Gilead’s freshly approved Biktarvy faces patent hurdle

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Gilead’s freshly approved Biktarvy faces patent hurdle

By David Salazar - 02/09/2018
Gilead Sciences’ new HIV treatment Biktarvy has been approved by the Food and Drug Administration — but its novel component is also the subject of patent infringement litigation from GSK.

Biktarvy is a triple-therapy HIV treatment that brings together bictegravir’s unboosted integrase strand transfer inhibitor with the dual nucleoside transcriptase inhibitor backbone of emtricitabine, tenofovir alafenamide — which are the two components of Gilead’s Descovy.

“Gilead is committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including therapies that could potentially cure HIV patients,” Gilead president and CEO John Milligan said. “We are pleased to offer Biktarvy, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with the most-prescribed dual-NRTI backbone in a once-daily single tablet regimen.”

However, now bictegravir is at the center of GSK’s lawsuit, which was filed in the U.S. District Court for the District of Delaware, as well as in Canadian Federal Court in Toronto. GSK’s majority-owned Viiv Healthcare said it is looking to prove that Biktarvy’s use of bictegravir infringes on a patent covering its dolutegravir and other compounds that use dolutegravir’s chemical scaffold. The company said it would seek financial redress.

“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,” GSK said. “It is this cycle which continues to result in the development of new and much-needed treatments for people living with HIV.”

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