UW challenges rejection of patents;

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Stem cell advances were ‘landmark’ in field

Milwaukee Sentinel-Journal (Wisconsin)

With its patents on the stem cell work of University of Wisconsin-Madison professor James Thomson preliminarily rejected, the foundation that helps shepherd the school’s research discoveries to market fired back Thursday, saying the rejection was wrong on multiple counts.

Formally filing its arguments with the U.S. Patent and Trademark Office, the Wisconsin Alumni Research Foundation defended Thomson’s stem-cell advances as “novel,” “a landmark invention” and “true innovation.”

In a preliminary determination two months ago, Patent Office examiners concluded just the opposite. Previous scientific advances made Thomson’s work — in 1998 he became the first person to isolate human embryonic stem cells – obvious, the examiners said. Ruling on challenges to three key patents owned by WARF, the examiners held that the patents should be rejected.

That’s not a final ruling, and Thursday’s response by WARF was simply one more step toward an ultimate determination of the contentious issue.

In a filing that ran more than 1,000 pages, the foundation argued its case on a host of highly complicated scientific points, and raised two overarching questions.

If Thomson’s work was obvious – work that is widely viewed as holding huge potential for fighting human disease – why didn’t someone else do it?

If Thomson’s work was obvious, why has he been acclaimed by, among others, the American Association for the Advancement of Science, the American Academy of Achievement, the Biotechnology Hall of Fame, the World Technology Network and the American Association for Laboratory Animal Science?

Thomson “managed to accomplish what others had tried for years and failed to do,” stem cell scientist Colin Stewart said in a declaration filed with WARF‘s arguments.

“Dr. Thomson’s achievement of isolating primate / human embryonic stem cells and identifying their composition has been widely recognized by those with knowledge of the field as one of the major scientific breakthroughs in biology,” Stewart wrote.

A principal investigator at the Institute of Medical Biology in Singapore, Stewart has researched mouse embryonic stem cells since 1980. The patent examiners cited the isolation of mouse stem cells – achieved decades ago – as paving the way for Thomson’s work.

But, Stewart wrote, until Thomson, no one had been able to isolate stem cells from any other species.

“Dr.Thomson’s invention was all the more remarkable because the scientific literature was replete with examples of failures to isolate (embryonic stem) cells from any species except the mouse,” Stewart wrote.

Among those who tried and failed, he wrote, are scientists whose work, in the eyes of the patent examiners, make Thomson’s advances obvious and not worthy of patents.

WARF‘s opponents said the foundation’s arguments are nothing new.

The documents appear to be “largely a rehash” of the case WARF made earlier, and which the patent examiners rejected in their preliminary ruling, said John M. Simpson, stem cell project director at the Foundation for Taxpayer and Consumer Rights, a Santa Monica, Calif.-based group that challenged the patents.

“This is pretty much what we expected them to do,” Simpson said.

In asking the government last year to revoke the WARF patents, the consumer group said the patents were hindering research, driving scientists overseas and wasting taxpayer money. The group said at the time that the patents stymied research by allowing WARF to require researchers, including those receiving tax-supported grants, to pay royalties and obtain approval for initiating stem cell work.

In Wisconsin, meanwhile, the patents and Thomson’s research and stature have helped bolster the state’s bid to become a biotechnology center.

While WARF‘s opponents — also joining the challenge last year were the Public Patent Foundation and stem-cell scientist Jeanne Loring — won the first round in the patent battle and were heartened by a U.S. Supreme Court decision in another case a month ago, relatively few patents get overturned. Only about 12% are canceled, the Patent Office has said.
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