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AbbVie's Imbruvica patent dispute with Sandoz to face US Patent Office review

The U.S. Patent Office's Patent Trial and Appeal Board will review Sandoz Inc.'s challenge of one of AbbVie Inc.'s patents on the blood cancer drug Imbruvica.

Sandoz, Novartis AG's biosimilar and generic-drug development arm, filed a petition arguing against the validity of AbbVie's '604 patent on Imbruvica, or ibrutinib, in March. The Patent Trial and Appeal Board instituted a review Sept. 26 to evaluate the patent's validity. Sandoz is seeking to create a generic version of Imbruvica.

The '604 patent, held by Imbruvica manufacturer and AbbVie subsidiary Pharmacyclics LLC, specifically covers the drug's treatment of chronic graft versus host disease, or GVHD, a condition that can occur after stem cell or bone marrow transplant that causes the donated cells or bone marrow to attack the body.

According to AbbVie's preliminary response to Sandoz's petition, published June 28, Imbruvica is "the first and only" approved treatment for chronic GVHD.

The patent granted Imbruvica's treatment of chronic GVHD market exclusivity through October 2034, according to the U.S. Food and Drug Administration Orange Book.

Imbruvica, approved for multiple blood cancers in addition to chronic GVHD, is an integral revenue driver in AbbVie's product portfolio, especially as the North Chicago, Ill.-based company braces for biosimilar competition against its flagship immunology drug Humira.