USPTO rejects WARF's stem cell patent claims

In what two consumer groups today praised as a victory for open scientific inquiry, the U.S. Patent and Trademark Office has rejected 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 Stem Cell Project Director. The nonprofit, nonpartisan Consumer Watchdog had joined with the Public Patent Foundation 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. Word of the the USPTO board's April 28 decision was received over the weekend.

"We've said from the very beginning that WARF's patents on stem cells are undeserved," said Dan Ravicher, PUBPAT Executive Director. "Should WARF continue to try to defend their unjustified patents, we will continue to prove them invalid."

Joining the two consumer groups in the challenge from the beginning was Dr. Jeanne Loring, now director of the Center for Regenerative Medicine at the Scripps Institute. Later in the case Dr. Alan Trounson, then of Australia's Monash University and now president of the California Institute for Regenerative Medicine, Dr. Douglas Melton of Harvard and Dr. Chad Cowan of Harvard filed affidavits supporting the challenge.

"This is great news for medical research. Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them." said Dr. Loring. "

Read the PTO Board of Appeals decision here: http://www.consumerwatchdog.org/resources/WARFDecision042910.pdf

Consumer Watchdog, formerly The Foundation for Taxpayer and Consumer Rights, and the Public Patent Foundation appealed to the U.S. Patent Office's Board of Appeals and Interferences after a PTO examiner granted the patent after narrowing its claims. The two groups originally requested a re-examination of the patent in July 2006, along with two other seminal stem cell patents held by WARF. Initially all three patents were rejected, but in 2008 a PTO examiner granted them with narrowed claims.

Under current patent law only one of the three patent rulings could be appealed by the two groups. That was the patent rejected by the Board of Appeals and Interferences. However, said the groups, 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 two public interest groups noted that the original three 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.

"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 James 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.

"The best course if WARF truly cares about scientific advancement" said Simpson, "would be to simply abandon these over-reaching patent claims."