GlaxoSmithKline-owned Viiv healthcare has filed a lawsuit against American biopharma company Gilead for an alleged patent infringement of a newly-approved HIV drug.

The US Food and Drug Administration (FDA) approved Biktarvy, a once-daily, single-tablet regimen for the treatment of HIV-1 manufactured by Gilead, on 7 February 2018.

On the same day, Viiv Healthcare announced that it has filed patent infringement litigation against Gilead Sciences over Biktarvy. ViiV Healthcare will seek to prove Biktarvy, which contains the HIV integrase inhibitor bictegravir marketed by Viiv as Tivicay, infringes ViiV Healthcare’s patent.

Viiv announced that the suit involving US Patent No. 8,129,385 was filed in the US District Court for the District of Delaware, along with a case for a Canadian patent filed in the Canadian Federal Court in Toronto.

Viiv claims that it developed bictegravir’s ‘unique chemical scaffold’, which is covered by a patent, and this was copied by Gilead in the development of its own HIV regimen. Viiv claims that Gilead was aware of the patent due to journal coverage. The company will therefore seek financial redress for patent infringement.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Viiv received FDA approval for its own once-daily regimen Julucc─which contains Tivicay─ in November 2017.

In a statement, Viiv Healthcare 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.”

Gilead has denied patent infringement.

ViiV Healthcare is a global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi as minority shareholders. Patented in 2012, Tivicay is one of Viiv’s best-selling drugs, generating sales of £1.4 billion in 2017.

Gilead Sciences has long dominated the market for HIV treatment. Biktarvy is expected to achieve blockbuster status and could become a rival to Julucc, with Wall Street analysts forecasting sales of around $1 billion in 2018.

The two companies have been developing simpler treatments to keep HIV under control. Before single-tablet regimes were approved, HIV sufferers generally had to take multiple pills every day.