WARF amends stem cell suit

The Wisconsin Alumni Research Foundation filed an amended complaint in federal court today, Sept. 24, to ensure broad access to the pharmaceutical, medical, scientific, research and development communities of the stem cell research products to which Geron Corporation of Menlo Park, Calif., asserts it has exclusive rights.

The amended lawsuit against Geron seeks to have the court declare that Geron has no exclusive rights to Research Products except in those cases when Geron added any proprietary, patented technology owned by Geron. Examples of applications for research products include: using the cells to screen for drug compounds, using genes derived from the cells to screen compounds, and using gene expression data.

In the complaint, WARF contends that “Geron’s assertion of exclusive rights to stem cell research products or services … is not consistent with the express terms of the License Agreement and is contrary to the clear intent of the parties in entering into the License Agreement. Geron’s interpretation of the Research Products provisions is also commercially unreasonable and against public policy, including … the Research Tool Guidelines of the National Institutes of Health.”

“It is important that WARF be able to license Research Products on a non-exclusive basis,” says Carl Gulbrandsen, WARF’s managing director. “Using human embryonic stem cells for research products is one of the quickest ways to use this technology to find new therapies to benefit humankind. It is also our obligation under federal law that governs federally sponsored inventions to ensure that research tools are made widely available.”

WARF, a non-profit Wisconsin foundation, licenses patents for the benefit of research at the University of Wisconsin–Madison has licensed certain rights for human embryonic stem cells to Geron since 1999.

“We hope that federal funding and access to stem cell research products will increase the number of researchers who work with human embryonic stem cells. A greater number of good researchers promise to bring the medicine of tomorrow closer to today,” says Gulbrandsen.

Embryonic stem cell lines were first successfully established late in 1998 by a team of scientists headed by developmental biologist James Thomson.

The work was supported in large part by Geron Corp., but the patents that govern the technology and use of the cells are held by WARF.

More than 100 academic researchers and numerous companies have approached WARF about licensing stem cell technology in the past two years.

Embryonic stem cells are of great interest to medicine and science because of their ability to develop into virtually any other cell made by the human body. The first potential applications of human embryonic stem cell technology may be in the area of drug discovery. In addition, the ability to grow human tissue of all kinds opens the door to treating a range of cell-based diseases and to growing medically important tissues that can be used for transplantation purposes.

The federal lawsuit was filed earlier in Madison, Wis. and assigned to Judge Barbara Crabb. The complaint seeks a declaratory judgment. The original complaint was filed Aug. 13.