Key stem cell patents rejected;

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US Patent and Trademark Office sides with scientists and consumer groups who had asked for a review of Wisconsin intellectual property

The Scientist Magazine

Primate embryonic stem cell research patents held by the Wisconsin Alumni Research Foundation (WARF) are not valid, according to the US Patent and Trademark Office. After re-examining the patents, the agency ruled that WARF‘s methods for isolating a primate stem cell line were obvious based on previous work, and therefore not patentable.

The decision, announced yesterday (April 2), was met with widespread enthusiasm among the scientists and consumer groups who have long argued the patents severely — and unjustly — limited research.

Because of WARF‘s patents, “academic scientists were having difficulty getting stem cell lines,” John Simpson of the Foundation for Taxpayer and Consumer Rights, one of the groups who asked the PTO to re-examine the patents, told The Scientist. “I think [this decision] is going to free things up tremendously.”

This decision creates an “earthquake” in the stem cell community, agreed Michael West, president and chief scientific officer of Advanced Cell Technology, which studies human embryonic stem cells and holds a research license from WARF. “It’s a good day for Advanced Cell Technology,” he told The Scientist.

WARF spokesperson Andy Cohn said in an Email that the PTO’s decision is “preliminary,” and “there are many steps left in the process.” WARF now can appeal the PTO’s decision, and the ensuing process could take years. In the meantime, WARF asserts that its patents remain valid.

WARF‘s three stem cell patents (7,029,913; 5,843,780; 6,200,806) cover discoveries by James Thomson, a University of Wisconsin-Madison developmental biologist whose group was the first to isolate human embryonic stem cell lines in 1998. WARF patents and licenses discoveries of University of Wisconsin-Madison researchers.

The patents cover a purified preparation of primate embryonic stem cells expressing specific cell surface markers, which can proliferate in an undifferentiated state after continuous culture for 11 months, and differentiate into tissues from all three embryonic germ layers. The patents also cover the method used to isolate a primate embryonic stem cell line.

Jeanne Loring of the Burnham Institute for Medical Research in La Jolla, California, who has been fighting against the WARF patents since they came into existence, argued that the methods Thomson used were “virtually exactly” the same ones used in the 1980s by researchers working with mouse cells.

In a statement, WARF Managing Director Carl E. Gulbrandsen defended the unique quality of Thomson’s work, noting that the discovery was hailed by both Science and the former director of the National Institutes of Health. According to WARF, the PTO’s preliminary rejection of the patents is “not at all unusual,” and the re-examination process contains “multiple layers” of review. “This first rejection, for example, gives WARF the opportunity to respond directly to the [PTO], a response in which WARF will vigorously defend its patent claims.”

If the agency does not reverse its latest decision, WARF‘s statement said it “could, and most probably would” appeal to the PTO Board of Patent Appeals, and take the case to the courts if necessary. “WARF has absolute confidence in the appropriateness and legitimacy of these patents,” Gulbrandsen said. “We are confident that, when all of the facts are known and the process runs its course, our patents will be upheld.”

Earlier this year, WARF loosened its patents by implementing changes such as letting companies sponsor research by academic or non-profit scientists without a license, and enabling researchers to transfer cells for free.

Simpson noted that WARF‘s decision to loosen its patents made a difference, but as long as the patents were in existence, there was always a possibility that the foundation might decide to reinstate its initial restrictions. “If the patents aren’t valid, it ensures a free flow of scientific information,” he said.

Loring noted that yesterday’s news may send a message to scientists who feel their work is limited by patents they believe were unfairly awarded. “One of the things [the PTO’s decision] shows is that you can challenge a patent,” she told The Scientist. “And sometimes, [the PTO] will agree with you.”
Contact the author at Alison McCook at [email protected]

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