Kite Flies Away With CAR-T Patent Challenge Win Based On Written Description Battle

• Published date: 06 December 2021
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Wolf, Greenfield & Sacks, P.C.
• Author: Ms Dhara A. Patel

In Juno Therapeutics v. Kite Pharma, the Court of Appeals for the Federal Circuit (CAFC) reversed a $1.2 billion dollar judgment to Juno, finding that Juno's asserted claims, which they alleged were infringed by Kite's CAR-T therapy YESCARTA' (axicabtagene ciloleucel), lacked written description. The decision follows a line of cases involving antibodies and written description, extending recent antibody-related jurisprudence into the realm of cell-based immunotherapies, such as chimeric antigen receptor (CAR) T cells. The court determined that while the binding element of CARs (in this case, an scFv) and methods of making them were generally known in the art, the scope of the claimed CARs was too vast to be sufficiently supported by the limited number of exemplary binding elements in the specification, as well as the absence of common structural features defining the claimed genus. The decision means that those seeking claims that aim to broadly protect CARs with functional definitions will face significant challenges based on written description.

Background

Kite manufactures YESCARTA', a CD19-directed CAR-T cell-based therapy that was approved by the US Food and Drug Administration (FDA) in 2017 for certain B-cell malignancies and gained rapid adoption, providing revenues of more than $264 million in 2018 and double that in 2019. Treatment with YESCARTA' involves removing a patient's own T cells and genetically modifying them to express a CAR which causes the T cells, when returned to the patient's blood, to specifically target and kill the desired cancer cells. The CAR includes three components: an intracellular signaling domain, a co-stimulatory domain, and an extracellular binding element (e.g., an scFv) that targets the T cell to the desired cancer cells by binding to a specific marker on the target cells (e.g., an FMC63 ScFv targeting CD19).

Juno sued Kite for infringement of claims in US 7,446,190 (the '190 patent) in district court. Kite filed counterclaims seeking declaratory judgments of noninfringement and invalidity of the '190 patent. The jury disagreed with Kite, finding that the claims were not invalid for lacking written description and enablement, and found that Kite willfully infringed the '190 patent, awarding Juno $585 million in damages. In post-trial motions, Kite unsuccessfully moved for JMOL, asserting that Juno's claims lacked written description and enablement. In the end, the district court agreed with the jury and awarded $1.2 billion in damages. Kite appealed, arguing that...