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Patenting Mother Nature

Under today's law, individuals can patent sequences of the human genome, effectively giving them ownership rights to that DNA.
by Rosalie Westenskow, UPI Correspondent
Washington (UPI) Jul 11, 2007
Legislation currently pending in Congress would prohibit researchers from patenting genes, but experts disagree on whether such a measure would help or hinder healthcare innovation. By granting patents for human genes, some experts argue the government encourages invention and discovery by rewarding researchers. It also leads to investments in businesses that own patents and prevents free riders, who pay nothing to sell a product that cost the original developers millions, said Robert Cook-Deegan, director for the Duke University Institute for Genome Science and Policy's Center for Genome Ethics, Law and Policy.

"The system of innovation will not work ... if, as soon as you put something on the market, someone else can make your product and they don't have to pay you anything," Cook-Deegan said Tuesday at a panel discussion on intellectual property and the human genome, hosted by the Genetics and Public Policy Center at Johns Hopkins University.

But some argue the very nature of genes exclude them from ownership. A 1981 U.S. Supreme Court case, Diamond vs. Diehr, excluded "laws of nature, natural phenomenon and abstract ideas" from patent law. The human genome fits into the natural phenomenon category and, as a result, is ineligible for individual ownership, said Barbara Caulfield, executive vice president and general council of Affymetrix, a California-based scientific and technical instruments company.

"To own the human genome, which has been around since the first ancestor any of us has ever had, whether you own one piece of it or all of it, is not what the law was meant to protect," Caulfield said. "Let's put the ownership where the innovation is really occurring, which is at the test ... (and) drug (level)."

Under today's law, individuals can patent sequences of the human genome, effectively giving them ownership rights to that DNA. Before the 1990s, few patent applications included references to DNA, but, from 1994 to 1999, the number of gene patents skyrocketed. Since then, the number has fluctuated from year to year, but one group of researchers recently put the tally of total gene patents granted in the United States at 4,270, which, altogether, cover 20 percent of the complete human genome.

But experts like Caulfield worry that allowing businesses and individuals to patent genes will stifle research and create monopolies. Caulfield pointed to the 1997 patent of BRCA, one of the primary genes involved in breast cancer. The patent holders, University of Utah and the biopharmaceutical company Myriad, own any tests that involve BRCA as part of their patent. As a result, if women want to be tested for their risk of breast cancer, they must go through Myriad.

The test currently runs at $3,000 -- a price tag that reflects Myriad's exclusive ownership of the gene itself, Caulfield said.

But colon cancer tests, which have no primary patent owner, also carry a hefty cost, averaging $2,500.

However, other evidence also points toward a low impact on research as a result of gene patents.

A survey of biomedical scientists conducted in 2005 for the National Academy of Sciences' Committee on Intellectual Property Rights in Genomic and Protein-Related Research Inventions, found little evidence of gene patents obstructing research.

In general, gene patents have not negatively affected healthcare research, said Scott Keiff, a research fellow at the Hoover Institution at Stanford University and a law professor at Washington University in St. Louis.

Other countries that have stricter rules about gene patents have not seen as much innovation as the United States, Keiff said.

"Only in the United States and after 1980, do you see an increase in the number of new drugs and devices on the market" said Keiff, who correlated these discoveries with the increase in gene patents in the last couple of decades. Not everyone agrees.

Rep. Xavier Becerra, D-Calif., has introduced legislation that would prohibit further patenting of genes.

The Genomic Research and Accessibility Act is currently in the House Judiciary subcommittee on Courts, the Internet and Intellectual Property, and Steve Haro, senior adviser for Becerra, said he has high hopes for the bill but expects it will be a fight to pass it.

"We're not running into obstacles yet because it's such a complicated issue that it's still too early for members to say whether they're for or against it," Haro said.

Passing the bill is crucial to leaving DNA in the public domain, he said.

"Patenting (a specific) gene ... is the analogous equivalent of patenting air, water, birds or even diamonds," he said.

Source: United Press International

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