The U.S. Patent and Trademark Office's Board of Appeals and Interference has reversed an earlier decision from the Patent Office's re-examination division that upheld the claims of one of the stem cell lines held by the Wisconsin Alumni Research Foundation.
The patent covers one of the three key stem cell lines that were challenged through re-examination proceedings initiated in October 2006 at the request of consumer watchdog groups New York City-based Public Patent Foundation and the Santa Monica, Calif.-based Foundation for Taxpayer and Consumer Rights, now called Consumer Watchdog.
The re-examination division upheld the validity of the patents in mid-2008, and the groups were allowed to challenge one of the patents in an appeal to the Board of Appeals and Interference.
The groups argue that the work done by University of Wisconsin researcher James Thomson to isolate stem cell lines was obvious in the light of previous scientific research, making his work unpatentable. The groups claimed the three WARF patents were "impeding scientific progress and driving vital stem cell research overseas."
The patent office rejected the arguments by the groups that Thomson's discoveries were obvious in light of previous research, finding that the expert declarations they submitted were "flawed by hindsight reasoning."
Stem cell research, pioneered at the University of Wisconsin-Madison, is viewed by many to be the gateway to finding cures to debilitating neurological and muscular diseases. Such research is also believed to hold commercial opportunities that could result in economic development.
The true impact of the Patent Office's decision remained unclear. While the groups characterized the Patent Office's decision as a big win, Geron Corp., the California biotechnology firm that's licensing the patents from the Wisconsin Alumni Research Foundation, said in a press statement that the ruling only reopens the patent to further examination.
"This is not a final rejection of the patent claims," noted David Earp, Geron'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."
John Simpson, Consumer Watchdog's Stem Cell Project director, had a different opinion.
"This is a major victory for unfettered scientific research that could lead to cures for some of the most debilitating diseases," Simpson said.
The consumer watchdog groups said that under current patent law only one of the three patent rulings could be appealed by the two groups. However, the groups say 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.
"WARF executives were acting like arrogant bullies blinded by dollar signs," said Simpson "Our challenges prompted a more co-operative stance towards the stem cell research community on their part."
Both Consumer Watchdog and the Public Patent Foundation stressed that while University of Wisconsin researcher Thomson deserved acclaim for his research that isolated human stem cells, important scientific accomplishments are not necessarily patentable. They said one 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 may 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.