Celltrion, Inc. (“Celltrion”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on February 21, 2017 for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab). The challenged claims of the ’897 patent are directed to methods for treating patients with nonmetastatic HER2-positive breast cancer by administering anthracycline/cyclophos-phamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab.
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 proceeding is IPR2017-00959. The real parties-in-interest identified for Petitioner are Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH.
In addition to the four petitions filed by Celltrion for the ’897 patent, several other petitions for IPRs on other patents related to Herceptin® have been filed with the PTAB by Hospira (discussed here and here) and Mylan. A complete list of IPRs can be found in RFEM’s IPR Dashboard.
We will continue to provide updates as these cases progress.