The European embryonic stem cell patent ban: The Other Side of the Coin?

Geoff Lomax is CIRM's Senior Officer to the Standards Working Group 

Last week we posted on the initial views of scientists and policy analysts on the 10/18 European Court of Justice decision regarding the patentability of hESC products. The initial views were quite pessimistic with regard to hESC-based therapy development, although James Lawford-Davies did offer a few rays of hope for the field.

This week Nature published a piece suggesting there may be a "silver-lining" to the decision. Some commentators believe companies may focus on patents covering the tools and technologies as opposed to cells and their biological products. Further, the absence of a 'patent thicket" may speed therapy development by reducing the chance of infringement of intellectual property rights.

Nature quotes physician scientist Chris Mason of University College London:

"If anything the ruling is an opportunity. It's not the end of stem cells in Europe."

The piece goes on to explain that even a restrictive interpretation should allow companies to patent new and innovative technologies needed to turn human ES cells into treatments. The goal becomes patenting the innovative tools, rather than patenting the cells themselves.

"If the sum total of this market were some cell lines, I would be deeply, deeply worried," says Julian Hitchcock, a life-sciences lawyer at Field Fisher Waterhouse in London. Growth media, equipment and chemicals that help scientists to work with stem cells could all be patented in Europe without running afoul of the high court's ruling, he says.

In addition to debate over the ruling's long-term effects, there is some uncertainty over which cell types would fall under the ruling. Advanced Cell Technology, based in Marlborough, Mass., has developed a technique to create embryonic stem cell lines that does not destroy the embryo. They've issued a press release indicating that their cell lines would not be covered by the ban. They write:

”This is a huge setback for stem cell research in Europe,” said Robert Lanza, M.D., ACT's chief scientific officer. “However, the Court went out of its way to stress that inventions are unpatentable if they ˜necessitate' the destruction of human embryos. Therefore, this ruling does not appear to affect our single-blastomere technology, which does not require the destruction of embryos at any point. We will do whatever we can to ensure that therapies derived using these stem cells are made available to the patients in Europe who need them.”

G.L.