Novartis to pay nearly $178M in lawsuit over BRAF drug — and will be on the hook for royalty
After a four-year battle over a cancer drug patent, Novartis has been ordered by a California judge to pay a Daiichi Sankyo subsidiary $177.8 million.
Plexxikon filed a lawsuit against the pharma giant in 2017, alledging that Tafinlar, a rival to its melanoma drug Zelboraf that was brought to market in collaboration with Roche, has stepped on its intellectual property. The jury ruled in its favor, adding that the infringement is in fact willful.
On top of getting compensated for the past infringements, Plexxikon says it will receive “additional royalty payments for future sales of Tafinlar in the United States through the life of the patents.”
Sales for Tafinlar and Mekinist, the MEK inhibitor it was approved with, hit $672 million in 2016. Fast forward to 2020 and the duo generated $1.5 billion in revenue. In 2021, the combo has raked in $818 million in the first half of the year alone for Novartis, a number that is already up 11% from last year. Comparatively, Roche reported $218 million in sales of Zelboraf in 2016, and revenue was not reported in its most recent mid-year update.
The Plexxikon patents are for compounds that reduce cancer cell growth by blocking V600E mutated BRAF. Patents were filed as early as 2005.
Novartis and GSK carried out a swap of its vaccine and cancer drugs back in 2015. GSK paid $5.25 billion to Novartis for its vaccine business, and Novartis sent $16 billion for GSK’s oncology programs. Tafinlar and Mekinist had already been granted FDA approval at the time of that deal, and as a part of that deal, Novartis agreed to divest its own BRAF and MEK inhibitors to avoid creating a monopoly.
According to Plexxikon, GSK scientists were only able to make Tafinlar after talks with Plexxikon about a potential partnership; although those talks never turned into a licensing deal, GSK apparently channeled that information and created a rival drug.
The suit says that while BRAF kinase inhibitors existed prior to Plexxikon’s discoveries, they were not selective, and Plexxikon’s have a core molecular structure that allows them to bind selectively to kinase created by the BRAF mutation. That allows for higher doses to be administered.
“The jury was careful and awarded us what we’d asked for down to the penny,” Plexxikon’s lawyer Daralyn Durie told Bloomberg after the verdict came down.
The jury unanimously ruled in Plexxikon’s favor on all seven questions, including that Novartis has not proved the specification of the patent was full and clear enough to enable a person of “ordinary skill” to make and use the invention.
