Replies to post #205837 on Biotech Values

[DewDiligence]

MYL, Roche settle Herceptin patent case on undisclosed terms, allowing MYL to proceed with applications for Herceptin FoBs in US and other countries:

http://finance.yahoo.com/news/mylan-announces-global-settlement-license-120000482.html

…Mylan 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.

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 U.S. Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S.

All other terms and conditions of the settlement and license agreement are confidential.

Herceptin is one of the FoBs on which MYL is partnered with India’s Biocon (#msg-72421544), and it is unrelated to the MNTA-MYL collaboration on six FoBs (#msg-119689602).

MYL/Biocon submitted the 351(k) application for their Herceptin Fob in Nov 2016 (#msg-126393675), and today’s settlement presumably arose from the exchange of information between MYL and Roche during the BPCIA “patent dance.”

[DewDiligence]

FDA approves Ogivri (Herceptin FoB) from MYL/Biocon:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm

Note: MYL has two global FoB partnerships: one with Biocon (#msg-39119393) and one with MNTA (#msg-119689602).