Stem cell patents challenged

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Sacramento Bee

While Congress argued the morality of embryonic stem cell experimentation Tuesday, a separate national fight erupted over rights to the financial fruits of such research.

A Santa Monica-based consumer advocacy group announced that it has appealed to the U.S. Patent Office to revoke three patents held by a University of Wisconsin foundation that cover virtually all embryonic stem cell research.

The patents cover the process by which researchers isolate stem cells from a week-old embryo. This standard method yields the cells used in virtually all embryonic stem cell experiments. So, any university or biotech company that wants to do that sort of research in the United States must negotiate a license from the Wisconsin Alumni Research Foundation.

The group argues that the patents are overly broad and will discourage companies from bringing stem cell treatments to market. The issue is particularly glaring in California, where many hope to see medical breakthroughs from $3 billion in bond funding authorized by Proposition 71.

“We don’t think the research developments are going to come to fruition” if the patents stand, said John Simpson, spokesman for the Foundation for Taxpayer and Consumer Rights. “That’s why we’re trying to break the patents.”

Embryonic stem cells are drawn from an embryo soon after fertilization. They can mature into any kind of cell of the body. Because of that special characteristic, they are thought to hold a key to treating a wide variety of diseases, such as AIDS and diabetes. Treatments employing embryonic stem cells, however, are still years away.

While the Wisconsin group gives out free licenses to academic researchers, the patents give it a right to negotiate a cut of the royalties from any treatments that arise from that research.

Because the patents don’t apply outside the United States, Simpson said, biotech companies will be motivated to set up shop abroad to avoid the licensing requirements.

In a short statement Tuesday, Carl Gulbrandsen, managing director of the Wisconsin research foundation, said that the group stands behind the patents and called the challenge “politically and financially motivated.”

Negotiating patents and licenses is an everyday part of biotech research and development. But, said Wendy Streitz, policy director for the University of California’s office of technology transfer, the way that Wisconsin is choosing to exercise its patent rights is unusual.

“It’s not the cost of the license that’s the issue. It’s the very fact that we’re being asked to take one” — a requirement that breaks with academic tradition, she said. “There is the concern that if this became common practice, university technology transfer offices would be spending all of their time issuing licenses to each other.”

In its appeal to the Patent Office, Simpson’s group argues that the patents should be invalidated because they don’t represent an original advance deserving of intellectual property protection.

“The ‘Eureka moment’ that WARF claims was the decision (by a University of Wisconsin researcher) to use the same methods that everybody had used before” to isolate stem cells from embryos of other mammals such as mice, said Jeanne Loring. Loring is a San Diego-based stem cell researcher who submitted a sworn declaration in support of the challenge.

The U.S. Patent Office likely will decide whether to consider the patent appeal within six months, said Bill Warren, an intellectual property attorney in Atlanta.

A full review of the patent could take several years, he said.

Consumer Watchdog
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