29 Feb Patent office upholds key WARF stem cell patent; appeal is likely
Madison, Wis. – In the first of several decisions expected in a patent dispute involving human embryonic stem cells, the Wisconsin Alumni Research Foundation said today it has been notified that the United States Patent and Trademark Office has upheld the claims of one of the foundation’s key stem cell patents.
The patent challengers, however, said they will continue their challenge of what they termed “three overreaching patents on human stem cells.”
According to WARF, the licensing arm of the University of Wisconsin-Madison, the decision pertains to the patent for primate and human embryonic stem cells known as “913.”
Carl Gulbrandsen, managing director of WARF, called the decision of patent examiner Gary Kunz an affirmation. “We’re extremely pleased with this decision,” he said in a statement released by WARF. “It affirms what WARF has believed all along, that Dr. Thomson’s breakthrough discoveries are patentable inventions.”
Gulbrandsen referred to Dr. Jamie Thomson, the UW-Madison professor who first isolated human embryonic stem cells in 1998. The 913 patent follows a different process than the other two patents, known as “780” and “806.” Those two patents are still under review by the patent office.
The decision to uphold the 913 patent is the first in a review process that began in October 2006, when the patent office agreed to re-examine three UW-Madison stem cell patents following challenges brought by the New York-based Public Patent Foundation and the California-based Foundation for Taxpayer and Consumer Rights.
The two consumer organizations, which can appeal the decision to the Patent and Trademark Office’s Board of Patent Appeals once it is deemed final, have argued that the patents are overly broad and should never have been granted. They also contend that the patents have served to limit stem cell research in the United States.
They vowed to continue their patent challenge despite what they called “a non-final” decision by patent office regarding the inter partes re-examination of the 913 patent. WARF has 30 days to respond to the ruling, which is unlikely since it is a favorable one, and then the challenging parties would have 30 days to respond to WARF.
Therefore, Simpson expects the determination to become final in 30 days, and both challengers indicated they would appeal any final decision supporting WARF’s claims to the Board of Appeals. They also maintained the right to appeal any decision of that board to the U.S. Circuit Court for the Federal Circuit.
“We won the first round when the PTO rejected all claims of the ‘780, ‘806 and ‘913 patents,” said John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, in a statement released by the FTCR. “Now WARF has won the second round with respect to just one of the patents, but the battle is hardly over.
“We’re in this for the long haul.”
Dan Ravicher, executive director of the Public Patent Foundation, took issue with Kunz’s decision on the 913 patent, saying it was based on personal opinion about patent obviousness, not expert testimony. Part of the foundation’s case against WARF’s stem cell patents is the assertion that Thomson’s stem cell discoveries were “obvious” based on knowledge gleaned from prior scientific work, and therefore unpatentable.
“The examiner based his decision on his own belief that it would not have been obvious to isolate human stem cells using widely known methods to isolate mouse stem cells, which contradicts the sworn testimony that we provided of four renowned stem cell embryologists who were doing such work,” Ravicher argued in a statement released by the Public Patent Foundation. “Thus, the examiner took his own opinion over the opinions of our four leading stem cell scientist witnesses.”
Those experts include Dr. Jeanne Loring, now of the Scripps Institute, who has joined the two consumer groups in challenging the patents. Also filing affidavits in support of the challenge were Dr. Alan Trounson president of the California Institute for Regenerative Medicine, and Drs. Douglas Melton and Dr. Chad Cowan of Harvard University.
Grady Frenchick, a patent attorney with Whyte Hirschboeck Dudek in Madison, felt the challenge to this particular patent might be the most problematic for WARF. Frenchick said he’s surprised by Kunz’s ruling because in his April 2007 decision to uphold the patent challenges, Kunz did not adopt any of the challengers’ arguments, nor did he use any of the prior art they submitted. Instead, he based his ruling on his own opinions and research of prior art.
In that ruling, Kunz opined that Thomson’s discoveries were “obvious to one of ordinary skill.”
After WARF replied to Kunz’s initial ruling, his view turned around. “WARF’s reply obviously was very persuasive and caused Kunz to change his mind,” said Frenchick, who characterized Kunz’s first office action as that of a “rogue examiner.”
Gulbrandsen, an attorney with experience in defending challenges to intellectual property, said he is pleased with the thoroughness of the patent examiner’s decision, noting that it is 82 pages long. “It addresses every single argument of the requestor,” he said.
He does not envision a domino effect where this ruling impacts the PTO’s judgment on the other two patents. “These are supposed to be independent re-examinations with different examiners on each one,” Gulbrandsen noted.
Simpson agreed, noting that each patent is a separate matter.
Stem cell licensing
The patent challengers have taken credit for WARF’s decision to ease its licensing requirements, which was announced after the patent office agreed to re-examine the three patents.
Simpson, who charged that WARF executives were “acting like arrogant bullies blinded by dollar signs” prior to the re-examination, said the patent challenge has engendered a more co-operative stance on WARF’s part and has improved the situation for stem cell researchers.
“We think there already has been a huge victory in this whole challenge,” Simpson said, referring to WARF’s decision to ease its licensing requirements.
Simpson also said the original 913 patent was narrowed as part of the amended “non-final” ruling. The original patent covered all embryonic stem cells no matter how they are derived but while the amended ruling permitting the patent, it narrowed the claim only to stems cells derived from pre-implantation embryos.
The patent challenges also claimed that the newest stem cell research technology – Induced Pluripotent Stem Cells (IPS cells), which are derived without destroying embryos – would “clearly not be covered” by the narrowed patent. In addition, they said that stem cells derived from fetal tissue could have been claimed under the old patent, but now cannot be.
Meanwhile, WARF said it continues to support the distribution of cell lines and methodologies for isolating and culturing human embryonic stem cells to academic researchers. The foundation does this through its affiliate, the non-profit WiCell Research Institute, which is home to the National Stem Cell Bank.
According to WARF, WiCell has fulfilled 914 licenses for stem cells, which have been shipped to more than 563 researchers in 25 countries and 40 states since 1999. Two vials containing approximately six million stem cells capable of establishing multiple new colonies are priced for academic researchers at only $500, WARF noted, while private companies and labs can buy WARF stem cells for $125,000 and reap much more if they produce something commercially viable from their investment.
WARF also notes that academic scientists using these cell lines and methodologies face no restrictions on patenting or publishing their work.
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