Novartis and Juno settle CAR-T patent dispute

Novartis and Juno Therapeutics have settled a patent dispute centring on CAR-T therapies – one of the most anticipated research areas in the hot topic of cancer immunotherapy.

The agreement gives Juno and Novartis free rein to advance their CAR-T (chimeric antigen receptor T-cell) treatments, which focus on engineering a patient’s own immune cells to be more effective at identifying and destroying malignant cells.

Along with checkpoint inhibitors such as Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab), CAR-T therapies are considered to be one of the most promising new approaches in immuno-oncology.

The settlement will see Novartis and its partner – the University of Pennsylvania – pay $12.5m to Juno and St Jude Children’s Research Hospital. Novartis will also have to hand over undisclosed milestone payments as well as royalties on all sales of CAR-T-based therapies in the US.

St Jude and UPenn had been locked in a legal dispute over intellectual property and a contract related to the technology since 2012, but this has now been dropped. Novartis and Juno got embroiled into the lawsuit after signing licensing deals with their academic partners.

UPenn had been trying to invalidate a St Jude patent while the latter claimed violations of the terms of a material transfer agreement, according to news reports.

“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 chief executive Hans Bishop in a statement.

Novartis and Juno are considered the leaders in the emerging category. Novartis has a therapy called CTL019 in Phase II testing for acute lymphoblastic leukaemia, while Juno’s lead candidate JCAR015 is in Phase I for the same indication. Both therapies have been awarded breakthrough status by the US Food and Drug Administration (FDA).

Other pharma companies have been eagerly signing deals to get a slice of the action, with Merck KGaA subsidiary Merck Serono signing a $941 million deal with Intrexon for CAR-T therapies last month, Amgen agreeing a $1 billion collaboration with Kite Pharma in January and Johnson & Johnson licensing a CAR-T candidate from MacroGenics for $625 million at the end of 2014.

A UK company called Autolus was recently spun out of University College London (UCL) with a £30 million warchest to develop CAR-T-based therapies.

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