WARF hESC Patent Update: Seven Years and Challenge Still Underway
By Dr. Matthew Watson
Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.
but she is the key figure in the ongoing challenge to the WARF
(Wisconsin Alumni Research Foundation) patents on human embryonic
stem cells. Her effort began in 2006 but has dropped out of the news.
We asked her for an update on the case.
“Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds.
“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents. Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.
“This is Dan's summary of the current
situation:
"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology."
“The 'narrowing' of the patents has
had an unexpected consequence. Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”
which also involved an interesting discussion of IPS research,
Loring said,
“Patents
on fundamental things --
genes, human embryonic stem cells, iPS cells --
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.
“Patents
are supposed to stimulate investment in development. Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?
“But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells. One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.
“There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs. I’m paying attention to the patent 'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves. It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”
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