Impact of new stem cell extraction on WARF patents remains unclear

Wisconsin Technology Network

Madison, WI — The United States Catholic Bishops did not waver, and after some initial signs of hesitation, neither did the White House.

Wisconsin Right to Life, however, is not yet prepared to rule out a new method of deriving stem cells from human embryos that does not destroy embryos, and gubernatorial candidate Mark Green believes it’s a promising development.

While various objections still remain, could the fact that this new method of deriving stem cells, which appears to avoid one of the principal objections to existing methods, shift public opinion even further in the direction of new federal funding for embryonic stem cell research?

That’s exactly what researchers at Advanced Cell Technology claim to have accomplished, and one of the company’s top executives wasted no time framing the debate.

“There is no rational reason left to oppose this research,” Dr. Robert Lanza, vice president of Advanced Cell Technology, told the New York Times.

Following the announcement, there was widespread optimism that the new method could end the impasse over new federal funding for human embryonic stem cell research. Federal policy now prohibits using any federal money for new lines of human embryonic stem cells, but does not restrict private money.

Even Wisconsin Right to Life and Congressman Mark Green, both ardent opponents of human embryonic stem cell research that requires the destruction of embryos, did not take an immediate stand against the new method.

“We really need to first confer with out scientific experts,” said Susan Armacost, legislative and political action committee director for the pro-life organization.

Luke Punzenberger, press secretary for the Green Campaign, said the Republican gubernatorial candidate is encouraged by the news. “He thinks this is a very promising development in stem cell research, and it’s clear that we may be able to conduct this research without grappling with some of these signficant ethical questions,” Punzenberger said.

New method

Researchers believe human embryonic stem cell research could result in cures and treatments for a range of maladies, including heart disease, Alzheimer’s, Parkinson’s, and diabetes. These cells are called “pluripotent” because they can be used to replicate virtually any cell in the human body, but before now they have been derived in a method that required destruction of later-stage embryos called blastocysts.

There are an estimated 400,000 unused embryos available in in-vitro fertilization clinics that supporters of stem cell research say would be discarded if not used for human embryonic stem cell research.

The new method would be performed after the fertilized egg has divided into only eight cells, which are called blastomeres. In-Vitro clinics will occasionally remove one of the blastomeres for diagnostic testing for Downs Syndrome and other conditions. If no defects are found, the remainder of the embryo is implanted in the woman and is capable of producing a healthy baby. Roughly 1,000 such babies have been born without any noticeable harm.

The cell that is removed from the embryo also can be used to derive stem cells, but more testing is needed to evaluate whether it can produce stem cells that are comparable to those derived in existing methods.

If the new method is be confirmed by other scientists, it could be an important breakthrough.

More legal battles?

But what about the legal ramifications, particularly with the stem cell patents granted to the Wisconsin Alumni Research Foundation? What happens if Advanced Cell Technology is successful in securing a patent for its method of deriving stem cells when WARF not only holds patents for its method, derived by University of Wisconsin-Madison researcher James Thomson, but also a composition-of-matter patent on all embryonic stem cells?

WARF manages inventions by UW-Madison professors and claims United States patents on all human embryonic stem cells in the U.S., no matter where or how they are derived. These patents, which are likely to produce a windfall for the UW, were obtained by WARF after Thomson grew human embryonic stem cells in a laboratory.

Andrew Cohn, a spokesman for WARF, said the new method of deriving stem cells should not hurt Wisconsin’s standing as a leader in stem-cell research. He also said WiCell, the nation’s first stem-cell bank and a subsidiary of WARF, would be interested in helping distribute stem cell lines derived from this method.

He also said it’s too early to tell how the new method would impact WARF‘s stem cell patents. “We don’t even know what they claim in their patents, but that’s the last thing we’re concerned about,” Cohn said. “We need time to dissect and digest its full impact.”

The WARF patents already are embroiled in a legal challenge. The Public Patent Foundation, on behalf of the California-based Foundation for Taxpayer and Consumer Rights, has filed a formal request with the United States Patent and Trademark Office to re-examine three patents held by WARF. The filing contends that WARF patents are restricting scientific research and never should have been granted.

If the WARF patents are upheld, would the organization have the right to make a claim on stem cells derived by this new method? John Simpson, stem cell project director for the Santa Monica-based Foundation for Taxpayer and Consumer Rights, believes they would. “They would claim the right to human embryonic stem cell patents derived in this [new] way,” Simpson stated.

He also said the new method of deriving stem cells doesn’t make the WARF patent a moot point because it hasn’t been replicated elsewhere, and the research community still isn’t sure how robust it is.

“It’s unclear how effective it will be in deriving all the different types of stem cells that are needed [for research],” he said.