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 for 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).