Gilead to pay $1.25 billion plus royalties to ViiV Healthcare for bictegravir infringing on dolutegravir patent
7 February 2022. Related: Antiretrovirals.
Simon Collins, HIV i-Base
A long-running legal challenge that bictegravir was so similar to dolutegravir that Gilead infringed the ViiV patent has now been resolved. [1, 2]
In a press release on 1 February 2022, Gilead announced that it will pay a one-time payment of $1.25 billion for ViiV to withdraw all claims. Gilead will also pay “an ongoing royalty payment of 3% until 2027 on future sales of Biktarvy and on the bictegravir component of any future bictegravir-containing products sold in the US.”
In 2020, Gilead sales were more than $6b in the US with 17% growth in 2021. [2, 3]
comment
This is a relatively small settlement. Gilead year-to-date sales including 3Q2021 were $11.8b. Biktarvy is the most widely prescribed US treatment with a patent claim until 2030. Gilead drugs account for 75% of US market share. [3]
Dolutegravir was approved in the US in August 2013 and Biktarvy (containing bictegravir) was approved in February 2018.
The similarity between these two integrase inhibitors is so close that the side effect profile of dolutegravir – which has been described for an additional five years – is believed by many researchers to also apply to bictegravir. unless proved otherwise.
References
- Gilead Sciences press statement. Gilead announces global resolution of bictegravir patent dispute with ViiV Healthcare. (1 February 2022).
https://www.gilead.com/news-and-press/company-statements/gilead-announces-global-resolution-of-bictegravir-patent-dispute-with-viiv-healthcare - ViiV Healthcare press statement. GSK announces settlement between ViiV Healthcare and Gilead Sciences resolving litigation relating to Biktarvy and ViiV’s dolutegravir patents and entry into a patent licence agreement. (1 February 2022).
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/gsk-announces-settlement-between-viiv-healthcare-and-gilead-sciences/ - Gilead presentation. innovation for sustainable growth. JP Morgan Healthcare Conference. (10 January 2022).
https://investors.gilead.com/events/event-details/gilead-sciences-40th-annual-jp-morgan-healthcare-conference (webcast and link page)
https://investors.gilead.com/static-files/5808fec3-0d26-4d9f-8df7-c4ecba89204d (PDF)
This report was first published on 1 February 2022.