The largest AIDS organization in the US has been given the green
light to launch a patent invalidity action against pharmaceutical
company GlaxoSmithKline (GSK).
On July 24, a California district court rejected GSK's motion to
dismiss a lawsuit over its patent for the AIDS drug AZT (Retrovir)
brought by the AIDS Healthcare Foundation.
The court upheld 16 of 17 causes of action brought by AHF
relating to the AZT patent and subsequent derivative AIDS drugs
Combivir and Trizivir.
The Foundation's general counsel Tom Myers said that the
organization intended to file a motion for preliminary injunction
to prevent "irreparable harm" to AIDS patients caused by GSK's
invalid claim on AZT.
The Foundation wants the patent for AZT to be invalidated, or to
prevent GSK from enforcing its patent, in order to free up the
market to competitors and drive the price of the drug down. The
organization contends that GSK fraudulently obtained the AZT
patent.
GSK has consistently stated that the action relating to AZT is
unfounded. A GSK spokesperson told MIP Week: "The claims
made by the Foundation 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."
He added: "We will continue to defend our company vigorously
against the lawsuit. We deplore the waste of time and money spent
that could be used to improve the quality of life of HIV
sufferers."
The decision follows the same court's dismissal without
prejudice of the Foundation's case in March. The organization
re-filed an amended action in May, which removed previous claims
made under the Bayh-Dole Act – federal legislation that governs
products developed with taxpayer money. GSK moved to have the case
dismissed.
According to GSK, the issues in the Foundation's case were
scrutinised by the courts in the 1990s when Barr Laboratories and
Novopharm Ltd attempted to launch generic versions of AZT.
In 1993, a district court judge upheld Burroughs Wellcome's
patent on AZT, rejecting claims by Barr and Novopharm that the work
of federal scientists was instrumental in the development of
AZT.
The decision was upheld by the Court of Appeal in 1994, and the
Supreme Court declined to consider an appeal.
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