The following Op-Ed commentary by FTCR's John M. Simpson was published in the Sacramento Bee on Sunday, July 2, 2006:
Suppose a California couple have completed treatment at an infertility clinic and now have two children. Thankful for their blessing, they donate surplus embryos from the process for research. Otherwise, the embryos would be discarded.
A university researcher uses one of the donated embryos to derive a line of embryonic stem cells. These cells are the basic biological building blocks and can develop into any of the 220 cells in the human body, from blood to muscle to nerve. Scientists believe they can learn to use stem cells to repair or replace damaged or diseased tissues, curing aliments such as Alzheimer's, Parkinson's, diabetes and spinal cord injury. Because of the potential of stem cell research, Californians overwhelmingly approved Proposition 71 in 2004, creating the California Institute for Regenerative Medicine (CIRM) to provide $3 billion for research over a decade by selling bonds.
In the laboratory, the researcher cultivates the cells for her project. Another scientist across the country is doing similar work and believes this line of cells could help his study. The Californian is glad to oblige and send some cells to further science.
Unfortunately, it's not that simple. The cells can't be sent unless the Wisconsin Alumni Research Foundation (WARF) says it's OK. WARF is a nonprofit foundation affiliated with the University of Wisconsin that manages inventions made by the university's professors.
Researchers can do nothing with human embryonic stem cells in the United States unless the foundation approves. It controls three patents. One on all primate embryonic stem cells, which includes humans, was issued in 1998. A second, specifically on human cells, was granted in 2001, and a third was issued last April. These patents cover not only the way University of Wisconsin researcher James Thomson isolated stem cells, but also the very cells themselves.
Patenting embryonic stem cells is like patenting food because you can cook.
Nonetheless, WARF claims -- and has for now been granted -- rights to all human embryonic stem cells in the United States. The patents' dubious validity is underscored by the fact that no other country in the world recognizes these claims.
WARF would have us believe it wants to "partner" with other researchers. But stem cell scientists, many of them reluctant to speak publicly because they fear they must work with the foundation in the future, say that its aggressive demands are impeding research.
Earlier this spring, Dr. Robert Goldstein, chief scientific officer for the Juvenile Diabetes Research Foundation, told a CIRM committee meeting that the patents are "a major inhibition to productive scientific research." Because of WARF's claims, Goldstein said, his foundation has funded scientists in other countries "to create new and better stem cell lines, and that process ' is currently flourishing." U.S. companies interested in conducting stem cell research report they have had difficulty getting funding because of the WARF patent demands.
Elizabeth Donley, WARF's general counsel, told a conference packed with biotech executives in San Francisco this spring that because California will require that 25 percent of eventual royalties received by nonprofit grantees be returned to the state, it is a commercial enterprise. Therefore, WARF would demand that CIRM fork over license fees on all state-funded embryonic stem cell research.
The WARF licensing claim is little more than an outrageous attempt to raid the taxpayers of California, who, when the bond financing is included, have $6 billion at stake.
Experts agree patents are necessary in later stages of research to commercialize a drug or treatment. The problem with the WARF claims is that they are too far upstream in the process. Its executives need to get the dollar signs out of their eyes and stop impeding lifesaving research.
About the writer: John M. Simpson is the stem cell project director for the Foundation for Taxpayer and Consumer Rights, a nonprofit, nonpartisan consumer advocacy group in Santa Monica. Reach him at [email protected]