UW seeks patent on breakthrough;

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Stem cell method clears ethical barrier

Milwaukee Journal Sentinel (Wisconsin)

Stunning advances in embryonic stem cell research by two teams oceans apart have a Wisconsin foundation knocking on the patent office’s door again.

The Wisconsin Alumni Research Foundation has filed patent applications, which are not yet public, on the latest research done by the University of Wisconsin-Madison team led by James Thomson, said Janet Kelly, a spokeswoman for the university’s technology transfer arm.

The foundation, known as WARF, already has 12 approved stem cell patents, Kelly said.

Both the Madison team and a Kyoto University-based team in Japan used four genes to program human cells so they had all the characteristics of embryonic stem cells. It was the first time this had been done without using eggs or embryos, and another high point for UW-Madison’s embryonic stem cell efforts.

“This is a world changer,” said Nick Seay, a patent attorney and an executive at Cellular Dynamics International and Stem Cell Products Inc., companies that were founded by James Thomson and other UW-Madison researchers.

“This development means one of the problems in stem cell therapy — the problem of tissue rejection — is no longer an issue. It also means the political controversy about these cells should be over.”

The new technologies, if they work, have the potential to mend political and ethical divisiveness over embryonic stem cell research, open up a flood of government funding and keep Wisconsin in the forefront of one of the most cutting edge technologies from a scientific, patent portfolio and business perspective, sources said.

WARF has 12 U.S. patents for stem cells and about 50 pending U.S. patents. It’s WiCell subsidiary manages the National Stem Cell Bank and was the first national exploratory stem cell center.

WARF was careful about how it distributed the embryonic stem cell lines that came out of Thomson’s original work and charged what some viewed as excessive fees to researchers and companies that wanted to use his original embryonic stem cells.

If the patent applications on the new work are approved, WARF will manage the patents on the new work much differently, said Carl Gulbrandsen, WARF‘s managing director.

“As far as doing research with this material, we invite anybody anywhere in the world to do research with it,” Gulbrandsen said. “The technology is as big a platform as we could ever hope to have because our researchers can now make a disease stem cell they can study – which they’ve been hungering for – without having to go through the baggage of sacrificing an embryo.”

WARF holds three key embryonic stem cell patents on Thomson’s breakthrough work that are being challenged at the patent office by two foundations. The Foundation for Taxpayer and Consumer Rights in Santa Monica, Calif., and the Public Patent Foundation in New York City are arguing that any good scientist with access to embryos and funding could have done what Thomson did.

“This is an important development in the biology of human cells, but like all scientific progress, it is built on earlier work,” said John Simpson, stem cell project director at the Foundation for Taxpayer and Consumer Rights. Simpson said his views about the validity of WARFs three patents haven’t changed because of the new work.

It’s difficult to tell whether the new work would be covered by the original patents or not, said Joseph T. Leone, a patent lawyer and partner at DeWitt Ross & Stevens in Madison.

But it is clear Thomson and UW-Madison are in the forefront of an exciting international technology.

“It takes a huge amount of effort and institutional knowledge and laboratory knowledge, and they were there from the outset and they’ve got a domineering position,” Leone said. “It’s not like you can decide that tomorrow ‘we’re going to be GM.”

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