WARF stem cell patents challenged;

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Research could get faster and cheaper if the patents are narrowed, some scientists say

The Scientist Magazine

At the request of a coalition of non-profit groups, the U.S. Patent and Trademark Office (PTO) is reexamining patents covering all primate embryonic stem cells, as well as stem-cell culturing techniques, held by the Wisconsin Alumni Research Foundation (WARF), which patents and licenses discoveries of University of Wisconsin-Madison researchers.

The groups challenging the patents argue that the methods for isolating a primate stem cell line were obvious based on previous work and therefore not patentable.

A narrowing or invalidation of the patents could speed up research, many scientists say. Some researchers complain that the licensing process slows their work down, while others say it is prohibitively expensive. Jonathan Auerbach, president of GlobalStem, Inc., has not licensed rights to the technology from WARF and currently uses mouse embryonic stem cells and embryonal carcinoma cell lines, which he finds to be less expensive and more accessible. However, in the long run, he said he will have to translate his work to human stem cells. “It slows things down and sort of sets up an artificial step in the process,” he told The Scientist.

Mahendra Rao, who recently resigned his post as head of the stem cell group at the National Institute on Aging to join Invitrogen Corp., is concerned that the distribution of reagents that could accelerate stem cell research has been slowed down by WARF. “There is no agreement to make them widely available to the community, so when someone needs the reagent, they need to remake it, [which] takes about three months,” he told The Scientist. Rao said he filed a request to commercialize the reagent OCT4/GFP a couple of years ago, but has yet to hear back from the foundation.

WARF maintains that its licensing process can be beneficial because it includes training for researchers and helps organize the distribution of stem cells. The foundation has two months to respond to the issues raised in the challenge. A final ruling may be some time away, as the PTO takes an average of 21 months to reach its decisions on patent reexaminations.

Patenting all human embryonic stem cells is “like Microsoft patenting computing,” said John Simpson of California’s Foundation for Taxpayer and Consumer Rights, one of the groups challenging the patents. “It’s overreaching.”

Simpson worked with attorney Dan Ravicher of the Public Patent Foundation and stem cell researcher Jeanne Loring of the Burnham Institute to file the challenges to the WARF 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.

Carl Gulbrandsen, managing director of WARF, maintains that it is “ludicrous” to suggest that the discovery was obvious. “It certainly was novel and was considered by Science as being the discovery of the year and was on the cover of Time magazine,” he said during an interview with The Scientist.

However, according to Loring, the technique used by Thomson to cultivate the human embryonic cells was the same method used to make mouse embryonic stem cell lines in 1981. Loring said the first person to isolate human stem cells was Ariff Bongso at the National University of Singapore in 1994.

That begs the question why, if the leap to cultivating human stem cells was an obvious one, it wasn’t done sooner. Bongso told The Scientist that the scientific community seemed disinterested in the discovery, and so he did not pursue the research further.

Loring said the first human embryonic stem cell line wasn’t created until 1998 in part because the National Institutes of Health did not fund research on human embryos before 2001, which made it “pretty close to impossible” for any U.S. academic lab to derive human embryonic stem cells. In addition, it was “not easy to find an in vitro fertilization clinic that wanted to go to the trouble of providing embryos for this research.”

Thomson, however, maintains that his discovery was far from obvious. “In the early 1990s, when we started this work, it was not at all clear that the isolation of human embryonic stem cells was really possible, as other groups had tried and failed,” he told The Scientist in an email.

One of the groups that tried and failed included researcher Michael West, CEO of Advanced Cell Technology and founder of Geron Corporation. “From firsthand painful experience, [the techniques were] not obvious in the scientific community,” West told The Scientist. The challenge based on the discovery being obvious “is easy in retrospect, but you really have to base it on real firsthand experiences of the people in those days.”

Invitrogen‘s Rao predicts that there will be a narrowing of the patents to the lines originally generated by Thomson. Such a decision would alleviate the concerns of many scientists who feel that the WARF patent on all human embryonic stem cells, regardless of how they are derived, is too broad.

“It wouldn’t bother me if they retained the [patents on] techniques,” Loring told The Scientist. Those patents “do not have as big of an impact on science, since they are very narrow. Scientists are always looking for new ways of doing things.”

The patent challenge was initiated by groups in California, a state that has a lot at stake as a result Proposition 71, which authorizes it to issue $3 billion in bonds over 10 years to fund embryonic stem cell research. However, the California Institute for Regenerative Medicine, which was created to disseminate the funds, has no formal position on the patent battle, according to spokesperson Dale Carlson.
Conact the author Cathy Tran at: [email protected]

Links within this article:

U.S. Patent and Trademark Office: http://www.uspto.gov

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

United States Patent 5,843,780: http://patft.uspto.gov

GlobalStem, Inc.: http://www.globalstem.com

K. Pallarito, “NIH stem cell chief resigns,” The Scientist, April 21, 2006: http://www.the-scientist.com/news/display/23340

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

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

Public Patent Foundation: http://www.pubpat.org

J. Loring, “Sharing Stem Cell Information,” The Scientist, May 9, 2005: http://www.the-scientist.com/article/display/15443

Burnham Institute: http://www.burnham.org

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

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

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

California Institute for Regenerative Medicine: http://www.cirm.ca.gov

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