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HIV-2 patent prevents licensing of rapid HIV tests in the U.S.

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  • LAMBDA staff
    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
    Message 1 of 1 , Jan 8, 2002
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      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
      States.

      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
      investigation.

      Source: The Advocate
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