Wednesday 12 March, 2008

Wisconsin Alumni Research Foundation (WARF) won patent battle on key embryonic stem cell patents

The Wisconsin Alumni Research Foundation announced that USPTO has rejected challenges to its two key embryonic stem cell patents.
The decision marks a complete victory for the foundation, known as WARF, and makes Wisconsin a critical stop for anyone aiming to commercialize products that rely on embryonic stem cells.
The patent office in late February rejected a challenge to a third embryonic stem cell patent held by WARF.
All of the patents are based on discoveries made by James Thomson, the first person to isolate human embryonic stem cells, from which virtually all organs, cells and other body tissues arise.
The victory will not cause WARF to raise fees on its commercial licenses, Gulbrandsen said.
WARF is seeing a small amount of commercial royalties coming in from stem cell licenses that involve research products. Two companies - Menlo Park, Calif.-based Geron Inc. and Los Angeles-based Advanced Cell Technology - have said they hope to enter clinical trials this year with therapeutic products based on embryonic stem cells. The patent office decision might spur some companies that haven't yet negotiated stem cell licenses with WARF.
The challenges had been brought by the Foundation for Taxpayer and Consumer Rights in Santa Monica, Calif., and the Public Patent Foundation in New York City. The groups had argued that the pioneering work done in the mid-1990s by Thomson, a University of Wisconsin-Madison scientist, could have been done by any good scientist with access to embryos and funding.
The patent office decisions said the challengers failed to prove that.
The foundations had pulled in four stem cell scientists to file declarations in support of overturning the patents: Douglas Melton and Chad Cowan of Harvard University; Alan Trounson, who recently left Monash University in Australia to run California's stem cell agency; and Jeanne Loring of the Scripps Research Institute.
The patent office said their declarations didn't put a dent in WARF's claims. For example, Loring's declaration relied on "opinion on the ultimate legal issue without providing sufficient underlying factual support," the patent office decision said.
The foundations still claimed a victory, saying they had pushed WARF to loosen its licensing requirements during the challenge. John Simpson, stem cell project manager for the Santa Monica group, said the two groups intend to appeal the patent office's February decision on one of the patents - the only one it can appeal based on patent office procedures.
During the re-examinations, WARF saw no downturn in its stem cell licensing, Gulbrandsen said.
The three key stem cell patents expire in 2015, but it's likely that "improvements" WARF has made to them will generate royalties for WARF after 2015, Frenchick said. Improvements are subsequent patent filings made by WARF that represent material changes to the original ones.
One such improvement has likely been filed on the work announced by Thomson and a team of scientists in November. By genetically manipulating human skin cells, they said they were able to reprogram them to act like embryonic stem cells without using human embryos.

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