US Approves Embryonic Stem Cell Research Trials

The US regulator, the Food and Drug Administration (FDA), has approved the first trials in humans of embryonic stem cell research.

The approval came just 2 days after the inauguration of President Barack Obama, causing some to speculate that the new administration is set to remove some of the financial obstacles faced by research in this area. Soon after taking office for his second term in 2001, President George W Bush announced, 9th August, a restriction on federal funding for embryonic stem-cell research. Although not a ban of the research per se, the lack of federal funding was variously described as leading to more or less the same result. In 2oo6, President Bush vetoed H.R 810 / S 471 to amend the Public Health Service Act to provide for human embryonic stem cell research. President Barack Obama had been expected to reverse the ban soon after taking office this year.

The approval authorises the US biotech company, Geron, to commence clinical trials of GRNOPC1 in patients with severe spinal cord injuries. Upon the completion of these trials, the company will be required to demonstrate efficacy before marketing authorisation can be granted. The Financial Times reports that such commercial availability could be achieved within 3 years. In a news release, Geron describes the approval as "A new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing."

The Christopher and Dana Reeve Foundation responded to the announcement in a news release welcoming the decision. The actor Christopher Reeve sustained serious spinal cord injuries in a horse-riding accident, 27th May 1995. Shortly before his death, 10 October 2004, Reeve spoke on the US stem cell debate saying, "No obstacle should stand in the way of responsible investigation."

USPTO to Reexamine 3 Stem Cell Patents

A request to the United States Patent and Trademark Office (USPTO) to reexamine 3 patents relating to stem cell technology has been granted.

The requests came from California-based consumer group, Foundation Taxpayer and Consumer Rights (FCTR), and were filed in July on the Foundation's behalf by the Public Patent Foundation (PUBPAT).

The patents are owned by the Wisconsin Alumni Research Foundation (WARF) whose researchers include James Thomson (pictured at left), who led the team which, in 1998, made the first successful isolation of human embryonic stem cells. Thomson later founded Cellular Dynamics International (CDI), a private biotechnology company based in Madison, Wisconsin. Last year, the State of Wisconsin granted CDI a US$1M Technology Development Grant and a US$1M Technology Development Loan.

The 3 patents in question are US Patent 5,843,780 (780 communication); 6, 200, 806 (806 communication); and 7, 029, 913 (communication forthcoming). The requests from FCTR were accompanied by the declaration of Jeanne F Loring, Adjunct Associate Professor at the Burnham Institute, and include references to prior art not considered at the time the patent was granted. This raises a "substantial new question" (SNQ) of patentability and grounds for a complete reexamination of the patent claims on the basis of prior art.

The requests also included reference to public harm, but the USPTO communication is clear that this is beyond the scope of reexamination. Nevertheless, John M Simpson, Stem Cell Project Director of FTCR, has welcomed the announcement and condemned WARF's patent policy, described in the press release as "WARF's aggressive assertion of patents." Simpson claims that WARF has "a history of putting profits before public benefit." An earlier press release quotes the Juvenile Diabetes Research Association (JDRF) as saying that WARF patents pose a "major inhibition to productive scientific research."

Should WARF really have a monopoly on the toolbox?