In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy

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Chimeric antigen receptor T-cells (also known as CAR T-cells) are T-cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy. In recent years CAR-T cell therapy has emerged as an important new modality of cancer treatment, particularly for blood-borne cancers like leukemia. As would be expected, important advances in the development of CAR T-cell therapy have been the subject of extensive patenting and licensing activity. Juno v. Kite, a recent decision of the Court of Appeals of the Federal Circuit striking down a foundational CAR T-cell therapy patent, has raised serious questions as to the validity in general of patents relating to CAR T-cell therapy. Beyond that, the decision heightens concerns as to the validity of groundbreaking biotech patents in general, such as the patents. This article provides a review of CAR T-cell technology and FDA-approved CAR therapies, including a look at some of the early patenting activity in the field. It then summarize the facts leading up to Juno, and the decision itself. This is followed by some commentary on the decision, including the Federal Circuit’s apparent failure to take adequate account of the claimed invention’s point of novelty and pioneering status. This commentary includes a discussion of some other recent patent disputes involving CAR T-cell technology, including a look at the claims in the patents, the perceived validity of which might have been put into question by the Federal Circuit’s decision in Juno.

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Biotechnology Law Report