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WARF Updates Embryonic Stem Cell Policy; IP Battle Unfolds

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The Wisconsin Alumni Research Foundation, eager to make human embryonic stem cell lines available “to as many researchers as possible,” in February changed and clarified policies that govern how it licenses the cells.

The changes, which include new guidelines for company-sponsored academic research and lab-to-lab transfer of cells, have thus far been welcomed by the hESC research community.

However, a pair of non-profit watchdog groups and a prominent stem-cell researcher maintain that the changes are inadequate, and that the patents that protect WARF’s stem cells are invalid. As a result they have asked the US Patent and Trademark Office to re-examine the IP that covers the stem cells.

WARF doesn’t buy it. “I think that there has been a lot of misunderstanding from the beginning about our efforts to distribute the cells and to make them available to researchers,” says Andy Cohn, director of government and public relations for the foundation.

“From the beginning, our policy was that a researcher could get our cells for what it cost us to set up a lab and distribute those cells,” Cohn says. “And then they could patent any discovery they then made with those cells — they wouldn’t have to check with us, and they would own the patent, and there would be no restriction on publication.”

The patents in question — US Patents 5,843,780; 6,200,806; and 7,029,913 — are all entitled “Primate embryonic stem cells,” and pertain to specific purified preparations of primate ESCs, as well as methods for isolating the cells. The inventor on all the patents is University of Wisconsin professor James Thomson.

In February, WARF announced three changes and clarifications to the policies governing how it licenses the cells. First, WARF created a policy allowing companies without a license to the cells to sponsor research on hESCs at academic or nonprofit institutions. WARF added that companies would need a license if and when they brought the research into their laboratories.

Second, WARF has enacted policies that will enable “easier and simpler, cost-free cell transfers among researchers,” according to the statement. Finally, the foundation clarified that the California Institute for Regenerative Medicine does not require a license or agreement from WARF to fund hESC research in California.

The latter clarification coincided with an announcement by CIRM, a nonprofit research institute established in early 2005, that it had approved 72 stem cell-related research grants totaling $45 million over two years to 20 academic and nonprofit research centers in California.

On the same day that WARF issued its statement on policy changes, the Foundation for Taxpayer Consumer Rights, a California-based consumer watchdog group, said that the changes were “a step in the right direction, but don’t go far enough.”

In fact, the FTCR, along with New York-based watchdog group Public Patent Foundation and Burnham Institute for Medical Research stem cell scientist Jeanne Loring, believe that the patents shouldn’t even exist, and have publicly stated that WARF should abandon its claims to them.

University of Wisconsin professor “James Thomson did not invent human embryonic stem cells,” says Dan Ravicher, executive director of PPF. “No matter how many people say that he did, he did not. He doesn’t deserve to have these patents, and WARF doesn’t deserve to have these patents.”

WARF’s Cohn says, “If anybody thinks that what Dr. James Thomson discovered is not a new discovery — that if 50 other scientists weren’t trying to do the same thing — then how come everybody is so excited about it?”

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