BMS takes Gilead $1.2B CAR-T patent case to SCOTUS

June 17, 2022

Bristol Myers Squib is not giving up yet on its quest to cash in on $1.2 billion from Gilead over CAR-T technology patent infringement.

Following an overturned $1.2 billion court of appeals verdict, BMS is now lobbying to take the case to the Supreme Court. In its petition, BMS argues that “the consequences of this judicial embroidery have been devastating for innovation. It has led the Federal Circuit to invalidate numerous patents by demanding the impossible.”

This patent tug-of-war started in 2017 over allegations that Kite Therapeutics, a Gilead company, had copied and commercialized CAR-T technology developed by researchers at Sloan Kettering and licensed exclusively to Juno Therapeutics, a BMS company.

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.

Then, surprisingly, in 2021, Gilead took the case to the 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. Accordingly, we reverse.”

In their recent petition, BMS adds that in biological sciences, possession tests applicable to other patent litigations might not work and can be impossible to meet but unless the Supreme Court looks at the case, Gilead won’t have to pay.

As the cell and gene therapy industry booms, similar patent litigations between pharma players could become more common. To learn more about other issues impacting this promising new field, read our latest cover story.