Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 16, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,807,799 (“the ’799 patent”) related to Genentech’s Herceptin® (trastuzumab). On March 15, 2017, the PTAB issued a decision instituting review of claims 1–3 and 5–11 of the ’799 patent. The ’799 patent is generally directed to methods for reducing leaching of protein A during protein A affinity chromatography by reducing temperature or pH, or by adding protease inhibitors. The challenged claims are specific to a method of purifying a protein that comprises a CH2/CH3 region, including an antibody, and certain claims specify a method of purifying 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 IPR2016-01837. The real party-in-interest identified for Petitioner is Hospira. 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 real party-in-interest identified for Patent Owner is Genentech, Inc. (“Genentech”). Hospira has several petitions for IPR pending for other patents related to trastuzumab. Institution decision on Hospira’s other petitions are expected in July and August. A complete list of IPRs related to trastuzumab and other proposed biosimilars can be found in IPR Dashboard. We will continue to provide updates as these cases progress.
In related news, Mylan announced earlier this week that it reached a global settlement agreement with Roche and Genentech that will provide Mylan with global licenses for its trastuzumab biosimilar as reported in an update to this post on Monday. According to the press release, Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand, and in the European Free Trade Association countries, and Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world. Mylan and Biocon announced in November 2016 that Mylan had submitted an application for a trastuzumab biosimilar to the FDA. The BSUFA date (FDA’s target goal) for Mylan’s trastuzumab application is September 3, 2017.