Stem-cell patents to be reviewed

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Wisconsin State Journal

The federal government will re-examine three stem-cell patents held by the Wisconsin Alumni Research Foundation, a move that could threaten WARF‘s financial windfall from the research and Madison’s prominence in the field.

About 70 percent of such reviews result in patents being altered or revoked, said Brigid Quinn, spokeswoman for the U.S. Patent and Trademark Office.

The review, requested in July by a California consumer watchdog group, could take up to two years, Quinn said. The patents will remain active during the process, she said.

The patent office made the decision Friday, but the parties involved didn’t learn about it until Tuesday.

The patents, based on work by UW-Madison scientist James Thomson, are controlled by WARF, the university’s nonprofit technology transfer arm.

The patents cover virtually all embryonic stem-cell research in the U.S. They apply to embryonic stem cells, the blank- slate cells thought capable of becoming all of the body’s 220 cell types, as well as the methods used to grow them.

Thomson is widely credited with being the first person to grow the cells in a lab, in 1998. He derived five of the 21 stem- cell lines available for federal funding by the Bush administration.

The review was requested by the Los Angeles-based nonprofit Foundation for Taxpayer and Consumer Rights, which is involved in California’s new $3 billion stem-cell research initiative.

The watchdog group and others involved in the initiative have been sparring with WARF over the patents and associated commercial research license fees to use stem cells. The licenses range from $75,000 to $400,000.

WARF can also earn money through royalties from products.

The critics say the patents are impeding research and forcing scientists and biotech firms to go overseas, where the patents are not in effect.

“We acted because of what we see as a true impediment to serious scientific research,” said John Simpson, stem-cell project director of the watchdog group. “We think we have a good case.”

Joining the watchdog group in the request for a review were attorneys at the New York- based Public Patent Foundation, which claims to have successfully narrowed patents held by companies such as Microsoft and Pfizer.

Jeanne Loring, a stem-cell researcher at the Burnham Institute for Medical Research in California, filed papers supporting the request.

Beth Donley, executive director of the WiCell Research Institute, the stem-cell subsidiary of WARF, said the patent office’s decision to review the patents did not come as a surprise because most requests are granted.

She denied the patents inhibit research, saying WiCell has provided licenses to more than 300 academic and nonprofit scientists for free as long as they are not commercializing their research.

“We believe this is a politically and financially motivated challenge to which we will respond in the appropriate legal forum,” Donley said in a prepared statement.

WARF‘s patents were issued in 1998, 2001 and this year.

The first patent is for stem cells from primates, while the second patent is for stem cells from humans. The third patent involves a new method to grow stem cells without using animal products.

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

Cited in the request for a review were 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.

Each citation raises a “substantial new question” about the validity of the patents, patent office examiners said in their decision to grant the review.

“There is a substantial likelihood that a reasonable examiner would consider the teachings (of each work cited as) important in deciding the patentability of claims,” the examiners wrote.

Donley said WARF “will affirm the validity of the patents.”

In third-party requests for patent reviews such as this one, one or more of the patent claims are changed 59 percent of the time, Quinn said. In 12 percent of cases, the patents are canceled. Patents are fully upheld 29 percent of the time.

The average review takes 21 months, and the patent office tries to complete each review within two years, Quinn said.

Patent challenge

WHAT’S NEW: The U.S. Patent and Trademark Office has decided to grant a California group’s request to re-examine three patents on stem cells held by the Wisconsin Alumni Research Foundation.

WHAT’S NEXT: WARF, affiliated with UW-Madison, can file a response with the patent office within two months. The average review takes 21 months.

THE EFFECT: If the patents are overturned or narrowed, WARF could lose future licensing fees and royalties on stem-cell developments.
Contact the author at: 608-252-6125 or [email protected]

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