[Ip-health] WARF stem cell patents challenged: Research could get faster and cheaper if the patents are narrowed, some scientists say

[James Love]

http://www.the-scientist.com/news/daily/25037/

the Scientist

By Cathy Tran

WARF stem cell patents challenged: Research could get faster and
cheaper if the patents are narrowed, some scientists say

[Published 10th October 2006 05:14 PM GMT]

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.

Cathy Tran
ctran@the-scientist.com


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/netacgi/nph-Parser?
Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/PTO/
srchnum.htm&r=1&f=G&l=50&s1=5843780.PN.&OS=PN/5843780&RS=PN/5843780

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



---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton