On December 19, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported several updates to its broad intellectual property portfolio relating to the use of chimeric antigen receptors (CARs) to harness the power of a patient’s immune cells (Press release, Kite Pharma, DEC 19, 2016, View Source [SID1234517123]). These updates include a recent U.S. Patent and Trademark Office (USPTO) decision concerning one narrow patent related to CAR products containing a pre-specified CD28 costimulatory domain, and a recent favorable result in a challenge at the USPTO to one of Kite’s important CAR-T patents, U.S. Patent Number 6,319,494.

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In August 2015, Kite preemptively filed a petition with the U.S. Patent and Trademark Office (USPTO) to institute an inter partes review (IPR) of U.S. Patent No. 7,446,190 owned by Sloan Kettering Institute for Cancer Research and licensed by Juno Therapeutics, Inc. The IPR was aimed at invalidating the ‘190 patent, which has a narrow scope directed to CAR products containing a pre-specified CD28 costimulatory domain. The USPTO’s recent ruling in this matter did not revoke the patent. However, Kite continues to believe the patent to be invalid and plans to appeal the USPTO decision to the U.S. Court of Appeals for the Federal Circuit. This patent does not have any counterpart patents outside of the United States.

The USPTO’s decision will have no impact on the timing of the rolling submission or review of the Biologics License Application for Kite’s lead product candidate, axicabtagene ciloleucel (KTE-C19), a potentially lifesaving investigational therapy that has demonstrated the most advanced utilization of the CD28 costimulatory domain in a CAR-T therapy to date. Axicabtagene ciloleucel is currently being developed for the treatment of CD19 positive B cell malignancies, including non-Hodgkin lymphoma and acute lymphoblastic leukemia.

Separately, Kite recently defeated an anonymous challenge filed against U.S. Patent Number 6,319,494, developed by Kite’s Senior Vice President of Discovery Research, Margo Roberts, Ph.D. and colleagues. This patent, which covers methods for treating a viral disease or malignancy using modified T cells that contain single-chain variable fragment (scFv) binding elements and other key CAR-T features, impacts multiple competitor CAR-T cell product candidates under development.

In addition to the Roberts patent, Kite’s growing intellectual property portfolio encompasses more than 150 patent assets including an exclusive license to U.S. Patent No. 7,741,465, a leading and widely significant patent directed to CAR-T constructs, developed by Dr. Zelig Eshhar and colleagues. This patent, currently under reexam by the USPTO, potentially impacts CAR-T products under development by multiple Kite competitors.