Was stem-cell advance ‘obvious’?

Published on

The Wisconsin State Journal

A federal review of Wisconsin’s embryonic stem-cell patents won’t question what everyone concedes: that UW-Madison scientist James Thomson was the first to grow a colony of the cells from humans in a lab.

Instead, the U.S. Patent and Trademark Office‘s review of three patents held by the Wisconsin Alumni Research Foundation will ask if Thomson’s accomplishment in 1998 was “obvious” because other scientists had done similar work in species such as mice and pigs.

The stem-cell patents have brought $3.2 million in license fees to WARF, UW-Madison’s nonprofit technology transfer arm. Much more money could come before the patents expire in 2015 if they are not overturned in the review, which started last month and could take years.

WARF‘s patents, which cover both the cells and the methods to grow them, are being challenged by the Los Angeles-based Foundation for Taxpayer and Consumer Rights. The foundation, involved in California’s new $3 billion stem-cell research initiative, is being joined in the effort by the New York-based Public
Patent Foundation.

The groups say the broad patents are impeding research. They argue that the patents should not have been issued because the stem-cell recipe Thomson followed for humans and other primates had already been published for other species.

WARF‘s stance, that Thomson’s work is worthy of patents, “is like saying that just because heating in water works for cooking a chicken egg, it’s novel to consider using heating in water to cook a duck egg,” said Jeanne Loring, a stem-cell researcher at the Burnham Institute for Medical Research in California.

Loring filed papers supporting the groups’ request for the patent review.

WARF officials wouldn’t comment directly on the challenge but said they would prevail.

“I can’t say whether there might be some small narrowing (of the patents), but I am confident that on the whole they will stand,” said Beth Donley, executive director of the WiCell Research Institute, WARF‘s stem-cell subsidiary.

Obvious afterward?

Thomson said no scientists were able to grow the cells from humans before he did, even though the method for doing so in mice had been available since the cells were first grown from that species in 1981.

“Although sometimes things seem obvious in retrospect, it is curious that no one accomplished the derivation of human (embryonic stem) cells between 1981 … and 1998,” he said in an e-mail interview. “Some very good, simple ideas only seem obvious afterwards.”

Thomson said the challengers are attacking WARF‘s patents because they want California to profit from future patents on discoveries made through its stem-cell research initiative. The initiative is run by the California Institute for Regenerative Medicine, or CIRM.

“The only real difference is that the CIRM-funded patents will largely benefit California, and the WARF patents largely benefit Wisconsin,” he said.

John Simpson, stem-cell director for the Foundation for Taxpayer and Consumer Rights, said the license fees demanded by WARF for commercial research using the patented cells or processes are “stifling research in the United States and forcing some money overseas.”

The stem-cell patents were issued in 1998, 2001 and this year. Stem cells, thought capable of becoming all of the body’s 220 cell types, could someday be used in therapies for diabetes, Parkinson’s disease and other conditions.

Academic and nonprofit scientists pay $500 to obtain the cells and can study them for free. Companies wanting to perform research on the cells must pay $75,000 to $150,000 up front to WARF plus annual maintenance fees of $25,000 to $60,000, Donley said. The fees vary based on the size of the company and the scope of the license.

Companies developing products from the cells must pay $200,000 to $2 million up front, Donley said. They face annual fees of $25,000 to $200,000 and must hand over 1 percent to 5 percent of royalties.

Five companies have obtained product licenses from WARF and eight have research licenses, Donley said. About 75 percent of the money is funneled back to stem-cell research on campus.

WARF holds nine stem-cell patents and has applied for 22 others, she said. The three under review are the most broad.

Patent office reviews take an average of 21 months, officials say, and can be followed by lengthy appeals. Patents remain active during the process, which 70 percent of the time results in patents being narrowed or cancelled.

The previous research

Central to the challengers’ argument that Thomson’s discovery was obvious are four documents cited in their request filed with the patent office:

A patent awarded in 1992 to Robert Lindsay Williams, an Australian researcher who was working for a company called Amrad;

Two book chapters, written in 1983 and 1987, by Elizabeth Robertson, now at Oxford University in England; and

A research paper published in 1990 by Jorge Piedrahita, now at North Carolina State University in Raleigh.

The works discuss ways to grow stem cells from rodents and from pigs, sheep and other mammals.

Williams, who could not be located, in no longer with Amrad, which is now called Zenyth, said Gerard Henry of Zenyth. Robertson, reached by e-mail in Oxford, did not respond to requests for an interview.

Piedrahita, who didn’t want to talk specifically about the patent challenge, said his work involved trying to grow stem cells from pigs.

“We isolated some cell lines,” he said. “But we could never convincingly prove they were (embryonic stem) cell lines.”

Piedrahita, who now studies cloning in pigs, said he’s not surprised the stem-cell patent challengers referenced his paper. “We did a tremendous amount of work in a single species,” he said.

The method to grow stem cells described in WARF‘s patents “is in fact the exact same method” Robertson and Piedrahita used, said Dan Ravicher, executive director of the Public Patent Foundation. “It would have been obvious in light of what had been done before.”

Unintended consequence?

Some outside observers have speculated that the challengers may also try to bring up work by Ariff Bongso, a scientist in Singapore. The National Institutes of Health credits him with being the first to isolate embryonic stem cells from humans, in 1994, but he didn’t substantially grow the cells as Thomson did.

Ravicher wouldn’t say whether Bongso’s research would be introduced.

Gary Frenchick, a Madison patent attorney who has done work for WARF but not involving stem cells, said the patent office’s review could have the unintended consequence of strengthening the patents.

Even if the patent office narrows some claims, the remaining claims would be more likely to endure future court challenges after having gone through the additional scrutiny of the patent office review, he said.

“They may have done WARF a favor here, to temper their claim coverage in a way that can make it stronger,” said Frenchick, with Whyte Hirschboeck Dudek, who is also a lecturer at UW-Madison.

Robert Schwartzman, a patent attorney with Sterne, Kessler, Goldstein & Fox in New York, said the challengers are taking advantage of a new type of patent office review: an “inter partes” review, in which challengers can participate more fully, at each step along the way.

That type of review, available since 1999, is being conducted on the WARF patent issued this year. The reviews of the two older patents are the more traditional variety, with less third-party input.

Unlike the traditional review, the inter partes review also allows challengers to appeal the patent office’s decision. That means the process could take longer and go in unexpected directions.

“It could easily be a couple of years or more before there’s an answer,” Schwartzman said. “I don’t think there’s really anything predictable about this process.”

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