Gilead Science Inc. and Viiv Healthcare fight over HIV
The healthcare companies Gilead and Viiv Healthcare fought over the legal patent for an HIV medication. Viiv Healthcare, a company owned by GlaxoSmithKline, Pfizer Inc. and Shionogi & Co., claims to act as “the global specialist company in HIV care.” Gilead Sciences Inc. similarly aims to “overcome the barriers to HIV care that still exist around the world” and to “help end the epidemic for everyone, everywhere.”
Gilead Science Inc. is Viiv Healthcare’s biggest competitor. The drug Biktarvy, manufactured by Gilead, produced a revenue of $7.05 billion in 2021, acting as one of Gilead’s top selling treatments. Biktarvy combines three different HIV medicines into one daily tablet.
Source: POZ Digital (2019).
Gilead Sciences Inc. produces Biktarvy to treat HIV.
In an article sponsored by the Canadian AIDS treatment information exchange, which compared Gilead Science’s drug Biktarvy to Viiv Healtcare’s drug Dolutregravir, Sean R. Hosein found “that both regimens were highly effective and tolerated over the course of one year. Side effects were less common among bictegravir users (18%) compared to dolutegravir users (26%).” The study involved over 600 hundred participants in ten different countries, over a one-year timeline.
Legal Battle and Financial Implications
Viiv Healthcare and partners alleged that Biktarvy infringed certain of their patents regarding dolutegravir. They entered a settlement and patent license agreements to grant Gilead a worldwide license to certain Viiv Healthcare patents, and for Viiv Healthcare not to enforce their patents to any future Gilead product containing bictegravir or dolutegravir, all under the hefty price of $1.25 billion.
Source: Pharmaceutical Technology (Admin, 2013).
Viiv Healthcare has the US patent for HIV inhibitor dolutegravir.
In a statement by Viiv Healthcare, the pharmaceutical company announced that other than the upfront payment of $1.25 billion, Gilead will also pay a 3% royalty for all future US sales of Biktarvy, which amounted to $6.09 billion in 2020. Regarding Gilead products containing the chemical bictegravir, Gilead started paying these royalties February 1st, 2022, and will do so until Viiv Healthcare’s patent No. 8,129,385 expires on October 5th, 2027. In addition, the statement explained that the stakeholders would distribute upfront payment and upcoming royalties, in proportion to the shareholder percentages for Viiv Healthcare: 78.3% for GSK, 11.7% for Pfizer and 10% for Shionogi.
A corresponding statement by Gilead Sciences reinforced this information and added that settlement dismisses all pending lawsuits regarding the drug bictegravir, ensuirng“Gilead’s ability to obtain and defend its patents and other intellectual property rights and to operate without infringing upon the patents or other proprietary rights of third parties.”
Media Coverage and Ramifications
In an article by science newspaper The Lancet, Nayanah Siva reported the legal patent battle and ensuing financial ramifications as “one of the largest pharmaceutical settlements.” While pointing out the differences between the two drugs, Siva added that the legal battle shows the complexity that intellectual property patents can add to drug discovery and production.
In a statement for Litigate, Andrew Moeser claims to have given Gilead legal counsel regarding Biktarvy’s patent infringement action.
“Gilead to fork over $1.25B, pay 3% royalty on blockbuster Biktarvy in GSK patent settlement,” Eric Sagonowsky titled a Fierce Pharma article, about the dispute. Sagonowsly says that the deal favors Viiv Healthcare, considering that Biktarvy was projected to generate $50 billion in revenue between February 2022 and October 2027 in the US alone.
In the third quarter of 2022, Gilead Science’s Biktarvy sales increased 22% to 2.8 billion.
Sources
Aripaka, P. (2022, February 2). GSK to get $1.25 bln to settle HIV drug patent row with Gilead. https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-announces-125-bln-settlement-between-viiv-healthcare-gilead-2022-02-01/#:~:text=Gilead's%20Biktarvy%2C%20which%20combines%20three,2021%20from%20the%20U.S.%20market
Gilead Press Releases. (2022, October 27). Gilead Sciences Announces Third Quarter 2022 Financial Results. Gilead. https://www.gilead.com/news-and-press/press-room/press-releases/2022/10/gilead-sciences-announces-third-quarter-2022-financial-results
Gilead Public Affairs. (2022, February 1st). Gilead Announces Global Resolution of Bictegravir Patent Dispute with ViiV Healthcare. Gilead. https://www.gilead.com/news-and-press/company-statements/gilead-announces-global-resolution-of-bictegravir-patent-dispute-with-viiv-healthcare
Hosein, S.R. (2017, November 2). Bictegravir vs. Dolutegravir. The Body Pro. https://www.thebodypro.com/article/bictegravir-vs-dolutegravir
Moeser, A. (n.d.). ViiV Healthcare Company v Gilead Sciences Canada. Litigate. https://www.litigate.com/viiv-healthcare-company-v-gilead-sciences-canada/pdf
N.A. (2019, June 20). Biktarvy [Photograph]. POZ Digital. https://www.poz.com/drug/biktarvy
Pharmaceutical Technology’s Admin. (2013, November 24). ViiV Healthcare obtains European positive opinion for HIV drug Tivicay [Photograph]. Pharmaceutical Technology. https://www.pharmaceutical-technology.com/uncategorized/newsviiv-healthcare-obtains-european-positive-opinion-for-hiv-drug-tivicay/
Sagonoswky, E. (2022, February 1). Gilead to fork over $1.25B, pay 3% royalty on blockbuster Biktarvy in GSK patent settlement. Fierce Pharma. https://www.fiercepharma.com/pharma/gilead-to-fork-over-1-25-billion-pay-3-royalty-blockbuster-biktarvy-gsk-patent-settlement
ViiV Press Releases & Company Statements. (December 2022). GSK Announces Settlement Between Viiv Healthcare and Gilead Sciences, Inc. Resolving Litigation Relating to Biktarvy and Viiv’s Dolutegravir Patents and Entry into a Patent License Agreement. Viiv Healthcare. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/gsk-announces-settlement-between-viiv-healthcare-and-gilead-sciences/
