[Ip-health] PUBPAT News: Consumer Groups Support Stem Cell Patent Rejection
Public Patent Foundation
info@pubpat.org
Mon Jul 2 16:10:16 2007
CONSUMER GROUPS FILE COMMENTS SUPPORTING U.S. PATENT OFFICE'S STEM CELL
PATENT REJECTION: University of Wisconsin Affiliate Has Narrowed Claims;
Four Leading Scientists Agree Work Was =93Obvious=94
Santa Monica, CA =97 Two consumer groups have filed comments with the U.S.
Patent and Trademark Office supporting its rejection of human embryonic
stem cell patent claims asserted by the Wisconsin Alumni Research
Foundation (WARF) because the claimed advances are obvious in the light
of previous stem cell research, the groups said today.
Last July the groups, the Foundation for Taxpayer and Consumer Rights
(FTCR) and the Public Patent Foundation (PUBPAT) challenged the patents
because they are hindering stem cell research.
Four internationally known stem cell scientists, Dr. Douglas Melton of
Harvard University, Dr. Alan Trounson of Monash University in Australia,
Dr. Chad Cowan of Harvard University and Dr. Jeanne Loring of the
Burnham Institute for Medical Research, filed declarations supporting
the consumer groups and the PTO=92s earlier finding that the work done by
Dr. James Thomson does not deserve a patent.
In papers filed on Friday, FTCR and PUBPAT said that although WARF has
narrowed its claims and made several arguments in its response to the
PTO =93none of the Patent Owners=92 arguments have sufficient merit to
overcome the rejections.=94
=93I very much believe Dr. Thomson deserves the scientific and public
recognition he has received,=94 Dr. Melton=92s declaration said. =93Howeve=
r,
he deserves that recognition because he undertook the arduous and timely
task of getting fresh and high quality embryos to use as starting
material for his work, and sufficient funding for such research, not
because he did anything that was inventive... His perseverance and
commitment deserve recognition and accolades. But I believe that had any
other stem cell scientist been given the same starting material and
financial support, they could have made the same accomplishment, because
the science required to isolate and maintain human embryonic stem cells
was obvious.=94
WARF holds three stem cell patents, numbers =91780, =91806 and =91913, base=
d
on work done by Thomson. The PTO granted the requests for
re-examination and in March rejected all the claims of all three
patents. WARF had the opportunity to respond to all three rejections.
The rules applicable to the =91913 case under a so called =93inter partes=
=94
re-examination allow the challengers to comment on WARF=92s response in
that proceeding.
The two earlier patents are undergoing =93/ex parte=94 /re-examination and
those rules do not allow formal comment from FTCR and PUBPAT.
Nonetheless, the case made by FTCR and PUBPAT in the =91913 case is
relevant to the other two.
=93What Dr. Thomson did was admirable,=94 said John M. Simpson FTCR Stem
Cell Project Director. =93It just isn=92t patentable.=94
WARF narrowed its claims in its response to the PTO finding, seeking to
patent only stem cells derived from =93pre-implantation embryos.=94 This
means that stem cells derived by other methods =97 such as therapeutic
cloning =97 may not be covered. In January WARF eased its licensing
requirements on stem cells, a move many observers believed was an effort
to blunt widespread criticism of its aggressive patent policy from the
stem cell research community.
Dan Ravicher, executive director of
PUBPAT, said that while the challenge has already improved the situation
for researchers, the patents are still not justified. In the =91913 case
the patent examiner cited five grounds for rejecting WARF=92s claim,
basing the decision on earlier publications and patents by Robertson,
Piedrahita, Williams and Hogan. (Read the PTO decision here:
http://www.consumerwatchdog.org/resources/913rejected.pdf ). In their
formal comments FTCR and PUBPAT agreed with the examiner and rebutted
WARF=92s arguments making these five essential points:
* WARF incorrectly argues that a skilled stem cell scientist would
not have used teachings relating to mouse, sheep and pig embryonic
stem cells to derive human embryonic stem cells. To argue that
what such scientists knew about embryonic stem cells of other
mammals was not relevant to human embryonic stem cells is simply
ludicrous.
* Despite WARF=92s assertions, not a single scientist in the field
tried and failed to achieve Thomson=92s accomplishment. Comparisons
made by WARF to the work of others are misleading because the
others did not have the access to the materials they needed.
* WARF attempts to read the cited publications and patents too
narrowly and does not take into account all the suggestions and
motivations actually included in the documents.
* The recent Supreme Court decision in KSR International v. Teleflex
in the doctrine of the law of obviousness supports and
strengthens the examiner=92s rejection of WARF=92s claims.
* Simply because a scientific accomplishment is important does not
necessarily mean that it was an advance worthy of patenting.
Read FTCR and PUBPAT=92s comments filed with the PTO here:
http://www.consumerwatchdog.org/resources/913Comments.pdf
In his declaration Dr. Trounson speaks about the relevance of isolating
mouse embryonic stem cells to isolating human embryonic stem cells: =93In
January, 1995, it was obvious to me and others in the art of ES cell
derivation that the process taught by Robertson =9183 and Robertson =9187
for isolating mouse stem ES cells could be used to isolate human ES
cells. The motivation to do so came at least from the general
understanding in the field of the applicability of mouse studies to
human research.=94
Dr. Cowan's and Dr. Loring's declarations agree that the patent's claims
were obvious and apparent to anyone working in the field at the time.
Dr. Loring, who has long supported the patent challenges added: "Dr.
Thomson is a valued colleague in the stem cell scientific community, and
the challenge to his patents is not personal. His work was impressive,
and contributed greatly to the field, but it wasn't patentable."
Dr. Trounson=92s declaration also discusses work by Dr. Ariff Bongso, a
stem cell scientist in Singapore, who successfully isolated human ES
cells, but did not maintain the cultures for a long period of time. Dr.
Bongso did not use feeder layers, but tried LIF to culture the cells.
Dr. Thomson used feeder cells. Dr. Trounson=92s declaration notes: =93Two o=
f
the authors of Bongso et al. and I recognized by 1995 that by using
feeder layers with or without LIF would work to successfully maintain
isolated human ES cells over an extended period of time. We made this
recognition well before Dr. Thomson published the results of his work,
as it was obvious to us at the time that, had Bongso et al. simply not
dispensed with the feeder layer in the passaging step, they would have
successfully developed the claimed invention. A successful result of
such an obvious modification was entirely predictable to us.=94
Read the Dr. Melton=92s declaration here:
http://www.consumerwatchdog.org/resources/MeltonDecl.pdf
Read Dr. Trounson=92s declaration here:
http://www.consumerwatchdog.org/resources/TrounsonDec.pdf
Read Dr. Cowan=92s declaration here:
http://www.consumerwatchdog.org/resources/CowanDec.pdf
Read Dr. Loring=92s declaration here:
http://www.consumerwatchdog.org/resources/LoringDec.pdf
Dr. Melton is currently the Thomas Dudley Cabot Professor of the Natural
Sciences at Harvard University, and an Investigator at Howard Hughes
Medical Institute. He is also a Co-director of the Harvard Stem Cell
Institute. His biographical background is available here:
http://www.consumerwatchdog.org/resources/meltoncv.PDF
Dr. Trounson is Director of the Monash Immunology and Stem Cell
Laboratories (MISCL) and founded the Australian Stem Cell Centre in
2003. He is chairman the Government Affairs Committee of the
International Society for Stem Cell Research and a member of the
society=92s board. His biographical background is available here:
http://www.consumerwatchdog.org/resources/trounsoncv.pdf
Dr. Cowan is on the Principal Faculty of the Harvard Stem Cell Institute
and is an ad hoc reviewer for various journals, including Developmental
Biology, Journal of Biological Chemistry, Developmental Cell, and Cell
Stem Cell. He is also a member of the International Stem Cell
Initiative. His biographical background is available here:
http://www.consumerwatchdog.org/resources/cowancv.pdf
Dr. Loring is a member of the faculty of the Burnham Institute for
Medical Research, where she directs human embryonic stem cell research.
She is Director of the Stem Cell Resource, NIH Human Embryonic Stem Cell
Training Course, and Co-Director of the NIH Exploratory Center for Human
Stem Cell Research. Her biographical background is available here:
http://www.consumerwatchdog.org/resources/loringcv.PDF
Contact:
John M. Simpson
Foundation For Taxpayer and Consumer Rights
(310)392-0522, ext. 317
(310) 292-1902, cell
Dan Ravicher
Public Patent Foundation
(212)-796-0571
- - -
The Foundation for Taxpayer and Consumer Rights is California's leading
non-profit and non-partisan consumer watchdog group. For more
information visit us on the web at: www.ConsumerWatchdog.org.
The Public Patent Foundation (PUBPAT) is a not-for-profit legal services
organization that represents the public's interests against the harms
caused by the patent system, particularly the harms caused by undeserved
patents and unsound patent policy. For more information, visit the web
at: www.pubpat.org.