Wisconsin State Journal
The federal government has preliminarily rejected three controversial stem-cell patents held by UW-Madison, saying discoveries by researcher James Thomson were “obvious to one of ordinary skill.”
The decision could greatly affect the university’s prominence in the burgeoning field and stop the millions of dollars the patents are bringing in.
Critics of the patents, who say they stifle research, said the decision will likely kill the patents. But UW-Madison officials said they will appeal, a process that could take months or years. During that time, the patents will remain active.
“Although these patents aren’t dead, they have been diagnosed with severe cancer,” said Dan Ravicher, executive director of the New York-based Public Patent Foundation. “The chilling effect caused by (UW- Madison’s) aggressive pursuit of these patents could be over and people could be free to do research.”
The patent foundation — along with the Los Angeles-based Foundation for Taxpayer and Consumer Rights, involved in California’s $3 billion stem-cell research initiative — asked the U.S. Patent and Trademark Office to review the patents in July.
The patent office posted the rejection on its Web site Friday, and the California group distributed the documents Monday. The decision is preliminary, patent officials said, and the university has two months to file an appeal.
“This is no way a final action,” said Andy Cohn, spokesman for the Wisconsin Alumni Research Foundation, the nonprofit tech-transfer arm of UW-Madison. “It gives us an opportunity to show (the patent office) why they’re in error.”
At issue are three of WARF‘s six stem-cell patents. Each is based on work by Thomson, who in 1998 became the first scientist in the world to grow a colony of the cells from humans in a lab. The patents, which cover virtually all stem-cell research in the country, were issued in 1998, 2001 and 2006.
The patents have brought in at least $3.2 million to WARF and could net much more money before they expire in 2015. Companies wanting to study the cells must buy licenses costing $75,000 to $400,000, though since January, WARF waives the fees if the research is conducted at universities or by nonprofit groups.
Critics say the fees have driven some stem-cell research overseas.
Embryonic stem cells, believed capable of becoming all of the body’s 220 cell types, could someday be used in therapies for diabetes, Parkinson’s disease and other conditions.
Critics argue that Thomson’s accomplishment in 1998 was not worthy of patents. His work was “obvious,” they say, because other scientists had done similar research in mice, pigs and sheep.
In its preliminary rejection, the patent office agreed. Its explanation focused on Thomson’s extraction of stem cells from blastocysts, or embryos about 5 days old.
“It would have been obvious to one of ordinary skill in the art at the time the instant invention was made to extend the blastocyst method of isolating embryonic stem cells from one (or more) mammalian species (mice and/or pigs and/or sheep) to another (humans),” examiners with the patent office wrote.
Thomson could not be reached for comment Monday. In a previous interview, he said, “some very good, simple ideas only seem obvious afterwards.”
Carl Gulbrandsen, managing director of WARF, said in a prepared statement Monday that “when all of the facts are known and the process runs its course, our patents will be upheld.”
After WARF files its appeal, the patent office will issue a final decision. That decision could uphold or reverse the preliminary rejection of the patents, or narrow some of their claims.
WARF could appeal the final decision to the patent office’s board or to federal court, said Brigid Quinn, a spokesman for the patent office.
Patent office reviews ultimately result in patents being narrowed or canceled about 70 percent of the time.
The UW patents case:
WHAT’S NEW: The U.S. Patent and Trademark Office has preliminarily rejected three stem-cell patents held by the Wisconsin Alumni Research Foundation.
WHAT’S NEXT: WARF will file an appeal, due in two months. The patent office will then issue a final decision, which WARF could appeal to the patent office’s board or to federal court.
THE EFFECT: If the patents are ultimately rejected, that could threaten UW-Madison’s prominence in stem-cell research and halt the millions of dollars the patents are bringing to the university.
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Contact the author David Wahlberg at 608-252-6125.
