The U.S. Patent and Trademark Office on Monday released on its Web site a preliminary ruling that invalidates three "broad" patents on human embryonic stem cells held by the Wisconsin Alumni Research Foundation, the New York Times reports (Pollack, New York Times, 4/3). The foundation, called WARF, has patented the technology used to derive embryonic stem cells (Kaiser Daily Women's Health Policy Report, 5/22/02). The Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation in July 2006 filed a challenge with the patent office to the three patents, which were issued in 1998, 2001 and 2006. According to the Times, the 1998 patent covers primate embryonic stem cells, the 2001 patent covers human and primate embryonic stem cells, and the 2006 patent covers cultures of human or primate embryonic stem cells, the Times reports. The two groups challenging the patents have said that that they are so broadly written that they give WARF potential to receive royalties from a broad range of stem cell-related treatments. The groups also have said that James Thomson -- the University of Wisconsin-Madison scientist who isolated embryonic stem cells in 1998 -- was not the first to isolate embryonic stem cells, the Milwaukee Journal Sentinel reports. According to the groups, WARF's control of the technology discourages potentially lifesaving research or moves it abroad (Schmid, Milwaukee Journal Sentinel, 4/2). According to the Times, patent examiners rejected all the claims of the three patents, saying that Thomson's cells appeared to be the same as, or clear variations of, cells described in earlier scientific papers or in other patents (New York Times, 4/3). WARF attorneys have two months to respond to the patent office's preliminary ruling, the Los Angeles Times reports (Kaplan, Los Angeles Times, 4/3). WARF said it would appeal the ruling at every potential venue, including federal courts (Milwaukee Journal Sentinel, 4/2).

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Daniel Ravicher, president and executive director of the Public Patent Foundation, said, "It's not the final nail in the coffin, but [the ruling is] a heavy body blow" to the patents. He added, "This rejection is substantial, and it will cause a significant deterioration in the impact the patents will have in the marketplace." Carl Gulbrandsen, managing director of WARF, on Monday in a statement said, "WARF has absolute confidence in the appropriateness and legitimacy of these patents. It is inconceivable to us that Thomson's discovery ... would be found to not be worthy of a patent" (New York Times, 4/3). Wisconsin Gov. Jim Doyle (D) in a statement said, "It's important to remember that the patent office's decision is only preliminary, and the patents will remain in effect while the appeal process goes forward," adding, "As long as I am governor, the state will aggressively invest in, support and nurture this research" (Steenhuysen, Reuters, 4/3).

The patent rulings are available online on the Public Patent Foundation's Web site. Note: You must have Adobe Acrobat to view the rulings.