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Request to re-examine WARF stem cell patents escalates war of words

Madison, Wis. - The legal challenge to stem cell patents held by the Wisconsin Alumni Research Foundation has escalated the war of words between two states -Wisconsin and California - with both questioning the other's financial motivations.

The most recent exchange came after the Public Patent Foundation, on behalf of the California-based Foundation for Taxpayer and Consumer Rights, filed a formal request with the United States Patent and Trademark Office to re-examine three patents held by WARF.

The filing, which contends that WARF patents are restricting scientific research and never should have been granted, came on the same day the United States Senate voted to expand federal funding for embryonic stem cell research.

In response to the filing, both sides fired verbal volleys, accusing one another of caring more about money than about science.

Carl Gulbrandsen, managing director of WARF, reiterated his earlier comments that John Simpson, stem cell product director for the Foundation for Taxpayer and Consumer Rights, is not motivated by the advance of research, but by his concern that California citizens will not be able to reap the royalties they were promised when they passed Proposition 71.
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Prop 71, a ballot initiative overwhelmingly approved by California voters, called for the budgeting $3 billion for stem cell research.

Simpson, in turn, noted that he represents a non-profit organization, and said he has been tracking complaints against WARF for some time. "We got involved in this for a number of reasons," Simpson said. "His [Gulbrandsen's] statement is completely off the mark. When it comes to money matters, it's WARF and WiCell that have dollar signs in their eyes."

Simmering to full boil

Concern over WARF's stem cell patents has been simmering for some time, but reached the boiling point earlier this year when WARF general counsel Elizabeth Donley delivered an address in San Francisco. Donley said that since the California Institute of Regenerative Medicine requires that 25 percent of royalties that non-profit grantees receive must be returned to the state, WARF therefore would demand license fees and payments on all embryonic stem cell research funded under Prop 71.

The method for deriving human embryonic stem cells was developed by UW researcher James Thomson. The first two patents, one for embryonic stem cells derived from primates (issued in 1998) and one for embryonic stem cells derived from humans (issued in 2001), are written to cover both embryonic stem cells and the method Thomson used to derive and grow them. A third patent, issued in April of this year, involves a new method to grow stem cells without using animal products.

Critics like Simpson have said the patents are so broad that they are putting the clamps on the distribution of stem cells to researchers in private laboratories and universities, and they are sending research overseas, a charge that WARF disputes.

Lending support to the court challenge, Simpson called it absurd that any person or organization could own the rights to life, itself, yet he said that has happened because of "over-reaching patents."

In challenging the WARF patent, the Public Patent Foundation submitted what it said was unseen "art" or evidence that the previous work of other scientists made the derivation of human embryonic stem cells "obvious and therefore unpatentable."

Dr. Jeanne Loring, a stem cell scientist with the Burnham Institute for Medical Research, said the real invention was made 25 years ago, when embryonic stem cells first were discovered. Loring said Thomson "just followed a recipe written by other scientists, and there's nothing patentable about that."

Loring has provided the USPTO with more than 30 pages of information chronicling previous stem cell discoveries.

Before any formal review is conducted, USPTO examiners will first have to determine whether a re-examination should take place. There is no time limit on either decision.

Striking back

WARF, armed with a $1.5 billion endowment, has said it is prepared to take on any legal challenges to its stem cell patents. In a statement released Tuesday, Gulbrandsen reiterated the organization's belief that its stem cell patents are valid.

"We will respond to what we believe is a politically and financially motivated challenge in the appropriate legal forum, which is the United States Patent and Trademark Office," said Gulbrandsen, who is serving a three-year term on the USPTO's Public Advisory Committee.

Gulbrandsen took issue with the contention that WARF stem cell patents inhibit research. He noted that WARF created the WiCell Research Institute to support stem cell researchers, and has provided a free license and cells to 324 research groups.

He also cited a recent study by Dr. Jason Owen-Smith of the University of Michigan, indicating that in 67 percent of the articles published in scientific journals between 2002 and 2005, researchers cited WiCell as the source for their cells.

"This license enables researchers to patent and publish any discovery they make [with stem cells]," Gulbrandsen added.

He indicated that WARF is willing to work with the California scientific community to come to an agreement on fair compensation "for our intellectual property."

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