HIV-2 patent prevents licensing of rapid HIV tests in the U.S.
- A patent on HIV-2, a rare variant of the AIDS virus found mostly in West
Africa, is preventing the rapid HIV tests used throughout most of the
world from being marketed in the United States, The Wall Street Journal
reports. The U.S. Supreme Court ruled in 1980 that biological organisms
can be patented, and the Institut Pasteur in Paris received a U.S. patent
on HIV-2 when the variant of the more common HIV-1 was discovered in 1986.
That patent was eventually licensed to a French pharmaceutical company
that was bought by U.S. diagnostic test manufacturer Bio-Rad Laboratories.
Although fewer than 200 cases of HIV-2 have been documented in the United
States, the Centers for Disease Control and Prevention still recommend
that all HIV tests conducted in the country scan for both HIV-1 and HIV-2.
Bio-Rad maintains HIV-2 licensing agreements with three other
firms--Chiron Corp., Abbott Laboratories, and Johnson & Johnson--that
manufacture slower HIV antibody tests that screen for both HIV variants,
but Bio-Rad has refused numerous licensing requests from rapid-HIV-test
makers, effectively preventing the use of rapid tests in the United
States.These quicker tests produce nearly instantaneous results and sell
for about $2 each in other developed countries. AIDS activists say the
tests would be useful in the United States because nearly one third of the
2.1 million Americans who receive HIV tests at public clinics each year do
not return for their results, which can take up to two weeks for
completion. Rapid tests also would be easier to administer by mobile
testing units across the country.
Bio-Rad, Abbott, and Johnson & Johnson manufacture rapid HIV tests sold in
other countries but say that the costs of conducting clinical trials so
that the tests can be approved for use in the United States are
prohibitive. Gerard Vaillant, chairman of Ortho-Clinical Diagnostics, a
division of Johnson & Johnson, also said that the company does not have an
adequate sales staff to market a rapid HIV test to doctors in the United
Officials at the CDC and at the U.S. Army say that Bio-Rad's refusal to
license the patent is part of a plan by Abbott, Bio-Rad, Chiron, and
Johnson & Johnson to maintain nearly complete control over the U.S. market
for HIV test kits. "They have, in effect, locked everyone out of the U.S.
market," said Nelson Michael, chief of molecular diagnostics at the Walter
Reed Army Institute of Research. Bernard Branson, who heads the CDC's HIV
diagnostic unit, said that the companies' actions amount to "restraint of
trade," adding that it is a "travesty to stand by and allow these tests to
languish." CDC officials also reportedly asked the Department of Justice
in November to look into a possible antitrust investigation of the
companies. A Department of Justice spokesperson refused to comment on the
Source: The Advocate
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