Euro decision disappoints Stem Cell Sciences

A decision by the European Patent Office (EPO) to revise the controversial 'Edinburgh' patent to exclude embryonic stem cells has disappointed Australian company Stem Cell Sciences.

CEO Peter Mountford told Australian Biotechnology News he thought the company had made a clear, well-argued case to the EPO in favour of the existing patent.

"We're a bit disappointed with the outcome," he said. "There was an enormous amount of opposition to the patent. It was the biggest case in the history of the European Patent Office."

Mountford said there was an option to appeal the ruling but the company would wait until it had read the written statement of the opposition panel's findings to ensure that it understood the full extent of the ruling before making a decision. The written statement will be released within the next few months.

The 'Edinburgh' patent was initially granted in December 1999 and was owned by the University of Edinburgh and Stem Cell Sciences. Under European patent laws, oppositions to a granted patent can be filed for up to nine months after its grant, and in this case, 14 oppositions were filed by parties including Greenpeace and the German, Dutch and Italian governments.

The patent describes a method to isolate and culture stem cells, including embryonic stem cells, using an introduced transgene as a selective marker.

The objections filed were primarily on the grounds of public morality claiming that the patent would allow researchers to use human embryos to create transgenic and cloned humans, even though the patent does not make any mention of cloning or claim to be applicable to cloning.

The opposition panel decided that the patent conflicted with the European Patent Convention in two ways. First of all, the European Patent Convention prohibits patenting of technology that would promote the use of human embryos for commercial or industrial purposes.

In addition, the opposition disallowed the claim for use of the technique on embryonic stem cells for technical reasons, basically saying that the claim could not be enabled at the time of filing.

The amended form of the patent was suggested by the University of Edinburgh and Stem Cell Sciences during the opposition hearing and excludes human and animal embryonic stem cells from the patent, but allows the technique to be used for other human and animal stem cells.