Four leading stem cell researchers submitted declarations to the US Patent and Trademarks Office endorsing its preliminary decision to declare invalid three stem cell patents held by the Wisconsin Alumni Research Foundation (WARF) at the University of Wisconsin, where Dr James Thomson led a team in 1998 to successfully isolate and culture the first human embryonic stem (ES) cells. The government, through WARF, patented the technique and the cells themselves, forcing researchers to pay licence fees, which critics argue is an unjust financial impediment driving vital stem cell research overseas.
The researchers have joined the legal battle launched last July by two consumer groups, New York-based Public Patent Foundation (PUBPAT) and California-based Foundation for Taxpayer and Consumer Rights (FTCR), agreeing with John M Simpson, FTCR Stem Cell Project Director that Thomson's work is 'admirable...just not patentable'. They contend that Thomson's research was not original, but the obvious next step from prior research. They believe Thompson deserves praise and recognition for his achievements but not patents. They claim they were doing the same research at the same time and did not need to reference Thomson's work because based upon studies done in mice, pigs and sheep, the 'science required to isolate and maintain human ES cells was obvious', as Dr Douglas Melton of Harvard University, one of the four authors, explained.
According to Dr Alan Trounson of Monash University in Australia: 'in January, 1995, it was obvious to me and others...that the process taught by Robertson...for isolating mouse ES cells could be used to isolate human ES cells'. The other two researchers, Dr Chad Cowan of Harvard University and Dr Jeanne Loring of the Burnham Institute for Medical Research, agree and all feel that Thomson had 'unique access' to an Israeli scientist who provided embryos, and better funding from Geron, a private biotechnology company that has exclusive licensing agreements with WARF to profit from the patents. These advantages allowed Thomson to be first but 'not inventive' stated Melton.
A patent must legally be deemed 'new, useful and non-obvious'. WARF has appealed the PTO's preliminary decision from April and will be able to appeal the final decision to the federal court if the rejection is maintained. Only the one challenge to patent 913, which was rejected on five grounds, procedurally allows counterarguments in response to WARF's defence. The FTRC and PUBPAT supported the PTO examiner with five grounds of rebuttal and released the researcher's declarations of support last Monday.
The patents are extremely broad over entire cells and have attracted international criticism from the European Union Patent Authority and several UK government bodies. Dan Ravicher, executive director of PUBPAT claims the challenge has already improved the situation referring to WARF's decision to slightly narrow their patents scope in response to the PTO decision. Thomson has not commented on the declarations but WARF spokesman, Andy Cohn, and Geron remain optimistic that the patents will be upheld on appeal stating that initial denial is routine.