In quick succession, Gilead Sciences has not only lost an early attempt to overturn a massive CAR-T patent infringement verdict, but now a judge has also ordered hundreds of millions of enhanced damages for plaintiff Bristol Myers Squibb.
Judge Philip Gutierrez in California expanded the total verdict to $1.2 billion from a prior award of $752 million. Bristol’s Juno Therapeutics unit, which it picked up in its recent Celgene deal, has been battling with Gilead’s Kite Pharma over research that went into the cancer drug Yescarta and prevailed following a December trial. Gilead now plans to appeal.
Juno originally sued in 2017, arguing Kite “copied and is now commercializing" CAR-T 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 said.
Juno alleged Kite scientific collaborators approached Sloan Kettering researchers and later lifted key work that led to the development of Yescarta.
Gilead purchased Kite in 2017, and the drug won FDA approval shortly thereafter. The medicine generated $456 million last year, and those sales were part of the court’s damages calculation. Celgene bought Juno in 2018, and that company has since been acquired by BMS.
Gutierrez wrote this week that Kite’s “infringement … has been willful.” The patent’s claims are not invalid as the company had argued, the judge wrote.
The verdict includes a $585 million upfront payment, plus $193 million in royalties based on Yescarta sales through Dec. 12. Gutierrez also ordered Kite to pay $32.8 million in pre-judgment interest and “enhanced damages” of more than $389 million, taking the total to about $1.2 billion.
BMS is also owed post-judgment interest based on how long it takes Gilead to pay, the judge wrote. He further ordered Kite to pay a running royalty of 27.6% of its Yescarta sales, or “any other therapy using the same infringing CAR” through the expiration of Juno’s patent in 2024.
Gilead is "steadfast in our opinion that Sloan Kettering’s patent is not infringed and is invalid," a spokesman said.
"Given that Kite independently developed Yescarta and assumed all of the risk in its discovery and development, we do not believe Sloan Kettering and Juno are entitled to any level of damages, much less punitive damages," he added. "We look forward to addressing these issues on appeal."
The decision marks a loss for Gilead and its CAR-T ambitions. The company has been looking to grow in cancer and made a big splash with its $11.9 billion Kite Pharma buyout back in 2017, but the deal has yet to yield close to what the drugmaker paid.
Following its Kite buyout, Gilead is again looking for growth avenues as a big patent loss nears. The company recently bought cancer biotech Forty Seven for $4.9 billion, and it's also heavily involved in studying remdesivir in COVID-19, with data expected soon. The company has said it doesn't plan to make a business out of the potential COVID-19 therapy, though.