Mylan Settles With Genentech Over Patents for Breast Cancer Drug

Pharmaceutical company Mylan (MYL) said Monday it has settled with Genentech Inc. and F. Hoffmann-La Roche  (ROG) over patents for Herceptin, its brand name for trastuzumab, a treatment for certain HER2-positive breast cancers.

The settlement provides Mylan with global licenses for its trastuzumab product. The licenses cover all countries except Japan, Brazil and Mexico.

When Mylan will begin marketing trastuzumab is unclear because the license effective dates are confidential.

"The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world," Mylan said in the news release.

Mylan shares were trading at $42.93 on Monday, down 1%.

In an e-mailed statement, a Genentech spokesperson said, "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," the spokesperson said.

As part of the settlement, Mylan agreed to withdraw its pending Inter Partes Review challenges against two U.S. Genentech patents. Genentech is a unit of Roche Holding AG.

Other terms and conditions of the settlement and license pact were not disclosed.

News of the settlement comes after the U.S. Food and Drug Administration in January accepted Mylan's biologics license application for MYL-1401O, a proposed biosimilar to branded trastuzumab. If approved, MYL-1401O could be the first biosimilar trastuzumab in the U.S.

The proposed biosimilar trastuzumab is among the six biologic products co-developed by Mylan and Biocon Ltd. for the global market.

Mylan, whose principal executive offices are in Hertfordshire, England and global headquarters are in Canonsburg, Pa., markets its trastuzumab products in 14 emerging markets. The company also has submissions pending in European Union, as well as in several additional emerging markets.

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