Patent office upholds challenge to WARF stem cell patents

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Wisconsin Technology Network

Madison, WI & Santa Monica, CA — The United States Patent and Trademark Office has upheld challenges to three stem cell patents held by the Wisconsin Alumni Research Foundation, but WARF is standing by the validity of the patents as the legal process continues to unfold.

Every WARF claim regarding the method of deriving stem cells, and the claim to stem cells, themselves, has been rejected by examiners in the patent office, but the organization still has opportunities to argue that the claims should prevail.

The challenges were filed by the Santa Monica-based Foundation for Taxpayer and Consumer Rights, which initiated a re-examination of what it calls “over-reaching” patents.

John M. Simpson, FTCR stem cell project director, called it a great day for scientific research. The foundation has argued that the WARF patents are impeding scientific progress and driving stem cell research overseas.

“I think it’s been generally acknowledged among stem cell researchers that the WARF patents were blocking efforts in the United States,” Simpson said, “and while it’s true that they did ease their licensing requirements in January, I think those patents were continuing to loom over the field. And so this is another vindication of the view that these patents should never have been issued, and that can only be good for science and for people who care about the results of stem cell research.”

WARF, which announced in January that it would ease its licensing requirements on human embryonic stem cells, has two months to respond to the PTO ruling.

WARF Managing Director Carl E. Gulbrandsen said WARF has “absolute confidence” in the appropriateness and legitimacy of the patents. “It is inconceivable to us that Dr. [James] Thomson’s discovery, which Science Magazine heralded as one of the greatest scientific discoveries in history, would be found to not be worthy of a patent,” he said in a release. “This discovery captured the imagination of people all over the globe from every discipline.

“We are confident that, when all of the facts are known and the process runs its course, our patents will be upheld.”

Issuing the challenge

The FTCR and the Public Patent Foundation filed the challenge last July. They argued that the work done by University of Wisconsin-Madison researcher James Thomson to isolate stem cell lines was obvious in the light of previous scientific research, making his work unpatentable.

According to the FTCR, the patent and trademark office released a statement saying, “a person skilled in the art would have been motivated to isolate primate (human) ES cells, and maintained in undifferentiated state for prolonged periods, since ES cells are pluripotential and can be used in gene therapy.”

The groups also said no other country in the world honors the WARF patents, which caused American researchers to send research monies abroad where they can avoid paying royalties to the Wisconsin foundation.

The foundation said third-party requests for patent re-examination are ultimately successful in having the patent either changed or completely revoked roughly 70 percent of the time.

Rather than seek to change the PTO’s the ruling, WARF should simply drop its claims, said Dan Ravicher, executive director of PUBPAT.

Legal hurdles

Gulbrandsen, however, said WARF would proceed with its own legal recourse, which will start with the patent examiner and could eventually reach the courts.

He said the patent re-examination process provides for multiple layers of review. This first rejection gives WARF the opportunity to respond directly to the examiner, and Gulbrandsen said WARF will vigorously defend its patent claims. He said that response could persuade the examiner to sustain the patents and terminate the re-examinations.

If the examiner maintains the rejection, WARF probably would appeal the examiner’s decision to the PTO Board of Patent Appeals. If that body fails to sustain the patents, WARF can then appeal to the courts.

The process can take many months, or even years, but while the review is underway, WARF said all of its patents will remain in place and are legally viable.

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