Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”) related to Genentech’s Herceptin® (trastuzumab). Celltrion has announced that it plans to submit an application for a trastuzumab biosimilar product to the FDA this year (possibly as early as next month), as reported in this post. Celltrion has filed IPR petitions challenging certain claims of other patents related to Herceptin® (trastuzumab) as discussed here and here.
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 new proceedings are IPR2017-01373 and IPR2017-01374. The real parties-in-interest identified for Petitioner are Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH. The ’213 patent, entitled “Method for Making Humanized Antibodies” issued on June 18, 2002. Genentech has publicly stated that the technology claimed by the ’213 was used in the development of Herceptin® (trastuzumab), as well as several other products.
Hospira has also filed IPR petitions challenging patents related to Herceptin®, as we reported earlier this year here and here. A complete list of IPRs related to trastuzumab and other proposed biosimilar products can be found in RFEM’s IPR Dashboard.
Mylan is also seeking approval of a trastuzumab biosimilar. In March, Mylan and Biocon announced that they had entered into a global settlement and licensing agreement with Genentech and Roche regarding Mylan’s trastuzmab biosimilar, as discussed in this post.