[e-drug] Patent on HIV2 Preventing Licence of Rapid Testing

[Gonsalves, Gregg <Greggg@gmhc.org>]

E-drug: Patent on HIV2 Preventing Licence of Rapid Testing
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[Reproduced here as fair use - TD]

Kaiser Daily HIV/AIDS Report (11/15/01)

Company's Patent on Rare Form of HIV Preventing the License of
 Rapid HIV Tests in the United States

A patent on HIV-2, a rare variant of HIV found mostly in West
Africa, is  preventing the rapid HIV diagnostic tests used 
throughout most of the world from being marketed in the United 
States, the Wall Street Journal reports.  A 1980 U.S. Supreme Court 
decision first allowed companies to patent biological organisms.  
When HIV-1, the strain of HIV most commonly found in the United
 States, was discovered in 1984, a joint patent was granted to NIH 
and the French Institut Pasteur.  Both receive royalties that amount 
to about 6% of sales on all tests and treatments for the virus.  In 
1986, the Institut Pasteur's Luc Montagnier discovered HIV-2, a 
variant form of the virus that does not register on the diagnostic 
tests for HIV-1, in the blood of a West African man with AIDS-like 
symptoms.  Although HIV-2 is very rare in the United States -- only
200 cases have been reported -- the CDC recommended in the 
early 1990s that all HIV diagnostic tests screen for both forms of the 
virus.  The Institut Pasteur was granted the U.S. patent for the 
strain, but later turned the patent rights over to Sanofi Diagnostics 
Pasteur, one of the institute's joint ventures with a French pharmaceutical
company.  In 1999, Sanofi was acquired by Bio-Rad
Laboratories Inc., a California-based diagnostic test maker, who 
continued Sanofi's HIV-2 licensing agreements with Chiron Corp., 
Abbott Laboratories and Johnson & Johnson.  All four companies 
manufacture and market in the United States HIV diagnostic tests 
that typically provide results in about two weeks.  Together they 
"dominate the $200 million U.S. market for the slower, lab-based"
HIV tests, the Journal reports.

Rapid Tests Make Headway Elsewhere

Rapid HIV tests, which sell for about $2 each and produce "nearly
instant results" much like a home pregnancy test, have been 
developed and marketed elsewhere in the world where HIV-2 is not 
patented.  The tests are useful in developing countries because 
they do not need to be refrigerated and do not require the patient to 
return for results.  CDC and U.S. Army officials say that a rapid test 
would provide much of the same benefit in the United States, where 
lab test results typically take two weeks and about a third of the
2.1 million people tested annually at public clinics do not return to
receive their results.  Rapid tests would also be easier to administer 
or mobile testing units.  The army is interested in using the tests to 
prevent the accidental transmission of HIV-positive blood on the 
battlefield.  "We'd hate to save someone's life and find out that by 
resuscitating them, we gave them unscreened blood that gave them 
a fatal disease," Dr. Nelson Michael, chief of molecular diagnostics 
at the Walter Reed Army Institute of Research, said, adding that it is 
"only a matter of time" before the situation arises.

Blocking the Path to Rapid Diagnostics

However, Bio-Rad has rebuffed numerous requests from rapid HIV 
test makers to license the patent.  Although U.S. HIV tests are not 
required to screen for HIV-2, the CDC recommendation is 
"powerfully influential."  Many companies fear that tests for HIV-1
alone will not sell well and have worked solely on double screening 
tests.  Together with Chiron, Abbott and J&J, Bio-Rad controls the 
U.S. HIV diagnostic market.  Bio-Rad, Abbott and J&J's Ortho 
Clinical Diagnostics unit all produce rapid HIV tests kits for use
overseas, but none of the companies have sought approval for them 
in the United States.  Abbott does make one faster test, the Single 
Use Diagnostic System, or SUDS, which takes about 15 minutes for 
results.  However, the test requires plasma-separation equipment, 
and a trained lab technician must interpret the results.  Bio-Rad 
recently applied for FDA approval to market a similar test that is 
also faster, but still requires "multiple steps" that would make it
difficult to use outside of a clinical setting.  Ortho's Chair Gerard
Vaillant said his company does not have the sales staff necessary 
to market a rapid test to doctors in the United States, and all of the 
companies have said that the cost of the clinical trials necessary for 
U.S. approval is prohibitive.  However, critics at the CDC and the 
Army say that the companies do not want to lose sales of slower 
tests to the rapid tests.  "They have, in effect, locked everyone out 
of the U.S. market," Michael said.  Bernard Branson, who heads the
CDC's HIV diagnostic unit, said that the companies' actions 
amounted to "restraint of trade," adding that it is a "travesty to stand 
by and allow these tests to languish."  CDC officials this month 
reportedly asked the Department of Justice to look into whether there
 was enough evidence to launch an antitrust investigation into 
the companies.  However, it is not known if an investigation is 
underway, as a Justice Department spokesperson refused to 
comment.  Meanwhile, the CDC has recently voiced its support for 
the development of HIV-1-only rapid diagnostic tests, sending 
manufacturers "racing" to conduct clinical trials, and some of the 
tests could receive approval by the end of the year (Anand, Wall 
Street Journal, 12/20).

Gregg Gonsalves
Director of Treatment Advocacy
Gay Men's Health Crisis
119 West 24th Street
New York, NY 10011
Phone: 212-367-1169
Fax: 212-367-1235
Email: greggg@gmhc.org

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