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Gilead, ViiV Healthcare Enter $1.25B Settlement Over HIV Drug
In 2018, Viiv Healthcare, GSK, and Shionogi alleged that Gilead’s HIV drug, Biktarvy, containing three HIV integrase inhibitors, infringed their patents relating to dolutegravir.
ViiV Healthcare, GSK, and Shionogi recently entered a $1.25-billion settlement over the global patent infringement litigation with Gilead concerning its HIV drug combined with three HIV integrase inhibitors.
The companies previously alleged that Gilead’s triple combination HIV medicine, Biktarvy- containing HIV integrase inhibitors bictegravir, tenofovir, alafenamide, and emtricitabine-infringed their patents relating to dolutegravir.
In 2018, ViiV Healthcare filed patient infringement litigation against Gilead over bictegravir in the US and Canada.
But in April 2020, the federal court granted Gilead’s motion for a summary trial. It dismissed ViiV Healthcare’s claim that Gilead infringed Patent No.282 by selling bictegravir as one of three medicinal ingredients in Biktarvy.
The court found that bictegravir sodium did not fall within the scope of the Patent claims.
The global settlement discontinues the patent infringement cases in the US, France, Ireland, Germany, Japan, Korea, Australia, and Canada.
Therefore, ViiV Healthcare, GSK, Shionogi, and Gilead entered into a global settlement agreement and a patent license agreement under which Gilead was granted a global license to certain ViiV Healthcare patents relating to dolutegravir.
The companies also signed an agreement not to enforce any patents they control against Gilead in connection with any past or future claims of infringement relating to Biktarvy. They also agreed not to enforce their patents against any future product containing bictegravir.
Under the terms of the agreement, Gilead’s $1.25 billion upfront payment and three percent royalty on all future US sales of Biktarvy will be payable from February 2020 until the end of the patent in October 2027.
In 2020, there were nearly 37.7 million people globally with HIV. Of these, 36 million people were adults and 1.7 million were children up to 14 years of age.
In October 2021, FDA approved a low-dose tablet form of Biktarvy for pediatric patients weighing at least 30 pounds and virologically suppressed or new to antiretroviral therapy. And in December, FDA approved ViiV Healthcare’s long-acting injectable pre-exposure prophylaxis (PREP) treatment, Apretude, to reduce the risk of sexually acquired HIV-1.
