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By John T. Aquino
Jan. 27 — The AIDS Healthcare Foundation (AHF) filed litigation Jan. 26 against Gilead Sciences Inc., asking for judgments that would invalidate five HIV/AIDS-treatment patents.
The complaint in the U.S. District Court for the Northern District of California against Gilead, Japan Tobacco Inc. and Emory University also asserted anticompetitive violations of the Sherman Act, 15 U.S.C. §§1 & 2, for Gilead's actions in allegedly blocking entry into the marketplace of potential generic competitors of the HIV drug tenofovir by illegally attempting to extend patent exclusivity.
Daniel Hipskind of Olavi Dunne LLP, Los Angeles, who represents AHF, said in a press statement, “Gilead's illegal acts prevent people living with HIV/AIDS from accessing lifesaving treatment and cost the public billions of dollars because of Gilead's unwarranted monopoly. Gilead must stop manipulating patent and FDA [Food and Drug Administration] law in order to charge exorbitant prices for HIV drugs.”
Los Angeles-based AHF is a large-scale nonprofit provider of specialized HIV/AIDS medical care in the U.S.
At issue are U.S. Patent Nos. 7,390,791; 7,800,788; 8,754,065; 8,148,374, and 8,633,219. They cover tenofovir, a component in Genvoya, Gilead's four-in-one fixed dose combination to treat HIV/AIDS patients, as well as in Gilead's similar predecessor Stribild.
According to the complaint, Gilead sold more than $15 billion of HIV antiviral drugs in the U.S. in the first three quarters of 2015 and yet faced the fact that the patents covering tenofovir are scheduled to expire in 2017 and 2018.
The foundation said in the complaint that Gilead manipulated the patent system and engaged in anticompetitive practices to prevent economical access to TAF, an antiviral agent used for treating HIV. “TAF is not a new compound. TAF is a prodrug of Tenofovir, which was first synthesized over thirty years ago in the Czech Republic,” the complaint said. The complaint explained that a prodrug converted into active form once processed inside the body.
AHF said that Gilead developed a “complex, anti-competitive scheme” to extend its exclusivity on drugs incorporating tenofovir:
Under the Hatch-Waxman regulatory regime governing generic drug approvals, “a generic manufacturer entering the market would have to invalidate the TAF patents as well as the patents that cover the three other compounds in the combination drug. Gilead has tactically chosen to not offer a standalone TAF drug so that any generic maker entering the market would be forced to either challenge 12 patents covering four separate pharmaceutical compounds, or go through the years-long and incredibly expensive process of conducting clinical trials,” AHF wrote.
AHF also alleged that TAF wasn't the first prodrug of tenofovir. “Several years before Gilead obtained a patent on TAF, Gilead had patented a similar prodrug called Tenofovir Disoproxil (TDF). Despite similarities between TAF and TDF and the weakness of the patents covering TAF, Gilead illegally seeks to extend the period of patent exclusivity for drugs incorporating Tenofovir by decades.”
According to the complaint, in January 2013, shortly after the Food and Drug Administration approved Stribild, the fixed dose combination on which Genvoya is based, Gilead filed a citizen petition with the FDA seeking an extension on its exclusivity on Stribild from three years to five years.
In October 2014, the FDA denied Gilead's petition.
AHF asked the court for declaratory judgments of invalidity of the ‘791, ‘788, ‘065, ‘374 and ‘219 patents and judgments that Gilead had engaged in illegal monopolization that was in violation of Section 2 of the Sherman Act, and conspiracy and agreement in restraint of trade that was in violation of Section 1 of the Sherman Act.
It asked the court for relief in the form of monetary damages that would be trebled as provided by law and attorneys' fees and costs.
A Gilead spokeswoman didn't immediately respond to Bloomberg BNA's e-mail and phone requests for comment.
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