ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline with Pfizer Inc and Shionogi Ltd announced that it has filed patent infringement litigation against Gilead Sciences Inc. over bictegravir in the United States and Canada.
Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide.
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. ViiV Healthcare will therefore seek financial redress for patent infringement.
The U.S. Food and Drug Administration on Wednesday approved Biktarvy, Gilead Sciences Inc’s once-daily, triple-combination tablet for treatment of HIV infection. Gilead, in a company statement, said it remained ”steadfast in our opinion that Biktarvy does not infringe ViiV’s U.S. patent, and that the court challenge did not affect the U.S. availability of the drug.”