FDAnews Drug Daily Bulletin

PTO Grants Additional Reviews of Herceptin Patents after Hospira Challenges

Aug. 4, 2017

The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by Hospira.

The three patents cover the treatment and dosing of certain genetic variants of breast cancer using Herceptin (trastuzumab). Last year, Herceptin earned more than $7 billion for Genentech and its parent company, Roche, with the U.S. accounting for 36 percent of sales.

Under the PTO’s process, the PTAB must conclude that a petitioner established a reasonable likelihood of winning before instituting inter partes review. Genentech’s responses are due before Oct. 30, and oral arguments, if requested, must begin before April 12, 2018.

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