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- In a decision that cannot be appealed, the United States Patent and Trademark Office has upheld the modified claims of the Wisconsin Alumni Research Foundation
on two of the foundation's most important human embryonic stem cell patents.
The ruling, which affects two patents for primate and human embryonic stem cells known as 780 and 806, follows a favorable determination on patent 913, which relates to the discovery and culture of human embryonic stem cells by researcher Jamie Thomson.
Since the challenge involving patent 913 has a different review process, the Feb. 25 determination can be appealed.
The decision on patients 780 and 806 marks almost complete vindication for WARF, the University of Wisconsin-Madison's
licensing arm, in its defense of the controversial stem cell patents. During the re-examination, all three patents were modified in ways that narrowed their scope, and WARF lost its eligibility to claim certain damages, but most of the patent claims in 780 and 806 have been upheld.
In essence, the patent office examiner ruled that Thomson's discovery was not "obvious" in light of prior art, or scientific discovery, which is a rebuke of an assertion made by the patent challengers. The ruling that Thomson's work is not obvious in light of prior art means that his work is patentable.
The decision to uphold the modified patents concludes a review process for 780 and 806 that began in October 2006, when the patent office agreed to re-examine the patents following challenges brought by the New York-based Public Patent Foundation
and the California-based Foundation for Taxpayer and Consumer Rights
. The groups have argued that WARF's stem cell patents are overly broad and are stifling stem cell research in the United States.
In praising the patent office rulings, Carl Gulbrandsen, managing director of WARF, said appropriate intellectual property protections are critical to stimulating private-sector investment in technology development and the subsequent commercialization of new therapies and treatments.
The patent office has conducted a thoughtful and thorough review of all three patents, and we applaud this final decision on our two most important base stem cell patents,'' Gulbrandsen said in a statement released by WARF. Dr. Thomson's groundbreaking work already has led to additional scientific breakthroughs, and this latest ruling affirms that his pioneering discoveries are patentable inventions.''
Thomson, a professor of anatomy at UW-Madison, first isolated human embryonic stem cells in 1998, setting the stage for the legal wrangling that has occurred over the subsequent granting of three stem cell patents.Remaining legal avenues
Dan Ravicher, president and executive director of the Public Patent Foundation, said the patent challengers disagree with the examiner's ruling on obviousness. He said they can point to victories such as the narrowing of patent claims and WARF's decision to ease licensing requirements, which was announced after the patent office agreed to re-examine the three patents.
"I don't think this is a clear-cut victory for either side," Ravicher said.
John Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, agreed that the patent challengers already have won a huge victory against what he called "these overreaching patents."
He said WARF has substantially decreased its aggressiveness in asserting the patents, and therefore the "chilling effect" they were having on research.
"Confronted by our challenge, early last year WARF substantially eased its licensing requirements," Simpson noted. "That change in behavior was tremendously important for researchers. We can appeal the decision on the 913 patent, and we will."
By modifying their claims, Simpson said that WARF has lost entitlement to current damages and now is entitled only to damages beginning when the patent challenge is complete, a process that could take several more months.
In addition to appealing the Feb. 25 patent office ruling on patent 913, Ravicher said the patent challengers still could request a re-examination of the modified patents, but Madison attorney Grady Frenchick expressed doubt the patent office would do that following the "rigorous examination and re-examination" that already have taken place.
Shortly after the ruling on patent 913, Frenchick predicted a similar result on patents 780 and 806. He also characterized the patent modifications as more along the lines of a "clarification." He said the clarifying language, which was added during the re-examination process, includes the phrases "derived from a pre-implantation embryo" and "in an undifferentiated state."
"That language that was added will now appear in the Certificate of Re-examination, which the Patent and Trademark Office will issue within about two months," he said.
Frenchick, a patent attorney with Whyte Hirschboeck Dudek
, also advised any private or public entity that has been waiting to license stem cell technology from WARF, pending the outcome of the patent challenge, to "leave the sidelines."
Gulbrandsen said WARF would maintain its current licensing policy, but denied the changes were linked to the patent challenge.
"Our decision had nothing to do with the challenge," he stated. "It had everything to do with our discussions with other universities and with our licensees."Chilling effect?
Gulbrandsen also said that if the patent ruling had gone the other way, it would have had ramifications beyond WARF, especially given the many patents issued for other biological material and cells. "It would be saying that very little is patentable in the technology area due to the obviousness issues," he said. "In this environment, people are worried enough about investing due to the credit crunch." Related stories
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