USA – Viiv Healthcare, a specialist HIV company majority-owned by GlaxoSmithKline with Pfizer and Japan’s Shionogi as shareholders, has settled a global patent infringement lawsuit with Gilead Sciences.

The case concerned ViiV’s patents on dolutegravir, an antiretroviral medication used in conjunction with other medications to treat HIV.

ViiV, Glaxo, and Shionogi claimed that Gilead’s Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide, and emtricitabine, infringed on their dolutegravir patents.

As part of the settlement, Gilead has been granted a worldwide licence to certain ViiV patents relating to dolutegravir, as well as a covenant not to enforce any patents controlled by ViiV, GSK, or Shionogi against Gilead in connection with any past or future claims of infringement relating to Biktarvy.

HIV medicines developed by ViiV, in which Pfizer and Shionogi (Japan) also have small stakes, are a key component of GSK’s strategy to support its lagging pharmaceuticals business as it prepares to spin off its consumer healthcare arm.

Gilead will pay ViiV Healthcare US$1.25 billion in exchange for the use of ViiV Healthcare’s patents related to the drug dolutegravir.

The payment is expected to be made in the first quarter of this year, according to GSK, which is listed on the London Stock Exchange.

ViiV, GlaxoSmithKline, and Shionogi have also agreed not to enforce their patents against any future bictegravir-containing product, to the extent that the patent enforcement relates to the bictegravir component of the product.

In addition to the upfront payment, Gilead will pay a 3% royalty on all future Biktarvy sales in the United States until 2027, as well as the bictegravir component of any future bictegravir-containing products sold in the United States.

Gilead will pay these royalties to ViiV Healthcare from 1 February until the expiration of ViiV’s US patent in 2027. GlaxoSmithKline will receive 78.3 percent of the profits, Pfizer 11.7 percent, and Shionogi 10%.

Gilead’s Biktarvy, which combines three HIV medications in a single daily tablet, poses the most competitive challenge to GSK’s ViiV and is one of Gilead’s top selling treatments, bringing in US$7.05 billion from the US market in 2021, reports.

While Gilead is the leading supplier of HIV treatments, GSK has been working to challenge it by focusing on longer-lasting treatments, such as the two-drug regimen Dovato, to reduce the number of medicines patients must take.

Earlier on, US regulators approved the use of ViiV’s Cabenuva injection, which is administered once every two months, for virologically suppressed adults with HIV who have not previously failed or developed resistance to cabotegravir or rilpivirine.

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