Stem cell debate raises ownership questions
By David Williams
ATLANTA, Georgia (CNN) -- President Bush's decision to allow federal funding for existing lines of embryonic stem cells raises questions about who owns the cells and controls the intellectual property rights to any medical discoveries that may come from the research.
Stem cells are blank cells that can be turned into specialized cells such as heart cells, or any kind of tissue in the body, such as skin, muscle or the brain. Embryonic stem cell research is controversial, because they are created from embryos, which are destroyed in the process.
Scientists believe stem cells could one day be used to create treatments for diabetes, Parkinson's disease, spinal cord injuries and other disorders.
The National Institute of Health has identified 64 lines of embryonic stem cells, held by 10 organizations in the United States, Sweden, India, Australia and Israel. However, there are questions about how many of these lines are suitable for research.
Sen. Edward Kennedy (D-Massachusetts), chairman of the Senate Committee on Health, Education, Labor, and Pensions, said Wednesday that President Bush's plan could create a monopoly on stem cell research.
"People complain about OPEC being a monopoly, and even they have 11 members," Kennedy said.
Companies seek a return for granting access
Health and Human Services Secretary Tommy Thompson announced Wednesday that his agency had reached a deal Tuesday with the Wisconsin Alumni Research Fund (WARF), which owns the U.S. patent on the method used to isolate embryonic stem cells.
Embryonic stem cells were discovered in 1998 by a team led by University of Wisconsin biologist James Thompson.
WARF and its subsidiary WiCell currently license stem cell technology to researchers at academic and nonprofit institutions, as well as corporations.
Thompson said that under the agreement, NIH scientists will be able to access the five stem cell lines WARF and WiCell control, without limits on their ability to publish their findings. He said the NIH would retain intellectual property ownership of any discoveries that result from that research.
"This is a groundbreaking agreement … that hopefully will serve as a model for making the other lines available." Thompson said. "It also gives an indication of how serious the owners of these lines are about making their products available for basic research."
BresaGen, an Australian biotech company with a stem cell laboratory in Georgia, announced last month that it would provide free access to the four stem cell lines it holds.
"BresaGen would like to give the cells away because we think from a moral and ethical standpoint, the more widely disseminated the cells are to do bona fide research and development, then the better off everybody would be because we want to find cures to degenerative diseases in a timely fashion," BresaGen senior vice president and chief scientific officer Allan Robins said.
Robins said his company would expect something in return.
"The return we would talk about is a first right to look at intellectual property they would develop, the first right for BresaGen to license that intellectual property, because in BresaGen's opinion that's the upside," he said.
Karen Hersey, senior counsel for intellectual property at the Massachusetts Institute of Technology, testified Wednesday that these kinds of arrangements are not uncommon when negotiating the terms for transferring scientific materials.
"Materials owners may require an exclusive license, royalty free, to all inventions or research results made through use of the materials, or they may require open-ended options or first refusal rights to license inventions relating to use of the materials," she said.
She said that in some cases, material transfer agreements are structured so that the owner of the material will also own any discoveries made by researchers using that material.
Hersey testified that agreements between researchers have gotten more complex since researchers and biotech firms discovered in the 1980's and 1990's that their discoveries could be patented.
"From then on, the materials, especially those that were unique took on an added value, and the transfer of them under terms that would protect the intellectual property rights of the owner became of singular importance," she said.
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