U.S. Agency to Review Wisconsin Stem Cell Patents

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Bloomberg News

The University of Wisconsin faces a U.S. review of patents it owns that require companies doing
embryonic stem-cell research to pay fees, after a request by a California consumer group.
The patents will be reassessed because there’s “a substantial likelihood” that previous research by other
scientists could supersede the Wisconsin claims, the U.S. Patent and Trademark Office said in a statement on its Web site today. The Foundation for Taxpayers and Consumer Rights challenged the patents in July.

The patents have been the subject of criticism from researchers who say they impose an undue burden on small companies working to develop stem cell-based treatments, and are forcing them to set up shop in other countries. The Wisconsin patents have not been recognized outside the U.S.

The Madison, Wisconsin-based school “has been bullying people with these patents,” said Dan Ravicher, the Public Patent Foundation attorney who filed the appeal, in a telephone interview today. “Now there’s a decision that says there are substantial questions about the validity of these patents.”

Companies wanting to use human embryonic stem cells in the U.S. have to pay fees of $100,000 or more to the Wisconsin Alumni Research foundation, known as WARF. Any U.S. company marketing a
stem cell-based treatment would also have to pay royalties to WARF or to Geron, the Menlo Park, California-based biotechnology company that has an exclusive license from the foundation to
three types of human embryonic stem cells.

Patent Office Record

Ravicher said the patent office either narrows or invalidates patents 70 percent of the time it grants a review. Elizabeth Donley, the executive director of WiCell, the university’s stem cell research institute, said the patent office grants a review in 90 percent of petitions, so the decision wasn’t a surprise.

WARF stem cell patents do not inhibit research; in fact, they support and encourage it,” Donley said in an e-mailed statement. “WARF believes the Thomson patents are valid. We believe this is a politically and financially motivated challenge.”

The fact that only U.S. companies have to pay for the right to use embryonic stem cells could put them at a competitive disadvantage in the future, said Mahendra Rao, a researcher at Invitrogen Corp., a Carlsbad, California based-company that makes laboratory products for researchers.

Rights Outside U.S.

“If you’re making a drug and are paying a huge patent fee and someone else is in another place where patent doesn’t apply and they don’t have to pay a fee, their costs are going to be lower,” Rao said in a telephone interview last June.

Rao said he left the National Institute of Aging early this year to work for Invitrogen, partly because it has offices outside the U.S. and thus can freely work with stem cells without paying fees to the university or Geron.

Academic researchers pay the university a more modest fee, recently lowered to $500, for the right to conduct research with human stem cells.

Embryonic stem cells are like blank slates that have the potential to mature into any type of cell or tissue. They are derived from days-old embryos that are developed in a laboratory and haven’t been implanted in a human female.

Scientists think research using the cells may one day lead to cures for conditions including spinal cord injury, Alzheimer’s disease and diabetes.

The Wisconsin patents were filed in 1998 after university researcher James Thomson said in a scientific paper he was the first scientist to isolate and replicate stem cells from a human embryo. The decision by the patent office said three studies describing methods of isolating animal and human stem cells were published before Thomson and his university submitted their patent application.

These studies raise “a substantial new question” about the validity of the Wisconsin patents, the decision said.

Consumer Watchdog
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