WARF stem-cell patents challenged

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Wisconsin State Journal

A California consumer watchdog group Tuesday asked the federal government to overturn three stem-cell patents held by the Wisconsin Alumni Research Foundation.

The challenge, over patents based on work by UW-Madison scientist James Thomson, could threaten WARF‘s financial windfall from stem-cell research and its prominence in the emerging field.

Thomson is widely credited with being the first person to successfully grow human embryonic stem cells in the lab, in 1998.

The Los Angeles-based nonprofit Foundation for Taxpayer and Consumer Rights, involved in California’s new $3 billion stem-cell research initiative, filed requests asking the U.S. Patent and Trademark Office to re-examine the patents.

The requests, which could revoke or restrict the patents in a process that could take years, argue that other scientists previously showed how to grow the cells.

The watchdog group was joined in the filings by attorneys at the New York-based Public Patent Foundation, which claims to have successfully narrowed patents held by such corporate big-hitters as Microsoft and the drug company Pfizer.

The California group announced its action on the same day the U.S. Senate approved expanded federal funding for embryonic stem-cell research, which President Bush has vowed to veto.

Leaders of the watchdog group said WARF‘s patents hinder stem-cell research more than Bush’s controversial policy limiting federal research money to certain groups of cells, including some developed by Thomson.

Bush’s policy aimed to prevent the destruction of human embryos, required to obtain the cells. Of the 22 viable stem-cell lines created before the policy was enacted in 2001, five are directly controlled by WARF, but its patents affect all such cells.

“The folks in Wisconsin need to get the dollar signs out of their eyes and stop impeding vital research that needs to go forward,” said John Simpson, stem-cell project director of the watchdog group.

Carl Gulbrandsen, managing director of WARF, said in a prepared statement that the patents don’t block research. “They support and encourage it,” he said.

WARF‘s patents, issued in 1998, 2001 and this April, cover most human embryonic stem cells used in U.S. labs. They require virtually all researchers to go through WARF to study the cells.

Companies wanting to commercialize research based on the cells also must negotiate licenses with WARF.

The first two patents cover not only stem cells but the methods used to derive and grow them. The first patent is for cells from primates, while the second is for cells from humans.

The third patent involves a new method to grow stem cells without using animal products. The technique is considered key to safely developing the cells as therapies for conditions such as Parkinson’s disease, diabetes and spinal cord injury.

The watchdog group and other critics say WARF‘s patents are slowing the progress of stem-cell research in the United States.

“It’s making scientists go overseas,” said Jeanne Loring, a stem-cell researcher at the Burnham Institute for Medical Research in California, who filed papers supporting the requests to re-examine the patents.

The requests say the patents should not have been issued because Thomson’s discoveries were “obvious,” meaning that other scientists had publicly paved the way for what he did.

Cited are three papers on how to isolate stem cells, published in 1983, 1987 and 1990, along with a patent on such work awarded to an Australian researcher in 1992.

The published papers discussed how to grow stem cells from rodents, pigs and sheep, and the Australian researcher’s patent also covered stem cells from humans, said Dan Ravicher, an attorney with the Public Patent Foundation.

WARF shouldn’t be given patents potentially worth hundreds of millions of dollars for coming up with what is essentially the same stem-cell recipe, Ravicher said.

“If you know of a way to deep-fry French fries, that same process can be used to fry zucchini, broccoli, chicken nuggets and everything else,” he said.

WARF wouldn’t respond to the specific charges in the filings or to Ravicher’s comments.

Thomson wasn’t available for comment, university officials said.

“We will respond to what we believe is a politically and financially motivated challenge in the appropriate legal forum,” which is the patent office, Gulbrandsen’s statement said.

WARF argues that it has sped up stem-cell science by shipping cells to more than 300 research groups in 21 countries. The price is $500 for academic researchers and up to $125,000 for private labs.

The California company Geron, which funded Thomson’s initial work, would have filed patents that would be more restrictive if WARF hadn’t sought them, Gulbrandsen has previously said.

Gulbrandsen has also hinted that WARF is prepared to defend challenges to its stem-cell patents. “It’s said that you draft a patent for the courtroom,” he said in a previous interview.

The federal patent office, which granted about 160,000 patents last year, gets about 450 requests for re-examinations of patents each year, spokeswoman Brigid Quinn said.

About 70 percent of the requests result in modifying at least one of the patent’s claims, with a small number leading to full cancellation of the patent, she said.

Ravicher, of the Public Patent Foundation, said the patent office generally decides within three months whether to proceed with a request. If it does, the review process can take 18 months to 10 years, he said.
Contact the author at [email protected] or 608-252-6125.

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