WARF stem cell patents to be re-examined

Madison, Wis. - As expected, the United States Patent and Trademark Office has granted requests from a consumer group and public service patent attorneys to re-examine three patents on human embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF).

The challenges, brought by the Foundation for Taxpayer and Consumer Rights (FTCR) and the Public Patent Foundation (PUBPAT), are directed against WARF patents that the groups say are impeding scientific progress and driving stem cell research overseas - a charge WARF has vehemently denied.

FTCR and PUBPAT argued that the work done by University of Wisconsin-Madison researcher James Thomson to isolate stem cell lines was obvious in the light of previous scientific research, making the work unpatentable.

John M. Simpson, FTCR's stem cell project director, has held that the patents were overly broad and never should have been granted. To avoid paying royalties on overly restrictive patents, he said American researchers have sent R&D money overseas, where no other country honors them.

"We brought the case because we thought it was well merited," Simpson said. WARF, armed with a $1.5 billion endowment, has said it is prepared to take on any legal challenges to its stem cell patents. Following the PTO decision, Beth Donley, executive director of the WiCell Research Insitute, a subsidiary of WARF, said the decision was not unexpected.

"The patent office grants more than 90 percent of the requests for re-examination, so this decision does not come as a surprise," Donley said in a statement. "WARF believes the Thomson patents are valid and will affirm the validity of the patents."

While patent reviews have taken anywhere from one year to 10 years to complete, Simpson said that in 70 percent of requested third-party reviews, the patents either have been overturned or narrowed.

Patented methods

The method for deriving human embryonic stem cells was developed by 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.

To receive a patent, something must be new, useful, and non-obvious. 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 at the Burnham Institute for Medical Research, said the real discovery of embryonic stem cells was made in 1981 by scientists Martin Evans, Matt Kaufman, and Gail Martin.

Loring filed a 30-page statement in support of the challenge.

Donley characterized the challenge as politically and financially motivated, and said WARF would respond in the appropriate legal forum - the Patent and Trademark Office.

She also took issue with claims that the patents inhibit research. Doney said WARF created WiCell to support stem cell researchers and has provided a free license and cells to 324 research groups.

Related stories

• Doyle, WARF announce partnership to lure stem cell companies

• WARF expects review of stem cell patents

• There's a new dynamic in the stem cell debate

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

• California group says ruling weakens WARF's stem cell patent