PTO Agrees To Re-Examine WARF Claims In Stem Cells

As consumer advocates trumpeted their victory, others took a longer view of the U.S. Patent and Trademark Office’s preliminary Denial of claims in three stem cell patents held by the Wisconsin Alumni Research Foundation (WARF).

“It’s almost a matter of courtesy to grant a re-look [at the patent claims],” as the PTO has done, said David Greenwood, chief financial officer of Menlo Park, Calif.-based Geron Corp., a major player in stem cell research. “We’re at the front end of the process.”

The PTO ultimately may revoke or modify the patents – or leave them entirely untouched, though some pundits believe the latest move likely means changes, and could embolden companies to start research that infringes on the WARF claims.

“It’s a big thing,” said Paul Lesko, patent attorney with SimmonsCooper in East Alton, Ill. “Most times there will be at least an amendment, if the patent survives,” although the process could take years.

“When it comes to a [final PTO action], I’d say a wholesale rejection is more common than anything else,” Lesko said, especially with patents that contain claims that are fewer in number, like WARF’s.

Geron, which has licensed the WARF patents, will not be directly involved in the continued dispute. “We work with WARF all the time on patent prosecution issues and always have, but they manage the process,” Greenwood said.

Claims made in the trio of patents “are justifiable and should be issued,” he insisted. “We support [them], notwithstanding that we have economics that flow to WARF,” which functions as the technology transfer arm of the University of Wisconsin. “If the WARF patents go away, it has no effect whatsoever on the concentric rings of [other] patents,” Greenwood added. Geron’s intellectual property includes 209 patents in all, with 24 issued in the U.S. and 44 issued in all.

Dated March 30, the PTO’s preliminary decision became known Tuesday. WARF has two months to appeal the finding that favors the arguments of the Foundation for Taxpayer and Consumer Rights, California’s main watchdog organization, which filed opposing paperwork last July. The Public Patent Foundation, a not-for-profit legal services outfit, joined the FTCR in the effort.

Another item of controversy: Carl Gulbrandsen, Madison, Wis.-based WARF’s managing director, sits on the PTO’s advisory committee. He was appointed to the post in February 2005.

Consumer groups charge that research done by University of Wisconsin researcher James Thomson in isolating stem cell lines was not novel, useful or non-obvious, and simply built on previous work. They note the discovery of embryonic stem cells in 1981 by Martin Evans and Matthew Kaufman in Great Britain and Gail Martin at the University of California, San Francisco – none of whom patented their efforts, allowing research to continue without impediments.

“WARF was first in the door, but they’ve always allowed licenses,” Lesko said, adding that others might not have skipped getting patents on earlier work just to keep the research gates open. “Every time I’ve heard that justification, [the real reason is] they didn’t think about it,” he said.

No country other than the U.S. honors the WARF patents, opponents said, and U.S. researchers have conducted their investigations overseas so they can avoid paying royalties to WARF – which has been taking considerable heat, and in January conceded not to demand licensing deals from outside scientists. (See BioWorld Today, Jan. 25, 2007.)

But WARF still asserts royalty rights as its reward for academic work that has paid off big before. Few in the pharmaceutical world can hear the WARF acronym without thinking of warfarin, the anticoagulant whose development began with research at the University of Wisconsin. New York-based Bristol-Myers Squibb Co sells warfarin as Coumadin.

Geron, for its part, does not consider competitors with regard to intellectual property, Greenwood said. “We think about collaborators and partners,” he said. “All of our patents are available for academic research licenses at no charge. It’s not a line of business for us. Any academic institution [can get] a license, with no strings, no mandatory license rights back or any of that.” If academic scientists invent something worthwhile, “we’ll queue up along with anyone else” to make a deal, Greenwood added.

An investigational new drug application for GRNOPC1, Geron’s first embryonic stem cell-derived therapeutic program for spinal cord injury, is expected in 2007.

“We have no lobby in Washington, and we don’t try to influence public opinion through the newspapers,” Greenwood said. “We’re the science shop. The ethics and politics will sort out over time.”

The sorting has been hectic so far, and may become more so. “If we file [the IND] and begin to treat spinal cord injury, and all of a sudden we can bring back some sensory perception or Motor skills to a Paraplegic, imagine the ethical question that raises,” he said. “There’s nothing else you can do for these people. Are you going to deny them the cells?”

The stem cell dispute has special meaning in California, where voters cleared Proposition 71, the nation’s biggest publicly funded stem cell research program, in 2004, allocating $3 billion in grants over the next 10 years, although the measure still faces court action.
“First, the judge rejected both lawsuits on their merits, but she didn’t throw [the case] out, and allowed the appeals process,” Greenwood noted. Prop 71’s opponents “have kind of lost round two, but the beat goes on,” with more legal skirmishing.

By Randall Osborne
West Coast Editor

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