The US Patent and Trademark Office (PTO) has issued a preliminary decision rejecting the validity of three existing embryonic stem cell (ES cell) patents held by the Wisconsin Alumni Research Foundation (WARF) at the University of Wisconsin Madison (UW-Madison), where James Thomson led a research team to discover and successfully isolate the first human ES Cells in 1998.
The global race to develop stem cell therapies caused the Foundation for Taxpayer and Consumer Rights, a consumer group based in Santa Monica, California, together with the Public Patent Foundation of New York to demand that the legality of three WARF patents be re-examined, claiming the patents were 'impeding scientific progress and driving vital stem cell research overseas'.
The decision has been hailed as an initial victory for scientists who wish to have free access to the stem cell lines for research. Currently scientists must apply to license ES Cell lines through WARF or companies, namely Geron, a Menlo Park, California biotechnology company which possesses exclusive licensing agreements with WARF for some of the stem cell technology protected by these patents.
The two groups who challenged the patents claim that James Thomson's isolation of ES Cells was not original work but was the obvious result that built upon prior research. In order for a patent to be granted, the work must be legally determined to be 'new, useful and non-obvious'.
UW-Madison now has two months to respond and seek to appeal. If the denial of the patents is ultimately upheld, then Geron will not pay for the licensing of technology from WARF but also then loses its exclusive right to profit on the potentially lucrative long-term developments of any ES cell therapies from that licensed technology. Geron has issued a statement saying that it is not concerned by the decision. It stated that such granting of patent review and initial denial of their validity is routine for the US authority, only to later support those patents in the appeal process.
Wisconsin Governor Jim Doyle has released a statement in support of the patents. After consultation with experts in the field, he too felt confident the patents will be deemed valid after further review, saying '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'. He emphasised that UW-Madison currently has three other unchallenged stem cell patents, with discoveries that have lead to roughly 30 additional patent applications.
In direct contrast, John Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights believes the review will result in the patents' nullification and hails the preliminary decision as a victory for scientific progress. 'Given the facts, this is the only conclusion the PTO could have reached. The patents should never have been issued in the first place', he stated.