It's in the Genes: Patent Barriers to Genetic Research

Article excerpt

IN 1998, WHEN UNIVERSITY OF WISCONSIN SCIENTIST Dr. James A. Thomson became the first person to isolate human embryonic stem cells, the patent on stem cells went into the hands of the Wisconsin Alumni Research Foundation (WARF). WARF then licensed the patent to the Geron Corporation to develop the stem cells into six specific types of human tissue.

But while the patent on stem cells was a boon to Wisconsin and Geron, much of the rest of the scientific community responded with a collective gasp. With control of such a patent, would WARF and Geron stand in the way of future research on stem cells either by exacting licensing fees for researchers who needed to use the patented cells or even preventing researchers from using the cells at all? With treatments for Parkinson's, heart disease and diabetes potentially hanging in the balance, such licensing questions were not just academic. But it wasn't until September 2001, when the National Institutes of Health forced WAKF to sign an agreement, that Wisconsin agreed to freely allow scientists from other universities to conduct their own research based on Wisconsin's patents.

Tales like this are beginning to raise concerns in the scientific community. With DNA-based treatments and procedures playing a growing role in the future of medicine, universities and private corporations alike have for years been rushing to be the first to patent new DNA-based "inventions." But a growing number of scientists are now beginning to raise concerns that excessive patenting could prove troublesome for the future of DNA-based research by placing costly infringement obstacles in the way of scientific discovery,

"There's definitely a lot of concern," says Tim Leshan, senior policy analyst at the National Human Genome Research Institute at the National Institutes of Health (NIH), which is in the process of issuing a best practices policy for genetic patenting.

"It's a big tax on the work going forward," adds Rebecca Eisenberg, a professor at the University of Michigan Law School. "It's a looming potential tax liability that might be dampening incentives to undertake risky, costly research."

GENETIC EXCLUSION

Since the field of genomic research is only about 10 years old, little data has been collected on what impact overzealous patenting has had. But already, some signs of danger are beginning to hint at a future where genetic research becomes increasingly difficult to conduct.

"Though there's not a lot of data, it's clear that some universities and companies are requiting exclusive licenses that make it so only a few people call conduct research, and that can stifle research," says Leshan.

Earlier this year, the National Research Council of the National Academies issued a report, "A Patent System for the 21st Century," that found problematic costs in the current patent system. "The gist was that it has increased costs of doing research at companies and universities," says Stephen Merrill, director of Science, Technology and Economic Policy at the National Academies and a lead author of the report. "Certainly, intellectual property complications delayed some work."

Meanwhile, a study led by Mildred Cho, the associate director of the Stanford University Center for Biomedical Ethics, has found that half of directors at genetic testing labs said the), chose not to develop a new test because of concerns about licensing. Additionally, one quarter of lab directors said that they had stopped providing at least one test because licensing fees made it too expensive.

Says Cho: "We also found that laboratory directors said people are less willing to share information they had found about certain diseases or genetic conditions because of the possibility somebody might want to patent it themselves or be working on getting a patent."

And, in a draft of new guidelines for best practices regarding genetic patenting and licensing, the National Institutes of Health writes that "anecdotal and empirical data is beginning to reveal a pattern of exclusive licensing practices for genomic technologies at U. …