AIDS RESEARCH: Will New Patent Hamper Progress?
Human Genome Sciences' newly issued CCR5 gene, which produces a protein receptor that allows HIV to penetrate cells, has some researchers and experts wondering whether it could slow the development of new AIDS drugs and "entangle basic research for years to come," the Los Angeles Times reports. Human Genome Sciences' patent gives the company "sweeping control over who gets to use the gene in commercial development of a new class of AIDS drugs, even though the firm knew nothing of the gene's role in AIDS when it sought its patent." Some critics, including those who discovered the role of CCR5 in AIDS, say that granting the company a 17-year claim to the gene "is a case of the patent system gone awry." Although several researchers were on the right track and closing in on "a whole new way of treating" HIV, Human Genome Sciences, which had already sequenced the gene, "had beaten the scientists to the patent office door." Stanford University Law School Professor John Barton said, "All this patent does is carve out an area where nobody else can do research. If (Human Genome Sciences) can keep you from making this (protein) in enough quantity to be able to do research, then they can in essence control the entire area. ... If it doesn't produce a product and keeps others from doing research that would, then that's a big negative." But Human Genome Sciences Chair and CEO William Haseltine said, "The patent office does not reward perspiration. They ... reward priority." Although company officials acknowledged that they knew little of the gene's function in regard to HIV when they applied for a patent in 1995, Haseltine made it clear that the company would enforce its position. "If somebody uses this gene in a drug discovery program after the patent has been issued to find drugs ... and does it for commercial purposes, they have infringed the patent." Haseltine added that if a company wanted to use CCR5 in research, they may need to get two licenses -- "[Human Genome Sciences'] license for composition of matter and a license (from NIH research by Edward Berger) to practice HIV inhibition."
A Guessing Game?
The patent award has become an "example for critics of what's gone wrong with U.S. patent policy," the Los Angeles Times reports. Dr. Robert Gallo of the University of Maryland led the team that "clinch[ed] the role of the gene in AIDS," only to find that Human Genome Sciences was steps ahead and had already filed a patent application that was not yet publicly disclosed. The patent made no mention of the protein's role in HIV/AIDS and gave only a "single passing reference to the fact that proteins in the same class ... can be targets of viruses." Haseltine said, "In this case, we were clever enough to guess right that this is a viral receptor." But Gallo said the patent underscores the problems with the process. "If the patent office awards a patent to someone who clones a gene, even though they have no notion of its function and no real idea of its use, that would be like saying, 'I found a fungus, therefore I should get credit for penicillin.'" And New York University's Dan Littman said, "Now you have companies coming from a completely different direction and not even trying to understand function before seeking patents. ... They can just sit there and wait for others to do the research for them." Calling Human Genome Sciences researchers "the robber barons of the genetic age," Gregg Gonsalves, policy director for the New York-based Treatment Action Group that lobbies for AIDS research, argued, "They are going to patent everything they can get their hands on and squeeze as much money out of it as they can. This is not about making progress on AIDS; it is about making money." Some legal scholars argue that the patent will slow development of new drugs. Rebecca Eisenberg, a University of Michigan law professor, said that awarding such all-encompassing patents "will impede those who work on developing new drugs by forcing them to pay licensing fees and royalties both to those who isolated the gene as well as those who later discover its role in disease." She added, "Each of the licenses cost something, and if there is a proliferation of these claims, it becomes daunting to pull together all the licenses." For their part, Human Genome Sciences officials maintain that the patent "will not impede research," arguing that "the company is making the gene widely available to drug company clients in exchange for fees and future royalties and to academic researchers at no cost." Companies that had developed drugs before the patent was issued can proceed without paying royalties or licensing fees, including Schering-Plough Corp., which already is working on AIDS drugs that block CCR5 (Jacobs/Gosselin, 2/28).