31 May WARF questions relevancy of documents used to uphold patent challenge
Madison, Wis. – Claiming that patents and publications used to uphold a challenge to its stem cell patents are irrelevant to the isolation and proliferation of human embryonic stem cells, the Wisconsin Alumni Research Foundation has filed a response refuting an initial determination by the U.S. Patent and Trademark Office.
Those observations on relevancy, made by Carl Gulbrandsen, managing director of WARF, were supported by Dr. Colin Stewart, a stem cell researcher at the Institute of Medical Biology in Singapore.
Stewart submitted a declaration in support of the patents, emphasizing the differences between mouse stem cells, which were prominent in the PTO’s rejections, and the human embryonic stem cells that were isolated and characterized by University of Wisconsin-Madison researcher Jamie Thomson.
WARF, the patenting and licensing organization for UW-Madison, holds the patents on the discoveries of Thomson, who was the first to successfully isolate and culture human embryonic stem cells.
The patent challenge, filed by the California-based Foundation for Taxpayer and Consumer Rights, asserted the patents should not have been issued because Thomson’s work was “obvious” in light of prior discovery.
In late March, patent examiners rejected WARF’s patent claims in the first ruling of what promises to be a prolonged patent-review process.
WARF had 60 days to respond to that initial ruling and did so by noting that Thomson’s work was not obvious to a number of scientific organizations. WARF provided the PTO with a list of accolades bestowed upon Thomson, including honors from the American Association for the Advancement of Science, the Biotech Hall of Fame, the World Technology Network, and the American College of Veterinary Pathologists.
The foundation also noted that Time Magazine called Thomson one of the people “who are changing the world,” and that Science, the AAAS’ journal, called his invention “one of the most significant milestones in the history of science.”
“Clearly, at the time of the discoveries, leading scientists and scholars from around the world saw Thomson as the first scientist to isolate and proliferate human embryonic stem cells,” Gulbrandsen said in a release. “When the process has run its course, the patented inventions will remain intact.”
The patent challenge was pursued in part because the Foundation for Taxpayer and Consumer Rights, citing the complaints of scientists, felt the stem cell patents were restricting research. John Simpson, stem cell project director for the FTCR, said WARF acknowledged as much earlier this year when it announced it was easing its stem cell licensing restrictions.
In January, WARF said it would allow industry-sponsored research at academic and non-profit institutions without a license. The foundation also said it would allow simpler, cost-free cell transfers among researchers, and would not require a license or agreement from the California Institute for Regenerative Medicine.
In 2006, WARF announced it would expect CIRM to pay a portion of revenues it receives from research that it funds, a development that led to the patent challenge.
WARF has consistently refuted claims that its stem cell patents are restricting research, noting that it has provided cells to more than 400 research groups in 40 states and 24 countries, and that it has 18 commercial licensees with companies that are developing research products, diagnostics, and therapies.
In all, three WARF patents are being challenged in a process that could reach the federal courts and take several years to resolve.
Two of the patents are being considered under a process known as an ex parte re-examination, where the FTCR already has presented its case. A third patent is being considered under an inter partes process in which the organization will have an opportunity to respond to WARF’s response.
Simpson said the FTCR is still studying WARF’s arguments, but they appear to be a rehash of what already was before the PTO. “We think right now that this is about what we expected at this stage, and we’re optimistic,” he said.
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