Behind all the cell and gene therapy headlines—approvals, manufacturing snafus, new data—two of the industry’s biggest players have been battling over a single CAR-T patent.
Juno Therapeutics, now part of Bristol-Myers Squibb, is hoping to prove that Gilead’s Kite Pharma unit is infringing a patent with its blood cancer therapy Yescarta. And the two sides got their chance to air their arguments in court this week.
In its lawsuit, Juno says Kite Pharma “copied and is now commercializing" a cancer therapy that incorporates technology invented and patented by scientists at Sloan Kettering. Juno exclusively licensed the '190 patent from Sloan Kettering and the Memorial Sloan Kettering Cancer Center in November 2013, the lawsuit claims.
Before that license deal, back in 2007, a scientific collaborator with Kite named Steven Rosenberg posed some questions to Michel Sadelain, one of the inventors of the ‘190 patent, the suit says. Based on Rosenberg's position as a National Cancer Institute researcher, Sadelain referred his fellow scientist to a 2002 journal article that discussed the patent, the lawsuit suit says.
Rosenberg and other Kite collaborators then "copied the chimeric T cell receptor construct utilized in its Yescarta therapy from the work of the ’190 Patent inventors," the suit says. The Kite team has even acknowledged the work of Sadelain and others on numerous occasions, according to Juno.
In a report prepared for the trial, Juno's damages expert, economist Ryan Sullivan, said Kite "tried but failed" to license, design around and develop an alternative to the technology. By reaching the market first, Kite boosted its market share, sales and loyalty with doctors and patients, he found.
The economist calculated that Kite would've paid Juno royalties of $167 million on sales since approval. Upfront payment estimates came in at a wide range, with $243 million and $930 million proposed in one court doc.
Kite sought to exclude the economist's testimony on numerous grounds, including by arguing his logic was inconsistent and that he submitted an amended report just before the trial.
Kite and Juno didn’t immediately respond to requests for comment.
Further, Kite tried to challenge the '190 patent with an inter partes review at the U.S. Patent & Trademark Office, but fell short in that attempt. In a 2016 press release, Juno claimed a victory in that case and said it would sue Kite over KTE-C19, which eventually became Yescarta.
Following a series of deals, Juno is now part of Bristol-Myers Squibb. Celgene first bought the CAR-T focused biotech for $9 billion, and BMS just closed its massive Celgene merger. Kite Pharma joined Gilead under a 2017 buyout.
CAR-T drugs generated intense interest in 2017 after Novartis’ first-ever approval for Kymriah and Gilead’s Yescarta nod. The meds use a patient’s own T cells, which the teams extract and re-engineer to attack cancer. The drugs carry high price tags and are intended to be one-time cures.
Before its world-first CAR-T approval, Novartis itself settled a patent dispute with Juno. Novartis handed over $12.25 million plus future milestones and royalties on CAR-T meds, while Juno agreed to drop its 2012 lawsuit.
While Gilead and Novartis have each secured FDA nods for their respective CAR-T drugs, Juno had to abandon its lead drug due to trial deaths. The company now has various candidates in phase 1 and 2, according to its pipeline.