Hospira, Inc. (“Hospira”) filed three petitions with the Patent Trial and Appeal Board (“PTAB”) on January 20, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 7,846,441 (“the ’441 patent”) and 7,892,549 (“the ’549 patent”) related to Genentech’s Herceptin® (trastuzumab).  The challenged claims of the ’441 patent are directed to a method of treating cancers linked to the overexpression of the human ErbB2 protein by administering an anti-ErbB2 antibody that binds to epitope 4D5 and a taxoid chemotherapeutic agent in the absence of an anthracycline derivative.  The challenged claims of the ’549 patent are directed to a method of treating cancers characterized by the overexpression of ErbB2 by administering a combination of an anti-ErbB2 antibody, a taxoid chemotherapeutic agent, and another therapeutic agent which may be another antibody, a growth inhibitory agent, or a cytokine.

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 IPR2017-00731 (involving the ’441 patent), IPR2017-00737 (involving the ’549 patent) and IRP2017-00739 (also involving the ’549 patent). 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. The only real party-in-interest identified by the Patent Owner is Genentech, Inc.

This is not the first petition for IPR filed by Hospira regarding trastuzumab.  In September 2016, Hospira filed a petition for IPR on U.S. Patent No. 7,807,799.  Mylan has also filed a petition regarding Herceptin® (trastuzumab).  The PTAB has not yet issued a decision on institution in any of these proceedings.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.