Rules on stem cell licensing loosened;

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Lower research cost possible

Milwaukee Journal-Sentinel

Under pressure from researchers and foundations on both coasts, and under the guidance of a new licensing director, the Wisconsin Alumni Research Foundation said Monday it has loosened its licensing policies for embryonic stem cells.

The foundation, known as WARF, holds three broadly written, basic patents on embryonic stem cells based on the pioneering work of University of Wisconsin-Madison scientist James Thomson. Thomson in 1998 was first to isolate the cells, out of which virtually all organs, cells and other body tissue arise.

WARF will now allow companies to sponsor research at an academic or non-profit institution without a license. The foundation previously allowed such research to proceed without licenses only at Wisconsin-based institutions.

The new policy will allow companies to perform stem cell research for a lower cost, which is likely to cause companies to increase their funding for it, said WARF managing director Carl Gulbrandsen. The companies will still need a license from WARF when the stem cell research is brought into their own laboratories, he said.

“It’s clear they are responding to all the complaints” launched by the academic and research communities, said John M. Simpson, stem cell project director at the Foundation for Taxpayer and Consumer Rights in Santa Monica, Calif. WARF‘s “patents and the way WARF was doing business was clearly an impediment to research.”

The Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation in New York asked the U.S. Patent and Trademark Office in July to re-examine WARF‘s embryonic stem cell patents. They claim that Thomson wasn’t the first to isolate human embryonic stem cells. WARF‘s patents are “over-reaching and based on prior art,” Simpson said.

WARF‘s changes reflect ongoing discussions with researchers and university administrators around the country, Gulbrandsen said. They also are the result of a review of WARF‘s policies by Craig Christianson, who has been the foundation’s licensing director for about a year, spokesman Andrew Cohn said.

“We believe this policy will increase funding for stem cells and get the research into more companies more quickly. Therefore, if more companies are doing it, the chances are more companies are going to be successful and they’ll need a license,” Cohn said.

Other changes WARF announced are:

– As long as the proper paperwork for embryo donations is in place, WARF will allow academic researchers to transfer cells among themselves. Previously, they had to obtain WARF‘s permission first.

– The California Institute for Regenerative Medicine – the non-profit organization set up to allocate the $3 billion of state money allocated to stem cell research over the next 10 years – does not need a license or agreement from WARF. In early 2006, Beth Donley, WARF‘s then-general counsel, created a stir by answering questions at a stem cell conference that were interpreted as suggesting the institute would need a license.
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