With Kite’s PDUFA date looming, federal court tosses Juno’s CAR-T patent challenge — for now
Juno Therapeutics $JUNO was spoiling to battle rival CAR-T developer Kite Pharma $KITE in court over claims that its lead therapy had infringed on its patent. But today Juno says that the suit was thrown out after the U.S. District Court for the District of Delaware determined that it lacked jurisdiction until after an approval occurs.
According to Juno, the court determined that there was no evidence that an FDA approval of Kite’s therapy – axicabtagene ciloleucel, or KTE-C19 – “is imminent or even certain.”
So the suit was dismissed.
Juno’s statement comes as Kite faces a PDUFA date of November 29 for its marketing application, about two months behind the leader, Novartis. Kite, meanwhile, has been building a commercial team and honing its manufacturing speed to be ready for marketing once the FDA makes a decision, gambling that their promising 6-month data will win over regulators ready to field a new class of cancer therapy in the US.
Kite will take the win. The company put out a statement this morning noting:
We are pleased with the Court’s decision, which confirmed our position that the Juno/MSK lawsuit was contrary to the Safe Harbor provisions of the Patent Act. We continue to believe that the ‘190 patent is invalid and will defend our rights in any future patent disputes that might arise.
This ruling is an important next step as we continue to focus on critical milestones in 2017.
Juno saw its lead CAR-T effort derail after several patients were killed in the pivotal study by cerebral edema. The patent in question, interestingly, covers a CAR-T using a CD28 costimulatory domain, which Juno has now turned from in favor of 4-1BB as researchers try to determine which is the safest, most reliable approach.
Kite had attempted to invalidate the patent but was slapped down by the patent office late last year. It’s appealing the decision.