Regulatory Affairs

ViiV Healthcare sues Gilead over HIV drug patent infringement

PBR Staff Writer Published 09 February 2018

ViiV Healthcare has filed a lawsuit against Gilead Sciences alleging that bictegravir contained in the latter’s triple combination HIV drug infringes patent covering dolutegravir in the US and Canada.

Bictegravir is one of the three drugs used in Biktarvy, which secured approval from the US Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

As per the lawsuits filed in the US District Court for the District of Delaware and the Canadian Federal Court in Toronto, ViiV accused Gilead’s bictegravir of not only infringing patent covering dolutegravir but also several other compounds that include the drug’s unique chemical scaffold.

ViiV Healthcare, in a statement, said: “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.” 

The company said that it will seek financial redress for the alleged patent infringement by Gilead’s bictegravir.

ViiV Healthcare is a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, whose two-drug regimen Juluca was approved in late November 2017 by the FDA to treat certain adults with HIV-1.

Juluca is made up of dolutegravir 50mg produced by ViiV Healthcare and rilpivirine 25mg produced by Janssen Therapeutics.

In a separate development, ViiV Healthcare has launched a phase 3 trial to evaluate a two-drug regimen of dolutegravir and lamivudine against continued treatment through a tenofovir alafenamide fumarate (TAF)-based regimen in HIV-infected adults who are virologically suppressed and stable on the TAF-based regimen.

The trial, dubbed TANGO, aims to enroll about 550 adults with HIV-1, from clinical trial sites across North America, Europe, Japan and Australia.


Image: Gilead Sciences’ triple HIV-1 therapy Biktarvy contains bictegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg. Photo: courtesy of Gilead Sciences, Inc.