Pharmaceutical Business review

Gilead says it had no duty to develop less harmful AIDS drug in motion to dismiss AHF lawsuit

Earlier this year, AHF filed a federal lawsuit against Gilead Sciences and two other defendants in U.S. District Court, Northern District of California. It alleged drug patent manipulation and anti-trust claims with respect to Genvoya, the company’s new four-in-one Fixed Dose Combination (FDC) to treat HIV/AIDS patients.

Gilead unsuccessfully sought US patent extension on Stribild, its similar but previous FDC that features a form of Tenofovir.

AHF’s patent and anti-trust case revolves on slightly different formulations of Tenofovir.

According to the legal news website, Law360, Gilead attorneys, in a motion to dismiss AHF’s lawsuit, said, "Just as Gilead was under no antitrust duty to bring a standalone TAF product to market, it likewise had no duty to develop, test, seek approval of or launch its new product on any particular timetable."

AHF president Michael Weinstein said: "Despite the fact that Gilead is now widely touting its updated formulation of Tenofovir’s reduced risk of causing kidney damage and bone loss, it doesn’t matter one bit legally if they purposely delay bringing it to market.

"Instead, so they could continue to maximize profits — and run the patent clock — on its older, potentially more harmful Tenofovir formulation. Gilead delayed bringing TAF to market and has yet to do so for TAF as a standalone drug.

"An indefensible excuse by Gilead on moral grounds as well as a brazen defense on legal grounds that we will continue to challenge."