Bristol Myers can’t convince circuit to overturn $1.2bn ruling
The US Court of Appeals for the Federal Circuit has turned down a Bristol Myers Squibb subsidiary’s appeal to overturn a controversial $1.2 billion patent verdict loss against Kite Pharma.
The circuit denied Juno Therapeutics’ petition for a panel rehearing without comment in an order handed down on Friday, December 14.
Juno initially sued the Gilead Sciences subsidiary in California court in 2017, claiming that Kite’s lymphoma treatment Yescarta copied its cancer drug.
In 2019, a Jury found that Kite had willfully infringed the patent and awarded Juno $778 million, which was later increased to $1.2 billion in 2020.
However, on appeal to the Federal Circuit, the award was reversed. The three-judge panel unanimously ruled that claims of US patent 7,446,190 were invalid, backing Kite’s argument that “no reasonable jury” could find the patent’s written descriptions sufficient.
Juno attempted to appeal the decision, submitting a petition for rehearing in October last year.
The petition argued that the Federal Circuit had applied a “rigid, formalistic test” for evidence of the inventor's ownership of the “full scope” of the invention. It also claimed that the ruling could have a negative impact on similar drug patent ownership cases.
“The mischief of the court’s separate, rigid written-description inquiry is particularly devastating for pharmaceutical inventions, and especially biologics,” the petition said.
Following the submission of the petition, several other companies and public institutions filed amicus briefs in support, including the City of Hope, Amgen, and St Jude's Children's Research Hospital.
The amicus briefs echoed the sentiment that the Federal Circuit’s decision left “no other option” than to pursue “exceedingly narrow” patent protection that could easily be evaded by “copycats”.
They wrote that: “Amici are deeply concerned that the panel’s decision morphs the written description requirement into an unattainable standard—aimed (perhaps exclusively) at cutting-edge innovations in the biotechnology and pharmaceutical fields—that significantly threatens the lifesaving efforts of amici and their research collaborators.”
In December last year, Kite submitted its response to the rehearing request, saying that the circuit’s analysis of the written description requirement was in line with precedent in Ariad Pharms v Eli Lilly, and that Juno had offered “no new reasons to drastically change the status quo”.
The circuit seemed to agree, denying Juno’s rehearing petition.
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