This week, Gilead Sciences took a $1.25 billion hit after reaching a settlement with ViiV Healthcare on a patent dispute involving the HIV drug dolutegravir.
Josh Edelson/AFP via Getty
This week, Gilead Sciences took a $1.25 billion hit after reaching a settlement with ViiV Healthcare on a patent dispute involving the human immunodeficiency virus (HIV) drug dolutegravir.
ViiV Healthcare, along with majority owner GlaxoSmithKline and shareholders Shionogi & Co. and Pfizer, filed a global patent infringement lawsuit against Gilead for its Biktarvy HIV product. Biktarvy is a triple combination drug that contains the HIV integrase inhibitor bictegravir, emtricitabine and tenofovir alafenamide. ViiV alleged that Gilead infringed on certain aspects of its worldwide patent, particularly the use of dolutegravir and other compounds that include dolutegravir’s unique makeup.
“Intellectual property protections are critical for the life sciences industry, allowing companies to make a return on their investment, which in turn enables research-based companies to put new funding into research and development. It is this cycle which continues to result in the development of new and much needed treatments for people living with HIV. ViiV Healthcare will therefore seek financial redress for patent infringement,” ViiV said in a statement.
Gilead received the U.S. Food and Drug Administration’s approval to use Biktarvy on adult patients diagnosed with HIV-1 in 2018. Last year, it got the green light to also use it on pediatric HIV patients who are either new to antiretroviral therapy or virologically suppressed.
As a result of the $1.25 billion settlement, all patent infringement cases filed in the U.S., UK, Australia, Canada, Germany, Korea, Japan, France and Ireland will no longer be pursued. Also, part of the deal is granting Gilead a worldwide license to some of ViiV Healthcare’s dolutegravir-related patents and an understanding that no more of such Biktarvy-linked patent infringement cases will be filed against Gilead moving forward.
Gilead is expected to make payment upfront in the first quarter of 2022. Additionally, the company will pay a 3% royalty on all future Biktarvy sales in the U.S. and deals related to any product where bictegravir is identified as a component.
Such payments will be made to ViiV Healthcare starting February 1, 2022, and until the U.S. patent (No. 8,129,385) expires on October 5, 2027. The payment plus the royalties will be distributed according to the shareholdings of GSK, Pfizer and Shionogi at 78.3%, 11.7% and 10%, respectively.
The news came at the same time Gilead Sciences posted a 19% year-on-year increase in sales for the full year 2021, driven mainly by a 22% rise in Biktarvy revenues in the fourth quarter. In its 2021 financial report, the company did not specify the payment to ViiV Healthcare, although it said it had settled a legal dispute in the amount of $1.25 billion, which made a massive impact on its diluted earnings per share, dropping $0.30 each in Q4 2021.
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