The U.S. Patent and Trademark Office (PTO) should revoke three patents that cover most U.S. research using embryonic stem cells because their science was obvious and not new when the patents were granted, two nonprofit organizations said today at a press event in Los Angeles. The groups have filed an official petition to challenge the patents.
A successful challenge to the patents, held by the Wisconsin Alumni Research Foundation (WARF)--a nonprofit affiliate of the University of Wisconsin (UW)--could allow more companies to exploit the technology for basic research or marketed treatments. That's because WARF's patents, the first of which was granted to UW's James Thomson in 1998, cover the use, sales, or research on stem cells obtained from primates--regardless of who makes them or how. WARF doesn't charge for academic licenses, though Harvard pancreatic cell researcher Doug Melton calls WARF's licensing terms "onerous, restrictive, and uncooperative" barriers to cures.
"All [WARF] really did here was follow what a number of stem cell scientists were showing," says John Simpson with the Santa Monica, California-based Foundation for Taxpayer and Consumer Rights (FTCR), which is leading the effort with nonprofit patent-watchdog Public Patent Foundation. "They tried to pull a fast one on the Patent Office--they've been caught with their hand in the cookie jar," says Dan Ravicher, an attorney with Public Patent.
In their petition, FTCR charges that the first two patents are invalid because they cover a technique that was published in a 1992 patent granted to an Australian researcher deriving animal stem cells in culture. Also, in an attached declaration, molecular biologist Jeanne Loring of the Burnham Institute in San Diego, California, says that the techniques mentioned in a 1990 paper and two textbooks render Thomson's work obvious. But WARF, which contends that its licensing strategies are fair, says its critics are using hindsight to suggest what was obvious at the time. "What worked in mice didn't work in humans," says Elizabeth Downey, a WARF attorney. "If it were so obvious, it would have been done [elsewhere.]"
Experts say the case raises fundamental questions about the nature of patents. "You can say the technology was almost identical to what they did in mouse [cells], so you could argue it was obvious," says Allan Robins, molecular biologist with Irvine, California–based stem cell startup Novocell. But, "there had been failures in rats and pigs--therefore you could argue that it wasn't obvious." PTO can take up to two years to decide whether to do a full re-examination, and another year or more to rule.
A more in-depth news story on this topic will appear in this Friday's issue of Science.