Wisconsin Alumni Research Foundation changes stem cell policies to encourage greater academic, industry collaboration

The Wisconsin Alumni Research Foundation (WARF) announced today three policy changes and clarifications that are expected to have a positive affect on stem cell research. The new policies will affect industry-sponsored stem cell research, academic and commercial licensing, and WARF’s relationship with the California Institute for Regenerative Medicine (CIRM), and will apply to current and future license agreements.


“WARF’s stem cell policies have evolved over the years, always in favor of increasing access and making it easier for scientists to move the technology forward,” said Carl Gulbrandsen, managing director of WARF. “These latest changes reflect an ongoing dialog with researchers and university administrators across the country.”


Industry-sponsored stem cell research will be facilitated by a new WARF policy that will enable companies to sponsor research at an academic or non-profit institution without a license, regardless of location and regardless of intellectual property rights passing from the research institution to the company. This will enable companies to get started with stem cell research in a low-cost, visible manner and increase funding of stem cell research by for-profit companies. Companies will still need a license when they want to bring the research into their company laboratories or when they want to develop a product for the market.


These policy changes should help universities engage industry sponsors in human embryonic stem cell research projects,” said Jon Soderstrom, managing director of the Office of Cooperative Research at Yale University.Our collective research efforts will benefit from this new approach.”


Second, while ensuring provisions related to informed consent for embryo donations are communicated and honored, WARF is changing the cell transfer provisions in its academic and commercial licensing. The new policy will allow easier and simpler, cost-free cell transfers among researchers. This will facilitate collaborations within the human embryonic stem cell research community and thus advance the field.


“These policy changes will facilitate further research and discovery in a very exciting area of life sciences,” said James Severson, vice provost of intellectual property and technology transfer at University of Washington. “WARF is a respected leader in moving science from the laboratory bench to the marketplace.”


WARF is also clarifying its position with regards to the California Institute for Regenerative Medicine (CIRM). As a not-for-profit, grant-making organization, CIRM does not require any license or agreement from WARF to pursue its grant making policies. Further, WARF does not expect CIRM to remit to WARF or WiCell any portion of payment that CIRM receives from its grantees. WARF has been and will continue to be supportive of CIRM’s efforts to fund human embryonic stem cell research and move the technology forward.


Stanford University and other academic and non-profit institutions in California are in the process of making proposals to CIRM for collaborative efforts in stem cell research, according to Katharine Ku, director of the Office of Technology Licensing at Stanford University.


“We are delighted to have such a clear statement from WARF about the intellectual property implications for institutions funded by CIRM and who uses cells from WARF,” Ku said. “We believe that the best way to advance knowledge and ultimately to commercialize stem cell technology for the benefit of human health is to allow non-profit organizations to pursue stem cell research without licensing constraints. This change in policy is a thoughtful, responsible approach to licensing these patents.”


The WARF policy changes are effective immediately. Documents reflecting these changes are now available on the WiCell and NIH Web sites (www.wicell.org and http://stemcells.nih.gov/research/registry, respectively.)


WARF holds the basic patents on James Thomson’s method of isolating and defining human embryonic stem cells and has made those rights available free of charge to academic researchers. WiCell Research Institute, a WARF subsidiary, hosts the National Stem Cell Bank, which provides cells from University of California–San Francisco, ES Cell International and WiCell.


WiCell has distributed cells to more than 360 research groups in 40 states and 24 countries. It has trained more than 350 scientists in how to work with the finicky cells. In a recent article in the journal Nature Biotechnology, Jason Owen Smith found that of all of the academic papers published in scientific journals between 2002 and 2004, a full 67 percent used cells from WiCell.


Over the past year, the number of WARF commercial licenses has doubled, reflecting an increase in industry-supported research and development. Geron, a WARF licensee, has announced that it will begin clinical trials using human embryonic stem cells later this year.