the ʼ196 patent”); 7,371,379 (“the ʼ379 patent”). Earlier this month,
As we previously reported, Celltrion filed three petitions seeking inter partes review (“IPR”) of two patents related to Genentech and Biogen’s Rituxan® (rituximab). Celltrion filed two petitions seeking review of U.S. Patent No. 7,682,612 (“the ʼ612 patent”) and one petition seeking review of U.S. Patent No. 8,206,711 (“the ʼ711 patent”). The PTAB has now reached
Last week, Pfizer, Inc. (“Pfizer”) filed two petitions for inter partes review (“IPR”) of two patents related to Genentech and Biogen’s Rituxan® (rituximab). One petition challenges all but two claims of U.S. Patent No. 7,682,612 (“the ʼ612 patent”), and has been assigned IPR2017-02126. The other petition seeks review of all nine claims of U.S. Patent
On September 28, 2017, AbbVie and Amgen announced a global settlement of their patent dispute surrounding Amgen’s proposed biosimilar to HUMIRA. The terms of the agreement remain confidential between the parties, but according to the announcement, AbbVie will grant Amgen a non-exclusive license for the use and sale of Amgen’s biosimilar (AMGEVITA) to HUMIRA. Amgen
On October 3, 2017, Pfizer, Inc. (“Pfizer”) filed a petition for inter partes review (“IPR”) against U.S. Patent No. 7,846,441 (“the ʼ441 patent”), assigned to Genentech, Inc. (“Genentech”), entitled “Treatment with anti-ErbB2 antibodies.” The ʼ441 patent is related to Genentech’s Herceptin® (trastuzumab) product. Last November, Pfizer announced positive results in a pivotal safety and efficacy
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
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.
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
Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. (collectively “Plaintiffs”) filed a Complaint in the United States District Court for the District of Massachusetts seeking a declaratory judgment from the Court that the development, manufacturing, sale, and promotion of Dupixent® (dupilumab) does not infringe U.S. Patent No. 8,679,487 (“the ’487 patent”). The ‘487 patent,