What Does Mylan Settling Over Patents For Herceptin Mean For The Company Now?

Pharmaceutical giant Mylan announced on Monday that the company has settled with Genentech Inc. (a unit of Roche Holding AG), and F. Hoffmann-La Roche (ROG) over patents for Herceptin.

Herceptin is Mylan’s brand name for trastuzumab which is used to treat certain HER2-positive breast cancers. The company currently markets its trastuzumab products in 14 emerging markets and has submissions pending in European Union.

As part of the settlement, Mylan agreed to withdraw its pending Inter Partes Review challenges against two U.S. Genentech patents. The settlement also means that Mylan will now have global licenses for trastuzumab and they cover all countries except Japan, Brazil and Mexico.

Mylan commented, “The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world.”

It was in January that the U.S. Food and Drug Administration accepted Mylan’s biologics license application for MYL-1401O.

MYL-14010 is a proposed biosimilar to branded trastuzumab and If approved, MYL-1401O could be the first biosimilar trastuzumab in the U.S. It is among the six biologic products co-developed by Mylan and Biocon Ltd. for the global market.

Genentech wasn’t so pleased and a spokesperson said in an e-mailed statement, “We plan to continue to defend the patents protecting Herceptin as we do for all of our medicines.”

“Patients’ interests have always been front-and-center for us. We believe in a transparent and scientific approach to the assessment, approval, and use of biosimilars that supports doctor and patient choice.”

Disclaimer: We have no position in Mylan Br (NASDAQ: MYL) and have not been compensated for this article.