The Capital Times (Madison, Wisconsin)

A preliminary decision by the U.S. Patent and Trademark Office to reject three broad embryonic stem cell patents held by the Wisconsin Alumni Research Foundation threatens the University of Wisconsin’s leadership in the field, but is only a first step in legal maneuvers that could take years.

“It is one of those things where too much is being made of it at this point,” said Charles Sara, a patent attorney with Dewitt, Ross & Stevens in Madison. “Other parties challenging the patents are saying the Patent Office didn’t consider all the issues. If there is significant new evidence, it does go through the process. The patents are still valid during the process, and if it turns out to be a negative decision, WARF could still take the issue to court.”

The WARF patents were challenged by the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation last July. The public interest groups contend that UW-Madison researcher James Thomson’s work to isolate stem cell lines was obvious in light of previous scientific research, making his findings unpatentable.

“This is a great day for scientific research,” John M. Simpson of the Foundation for Taxpayer and Consumer Rights said Monday evening.

“Given the facts, this is the only conclusion the PTO could have reached,” Simpson said. “The patents should never have been issued in the first place. We are very happy with what the Patent Office has done.”

The Patent and Trademark Office decision issued March 30 stated in part: “The claimed human embryonic stem cells would have been obvious to the person of ordinary skill in the art at the time of the invention wanting to extend the isolation of embryonic stem cells from several species of mammals (mice, sheep)… to another species of mammals (humans) by using the procedures taught by the disclosure of these prior art references.”

Procedurally, any person may request the Patent Office to re-examine a claim for a patent based on previous patents or relevant printed publications. If the Patent Office determines that they raise a substantial new question, re-examination of the patent will be ordered.

WARF has two months to appeal the preliminary decision, and WARF Managing Director Carl Gulbrandsen contends that initial rulings rejecting patent claims are not unusual.

The patents stemming from Thomson’s research have brought international prestige to the University of Wisconsin, as well as millions of dollars in license fees to WARF, which handles technology transfer for the university.

Researchers in other states have contended that the patent control by WARF was impeding scientific progress and driving vital stem cell research overseas.

“WARF has absolute confidence in the appropriateness and legitimacy of these patents,” Gulbrandsen said in a written statement. “It is inconceivable to us that Dr. 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.”

Dr. Jeanne Loring, a stem cell researcher at the Burnham Institute for Medical Research, filed statements in support of the re-examination requests.

“The real discovery of embryonic stem cells was by Martin Evans, Matt Kaufman and Gail Martin in 1981, and none of these scientists considered patenting them,” Loring said. “It is outrageous that WARF claimed credit for this landmark discovery nearly 15 years after it was made.”

Gulbrandsen quoted past statements by scientific leaders about the importance of Thomson’s findings.

The former director of the National Institutes of Health, for instance, predicted the discovery would change the face of medicine.

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

But WARF eased its restrictions on licensing requirements after the challenges were filed.

Grady Frenchick, a patent attorney with White Hirschboeck & Dudek in Madison who teaches at the University of Wisconsin Law School, noted that the patent challenge process is heavily weighted toward the patent holder, which can appeal a decision, while the challenger cannot.

“About 70 percent of the time, the patents come through this proceeding with the same scope of rights they have. Another 15 percent of the time, they have some substantial reduction in the scope of rights, and 15 percent of the time all claims are found unpatentable.”
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