The 'Edinburgh Patent'

This briefing paper covers specifically the patenting of human embryonic stem cells and the decision by the European Patent Office concerning the ‘Edinburgh Patent’ and is intended to be read in conjunction with CIPA’s briefing paper on stem cells in general.

What is the patent about and why is the Edinburgh Patent controversial?

The invention described in the patent was made by Professor Smith and Dr Mountford in 1993 at the Centre for Genome Research (now the Institute for Stem Cell Research) and relates to methods of selecting for stem cells, enabling the stem cells you want to be isolated from contaminating cells. The original work was carried out on mouse cells. But the methods are said to apply to embryonic stem cells generally and the patent covers methods carried out on human embryonic stem cells and also covers human embryonic stem cells which have been genetically modified so that they can be used in the selection methods.

Shortly after the patent was granted, Greenpeace filed an opposition claiming the patent could and would be read so as to embrace human cloning. Greenpeace had other objections, e.g. that human stem cells of any sort were not suitable for patenting and, specifically, it would be contrary to morality to allow patents for such subject matter.

The Edinburgh Patent was also controversial in that some European countries, including Germany in particular, as this is where the European Patent Office is located, have laws prohibiting embryo research. The German, Dutch and Italian governments hence also filed oppositions to the patent, and in total 13 oppositions were filed.

What is the legal background?

As far as a European patent is concerned, the European Patent Convention governs what can be patented. National laws of each European country determine what is and is not legal to do or use in that country, and to some extent each country can pass separate laws that override or restrict European patent law. But, the Edinburgh Patent was judged by the law in the European Patent Convention and the key clauses are those relating to morality (Article 53 (a)) and exceptions to patentability (Rule 23d).

Article 53(a) recites:

What is the position today?

Based on the above law, human embryonic stem cells and processes carried out on human embryonic stem cells are not patentable. Claims to such inventions have been held to be contrary to morality, specifically contrary to Article 53(a) and Rule 23d(c). This was the decision taken by the European Patent Office in 2002.

There are many other patent applications on stem cells being considered by the European Patent Office. Where these applications contain claims that cover human embryonic stem cells the applications have to be amended so that they no longer cover such cells or processes carried out on such cells.

What happens next?

The decision taken in 2002 is under Appeal and we are waiting for a date for the Appeal to be heard. When this happens, the Appeal Board could approve the 2002 decision or could reverse it. The hearing could be in the next one to three years.

Is the Edinburgh Patent connected to Dolly the Sheep?

No. Dolly the Sheep was made using technology created by the Roslin Institute relating to cloning animals using nuclear transfer. The Roslin Institute is also in Edinburgh; apart from that Dolly the Sheep and the Edinburgh Patent are unrelated.

Will the Edinburgh Patent decision affect stem cell research in Europe?

The Edinburgh Patent decision concerns whether patents should be granted on human embryonic stem cell inventions. A separate issue is whether business or government will fund stem cell research. A further factor is whether stem cell research is permitted by the local laws in any given European country. UK and Switzerland permit such research, for example. In other countries there are laws which ban such research – these laws are separate to laws about patents.