WolfTracks Logo (15)

Following all of the latest IP developments in life sciences.

 

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

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.

Read More »