Gilead Sciences and Bristol Myers Squibb aren’t just fighting the CAR-T war in the clinic around their efficacy but also in court over patents. The latest winner? Gilead.
Thursday, a federal appeals court overturned a $1.2 billion fine on Gilead subsidiary Kite Pharma that was previously granted to Bristol Myers’ Juno Therapeutics unit and Memorial Sloan Kettering Cancer Center. The legal tussle focuses on whether Gilead’s CD19-targeted CAR-T therapy Yescarta infringed upon a Juno patent that’s licensed from MSK.
The three-judge panel found that a previous jury verdict validating the patent at question was “not supported by substantial evidence.”Juno brought the patent infringement suit against Kite in 2017, alleging that Kite’s scientific collaborators copied from MSK researchers to make Yescarta.
Bristol Myers said in an email to Fierce Pharma that it disagrees with the Federal Circuit’s decision and that it intends to seek a review of the verdict.
A jury in California previously sided with BMS and MSK and awarded them $778 million in 2019. U.S. District Judge Philip Gutierrez later raised the amount to $1.2 billion in 2020, noting that Kite’s infringement “has been willful.”
Kite appealed. The Gilead subsidiary’s argument rests on the relevant ’190 patent’s written description. It centers on the single-chain antibody variable fragment (scFv) that can recognize and bind to specific tumor antigens for a CAR-T cell to launch an immune attack on cancer cells.
Kite argued that the patent was invalid because it covered “millions of billions of” potential scFv candidates without disclosing specific structural features or representative species that would point to which scFvs might work. Therefore, the patent’s written description wasn’t sufficient to meet the patent law’s requirement, Kite noted.
The appeal judges agreed with Kite.
Evidence doesn’t support the jury’s finding that the ’190 patent “disclosed sufficient information to show the inventors possessed the claimed genus of functional CD19-specific scFvs as part of their claimed CAR,” the judges wrote in their opinion. “Without more guidance, in a vast field of possible CD19-specific scFvs with so few of them known, no reasonable jury could find the inventors satisfied the written description requirement,” they added.
The new ruling marks a big win for Gilead. Yescarta is the leading CD19 CAR-T drug, with $338 million in sales during the first six months. Bristol Myers recently launched rival CAR-T therapy Breyanzi after much delay. The drugs are allowed in third-line diffuse B-cell lymphoma. Both have recently reported positive clinical data that tee up potential expanded FDA approvals that could move them up the order to second-line treatment.
“Bristol Myers Squibb is committed to defending its intellectual property and that of its research partners, which drive scientific innovation,” the company said in the email. The outcome of the trial doesn’t affect the development of its CAR-T assets, it added.