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WARF expects review of stem cell patents

Madison, Wis. - While a decision by the United States Patent and Trademark Office might not come for another month, the Wisconsin Alumni Research Foundation expects the office to review its controversial stem cell patents.

Andy Cohn, government and public relations manager for WARF, said the foundation remains confident in the validity of its stem cell patents, but it believes a review is likely.

"Ninety-five percent of the requests to review patents are accepted," Cohn said, "so it would not be a major surprise if the PTO decided to review our patents. We will proceed as if the patents are going to be upheld."

The legal challenge to WARF's stem cell patents was announced on July 18 and was filed by the Public Patent Foundation on behalf of the California-based Foundation for Taxpayer and Consumer Rights. The patent foundation filed a formal request with the Patent and Trademark Office to re-examine three stem cell patents held by WARF, and contends the patents are restricting scientific research.

At the time, Dan Ravicher, president and executive director of the Public Patent Foundation, indicated that it usually takes three months for the patent office to determine whether it will review a patent, and several years to actually conduct the review. If the patent office sticks to that timetable, it would announce its decision on the review sometime in mid October.
John Simpson, stem cell project director for Foundation for Taxpayer and Consumer Rights, a consumer watchdog organization, said he remains confident that the patents will not only be reviewed, but revoked. Simpson and other critics have said the patents are so broad that they are inhibiting the distribution of stem cells to researchers in private laboratories and universities, and they are sending research overseas, a charge that WARF disputes.

"We think, obviously, that our claims have merit and that the patents should be revoked," Simpson said.

The method for deriving human embryonic stem cells was developed by University of Wisconsin-Madison 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.

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, who has provided the Patent and Trademark Office with more than 30 pages of information chronicling previous stem cell discoveries, said Thomson simply followed a recipe written by other scientists.

WARF, armed with a $1.5 billion endowment, has said it is prepared to take on any legal challenges to its stem cell patents.

California partnership

The WiCell Research Institute, a subsidiary of WARF, recently announced an agreement in principle with the Alameda, Calif.-based Advanced Cell Technology to jointly distribute to American scientists new stem cell lines produced using a controversial new technique that reportedly does not destroy embryos. The agreement is subject to federal recognition and funding of new stem cell lines, but Simpson charged it was made to convey the false impression that WARF and WiCell are accommodating stem cell research "when they are not."

Simpson noted that Advanced Cell Technology has a reputation for overstating the value of its research, and noted that its stem cell extraction technique has yet to be validated in other laboratories. After an initial splash of publicity, the company acknowledged that embryos were destroyed in its experiments, but said the technique still had the potential to produce stem cells without embryonic destruction.

Cohn, noting that WARF has collaborated with ACT in the past, called the agreement "another segment" of an existing relationship. "We've had an ongoing relationship with them for a long time," he said, "just as we have a relationship with 54 researchers in California."

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