Gilead dodges Supreme Court review—and a $1.2B fine—in CAR-T patent feud with Bristol Myers

After years of courtroom drama and amid a market clash, Bristol Myers Squibb has failed to open a new legal front in its cell therapy war with Gilead Sciences.

Monday, the U.S. Supreme Court declined to hear BMS’ case to resurrect a $1.2 billion win in the five-year dispute over a BMS CAR-T patent and Gilead’s cell therapy Yescarta.

The legal rebuff comes a little more than a year after a federal appeals court overturned the massive fine against Gilead’s Kite Pharma for allegedly copying and commercializing patented CAR-T technology. At the time, a three-judge panel ruled an earlier verdict favoring BMS’ subsidiary Juno Therapeutics was “not supported by substantial evidence.”

A Gilead spokesperson said the Supreme Court's decision "effectively ended" the dispute, noting that the company was happy with the result.

BMS, for its part, said it sought the high court’s review to “restore the proper balance to our innovation economy." The company "will continue to work to correct this imbalance and the erroneous standard that has been set by the Federal Circuit," a BMS spokesperson said.

“Naturally, we would have preferred a different decision from the Supreme Court," she added.

Gilead's Yescarta, along with BMS' Breyanzi, are approved in the U.S. to treat certain patients with large B-cell lymphoma. 

The intellectual property imbroglio originated with Juno and Sloan Kettering Institute for Cancer Research, which together sued Kite in 2017. The plaintiffs claimed Kite copied research from Sloan Kettering to advance its CAR-T work and eventually snare approval for the cancer cell therapy Yescarta. Back in 2013, Juno exclusively licensed a patent from Sloan Kettering and the Memorial Sloan Kettering Cancer Center centered on the technology.

The partners brought their case against Kite in federal court in Los Angeles. After a two-week trial in 2019, jurors ordered Gilead's Kite to pay $752 million to Juno and Sloan Kettering.

Kite’s attempts to overturn that loss fell on deaf ears the following year, while Juno—in its own post-trial motion—characterized its rival’s alleged infringement as “egregious” and “willful.”

In April 2020, Judge Philip Gutierrez concurred that Kite’s “infringement … [had] been willful,” raising BMS’ award to $1.2 billion.

As for the motivation behind the 2021 about-face reversing BMS' win, a trio of appeal judges later agreed with Kite that the relevant MSK patent licensed to Juno was invalid for lack of written description.

The Supreme Court's rejection shouldn't come as a total shock, as the justices rarely take up patent cases on petition, intellectual property lawyer Ronald Cahill explained in a recent interview. 

That said, the high court made a rare exception last week when it agreed to take up Amgen's bid to revive a pair of patents on its cholesterol drug Repatha. In that case, Amgen has been duking it out in court with Sanofi and Regeneron since 2014, claiming infringement by the partners’ rival PCSK9 cholesterol drug Praluent.