Rule changes expected to improve research

The San Diego Union-Tribune

Scientists expect access to human embryonic stem cells for research to improve thanks to new policies announced yesterday by a University of Wisconsin agency that controls the patents on the cells.

The policy changes and “clarifications” include one that is specifically directed at California: The taxpayer-funded California Institute for Regenerative Medicine will not have to buy a license to distribute funding for embryonic stem cell research.

“Hallelujah,” said Larry Goldstein, a University of California San Diego stem cell researcher who lobbied for the state stem cell initiative, when he heard about the policy changes.

“I’ve been writing letters all over the place complaining about their policies hampering research,” Goldstein said.

For several years researchers around the nation have accused the Wisconsin Alumni Research Foundation, or WARF, of stifling human embryonic stem cell research with its licensing policies on the cells.

WARF controls all human embryonic stem cells used in research in the United States because the process to derive them was patented by University of Wisconsin scientist James Thomson.

“These latest changes reflect an ongoing dialogue with researchers and university administrators across the country,” WARF managing director Carl Gulbrandsen said yesterday.

The new policies allow companies to support research at universities and nonprofit institutes without having to buy a license to use the cells. However, once the company wants to bring that research back in-house and use it toward a commercial product, it would have to buy a license.

“Our belief is that this will increase the number of companies involved in research and increase the funding for universities and nonprofit research institutes, which will lead to more treatments reaching patients,” said Andy Cohn, a WARF spokesman.

As a result, it could also increase the number of companies that ultimately seek a WARF license.

Researchers are also now free to provide their colleagues with copies of embryonic stem cells that they received from WARF.

“I couldn’t even share cells with colleagues before, so this is good,” said Jeanne Loring, an embryonic stem cell researcher at the Burnham Institute in La Jolla.

Loring and two taxpayer advocate groups have filed a challenge of the WARF patents with the U.S. Patent and Trademark Office, citing exorbitant licensing fees and arguing that Thomson’s work was not unique enough to qualify for a patent.

She suspects that the patent challenge and publicity about it contributed to the new policies.

But despite the policy changes, the patent challenge will not be dropped, said Loring and John Simpson, of the Foundation for Taxpayer and Consumer rights, one of the groups challenging the patents.

“A change in licensing policy of the human ES cell patents doesn’t solve the fundamental problem that the patents should not have been issued in the first place,” Simpson said. “The right thing for WARF to do is admit that it doesn’t deserve the patents and abandon them in their entirety.”
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Contact the author Terri Somers at: (619) 293-2028 or [email protected]