In the European court case, hESC research faces a threat not to its government funding but its patentability. After Greenpeace challenged Dr. Brüstle’s patent, the Bundespatentgericht (Federal Patent Court, Germany) declared his patent invalid to the extent that it allowed precursor cells to be obtained from hESCs. Dr. Brüstle appealed the ruling, and the European Court will now have to decide if human embryos must be exempt from patenting at all stages of life or are permissible at some stage of development.
Even if the European court rules against patenting hESCs, Frenchick said, the decision is unlikely to spark a similar challenge in the U.S. He noted that American law has no counterpart to European law that forbids patenting claims deemed “immoral and against public order,” which is the basis of Greenpeace’s argument.
Challengers of the WARF patents in the U.S. have nonetheless found a way to take legal action based on a basic tenet of patent law. The Public Patent Foundation and the Foundation for Taxpayer and Consumer Rights (now Consumer Watchdog) are arguing in part that the inventor was not the first to actually derive hESCs and that his work was “neither novel nor nonobvious.”
WARF survived challenges to two of its three stem cell patents, albeit with narrowed claims and after they were initially rejected as well. Last year the USPTO Board of Patent Appeals and Interferences rejected three claims of the 013 patent, siding with challengers’ arguments that the creation of hESC lines was obvious in light of similar research on other species. The patent remains before the appeal board; the loser, whether WARF or the challengers, will likely appeal the decision.
Among companies using WARF’s hESCs is Geron. Its clinical-stage candidate for spinal cord injuries comprises oligodendrocyte progenitor cells derived from hESCs obtained from WARF’s federally approved H1 line. It is one of numerous companies that has licensed patents granted to the Wisconsin group.
The first WARF patents were filed in the late 1990s and cover a 20-year term from when they were first filed. Given the time it takes to bring new biopharma drugs to market, “these early patents will expire long before the money would be made in a commercial sense based upon inventions that came from them,” Frenchick said.
So unlike with many life science discoveries, where stem cells are concerned even a patent is no guarantee of a sizeable return on investment. And with the state of the research in as much flux as the politics driving the issue, it’s fair to say the prospects for making big money from stem cell patents are brightest with a younger generation of researchers and investors.