The Aids Healthcare Foundation, the largest non-governmental supplier of Aids treatment to patients in the United States, won the first round of a legal battle yesterday to break GlaxoSmithKline’s hold over the patent on AZT, the first Aids drug.
A district court in California has thrown out almost all GSK’s arguments to block the patent challenge. The foundation is insisting the core technology in AZT and GSK’s successor drugs was developed using public funds. It has described GSK’s patent on the drug as ”piracy” and last year filed a lawsuit for triple damages.
”GSK officials have repeatedly called our AZT patent piracy lawsuit ‘frivolous’ and ‘without merit’, but this court ruling clearly says otherwise,” said Michael Weinstein, the president of AHF. ”We can now move forward with our challenge to GSK’s stranglehold on the patent for AZT — a drug it neither invented nor showed its efficacy against HIV.” AHF plans to ask the court to issue an injunction to prevent ”further irreparable harm” to Aids patients in its clinics.
AHF argues AZT was developed as a cancer drug with federal funding by the National Institute of Health in 1964. The foundation believes the drug was tested by institute scientists for HIV use 17 months before GSK decided to file its patent in the mid-1980s, and claims GSK’s patent locked out competitors and allowed it to price the drug at 32 times the cost of manufacture.
”It is patent piracy that has cost untold numbers their lives and is denying treatment to millions today,” Weinstein said. AHF is claiming damages as a major purchaser of AZT and its successor drugs, which it uses to treat its uninsured US patients. It believes GSK makes $5-million a year from its Aids drugs, which include Combivir and Trizivir.
He added that under US law, drugs developed with federal funds must legally be sold at a reasonable price which could, if necessary, be determined by the courts.
GSK, which is more used to defending its patents from legal claims brought by generic drug manufacturers, continues to insist that there is nothing new in AHF’s arguments against the AZT patent.
”The claims made by AHF 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,” a spokesperson said yesterday.
In 1993 US judge Malcolm Howard heard a claim brought by generic firms Barr Laboratories and Novopharm, which GSK believes was almost identical to the argument being put forward by AHF.
Judge Howard ruled: ”The evidence in this case is overwhelming and conclusive that the Burroughs Wellcome [now part of GSK] inventors, and only the Burroughs Wellcome inventors, first conceived of the idea of using AZT as a therapy for treating patients infected with HIV.”
The case went to the US court of appeal, which upheld the ruling in 1994. Two years later the supreme court refused a request to hear the case. AHF believes this week’s ruling marks out its claim as distinct from previous AZT patent challenges. – Guardian Unlimited Â