[Ip-health] Agency Agrees to Review Human Stem Cell Patents

[Ira Glazer]

http://tinyurl.com/gxylp

October 4, 2006
By Andrew Pollack
New York Times

The United States Patent and Trademark Office has agreed to re-examine
the validity of fundamental patents on human embryonic stem cells
granted to a scientist at the University of Wisconsin.

The decision, disclosed on the agency=92s Web site, could lead to a
narrowing or even a rescission of the three patents, which some
scientists and consumer groups say are hindering research into a
fledgling field that holds great medical promise.

The request for re-examination was filed in July by the Foundation for
Taxpayer and Consumer Rights, a California consumer group, and the
Public Patent Foundation, a New York organization advocating patent reform.

The patents are based on work by a University of Wisconsin scientist,
James A. Thomson, who was the first to isolate human embryonic stem
cells. The stem cells have the potential to turn into any type of tissue
in the body and could one day lead to treatments for numerous diseases.

In their request for a re-examination, the consumer group and the Public
Patent Foundation said Dr. Thomson=92s work did not deserve patents
because three scientific papers by others and one previous patent had
already laid out how to derive embryonic stem cells in various animals
including mice, pigs and sheep.

The patent office said the references cited in the petition raised
substantial new questions about the patentability of the Wisconsin work.

Re-examinations brought about by a third party, as this one was, result
in all the patent claims being canceled 12 percent of the time, said
Brigid Quinn, a spokeswoman for the patent office. In another 59 percent
of cases, smaller changes are made. Ms. Quinn said the patent office
receives 400 to 500 requests for re-examinations each year and grants 90
percent of them.

The Wisconsin Alumni Research Foundation, or WARF, a patent licensing
organization affiliated with the university, provides academic
researchers with free licenses and charges them $500 for cells.
Companies are charged $75,000 to $400,000, depending on their size and
the terms of the license. One company, the Geron Corporation, has
exclusive commercial rights to heart, nerve and pancreatic cells derived
from the embryonic stem cells.

The California consumer group and some scientists say these conditions
have slowed research and caused some of it to be moved offshore, since
the patents apply only in the United States.

Last week, Gov. James E. Doyle of Wisconsin announced an agreement with
WARF under which companies sponsoring stem cell research at academic or
nonprofit research institutes in Wisconsin would get free licenses to
the patents for such work. His office said that would give Wisconsin =93a
significant competitive advantage=94 over other states.

Elizabeth L. R. Donley, special counsel to WARF, said in a statement
yesterday that the patents do not impede research and that the
foundation had given free licenses and cells to 324 research groups. She
said she was confident the validity of the patents would be affirmed.

=93We believe this is a politically and financially motivated challenge,
to which we will respond in the appropriate legal forum, which is the
United States Patent and Trademark Office,=94 she said.

It could take years, however, for the patent office to finish its
re-examination.

Daniel B. Ravicher, executive director of the Public Patent Foundation,
said the fact that the patents are undergoing re-examination will make
it harder for WARF to charge high fees. =93Now WARF has lost a lot of the
credibility and leverage that these patents give them,=94 he said.