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As WARF Eases Requirements to License Stem Cells, IP Row Unfolds

NEW YORK (GenomeWeb News) — The Wisconsin Alumni Research Foundation, eager to make its human embryonic stem cell lines available “to as many researchers as possible,” last month 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.
But 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.
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,” Andy Cohn, director of government and public relations for the foundation, told BTW this week.
“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 said. “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.
“This is an effort by a non-profit foundation to get the cells out to as many researchers as possible,” he added.
The patents in question – US Nos. 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.
Last month, 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 non-profit 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.
On the same day that WARF issued its 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.
“James Thomson did not invent human embryonic stem cells,” Dan Ravicher, executive director of PPF, told GenomeWeb News sister publication Biotech Transfer Week. “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.”
Undeterred, Cohn said that in addition to the multiple academic stem cell licenses WARF has granted, it has negotiated licenses with 15 companies, including Advanced Cell Technology, Aruna Biomedical, Chemicon, ES Cell, Geron, ProteoSys, Stem Cell Technologies; and Cellular Dynamics International, which was co-founded by Thomson. WARF has 11 more licensing deals in the negotiation or draft phase.
But Ravicher shot back: “Just because you pay off the mob when they come over to your store doesn’t mean they have a right to exist. People pay a lot of money for a lot of things they shouldn’t have to.
“It does absolutely nothing to support the validity of the patents,” he said. “All it does is support the ability of WARF to harass people, and means that the price they’re paying is less than the risk of being harassed.”
But from WARF’s perspective, “what if a private company had made this discovery?” Cohn asked. “Do you think they would be in the business of distributing cells and announcing to the world and training people how to use their discovery?”

The complete version of this article appears in this week’s Biotech Transfer Week, a GenomeWeb News sister publication.

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