WARF lifts some licensing restrictions on industry and academic research, but critics vow to continue challenging the patents

The Scientist Magazine

The Wisconsin Alumni Research Foundation (WARF) is loosening some licensing terms for their patents covering primate embryonic stem (ES) cells in order to facilitate research, the foundation announced Monday (January 22). These patents have drawn criticism from scientists and non-profit groups who argue they severely limit stem cell science.

“For years, the research community has been asking WARF to relax its grip on human ES cells, and I applaud the changes,” Jeanne Loring of the Burnham Institute told The Scientist. “The change in policy will make collaborations among scientists much easier.”

However, Loring noted that the research community remains largely beholden to WARF as long as the patents are in place. John Simpson, stem cell project director for the California Foundation for Taxpayer and Consumer Rights, who joined Loring to challenge the WARF patents last year, told The Scientist he has no plans to withdraw the challenge, and hopes the patents eventually disappear. “We think what WARF did validates what we’ve said,” he noted — namely, that the patents are limiting research. “What [WARF] has done is very good. I just don’t think they’ve gone far enough.”

Loring, Simpson, and other non-profit groups joined together to challenge WARF‘s patents on the grounds that the methods for isolating a primate stem cell line were obvious based on previous work, and therefore not patentable. At the coalition’s request, the U.S. Patent and Trademark Office (PTO) agreed to reexamine WARF‘s stem cell patents, which cover discoveries by James Thomson, a University of Wisconsin-Madison developmental biologist whose group was the first to isolate human embryonic stem cell lines in 1998. WARF patents and licenses discoveries of University of Wisconsin-Madison researchers. A spokesperson from the USPTO told The Scientist the re-examination of WARF‘s patents is still ongoing.

On Monday, WARF announced that, effective immediately, it was implementing three changes and “clarifications” designed to facilitate stem cell research. Specifically, the group is now letting companies sponsor research by academic or non-profit scientists without a license, enabling researchers to transfer cells for free, and permitting the California Institute of Regenerative Medicine (CIRM) to administer grants and collect money from grantees without remitting any payments to WARF.

WARF spokesperson Andy Cohn told The Scientist that the policy has always enabled CIRM to work without a license, but there was some confusion in the community on this point, so one purpose of yesterday’s announcement was to “re-confirm” CIRM‘s situation. He added that WARF decided to loosen the patents’ licensing terms after consulting with experts both inside and outside the university on how to facilitate research. “We want to make it easier for scientists to do the research,” he said.

Dale Carlson, a spokesperson for CIRM, called the changes a “major step forward in facilitating the sharing and accessibility of materials that will move stem cell research closer to therapies and cures.”

Michael West, CEO of Advanced Cell Technology and founder of Geron Corporation (a WARF licensee), told The Scientist that he knew of instances where the WARF patents have limited research, by scientists in both industry and academia. The recent changes to the patent may not have a “major” effect on research, but will likely do some good. WARF‘s decision to loosen the patents’ licensing terms “certainly will be helpful,” he said.

Loring, however, echoed Simpson’s misgivings that science will suffer as long as these patents exist. “I’m concerned that as long as the patents are in effect, WARF retains the power to arbitrarily make the licensing of the human ES [cell] patents as unrestrictive or restrictive as they wish,” she told The Scientist in an Email, and the patents “still should be invalidated.”

Jonathan Auerbach, president of GlobalStem, Inc., agreed that the patents remain a significant “roadblock” for research. The changes to the licensing terms don’t affect in-house industry research, and if GlobalStem receives, for example, an NIH small business grant of $100,000 for human ES cell research, the company would still have to turn over a sizeable proportion — perhaps in the range of $75,000 — to WARF in licensing fees, Auerbach noted. Loosening the restrictions “is progress, but it’s not enough,” he told The Scientist.

WiCell Research Institute, a WARF subsidiary, has distributed cells to more than 360 research groups in 40 states and 24 countries. The number of WARF commercial licenses has doubled in the last year alone.

Links within this article:

Wisconsin Alumni Research Foundation: http://www.warf.ws/

R. Gallagher, “End this stem cell racket,” The Scientist, November 1, 2006:
http://www.the-scientist.com/article/display/25131

J. Loring, “Sharing stem cell information,” The Scientist, May 9, 2005: http://www.the-scientist.com/article/display/15443

Foundation for Taxpayer and Consumer Rights: http://www.consumerwatchdog.org

C. Tran, “WARF stem cell patents challenged,” The Scientist, October 10, 2006: http://www.the-scientist.com/news/display/25037/

R. Lewis, “Stem cells… An emerging portrait,” The Scientist, July 4, 2005: http://www.the-scientist.com/article/display/15592

United States Patent Office: http://patft.uspto.gov

James Thomson: http://www.news.wisc.edu/packages/stemcells/thomson_bio.html

G. Slack, “California stem cell program is legal: Judge,” The Scientist, April 24, 2006: http://www.the-scientist.com/news/display/23342

Michael West: http://www.michaelwest.org

GlobalStem, Inc.: http://www.globalstem.com
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Cathy Tran contributed reporting to this article.

Contact the author Alison McCook at: [email protected]