Gilead’s triple combination regimen Biktarvy was alleged of infringing patents relating to ViiV’s HIV therapy dolutegravir
ViiV and Gilead resolve patent infringement litigation. (Credit: GlaxoSmithKline plc.)
GlaxoSmithKline (GSK)’s subsidiary ViiV Healthcare has reached a $1.25bn settlement and licensing deal with Gilead Sciences to resolve patent infringement litigation related to its HIV therapy dolutegravir.
Gilead was alleged of infringing patents relating to dolutegravir, through its triple combination regimen Biktarvy, which contain bictegravir, tenofovir alafenamide and emtricitabine.
The settlement would suspend patent infringement cases between the two companies in the US, the UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada.
Under the terms of the settlement and licensing agreement, Gilead will make an upfront payment of $1.25bn to ViiV in the first quarter of 2022.
Also, the biopharmaceutical company will pay a 3% royalty on all future sales of Biktarvy in the US, along with any potential sales of bictegravir-containing products, in the US.
GSK said that the upfront payment will be reflected in its financial results as an adjusting item in the income statement for the first quarter of 2022.
The company would record the future royalty income in total and adjusted results in the income statements for 2022 to 2027 inclusive.
In addition to the settlement, ViiV and Gilead reached a patent license agreement that provides Gilead with a global licence to certain patents relating to dolutegravir.
The agreement also prevents any enforcement related to patents controlled by ViiV and its shareholders against Gilead, in connection with claims relating to Biktarvy.
ViiV has also agreed not to enforce their patents against any future product containing bictegravir, to the extent that it relates to the product’s bictegravir component.
Established in November 2009, ViiV Healthcare specialises in delivering advanced treatment for HIV and for people who are at risk of becoming infected with HIV.
In December 2021, the company received the US Food and Drug Administration (FDA) approval for Apretude as an oral PrEP option to reduce the risk of acquiring HIV.
Apretude is a long-acting injectable, indicated for adults and adolescents weighing at least 35kg, who are at risk of sexually acquiring HIV.