SANTA MONICA, CA — Legal papers just filed with the U.S. Patent Office cite two legal errors made by a patent examiner in confirming a patent on human embryonic stem cells and ask its claims be rejected, two consumer groups said today.
In their brief to the U.S. Patent Office’s Board of Appeals and Interferences, Consumer Watchdog and the Public Patent Foundation at Benjamin N. Cardozo School of Law said that the examiner made two mistakes of law leading him to make incorrect conclusions about the patentability of the stem cell research. He erroneously applied too high a standard for reasonable expectation of success and he applied too high a standard for obviousness.
The two groups maintain — and most scientists agree — that the creation of human embryonic stem cell lines was obvious in the light of work that had been done in other species. No other country in the world recognizes the disputed stem cell patent.
Consumer Watchdog and the Public Patent Foundation (PUBPAT) first challenged three stem cell patents — the ‘780,’806 and ‘913 — held by the Wisconsin Alumni Research Foundation (WARF) in July 2006. Initially all claims were rejected. This spring the PTO approved them with narrowed claims. The ‘913 patent is being re-examined under rules that provide for an appeal to the PTO’s Board of Appeals and Interferences.
The two groups noted that the patent challenge has already improved the situation for stem cell researchers; shortly after the PTO launched the re-examination, WARF announced a substantial easing of its licensing requirements.
"Our challenge prompted WARF to adopt a more co-operative approach toward the stem cell research community," said John M. Simpson, Consumer Watchdog Stem Cell Project Director. "However, even in its narrowed form this patent should never have been issued and we intend to demonstrate that."
In their brief the groups wrote:
"In this reexamination, the Examiner made two critical legal errors that led him to make incorrect conclusions regarding the patentability of the instant claims. First, the Examiner required the expectation of success to be an absolute certainty in order for it be considered "reasonable." This is too high a standard and conflicts with binding precedent.
"Second, the Examiner concluded that since human embryonic stem cell cultures as claimed had not existed before, they were not obvious. This effectively eviscerated the non-obviousnes requirement by collapsing it into the Examiner’s anticipation inquiry. This standard is too high and conflicts with binding precedent."
The groups stressed that while James Thomson deserved credit for his research, important scientific accomplishments are not necessarily patentable. They said that he was able to derive a stem cell line because he had access to human embryos and financial support that other researchers did not have.
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.
"It’s not just scientists that are affected by the patents" said Dr. Loring. "Patients and their families know that WARF’s iron-fisted control of stem cells is slowing life-saving research."
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Consumer Watchdog, formerly known as The Foundation for Taxpayer and Consumer Rights, is a leading non-profit and non-partisan consumer advocacy group. For more information visit: www.ConsumerWatchdog.org
The Public Patent Foundation at Benjamin N. Cardozo School of Law is a not-for-profit legal services organization that represents the public’s interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy. For more information visit: www.pubpat.org