Sunday, November 14, 2004

WARF's US 5,843,780 on stem cells

The November 13 issue of the Milwaukee Journal Sentinel has an article on WARF's patent in the stem cell area. However, the article does not mention the patent number or some of the issues surrounding the patent.

In 1998, James Thomson and his research team reported in Science [Science 1998, 282, 1145] that they were able to isolate and grow embryonic stem cells in a way that maintained their pluripotency—the ability to transform themselves into any kind of human cell. Using embryos that had been discarded by couples who sought in vitro fertilization at a University of Wisconsin clinic, Thomas generated five human embryonic stem cell lines derived from blastocysts, a hollow ball of about 150 cells that develops a few days after fertilization.

The patent in question is US 5,843,780, although note also US 6,200,806.

In October 1999, the WiCell Research Institute was set up, with Thomson as scientific director, specifically for stem-cell research and is operated by the Wisconsin Alumni Research Foundation (WARF), a not-for-profit entity that has managed patents on behalf of the University of Wisconsin since 1925. WARF has created an endowment that returns on the order of $20 million annually to UW-Madison for unrestricted use in research and education. Stem cell lines are one of their big products. Thomson's work was partially funded by Geron Corporation.

On August 9, 2001, President Bush announced that federal funds would be available to support limited human embryonic stem cell research. The new policy provided that federal funds could be used for research on 64 existing stem cell lines that have already been derived or were already in existence as of the date of the announcement.

On August 13, 2001, WARF filed a lawsuit 19 in U. S. District Court in Madison, Wisconsin asking the court to declare Geron's exercise of an option invalid [WARF v. Geron, Civ. No. 01-C-459-C (D. Wis. Aug. 2001)]. WARF later amended its complaint to ask the court to declare that Geron's license does not cover rights to research products that might be developed from the stem cells. WARF, which through the Bayh-Dole Act holds patents comprising claims on the methods described in the Science article, sued Geron for asserting that it had exclusive rights to research products and services. Calling such an assertion contrary to their contract with the company and NIH guidelines, WARF asserted its own right to sell and distribute the stem cells to researchers.

In September 2001, NIH began discussions with WARF concerning access by federally-funded researchers to human embryonic stem cells. WARF was said to hold patents affecting 64 stem cell lines, including absolute rights to five lines. HHS Secretary Thompson announced that an agreement has been reached with WARF that allowed federal researchers access. Further, as a result of guidelines set up in August-September 2001 time period, the NIH, not WiCell, will retain ownership of any new intellectual property arising from that research, and researchers may publish their results without restrictions.

from Milwaukee Journal Sentinel (Nov. 13, 2004):

Geron funded much of the early research at the University of Wisconsin-Madison leading to James Thomson's first-ever isolation of human embryonic stem cells in 1998.

The company has certain rights to develop therapeutic and diagnostic products involving certain stem cells. Geron has said it hopes to be in clinical trials by the end of 2005 or early in 2006 for therapies for spinal cord injuries.

That makes Geron a fan of WARF's patent.

"At the very root of stem cell research is the preparation of the stem cell lines," said Peter Balbus, managing director at Pragmaxis LLC in Glen Ellyn, Ill. "That's why that patent is so coveted and controversial."

Theoretically, the patent gives WARF the right to collect royalties until December 2018 on any products or therapies made with stem cells. In reality, WARF is likely in for a vicious fight.

"From what we've heard over here, (WARF's patent) will be difficult to hold up in Europe," said Stephen Minger, who says he and others who made three stem cell lines at King's College in London didn't make them with "anything resembling" the methods described in WARF's patent.

WARF is appealing a decision by European patent authorities denying it a stem cell patent, spokesman Andrew Cohn said.

WARF and Singapore-based ES Cell International are the world's biggest distributors of stem cells. WARF has licensed stem cells to 244 academic institutions and eight companies, Cohn said.


Carl Gulbrandsen, WARF's managing director: "One reason we have filed patent applications in some areas is to ensure that researchers here have freedom to operate. It takes the fun out of your research if somebody else owns it, and particularly if someone else can direct what you can do with it. If industry is going to own all the technology, and we're beholden to them to have rights to do the research, industry is going to set the agenda. If academia owns the technology, then academia can use it the way it wants to."

Compared to the often snail-like pace of academic publishing, the patent process can look comparatively swift. UW Animal Science Professor Mark Cook recalls that he once discussed an invention with a reporter, not realizing that the patent application hadn't been filed. Such a disclosure starts the clock on U.S. patents and could invalidate patent claims entirely in some countries. "I called WARF and said, "You've got until the evening news to get it done.' They got it filed by 5 o'clock," Cook says. "WARF can move very quickly if it needs to."


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