Researchers join stem cell patent debate

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The San Diego Union-Tribune

Four internationally recognized stem cell researchers are supporting a challenge to the embryonic stem cell patents held by the University of Wisconsin.

The process that Wisconsin researcher James Thomson used to create human embryonic stem cell lines was obvious to anyone skilled in stem cell research, the four scientists said in declarations filed Friday with the U.S. Patent and Trademark office.

“I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious,” Harvard stem cell scientist Douglas Melton wrote to the patent office.

The declarations are part of a legal challenge previously filed by two taxpayer advocacy groups against the Wisconsin patents. In April, the patent office issued a preliminary ruling rejecting the patents, but the university is exercising its right to appeal.

The patents were issued in 1998, 2001 and 2006. They cover the process used to pull stem cells out of fertilized embryos. They also cover the embryonic stem cells themselves, making it necessary for researchers to pay a licensing fee to use the cells no matter where the cells are obtained.

The nonprofit Foundation for Taxpayer and Consumer Rights in Santa Monica and the New York City-based Public Patent Foundation claim the patents never should have been issued because the science involved was not unique. Under U.S. law, a patent should be issued only if the science is new and not an obvious next step to anyone familiar with the particular field.

In their challenge filed last July, the groups said the patents are unjustly hampering human embryonic stem cell research within the United States.

Last month, the University of Wisconsin Alumni Research Foundation, which is responsible for licensing and patents, filed its appeal to the patent office’s preliminary ruling.

Research foundation Managing Director Carl Gulbrandsen said the patent office rejected the stem cell patents based on an analysis of several previous patents and scientific publications that were not relevant to Thomson’s work.

Colin Stewart, a stem cell researcher at the Institute of Medical Biology in Singapore, filed a declaration supporting Gulbrandsen’s argument. The previous work the patent office relied upon involved studies of mouse stem cells, not the human embryonic stem cells that were isolated and characterized by Thomson, Stewart said.

The challengers then were permitted one more opportunity to submit arguments for their case, before the patent office makes a final ruling.

In addition to Melton, who founded the Harvard Stem Cell Institute, other scientists who filed declarations opposing the patents were Alan Trounson of Monash University in Australia, Chad Cowan of Harvard University and Jeanne Loring of the Burnham Institute for Medical Research in La Jolla.

All the scientists said that at the same time Thomson was trying to create human embryonic stem cell lines, they were trying to do the same thing. As a guide, they used the previously published works of several other scientists who derived stem cell lines from mouse, sheep and pig embryos.

The purpose of doing work in animals is so scientists then can try the techniques on human cells, the scientists said.

All said they did not need to refer to Thomson’s work to create the stem cell lines.

The scientists said Thomson had an advantage because he had access to human embryos, which were difficult to obtain at that time, and he had funding from Geron, a private biotechnology company. At the time, there was no federal funding for the research. Human embryonic stem cell research was illegal in some states.

“I very much believe that Dr. Thomson deserves the scientific and public recognition he has received,” Melton said. “However, he deserved that recognition because he undertook the arduous and timely task of getting fresh and high-quality human embryos to use as starting material in his work, and sufficient funding for such research, not because he did anything that was inventive.”

If the University of Wisconsin Alumni Research Foundation loses its appeal to the patent office, it could take its case to federal court.
Contact the author Terri Somers at: (619) 293-2028; [email protected]

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