Why Rapid HIV Tests, Widely Sold Overseas, Have Eluded the US

During the past decade, many companies have developed HIV tests that produce nearly instant results in a clinic or doctor's office. According to CDC estimates, each year one-third of the 2.1 million people tested for HIV at public clinics don't come back for their results. The CDC and US Army officials say an easy-to-use, rapid HIV test is vital to the reduction of the US rate of HIV transmission. But simple, fast HIV tests, commonly used in dozens of other countries, aren't available in the United States. Bio-Rad Laboratories Inc. controls the patent and has refused licensing rights to several small companies seeking to sell their fast HIV tests in the US. The three big companies to whom Bio-Rad sold some licensing rights do not sell the tests in the United States.

Critics at the CDC and the military say Bio-Rad and its three licensees -- Abbott Laboratories, Chiron Corp. and Johnson & Johnson -- have little incentive to sell a rapid test domestically because they already dominate the $200 million US market for the slower, lab-based HIV tests.

"They have, in effect, locked everyone out of the US market," said Nelson Michael; chief of molecular diagnostics at the Walter Reed Army Institute of Research. "I'd call it restraint of trade. It's a travesty to stand by and allow these tests to languish," said Dr. Bernard Branson, the CDC's epidemiologist in charge of HIV diagnostics. The CDC earlier this month asked the Department of Justice whether there was reason to initiate an antitrust investigation into the use of the patent by Bio-Rad and its three licensees, according to a person familiar with the situation. At Bio-Rad, spokesperson John Hertia says the company may have held up the marketing of rapid HIV tests in the United States; but he says, "it's common in diagnostics to use your intellectual property strategically."

After the discovery of HIV-1, a patent was awarded jointly to the US National Institutes of Health (NIH) and the private French research center Institut Pasteur. Two years after the discovery of HIV-1, the Institut Pasteur's Luc Montagnier found a variant of the virus, now known as HIV-2. The Institut Pasteur was awarded a broad-based US patent that restricted others from using any portion of the virus. The institute then turned over control of the patent to Sanofi Diagnostics Pasteur, a joint venture it co-founded with a French pharmaceuticals company to commercialize the institute's discoveries. In 1999, Sanofi Diagnostics Pasteur was acquired by Bio-Rad. As part of the acquisition, Bio-Rad got the HIV-2 patent.

Meanwhile, many companies developed better and faster HIV tests that don't require a laboratory or even a refrigerator. These tests have quickly caught on overseas, particularly in developing countries that don't honor US patents, and where labs and refrigeration are scarce. As a result of the patent stalemate, last year the CDC changed its longstanding signal to doctors and hospitals that HIV tests be able to detect both forms of the virus. Instead the agency urged that the FDA approve tests for the HIV-1 virus alone. "We realized there was no other way to get around the patent," said Branson. In response to the CDC's move, several companies have recently been racing to conduct clinical trials of rapid, HIV-1 only tests, and some could win FDA approval as early as Dec. 31. The US military, in particular, wants rapid tests to prevent the accidental transfusion of HIV-infected blood on the battlefield.

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