25 Jul WARF says patent challengers omitted information on stem cell experts
Madison, Wis. – The Wisconsin Alumni Research Foundation has filed a statement with the U.S. Patent and Trademark Office that it believes will shed new light on the motivation of stem cell experts who support the challenge to WARF’s stem cell patents.
It is the latest salvo in a patent re-examination case that is expected to take several years to resolve.
The re-examination challenging the validity of the patents was requested by the California-based Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation. In support of their challenges, the organizations filed declarations from four stem cell researchers, but left out information that WARF considers material to the patent review.
That information, which pertains to two of the researchers that filed declarations on behalf of the patent challengers, includes the following:
• In her declaration, Dr. Jeanne Loring, an associate professor at the Burnham Institute for Medical Research, contends that University of Wisconsin-Madison professor Jamie Thomson’s invention was obvious at the time of discovery (1998). However, after the filing of the Thomson patent, Loring herself applied for a patent that covered the invention relating to isolating human embryonic stem cells. The application included a signed oath claiming that she was an original first inventor.
• Loring stated in her declaration that she had derived nine stem cell lines that were listed on the National Institutes of Health Stem Cell Registry in 2001. According to WARF, she failed to state that the NIH subsequently posted the listing under the category “cells lines not currently available for shipping,” noting that these lines failed to expand into undifferentiated cell cultures.
• Dr. Alan Trounson stated in his declaration that the isolation of human embryonic stem cells was obvious at the time of the patent, yet after the filing of this patent he declared in 2000 to the Patent and Trademark Office that he was a joint inventor in three human embryonic stem cell patents.
WARF, which patents and licenses the discoveries of UW-Madison researchers, said in a statement that it is bringing this information to the attention of the patent office because federal law imposes a “duty of candor” on patent owners. The law requires patent owners to bring to the attention of the patent examiner information that is material to the patentability of an invention.
Challengers defend their turf
Trounson could not be reached for comment, but in an e-mail to WTN, Loring said WARF’s statement didn’t reveal any secrets. She said the cell derivation issue was well documented in a 2002 Wall Street Journal article, and she wrote about it in a recent editorial. She indicated that her derivations were made during an experimental phase, using a method that she had developed and had filed a patent for.
In August of 2001, President Bush announced federal restrictions on funding for embryonic stem cell research, which Loring said came as a complete surprise to her. Since she wasn’t able to prepare for the announcement, most of the stem cell derivations on the original list were like hers – early stage and not recoverable.
“Tommy Thompson was Secretary of HHS then, and being from Wisconsin he may have given researchers there a heads-up, but not me or the Swedish group that had 19 derivations in process,” she wrote. “All of them failed to be recovered, too. It’s too bad. I wish we’d had some notice.”
Loring said the patent application she filed is for a method using a co-culture, somewhat like the method later used for single-cell culture. “We claimed cells derived by that method, but did not claim all human embryonic stem cells,” she said in the e- mail. “Jamie’s patent was already in prosecution by then, anyway. We didn’t pursue the patent after Jamie’s was issued, and it was abandoned. We probably could have eventually gotten the methods claims, but we didn’t have the deep pockets to pursue it.
“As you know, WARF abandoned Jamie’s first patent application on primate embryonic stem cells after the final rejection, and re-filed it at the same time that they appealed the rejection of the first filing. They do have deep pockets, and considerable knowledge of the patent office. I think that is the real story.
“The bottom line is that WARF wants money, and I want all researchers to be able to use human embryonic stem cells. Those two desires are incompatible.”
John Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said WARF’s statement is irrelevant to the fundamental issues raised by the patent challenge. Patent challengers have asserted that WARF’s stem cell patents are overly broad, are stifling stem cell research in the United States, and should never have been granted because Thomson’s discoveries are obvious in light of prior research.
“I think that issue misses the fundamental point,” Simpson said. “It’s not at all relevant to the patents that are under re-examination.”
Standing by their expert
In its response to the PTO’s initial ruling to uphold the patent challenge, WARF cited Dr. Colin Stewart, whose declaration affirms the validity of the Thomson patents. Stewart is a stem cell researcher at the Institute of Medical Biology in Singapore.
WARF Managing director Carl Gulbrandsen said the organization continues to stand behind Stewart’s delcaration. “Dr. Stewart was deeply involved in stem cell research at the National Institutes of Health during the time of Dr. Thomson’s discovery and understands the breakthrough nature of his discovery,” Gulbrandsen said.
In response to claims that its patents are restricting research, WARF has noted that through the WiCell Research Institute, its nonprofit affiliate, it has provided human embryonic stem cells to more than 400 research groups in 40 states and 24 countries. The organization also notes that scientists who receive the cells are free to patent and publish their findings.
WARF also says it has issued 18 commercial licensees for human embryonic stem cell technologies to companies that are developing research products, diagnostics, and therapies.
• John M. Simpson: California group turns up heat on WARF stem cell patents
• WARF enters licensing agreements for stem cell products
• WARF questions relevancy of documents used to uphold patent challenge
• John Scheller: High court sends message on patent obviousness
• Tom Still: Here’s why Wisconsin’s stem cell patents are being challenged