Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 16, Number 2, February 2002
Gregg Gonsalves

For the past several years, I have become increasingly worried about how patents could affect our response to the AIDS epidemic. Many of us are familiar with the international debates about patents on AIDS drugs and the fight to use cheaper, generic, equivalents in the developing world. However, my particular concern is about a kind of intellectual property that is more insidious: the patenting of human genes and other kinds of genetic material, particularly HIV itself.

Two years ago, Human Genome Sciences (HGS) of Maryland was granted a patent on the gene for CCR5, one of the cellular receptors that HIV uses to infect cells. HGS didn't discover this receptor's role in HIV infection; they simply sequenced large swaths of the human genome and claimed patents for everything they collected. They only found out that CCR5 was a lucky catch when William Paxton, Richard Koup, John Moore, Daniel Littman, Nathaniel Landau and other leading researchers did the hard work to pinpoint this protein's critical importance in AIDS.

The U.S. Patent and Trademark Office (USPTO) subsequently made it more difficult to patent genetic material without accompanying knowledge of a specific, substantial, and credible use for a given gene and its proteins. But over 6,000 gene patents had already been granted under the old criteria and at least 20,000 more were pending approval when the guidelines changed. Scientists trying to develop new drugs for HIV based on CCR5 or any other protected gene — human or retroviral — may have to negotiate a thicket of patents, perhaps paying licensing fees to more than one party. This could unduly hold up the development of novel therapeutics for HIV. As HGS CEO William Haseltine said in 2000, "If someone in a company wants to use the CCR5 cloned gene, they may need two licenses: our license for composition of matter and a license [from NIH research by Edward Berger] to practice HIV inhibition."

My concerns around the patent on CCR5 are theoretical as far as I know. However, there have been some real and devastating consequences from the patenting of HIV itself, in particular, the patent on HIV-2, owned by Bio-Rad Laboratories, Inc. Bio-Rad has refused to grant U.S. licensing rights for HIV-2 to several small companies with proven rapid diagnostic tests for HIV-1/HIV-2. These tests have revolutionized HIV testing outside of this country by providing reliable results within minutes. But the three companies with U.S. licenses from Bio-Rad, Abbott Laboratories, Johnson and Johnson and Chiron Corporation, either make their own rapid tests — though not for sale in the U.S. — or have no interest in developing these tests, perhaps because of lucrative franchises involving the more expensive, slower laboratory-based assays that dominate the market here in the 50 states.

Each year in the U.S. over 700,000 people come in for HIV testing but do not return for their test results according to the CDC. How many people have missed receiving an HIV diagnosis because of the intransigence of Bio-Rad and their secret licensing agreements that seem to be keeping rapid tests out of the U.S.? How many more HIV tests could be done with the resources saved by using these cheaper testing alternatives? The incidence of HIV infection in the African-American and Latino communities in the U.S., especially among young gay men, has skyrocketed over the past few years, with rates rivaling those of some countries in sub-Saharan Africa. Making HIV testing simpler and more accessible for hard-to-reach populations is a key part of improving our HIV prevention efforts in the communities hardest hit by the epidemic. Rapid tests would be an important new tool in our fight against HIV here in the U.S. According to Bio-Rad, they'll be submitting an application to the FDA sometime soon for approval of their own rapid test kit. I don't think we have the time to wait when there are dozens of different rapid tests already in use across the globe.

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