Keeper Of The Stem Cells

By MICHAEL D. LEMONICK

When President Bush laid out his long-awaited policy on stem-cell research on Aug. 9, he painted a rosy picture of the scientific flowering that might result. With some 60 lines of embryonic stem cells to study and the power of government funds behind them, scientists would now be able to use these biological wonders to search for possible cures for all sorts of ills, from diabetes and heart disease to Alzheimer's--all without taking a single additional embryo.

What the President didn't mention: to make all this happen, the University of Wisconsin would have to agree. It was at Wisconsin that biologist James Thomson first isolated embryonic stem cells in 1998. And it is at the affiliated, nonprofit Wisconsin Alumni Research Foundation that the patent governing such cells--whether they were isolated at Wisconsin or not--resides. Anyone who wants to work with them may well have to sign an agreement with WiCell Research Institute, which was set up to distribute WARF's stem cells.

Recognizing the concerns of many scientists, the National Institutes of Health and WARF plan to meet this week to establish guidelines to accommodate the deluge of researchers who are expected to want access to stem cells. "I'm pretty confident that we can craft an agreement," says Maria Freire, head of the NIH's Office of Technology Transfer. "It's in everybody's best interest."

Despite fears expressed by many scientists that they would have to pay dearly to work on stem cells, officials at WARF are echoing Freire's sentiments. The foundation has licensed the Menlo Park, Calif., biotech firm Geron to commercialize six specific cell types derived from Thomson's five primary stem-cell lines--though it is fighting the company's attempt to extend that license to 12 more derived types.

But when it comes to research on the basic stem cells themselves, WARF and WiCell insist that they are planning to get as many independent researchers involved as possible to maximize the chance that something useful will come of stem cells. Those researchers will have to pay WiCell a nominal fee--$5,000--and may have to share royalties with the foundation on any commercially successful therapies.

But WARF's royalties will be low--historically they have ranged from less than 1% to 5% of net sales, with a fifth of that going to the scientist who made the original discovery. That's partly to make research widely available while still compensating scientists for their intellectual-property rights. "We have tried to make this access as open as possible," says WARF spokesman Andrew Cohn. "Imagine if a private company had sole control of this patent." Indeed, says Todd Dickinson, a patent attorney and former head of the U.S. Patent Office, "it sounds like WARF is trying to keep access more open than it might otherwise be."

The NIH negotiations this week will apply only to scientists who work directly for the federal agency. But according to NIH officials, any agreement will serve as a future guideline for all researchers who get government stem-cell funding. And unless the NIH and the folks from Wisconsin are badly overestimating the goodwill on both sides, those guidelines shouldn't be awfully hard to live by.

--By Michael D. Lemonick. Reported by David Bjerklie and Andrew Goldstein/New York

With reporting by David Bjerklie and Andrew Goldstein/New York