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Patent on Human Embryonic Stem Cells Rejected after Appeal

The US Patent and Trademark Office (USPTO) rejected (4/28/10) a controversial patent on human embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF).

“This is a major victory for unfettered scientific research that could lead to cures for some of the most debilitating diseases,” said John M. Simpson, Consumer Watchdog’s (NYSE:CW) Stem Cell Project Director. The nonprofit, nonpartisan CW had joined with the Public Patent Foundation (PPF)  in challenging the validity of WARF’s stem cell patent claims. The USPTO’s Board of Appeals and Interferences agreed with the groups that the creation of human embryonic stem cell lines was obvious in the light of work that had been done in other species. In order to obtain a patent, work must be both new and non-obvious.

Some leading stem cell scientists feel that “human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them”. Is this a victory for open scientific inquiry?  Both the CW and the PPF stressed that while University of Wisconsin researcher James Thomson deserved acclaim for his research that isolated human stem cells, important scientific accomplishments are not necessarily patentable. They said 1 of the main reasons he was able to derive a human stem cell line was because he had access to human embryos and financial support that other researchers did not have. WARF could appeal the latest PTO decision by requesting a new hearing before the board. WARF could also opt to present new evidence to the original examiner or change the patent’s claims.

Under current patent law only 1 of 3 patent rulings could be appealed by the 2 groups. That was the patent rejected by the Board of Appeals and Interferences. However, the latest ruling by the Board of Appeals is a strong decision that could set a precedent leading to the revocation of the other two patents as well. The 2 public interest groups noted that the original 3 patent challenges had already improved the situation for stem cell researchers; shortly after the PTO launched its initial re-examinations in 2006 at the groups’ request, WARF announced a substantial easing of its licensing requirements.

Comments from GERN included: This is not a final rejection of the patent claims,” noted David J. Earp, J.D., Ph.D., GERN’s chief patent counsel and senior vice president of business development. “We are confident that WARF will make a strong case in support of the patentability of these claims in continued examination.” The 3 WARF patents that have been subject to reexamination proceedings cover the early work at the University of Wisconsin, dating back to the early 1990s, resulting in the first isolation of non-human primate and human embryonic stem cells.  “These pioneering, broad patents were filed at the very beginning of the development of human embryonic stem cell technologies and expires in 2015,” noted Dr. Earp.