Agency Agrees to Review Human Stem Cell Patents [NYT]
By ANDREW POLLACK
Published: October 4, 2006
The United States Patent and Trademark Office has agreed to re-examine the validity of fundamental patents on human embryonic stem cells granted to a scientist at the University of Wisconsin.
The decision, disclosed on the agency’s Web site, could lead to a narrowing or even a rescission of the three patents, which some scientists and consumer groups say are hindering research into a fledgling field that holds great medical promise.
The request for re-examination was filed in July by the Foundation for Taxpayer and Consumer Rights, a California consumer group, and the Public Patent Foundation, a New York organization advocating patent reform.
The patents are based on work by a University of Wisconsin scientist, James A. Thomson, who was the first to isolate human embryonic stem cells. The stem cells have the potential to turn into any type of tissue in the body and could one day lead to treatments for numerous diseases.
In their request for a re-examination, the consumer group and the Public Patent Foundation said Dr. Thomson’s work did not deserve patents because three scientific papers by others and one previous patent had already laid out how to derive embryonic stem cells in various animals including mice, pigs and sheep.
The patent office said the references cited in the petition raised substantial new questions about the patentability of the Wisconsin work.
Re-examinations brought about by a third party, as this one was, result in all the patent claims being canceled 12 percent of the time, said Brigid Quinn, a spokeswoman for the patent office. In another 59 percent of cases, smaller changes are made. Ms. Quinn said the patent office receives 400 to 500 requests for re-examinations each year and grants 90 percent of them.
The Wisconsin Alumni Research Foundation, or WARF, a patent licensing organization affiliated with the university, provides academic researchers with free licenses and charges them $500 for cells. Companies are charged $75,000 to $400,000, depending on their size and the terms of the license. One company, the Geron Corporation, has exclusive commercial rights to heart, nerve and pancreatic cells derived from the embryonic stem cells.
The California consumer group and some scientists say these conditions have slowed research and caused some of it to be moved offshore, since the patents apply only in the United States.
Last week, Gov. James E. Doyle of Wisconsin announced an agreement with WARF under which companies sponsoring stem cell research at academic or nonprofit research institutes in Wisconsin would get free licenses to the patents for such work. His office said that would give Wisconsin “a significant competitive advantage” over other states.
Elizabeth L. R. Donley, special counsel to WARF, said in a statement yesterday that the patents do not impede research and that the foundation had given free licenses and cells to 324 research groups. She said she was confident the validity of the patents would be affirmed.
“We believe this is a politically and financially motivated challenge, to which we will respond in the appropriate legal forum, which is the United States Patent and Trademark Office,” she said.
It could take years, however, for the patent office to finish its re-examination.
Daniel B. Ravicher, executive director of the Public Patent Foundation, said the fact that the patents are undergoing re-examination will make it harder for WARF to charge high fees. “Now WARF has lost a lot of the credibility and leverage that these patents give them,” he said.
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