Wisconsin State Journal
James Thomson’s breakthrough in growing human embryonic stem cells in 1998 is worthy of the patents he received because no researchers had done what he did, the Wisconsin Alumni Research Foundation said Thursday, in response to the federal government’s preliminary rejection in March of three patents.
The response by WARF, UW-Madison’s tech-transfer arm, said other researchers cited in the U.S. Patent and Trademark Office‘s rejection worked with mouse cells or human cells less viable than those developed by Thomson, of UW-Madison.
WARF disputed the patent office’s characterization that Thomson’s discovery, hailed by many scientists, was “obvious” to those working in the field at the time.
“Were the invention obvious, others would not have repeatedly failed to accomplish it, and such scientific and professional acclaim would not have been ascribed to (Thomson),” WARF attorneys wrote.
WARF submitted some 1,000 pages of documents to the patent office, including a declaration of support from a stem-cell researcher in Singapore.
The patent office will decide within a few months whether to uphold or reverse its rejection, authorities said. WARF has vowed to appeal to federal court if necessary.
The outcome could greatly impact Madison’s prominence in the burgeoning stem-cell field, in which scientists hope to use the blank-slate cells derived from 5-day-old embryos to develop therapies for diabetes, Parkinson’s disease and other conditions.
Losing the patents could make WARF lose millions of dollars in future revenue from license fees and royalties involving stem cells. So far, WARF has received more than $3.2 million from the patents.
The patents — granted in 1998, 2001 and 2006, and in effect until 2015 — cover virtually all embryonic stem-cell research in the country. They are the most visible of 11 stem-cell patents held by WARF, which also has 35 patent applications pending for stem-cell research at the university, according to WARF spokesman Andy Cohn.
The government’s review of the three patents started last year at the request of two groups: the Foundation for Taxpayer and Consumer Rights in Santa Monica, Calif., which is involved in California’s $3 billion stem-cell initiative; and the New York-based Public Patent Foundation.
John Simpson, stem-cell director for the California group, said WARF‘s licensing fees, of up to $400,000, impede stem-cell research. He called WARF‘s response to the patent office rejection a “rehash of old arguments.”
Dan Ravicher, executive director of the New York group, said he would reply to the patent office within a month to WARF‘s response concerning the patent granted in 2006. That patent is undergoing a kind of review that allows third-party input.
“The momentum is to reject the patents,” said Ravicher, who claims to have narrowed patents held by Pfizer and Microsoft.
But Carl Gulbrandsen, managing director of WARF, said in a prepared statement: “When the process has run its course the patented inventions will remain intact.”
WARF‘s response, filed late Wednesday but not released until Thursday, focuses on the work of three of the scientists cited in the patent office rejection issued March 30:
Robert Lindsay Williams, a stem-cell researcher from Australia who was awarded a patent in 1992.
Brigid Hogan, now at Duke University in North Carolina, whose work deriving stem cells from human fetuses received patents in 1995 and 1997.
Ariff Bongso, a scientist in Singapore. The National Institutes of Health credits him as being the first to isolate embryonic stem cells from humans, in 1994, but the NIH says Bongso didn’t substantially grow the cells as Thomson did.
WARF reiterated NIH‘s position regarding Bongso, saying his cells died after a few days, while Thomson’s lived in their primordial state for more than a year.
Williams grew only mouse stem cells, WARF said, and Hogan used embryos that had been implanted in the uterus, different from the pre-implantation embryos Thomson used.
The Wisconsin State Journal has been unable to locate Williams. Hogan did not respond this week to an interview request, and Bongso declined an interview.
Thomson did not respond Thursday to an interview request. Last year, in an e-mail interview, he said, “Some very good, simple ideas only seem obvious afterwards.”
In its response, WARF altered some of its patent claims, apparently in reaction to the patent office’s references to Williams, Hogan and Bongso. WARF specified that the stem cells covered by its patents come from pre-implantation embryos, for example, and that the cells can grow undifferentiated for more than a year.
Cohn, the WARF spokesman, would not characterize the changes as a broadening or a narrowing of the patents. “We’re clarifying the claims,” he said.
Grady Frenchick, a Madison patent attorney who has done work for WARF but not involving stem cells, said the changes narrow the patents — but probably not significantly.
Frenchick said that one of the most important parts of WARF‘s response is the inclusion of the declaration of support from Colin Stewart, a scientist with the Institute for Medical Biology in Singapore. Stewart worked with Thomson in the early 1990s, when the only embryonic stem cells anyone had cultured were from mice.
Thomson’s derivation of human embryonic stem cells in 1998 “was all the more remarkable because the scientific literature was replete with examples of failures by others to isolate (embryonic stem) cells from any species except the mouse,” Stewart wrote in his declaration.
Stewart’s support — along with proof WARF submitted of many scientific awards Thomson has won — is considered a “secondary factor” for courts in deciding whether a discovery was obvious and thus not worthy of a patent, Frenchick said.
A recent ruling by the U.S. Supreme Court could make such supporting documents more relevant, Frenchick said. In April, the court rendered a patent on an automobile brake, held by a company called Teleflex, invalid because the concepts involved were obvious. In its decision, the court cited a lack of secondary factors, Frenchick said.
WARF “would have done this anyway,” he said, “but the Teleflex case made it pretty clear this is something you should do.”
STEM-CELL PATENTS
WHAT’S NEXT:
The U.S. Patent and Trademark Office will decide within a few months whether to uphold or revoke its rejection. If the rejection is upheld, WARF could appeal.
THE IMPACT:
If the patents are overturned or significantly narrowed, WARF could lose millions in future revenue, and UW-Madison’s prominence in the stem-cell field could be diminished.
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Contact the author David Wahlberg at 608-252-6125.
