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Genes may become big business
Sunday, July 16, 2000 By Byron Spice, Post-Gazette Science Editor
Who owns your DNA?
You do.
But if you want your DNA tested to see if you carry certain mutated genes that increase your risk of breast and ovarian cancers, be prepared to pay a couple of thousand dollars to Myriad Genetics, a biopharmaceutical company in Salt Lake City, Utah, that owns the patent on those genes.
And if the day should come when parents can have their offspring genetically enhanced, it's just as certain that they will be paying a handsome fee to some company for souping up their baby's DNA with a patented technique.
As genetic discoveries move out of the laboratory and into the clinic, genes promise to be big business. Already, companies are finding several different ways to cash in on the trend.
Some, notably Celera Genomics, the Rockville, Md., firm that independently sequenced the human genome, plan to sell genetic information to researchers and pharmaceutical companies. Bioinformation firms such as Pittsburgh's Cybergenetics Inc. sell software for analyzing and processing the mountains of genetic data that are being generated.
Others, such as Affymetrix of Santa Clara, Calif., have developed technologies that allow doctors and researchers to rapidly test for thousands of genetic mutations.
But the companies that need gene patents the most are those developing gene-based tests and pharmaceuticals. These companies, including Human Genome Sciences, Incyte and Millennium Pharmaceuticals, have filed thousands of patent applications on genes as they seek exclusivity for their prospective products.
In fact, so many patent applications have been filed that researchers joke that 800 percent of the human genome has been patented.
A genetic test can be very lucrative, whether a company, such as Myriad, does the testing itself or simply licenses the technology to others. Several years ago, Dr. Mark Bogart of Biomedical Patent Management began enforcing a patent he owns on part of the "triple-marker" blood test given annually to 2.5 million pregnant women to screen for Down syndrome and other congenital abnormalities. The San Diego company demanded royalties of $5 to $9 per test. Bogart's attorney has said that agreements negotiated with major testing firms may bring his client $100 million over the term of the patent.
On a smaller scale, the University of Miami charges a $12.50 royalty on tests for Canavan disease. Miami has a patent on the gene for the rare disorder, which can result in mental retardation, inability to move muscles and blindness.
Tightening the rules
Scientists and physicians have grown uneasy about this race for patent rights. They worry that patents issued while knowledge of the genome is still sketchy might be overly broad, unnecessarily increasing the cost of medical care and cutting short work by other researchers.
The U.S. Patent and Trademark Office responded to these criticisms late last year.
It released proposed guidelines that would tighten the requirements for gene patents, requiring applicants to be more specific about how a gene discovery might be put to use. Predictably, some scientists, including leaders at the National Institutes of Health, say the new guidelines don't go quite far enough, while industry officials worry that the patent office has raised the bar too high.
The patent office says it will release its final guidelines this fall.
The concept of patenting a gene, or even an entire organism, is not new. In 1930, Congress made it possible to patent novel varieties of plants. Growers who discovered a particularly delicious peach or an everblooming rose, for instance, could win exclusive rights to grow it, even though they didn't create these plants.
In 1980, the U.S. Supreme Court ruled that Ananda Chakrabarty of the University of Illinois could patent an oil-eating bacterium he developed for use in cleaning up oil spills.
That might seem to suggest that each of us could patent our own genomes.
But that's not how patent law works.
Patents are issued to provide exclusive commercial rights for 20 years to someone who invents or discovers something that has a use. So even though we may own our genes, we don't have a right to patent them unless we discover new genes or otherwise perform some scientific analysis of them.
When the Chakrabarty decision was issued 20 years ago, both scientists and biotechnology firms were enthusiastic about it, said Daniel Kevles, a science historian at the California Institute of Technology in Pasadena, Calif.Biologists had invented genetic engineering techniques during the 1970s and both they and newly formed biotech firms such as Genentech believed the ability to patent genetically engineered organisms would encourage more research.
But the interests of scientists and industry now seem to be diverging, Kevles said.
"Many scientists worry that patenting will prevent them from working on patented genes," he noted.
Limiting research?
Jon Merz, a bioethicist at the University of Pennsylvania, said there is no research exception allowed under U.S. patent law, so researchers may be unable to search for new mutations in disease genes that already are patented, or may be inhibited from publishing their discoveries if they do. Patent holders are not required to license their discoveries to anyone, even researchers.
And if a scientist does work on a patented gene, or a gene for which a patent is pending, can that scientist obtain proper credit for a discovery? "If Celera owns a patent and I do work on it, I increase the value of Celera's patent," said Aravinda Chakravarti, a geneticist at Case Western Reserve University.
The fear is that companies are applying for patents -- and sometimes have been awarded patents -- on genes even though they have only limited knowledge about their function. Other researchers who learn additional information about the gene may unwittingly end up strengthening someone else's patent application.
For instance, many researchers were upset this winter when Human Genome Sciences was awarded a patent on CCR5, a gene that encodes a protein, called a viral receptor, found on the surface of immune system cells. CCR5 may be the main route that the human immunodeficiency virus uses to gain entry to a cell and thus may be useful for developing AIDS drugs.
What galled some scientists was that Human Genome Sciences didn't know CCR5 was involved in AIDS when it filed its patent application in 1995.
Its role in AIDS was established the following year by a National Institutes of Health team that included virologist Christopher Broder. "I'm flabbergasted," Broder told the journal Science after the patent was issued in February. The patent office, he complained, was rewarding "armchair science."
William Haseltine, chief executive of Human Genome Sciences, admits his company didn't know about the AIDS connection at the time of the patent filing. The company knew that CCR5 was involved in chronic inflammation and filed the patent application, describing how the information might be used for treating arthritis, liver disease and other ailments involving inflammation. But it noted that it also appeared to be a viral receptor and might be used to fight viral infections.
'The system worked'
Haseltine said he's sympathetic to those upset about the patent. But he argues that CCR5 is a good example of how the patent system should work.
When Haseltine's company won the patent, the discovery was published and the knowledge was made available to all. With patent protection in hand, the company is motivated to make the investment necessary to develop drugs and therapies that take advantage of CCR5, knowing competitors can't simply copy and market their own versions of the CCR5 drugs while the patent is in effect.
Developing new therapies is not without risk, he emphasized; earlier attempts to target another viral receptor proved a dismal failure in treating AIDS. Companies are not likely to take such a risk -- and benefit society if they are successful -- if they don't have exclusive rights on their developments for some period of time, he maintained.
Moreover, action by the patent office is not the final word. Disputes over patents can be taken to court, or cross patents can be negotiated to share royalties among parties who have contributed to a discovery, he added.
Although patent holders could keep other researchers from using their genes, Myriad spokesman William Hockett said his company doesn't see any advantage in that. The company can only benefit from uncovering new mutations to its patented breast cancer genes and, along with other researchers, regularly reports the new mutations it discovers to a public database.
Myriad allows researchers to do whatever testing they choose on the breast cancer genes without paying any royalty or obtaining a special research license, Hockett said, although they are prohibited from charging patients or insurers.
The company also performs tests at a discount for National Cancer Institute researchers.
"We've done everything we can to encourage research," Hockett said.
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