WASHINGTON – Federal health officials will meet this month with officers of a University of Wisconsin foundation to discuss the foundation's patents on embryonic stem cell lines.
The Wisconsin Alumni Research Foundation controls the absolute rights to five cell lines, but it also holds patents that may affect all 60 of the cell lines that President Bush has said federally funded scientists can use.
Officials said details of the meeting are still being sorted out, but the parties are expected to negotiate ways to satisfy any patent claims WARF has against embryonic cell lines created by laboratories outside the United States.
WARF officials said they believe that those foreign cell lines must be licensed under WARF's patent rights before they can be imported for use by American scientists.
Just how this claim will be resolved is one of the sticky issues to be negotiated with the National Institutes of Health, said Andy Cohn of WARF.
Dr. James Thomson of the University of Wisconsin was the first researcher to isolate and culture human embryonic stem cells. Scientists believe that embryonic stem cells can be coaxed to grow into any kind of cell in the body. It's believed that researchers can develop ways to culture cells that can energize ailing hearts, treat brain disorders such as Parkinson's disease, or perhaps even cure diabetes with new insulin-producing islets.
After the 1998 discovery, Thomson assigned the stem cell patents to WARF, a foundation that customarily controls the intellectual rights for discoveries made at the university.
Patents held by WARF include not only the five cell lines (endlessly growing colonies of identical cells) that were developed by Thomson, but also the laboratory methods that he used to produce those lines.
As a result, Cohn said, WARF believes that virtually all of the other embryonic cell lines now in existence come under the Thomson patent.
"Is it possible that there are cell lines not under our patent? I guess so," said Cohn. "But we believe they are all included."
Those foreign cell lines cannot be imported into the United States for use by NIH researchers unless they are licensed by WARF, said Cohn.
Bush said last week that federally funded embryonic stem cell studies would be limited to cell lines that were in existence on Aug. 9. This limitation, he said, meant that no more human embryos would be killed in order to get stem cells for federal research.
NIH officials said that an international survey found 60 or more embryonic stem cell lines -- in labs in Sweden, Israel, Australia, India and the United States -- that met the guidelines established by Bush. Federal officials said they plan to establish a registry of cell lines that meet Bush's requirements.
Some experts have said they are skeptical about how many of the 60 lines will eventually qualify for the registry. The WARF patent claims could add another complication.
Cohn said exactly how it will all be sorted out in negotiations with NIH is far from clear. "That's what this process will determine," he said.
Another complication is an agreement between WARF and Geron Corp., a Menlo Park, Calif., biotechnology company.
Geron financed much of Thomson's work, and WARF granted the firm research rights to the five cell lines and to six tissue cell types -- liver, muscle, nerve, pancreas, blood and bone -- that might be derived from those cell lines.
Some experts are concerned that Geron could lay claim to the results of any federally funded research involving cell types developed from the WARF stem cell lines.
But Cohn said that is not an issue in the NIH discussions about basic laboratory research.
"If a researcher makes a discovery using our stem cells, that researcher can patent that discovery and publish that discovery with absolutely no limitations from us," he said. "If that researcher wants to commercialize that discovery, then, and only then, would there be a negotiation with us or with Geron."