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 earlier in January 2017 as discussed here. The challenged claims of the ’196 and ’379 patents are generally directed to methods of treating cancers characterized by the overexpression of ErbB2 by administering an effective amount of an anti-ErbB2 antibody using a dosage regimen that provides a large initial dose, followed by the subsequent administration of additional dosages in amounts that are the same as or less than the initial dosage spaced two to three weeks apart (referred to in the specification as “front loading”).
Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.
The proceedings are IPR2017-00804 (involving the ’196 patent) and IPR2017-00805 (involving the ’379 patent). As in the earlier filed petitions, the real party-in-interest identified for Petitioner is Hospira, Inc. Petitioner also identified Pfizer, Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. Here again, the only real party-in-interest identified by the Patent Owner is Genentech, Inc.
With the filing of these most recent petitions, Hospira has filed a total of six IPR petitions related to Herceptin® (trastuzumab). Mylan has also filed a petition regarding Herceptin® (trastuzumab). The PTAB has not yet issues a decision on institution in any of the proceedings. A complete list of IPRs can be found in RFEM’s IPR Dashboard.
We will continue to provide updates as these cases progress.