As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents relating to Herceptin® (trastuzumab) and Rituxan® (rituximab) are non-infringed, invalid, and/or unenforceable. In response, Genentech filed a motion to dismiss in both cases arguing that the case was statutorily barred under the BPCIA. On May
The Patent Trial and Appeal Board (“the Board”) has decided not to institute inter partes review (“IPR”) on two patents owned by Biogen and Genentech. Pfizer, Inc. (“Pfizer”) filed two petitions asserting that the patents, U.S. Patent Nos. 8,206,711 (“the ’711 patent”) and 7,682,612 (“the ’612 patent”), were invalid as obvious in view of prior
Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab. In the announcement, Sandoz stated that it “stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter.” Sandoz further indicated that although disappointed, it “remains committed
We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, or unenforceable. That same day, Celltrion and Teva also filed a suit seeking declaratory
As we previously reported, Pfizer filed three IPR petitions against Biogen-owned patents claiming methods of treatment with rituximab in April 2017. The three proceedings are: IPR2017-01166, regarding U.S. Patent No. 8,329,172 (“the ’172 patent”); IPR2017-01167, regarding U.S. Patent No. 8,557,244 (“the ’244 patent”); and IPR2017-01168, regarding U.S. Patent No. 8,821,873 (“the ’873 patent”). Institution
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
Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s Humira® (adalimumab) rocketed to the best-selling drug in the world with sales generating over $16 billion USD in 2016. The top biologic drugs are all driving revenues well beyond the $1 billion sales revenue demarcation that
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s Rituxan® (rituximab), has been accepted for review by the Food and Drug Administration (“FDA”). The FDA is expected to act on the application in the first quarter of 2018.
Rituximab is an anti-CD20 monoclonal antibody approved for
On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s Rituxan®/Mabthera®. The approval follows the positive recommendation by the Committee for Medicinal Products for Human Use (“CHMP”) issued two months ago.
Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large