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February 2, 2022

GSK’s ViiV Healthcare enters patent dispute settlement agreement with Gilead

Under the deal, Gilead will pay $1.25bn in upfront payments to ViiV Healthcare in the first quarter of this year.

GlaxoSmithKline (GSK) has announced a settlement of a patent dispute between ViiV Healthcare and Gilead Sciences.

ViiV agreed to the settlement of the worldwide patent infringement litigation between GSK, Shionogi and Gilead over its patents linked to an antiretroviral therapy, dolutegravir, used for the treatment of human immunodeficiency virus (HIV), along with other medicines. 

A specialist HIV company, ViiV Healthcare is majority-owned by GSK while Pfizer and Shionogi are also the stakeholders of the company. 

ViiV Healthcare, GSK and Shionogi claimed that Gilead’s Biktarvy infringed some of the patents linked to dolutegravir. 

Biktarvy combines three HIV therapies namely an inhibitor of HIV integrase bictegravir, tenofovir alafenamide and emtricitabine.

Patent infringement lawsuits in the US, the UK, Ireland, France, Japan, Germany, Korea, Canada and Australia will be dropped as a result of the latest agreement.

The companies entered a worldwide settlement and patent licence agreements through which Gilead has obtained a global licence to specific patents of ViiV Healthcare linked to dolutegravir.

The deal also comprises a covenant to not impose any patents of ViiV Healthcare, GSK or Shionogi against Gilead linked to any previous or future claims of infringement regarding Biktarvy. 

In addition, ViiV Healthcare, GSK and Shionogi will not enforce their patents against any product in the future with bictegravir.

Under the deal, ViiV Healthcare will receive $1.25bn in upfront payment from Gilead in the first quarter of this year. 

Furthermore, Gilead agreed to pay a 3% royalty on all US sales of Biktarvy and the bictegravir ingredient in any other bictegravir-containing products in the future. 

Gilead will make these royalty payments to ViiV Healthcare until the expiration of the US patent of ViiV Healthcare. 

In June last year, ViiV Healthcare and Halozyme Therapeutics signed a partnership and licence agreement to use the latter’s ENHANZE drug delivery technology for developing ‘ultra long-acting’ drugs for HIV.

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