SCOTUS rejects BMS bid in Gilead CAR-T patent fight

Nov. 8, 2022

The U.S. Supreme Court has rejected a bid by Bristol Myers Squibb's Juno Therapeutics to reinstate a $1.2 billion award it won in its patent fight with Gilead Sciences' Kite Pharma over a CAR-T lymphoma drug.

At the center of high stakes patent battle is Kite's biologic drug Yescarta, which became the first CAR-T therapy approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma in 2017.

Upon the drug's approval, BMS' Juno and Sloan Kettering Institute for Cancer Research sued Kite in federal court, accusing it of copying the CAR-T technology that the institute licenses to Juno. In 2019, a jury determined that BMS was entitled to $752 million over the patent infringement, an amount that would later be increased to $1.2 billion by a judge.

In 2021, Gilead took the case to appeals court and was able to get the verdict overturned on grounds that the “CAR-T invention was not supported by the adequate description.” Because CAR-T therapy is a technology applicable to a wide range of diseases and therapeutic approaches, Gilead argued that the patent didn’t outline or disclose the structure or location of single-chain antibody targets. The court agreed, stating that “the ’190 patent does not disclose representative species or common structural features to allow a person of ordinary skill in the art to distinguish between scFvs that achieve the claimed function and those that do not."

Back in June, BMS petitioned the Supreme Court to take a look at the case.

Following the court's rebuff of Juno's petition, a BMS spokesperson told Reuters that it had sought high-court review to "restore the proper balance to our innovation economy by reaffirming the existing patent statute, which requires only a 'written description of the invention' that is adequate to inform skilled workers how to make and use it."