Gilead sued over HIV treatment
ViiV Healthcare, which was established by major pharma companies, has filed a patent infringement complaint against Gilead Sciences in a case involving an HIV treatment drug.
The case was filed at the US District Court for the District of Delaware on Wednesday, February 7.
UK-based ViiV develops solutions for the treatment of HIV and AIDS. It was established in 2009 through a partnership with GSK and Pfizer. In 2012, Japan-based Shionogi joined the ViiV partnership. Shionogi is also suing Gilead.
Gilead’s portfolio includes investigational drugs treating HIV and AIDS, liver diseases and cancer.
GSK began partnering with Japan-based Shionogi in 2001 to develop integrase strand transfer inhibitors (INSTIs), used in treating HIV and AIDS.
The GSK and Shionogi team explored different chemical scaffolds. The collaborative efforts resulted in the identification of a “novel structural scaffold for chemical compounds that inhibit HIV integrase”.
GSK and Shionogi patented the invention in 2012 under US number 8,129,385.
As part of the collaboration, Shionogi synthesised Tivicay (dolutegravir) in 2006. The drug is an INSTI which meets the limitations of at least three of the claims in the ‘385 patent.
On Wednesday, February 7, Gilead announced that the US Food and Drug Administration approved its drug Biktarvy (bictegravir, emtricitabine, tenofovir, alafenamide), a drug designed to treat the HIV-1 infection.
According to the claim, the drug uses the novel structural scaffold protected in the ViiV ‘385 patent.
It was alleged that the results of Gilead’s phase 3 clinical trials showed no meaningful clinical difference between dolutegravir and bictegravir.
In a press release issued by ViiV, the company said: “ViiV Healthcare will seek to prove that Gilead Sciences Inc’s triple combination HIV drug containing the HIV integrase inhibitor bictegravir infringes ViiV Healthcare’s patent covering Viiv Healthcare’s dolutegravir and many other compounds that include dolutegravir’s unique chemical scaffold.”
The plaintiffs are seeking damages for the alleged infringement.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
Do you work in a pharma or biotech company? Save $275 when you join us at LSPN Boston on April 26 at the special in-house early-bird rate of $525. Find out more here.
