Mylan Obtains Global License to Trastuzumab in IPR Settlement


Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab).  As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos.  6,407,213 and 6,331,415.

The license pertains to commercialization rights in all countries except Japan, Brazil, and Mexico.  In the U.S., Mylan’s aBLA for a trastuzumab biosimilar is currently under review by the FDA; with this settlement, Mylan anticipates being the first company to launch a biosimilar to Herceptin® in the U.S. No launch date was disclosed.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:


Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.