Federal agency to re-examine U.S. stem cell patents

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The San Jose Mercury News (California)

MADISON, WI — The U.S. Patent and Trademark Office will re-examine patents covering embryonic stem cell discoveries made by University of Wisconsin researchers.

The decision means the office could revoke, modify or leave intact patents that cover all embryonic stem cell research in the U.S. But any such action could be months to several years away.

Critics say the patents are too restrictive and have been impeding the field.

The patent office is acting in response to challenges brought by two groups who contend the patents should never have been issued because other researchers paved the way for the breakthroughs in Wisconsin.

Patent examiners said in recent rulings that the claims by the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation raise substantial new questions about whether the patents are valid.

“We take that as a positive thing,” said John Simpson of the California-based Foundation for Taxpayer and Consumer Rights. “We obviously would like to see them completely revoked because the way they are being asserted right now is an impediment to research.”

The patents cover research by University of Wisconsin-Madison scientist James Thomson and his colleagues, who were the first to grow and isolate human embryonic stem cells in 1998. They govern five stem cell lines grown at the school as well as the methods used to grow them.

The federal agency issued the patents to the Wisconsin Alumni Research Foundation, the university’s patenting arm, in 1998, 2001 and 2006. If allowed to stand, the patents are expected to eventually create a windfall of royalties for the school.

WARF has dismissed the challenge from the two groups as financially and politically motivated at a time when California is hoping to become the leader in the field with a $3 billion grant program.

“The patent office grants over 90 percent of the requests for reexamination so this decision does not come as a surprise,” Beth Donley, special counsel to WARF, said in a statement. “WARF believes the… patents are valid.”

The research foundation requires scientists to get licenses before their work can go ahead. It has made free licenses and cells available to more than 300 academic research groups, but charges companies as much as $400,000. WARF also claims royalties from products produced using the patents.

Critics say the restrictions have discouraged many U.S. researchers and sent some projects overseas, where the patents are not recognized.

The state of Wisconsin has tried to use the patents to its competitive advantage. Gov. Jim Doyle announced last week that companies who fund work at universities and nonprofits in Wisconsin will not have to pay licensing fees.

The agency decides to revoke or modify the patents in 70 percent of re-examination cases, said Dan Ravicher, executive director of the New York-based Public Patent Foundation. He said he expected an initial ruling in several months but that the appeals process could take years.

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