Bristol Myers petitions the Supreme Court in a final bid to prove Gilead's Kite infringed on CAR-T patents
Five years after Juno and Sloan Kettering launched a bitterly fought legal campaign against Gilead’s Kite Pharma, claiming the biotech rival had infringed on its CAR-T patents on the way to launching a pioneering cancer therapy, Bristol Myers Squibb is taking the case all the way to the Supreme Court.
The Juno acquirer says that a Federal Circuit decision that set aside a $1.2 billion verdict in its favor was not just incorrect, it has blighted the field of drug development and created a precedent that threatens the very foundation of innovation in America.
In their petition, Bristol Myers attorneys argue that the federal court created an impossible standard with “judicially crafted” requirements that the patent shows the inventor “possessed the full scope of the claimed invention,” including all “known and unknown” variations of individual components.
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. The effect has been particularly lethal in the biological arts, where it “represents both bad law and bad policy” and “may threaten innovation.”
For its part, Kite’s founders and acquirers have denied any wrongdoing and aren’t likely to fold now.
Kite came in as a close second to Novartis in winning an approval for its CAR-T, Yescarta. Juno, on the other hand, was forced to scrap its lead therapy after a series of patient deaths, forcing a pivot that led to a lengthy delay, especially after Celgene bought out Juno and took control of the development program. Bristol Myers later bought out Celgene and inherited the legal case in the process.
Juno built its case around the ‘190 patent from Sloan Kettering, which was exclusively licensed.
Calling Kite’s infringement on the central ‘190 patent “willful,” Judge Philip Gutierrez ruled two years ago that Kite should pay more than $778 million — consisting of a $585 million upfront and $193 million in royalties on $603.6 million in net revenue. Then he added more than $32 million in interest and “enhanced damages” of $389 million.
The Supreme Court justices now have to decide whether they will take the case before Bristol Myers and Sloan Kettering can find out whether they still have a chance of winning.