Supreme Court tosses Bristol Myers' bid to revive $1.2B CAR-T case against Gilead
In the latest setback for Bristol Myers Squibb in a years-long legal tussle with Gilead over a CAR-T patent, the Supreme Court of the United States has declined to hear its petition to revive a $1.2 billion verdict.
At its core, Bristol Myers claimed that Gilead’s pioneering CAR-T, Yescarta, infringed on its patent relating to the composition of a chimeric antigen receptor — the CAR in CAR-T — that can be genetically engineered into a T cell.
While a federal court had sided with Bristol Myers and ordered Gilead to pay $1.2 billion in damages, an appeals court reversed that ruling on the grounds that the patent in question was invalid because its “written description” didn’t cover the full scope of the claimed invention.
The Supreme Court case was a bid to reinstate that award.
In its petition, Bristol Myers argued that in invalidating its patent, the federal circuit was “demanding the impossible” as it would require inventors to outline an “essentially infinite number” of potential variations in a patent. The decision, it added, “represents both bad law and bad policy” and “may threaten innovation.”
Neither Bristol Myers Squibb nor Gilead was the original holder of the disputed patent or drug. The central patent, often referred to as ‘190 in court documents, originated from Memorial Sloan Kettering Cancer Center, which exclusively licensed it to Juno Therapeutics. Juno first mounted the legal challenge in 2017 before Yescarta’s approval — and before it was acquired by Celgene; Celgene, in turn, was acquired by Bristol Myers Squibb. Gilead inherited the case when it bought Kite Pharma.
Bristol Myers has some catching up to do with Gilead on the market, earning the first FDA approval for Breyanzi, Juno’s CD19-targeted CAR-T, for large B-cell lymphoma in 2021 — more than three years after Yescarta first crossed the finish line. Gilead also got a two-month headstart on expanding the label to include the second-line setting, which it said could double the market size.
Gilead recorded $823 million in Yescarta sales from the first nine months of 2022, while Bristol Myers reported $127 million in Breyanzi sales over the same period.