Under the terms of the settlement, Novartis agreed to make payments to Juno including an initial payment of $12.25m (€11.2m), future milestone payments, and mid-single digit royalties from US net sales of product candidates related to the disputed contract and patent claims, as well as a low double digit percentage of the royalties Novartis will pay to Penn for global net sales for the product candidates.
Both Juno and Novartis are developing cell-based cancer immunotherapies based on CAR-T cell receptor technologies that genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors.
Payments received by Juno will be shared with St. Jude under the terms of their license agreement, which also agreed to dismiss all claims in the relevant legal proceedings.
The litigation began in 2012 in connection with a contract dispute between St. Jude and Penn and was broadened in March 2013 to include a dispute concerning St. Jude’s US Patent, titled "Chimeric Receptors with 4-1BB Stimulatory Signaling Domain." In August 2012, Novartis and Penn formed a broad-based R&D alliance to advance novel T-cell immunotherapies to treat cancer.
The settlement could be an indication that disputes over CAR-T (chimeric antigen receptor and high-affinity T cell receptor technologies) therapy patents will be decided with royalties and further payments.
“We are pleased by this settlement, which benefits patients by allowing each party to advance its promising cancer immunotherapies and rewards the investigators on whose insights those developments are based,” said Juno CEO, Hans Bishop.
The settlement comes as Juno added a new biomanufacturing facility in Bothell, Washington, which, along with its undisclosed CMO partners, will help to provide investigational product for clinical trials and commercialization.