Bristol Myers Squibb takes its CAR-T patent case to US' top court in bid to revive $1.2B verdict against Gilead

The high-stakes patent war between CAR-T giants Gilead Sciences and Bristol Myers Squibb isn’t over just yet. After an appeals court overturned a $1.2 billion verdict against Gilead, BMS is asking the United States’ top court to take another look. 

In a petition to the Supreme Court, Bristol’s Juno Therapeutics says the restrictive patent stance taken by the U.S. Court of Appeals for the Federal Circuit has been “devastating for innovation." By requiring inventors to possess the "full scope" of their invention during the patenting process, the appeals court has forced them to meet an "impossible" test, the petitioners argue.

The case stems back to 2017, when Juno sued and alleged that 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.   

BMS and MSK prevailed in a 2019 jury trial and won a $752 million verdict, which a judge later expanded to $1.2 billion after ruling Kite’s infringement was “willful.”

But the Gilead unit was able to get the decision reversed in appeals in August 2021. In overturning the $1.2 billion verdict, the appeals court said the CAR-T invention at issue was not supported by an adequate written description. Gilead had said that the patent was invalid because it covered “millions of billions of” potential single-chain antibody variable fragment candidates without disclosing their structure or which ones might work.

In their SCOTUS petition, Juno and the Sloan Kettering Institute for Cancer Research argued the Federal Circuit decision burdens "straightforward" patent law with "convoluted, judicially crafted requirements that the patent show the inventor ‘possessed the full scope of the claimed invention,’ including all ‘known and unknown’ variations of individual components. 

“The Federal Circuit’s approach contravenes the plain statutory text and is erasing vast swaths of patents for failing to satisfy a disclosure standard found nowhere in the statute,” the petitioners wrote. “And because the Federal Circuit has exclusive jurisdiction over patent appeals, ... no other court of appeals will be able to address this question.” 

It remains to be seen whether the Supreme Court will take up the case. As it stands, Gilead is not on the hook for the large infringement verdict.

Bristol Myers Squibb acquired Juno for $9 billion in 2018. For its part, Gilead got into the CAR-T game with its $11.9 billion purchase of Kite in 2017.