Mylan N.V. announced that the company has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product.
The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico.
In addition to eliminating any legal uncertainty over the launch of Mylan’s trastuzumab, the settlement eliminates further patent litigation expenses associated with Genentech and Roche. Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement.
Following this settlement and the recent acceptance of Mylan’s application for its proposed biosimilar trastuzumab with the FDA, Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S. Mylan’s proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. 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. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
In the U.S., Mylan’s Biologics License Application for proposed biosimilar trastuzumab is under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act is Sept. 3.
Mylan markets its trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the U.S.
