NIH Negotiates with Wisconsin Group Over Stem Cell Patent

The New York Times features a front-page article on the Wisconsin Alumni Research Foundation's patent on human embryonic stem cells, and describes how the "complex tangle of intellectual property rights" has become a "pressing concern" for the NIH, as it seeks access to those cells for research. U.S. patent 6,200,806, issued to WARF on March 13, "is apparently the only one of its kind in the world," and covers both the method of isolating stem cells and the cells themselves. The patent grants the foundation control over who may work with the cells in the United States and for what purpose. As a result, WARF will be in a "powerful position" next week when health officials begin negotiations to permit federally funded researchers "broad access" to the cells. WARF Managing Director Carl Gulbrandsen said, "I don't want people to see us as an 800-pound gorilla. We will work very hard with the government to make sure that there is access to this technology and that our patents are not an impediment to researchers." The foundation filed for patent rights after University of Wisconsin biologist Dr. James Thomson successfully isolated the first embryonic stem cells in 1998. WARF then established the WiCell Research Institute to distribute the five patented stem cell lines developed by Thomson to academic researchers under a "materials transfer agreement," by which scientists pay $5,000 and agree to specific restrictions.

Now as the NIH works to negotiate its own materials transfer agreement with the foundation, many researchers are concerned that WARF's restrictions may impede stem cell science, or "push [it] overseas," where there are fewer research regulations. In addition, WARF granted commercial rights on six cell lines to the California biotech firm Geron Corp., giving the company "considerable say over who ultimately profits from stem cell therapies." The Times says that President Bush's decision to prohibit federal funding for the creation of new cell lines "may have strengthened the hands" of WARF and Geron by "reduc[ing] the chances that scientists would derive and patent cells that might challenge Wisconsin's dominance in the field" (Stolberg, New York Times, 8/17). On Monday, WARF sued Geron to block its efforts to extend these rights to 12 more cell types and ensure the "widest possible access" to stem cell research . Geron officials said yesterday that they are working to settle the suit with the foundation, adding that the firm supports stem cell research by other academic groups as long as they pay Geron for the right to use the technology commercially (Bloomberg News/Los Angeles Times, 8/17). WARF and Geron issued a joint statement saying they expect to resolve the suit "in the near future" (AP/Chicago Tribune, 8/17).