Oct. 7, 1999 (Washington) -- The rush to find gold in the human genome is well underway, but it's not clear yet how much of the mammoth research project will wind up in the public domain -- or be patented and then squirreled away into corporate treasure chests. An Oct. 2 editorial in The Lancet observed, "Since patent legislation has allowed so many precedents, it is ... too late for politicians to get high-minded by seeking to treat human DNA as a special case." It's hoped that thousands of drugs to treat genetic diseases will emerge from ongoing genomic studies.
The first genetically engineered drug was a form of human insulin approved in 1982, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). Since then, says PhRMA, more than 50 biotech products are in use, including treatments for cystic fibrosis and heart disease. Hundreds more are currently in development.
Meanwhile, an international consortium of researchers is furiously hurrying to finish sequencing the 3 billion bits of human DNA. A 90% complete rough draft is promised for next spring. In a biomolecular version of the moon race, a private, for-profit competitor, Celera Genomics, has promised to get the entire job done by 2001 -- two years ahead of the publicly sponsored genome initiative.
William Haseltine, the chairman and CEO of Human Genome Sciences, tells WebMD he sees such competition as healthy, and, as far as he's concerned, the controversy over gene patenting has already been resolved. He says the patent does not inhibit research but rather promotes it. In fact, Haseltine has been issued patents on 81 novel human genes and has filed for intellectual property rights on 6,700 others. He says the patenting of gene products has longstanding legal precedents, and that a patent is a way of sharing information with the public, not keeping it secret.
But with thousands of gene-related products already patented, some experts fear that the chunks of genetic material companies are staking out are too large. "The question is to what extent have people ... attempted to get patent protection on stretches of DNA sequences ranging from 100-base pairs to whole huge stretches of chromosomes ... how much will that stifle the ability of others to make secondary inventions?" Kathy Hudson, PhD, tells WebMD.
Hudson, who is the assistant director of the National Human Genome Research Institute, says she's not opposed to patents that have obvious biological use, since they wouldn't get in the way of research. Haseltine argues that large tracts of DNA simply can't be claimed, because the patent holder has to make some use of the invention or lose it.
But Hudson says "submarine patents" could have a chilling effect, "because you don't know it's there, and all of a sudden it comes up from below." Besides patent issues, ethical questions about genome research remain unanswered. "Please, let's get off the patent message and get on to something else, because that cat ran out of the bag," says Arthur Caplan, PhD, who is a medical ethicist with the University of Pennsylvania Health System.
Caplan, a paid consultant to Celera, says he has urged the company to make proprietary information available free to researchers. "The ability to exploit this new knowledge for benefit just imposes duties on people to treat it responsibly and with more of an eye toward good," Caplan tells WebMD.
However, he's concerned that the public will ultimately wind up paying twice for the genome -- once for the basic research, then again for the products when they're developed. "The race is set, the corporate guys have more resources than the public guys. I think the corporate guys are going to tie down significant chunks of the genome, and then it's going to require an appeal to their morality to get [the investment] back out in useful ways," says Caplan.