On March 10, 2017, the PTAB published a decision terminating the proceedings in IPR2016-1693 and IPR2016-1694 because the parties have reached a settlement. Mylan filed two petitions requesting inter partes review (“IPR”) of certain claims (1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69 and 71-81) of U.S. Patent No. 6,407,213 (“the ’213 patent”) issued to Carter, et al., entitled “Method for Making Humanized Antibodies.” Although the ’213 does not claim a specific product, 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.
Mylan and Biocon announced in November 2016 that Mylan had submitted an application for a trastuzumab biosimilar product to the FDA. 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 settlement was reached shortly before a decision on institution was expected from the PTAB. Mylan filed both petitions on the ’213 patent on August 30, 2016. The patent owner filed its preliminary responses on December 16, 2016, and the PTAB would have issued a decision on institution no later than March 16, 2017.
The real parties-in-interest identified for Petitioner are Mylan Pharmaceuticals Inc.,
Mylan Inc., Mylan GmbH and Biocon Ltd. Petitioner also identified Mylan N.V. out of an abundance of caution, but made no admission that Mylan N.V. is a real party-in-interest. The only real party-in-interest identified for Patent Owner is Genentech, Inc. Although these two IPRs have been terminated, there are several petitions pending on other patents related to Herceptin® (trastuzumab). A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.
3-13-17 UPDATE: Mylan announced on March 13, 2017 that the settlement of the ‘213 patent dispute is part of a broader settlement agreement with Roche and Genenetech that will provide Mylan with global licenses for its trastuzumab product. As part of the settlement, Mylan will also withdraw its IPR challenge to U.S. Patent No. 6,331,415.
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 Union and European Free Trade Association countries, and Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world. The BSUFA date (FDA’s target goal ) for Mylan’s trastuzumab application is September 3, 2017.