Federal District Court Rejects GlaxoSmithKline's Request to Dismiss AIDS Healthcare Foundation Lawsuit

A U.S. District Court in California on Thursday denied a request from drug maker GlaxoSmithKline to dismiss a lawsuit brought against the company by the AIDS Healthcare Foundation, which seeks to block the company's patent for its antiretroviral drug Retrovir, London's Guardian reports (Bowers, Guardian, 7/26). AHF, the largest nongovernmental provider of health care services for people with HIV/AIDS in the United States, in April filed an amended lawsuit in federal court against GSK, challenging the company's patents for three of its top-selling antiretroviral drugs. AHF's original suit, which was dismissed in March, charged that several of GSK's patents for its antiretroviral drugs are invalid and that its prices "exorbitantly exceed" its licensing, manufacturing and distribution costs (Kaiser Daily HIV/AIDS Report, 4/23). In the new suit, AHF says that GSK's Retrovir, which is more commonly known as AZT, was developed by NIH in 1964 as a cancer drug with federal funding and that the drug was tested by NIH scientists as an HIV drug 17 months before GSK filed its patent in the mid-1980s. Under U.S. law, drugs developed with federal funds must be sold at a "reasonable price" which can, if necessary, be determined by the courts, according to the Guardian. AHF alleges that the patent on Retrovir locked out competitors and allowed the company to price the drug at 32 times its manufacturing cost (Guardian, 7/26). Because Retrovir was developed with federal funding, the drug and subsequent derivative drugs -- such as the combination drugs Combivir and Trizivir, which include Retrovir -- should be sold at more reasonable rates, the suit states, according to an AHF release.

Moving Forward
AHF is claiming damages as a major purchaser of the drugs, which the foundation uses to treat an estimate 12,000 HIV-positive people in the United States, Africa and Honduras. Last week's ruling sustains 16 of AHF's 17 allegations against GSK, and the foundation intends to file a preliminary injunction against GSK (AHF release, 7/24). "GSK officials have repeatedly called our AZT patent piracy lawsuit 'frivolous' and 'without merit,' but this court ruling clearly says otherwise," AHF President Michael Weinstein said, adding, "We can now move forward with our challenge to GSK's stranglehold on the patent for AZT." A GSK spokesperson on Friday said that AHF's claims "are entirely without merit, offer no new information and are based on decades-old history that has already been thoroughly reviewed and decided by the courts" (Guardian, 7/26).

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